clinical research ethics case studies

Annual Review of Ethics Case Studies

What are research ethics cases.

For additional information, please visit Resources for Research Ethics Education

Research Ethics Cases are a tool for discussing scientific integrity. Cases are designed to confront the readers with a specific problem that does not lend itself to easy answers. By providing a focus for discussion, cases help staff involved in research to define or refine their own standards, to appreciate alternative approaches to identifying and resolving ethical problems, and to develop skills for dealing with hard problems on their own.

Research Ethics Cases for Use by the NIH Community

• Theme 23 – Authorship, Collaborations, and Mentoring (2023)
• Theme 22 – Use of Human Biospecimens and Informed Consent (2022)
• Theme 21 – Science Under Pressure (2021)
• Theme 20 – Data, Project and Lab Management, and Communication (2020)
• Theme 19 – Civility, Harassment and Inappropriate Conduct (2019)
• Theme 18 – Implicit and Explicit Biases in the Research Setting (2018)
• Theme 17 – Socially Responsible Science (2017)
• Theme 16 – Research Reproducibility (2016)
• Theme 15 – Authorship and Collaborative Science (2015)
• Theme 14 – Differentiating Between Honest Discourse and Research Misconduct and Introduction to Enhancing Reproducibility (2014)
• Theme 13 – Data Management, Whistleblowers, and Nepotism (2013)
• Theme 12 – Mentoring (2012)
• Theme 11 – Authorship (2011)
• Theme 10 – Science and Social Responsibility, continued (2010)
• Theme 9 – Science and Social Responsibility - Dual Use Research (2009)
• Theme 8 – Borrowing - Is It Plagiarism? (2008)
• Theme 7 – Data Management and Scientific Misconduct (2007)
• Theme 6 – Ethical Ambiguities (2006)
• Theme 5 – Data Management (2005)
• Theme 4 – Collaborative Science (2004)
• Theme 3 – Mentoring (2003)
• Theme 2 – Authorship (2002)
• Theme 1 – Scientific Misconduct (2001)

For Facilitators Leading Case Discussion

For the sake of time and clarity of purpose, it is essential that one individual have responsibility for leading the group discussion. As a minimum, this responsibility should include:

• Reading the case aloud.
• Defining, and re-defining as needed, the questions to be answered.
• Encouraging discussion that is “on topic”.
• Discouraging discussion that is “off topic”.
• Keeping the pace of discussion appropriate to the time available.
• Eliciting contributions from all members of the discussion group.
• Summarizing both majority and minority opinions at the end of the discussion.

How Should Cases be Analyzed?

Many of the skills necessary to analyze case studies can become tools for responding to real world problems. Cases, like the real world, contain uncertainties and ambiguities. Readers are encouraged to identify key issues, make assumptions as needed, and articulate options for resolution. In addition to the specific questions accompanying each case, readers should consider the following questions:

• Who are the affected parties (individuals, institutions, a field, society) in this situation?
• What interest(s) (material, financial, ethical, other) does each party have in the situation? Which interests are in conflict?
• Were the actions taken by each of the affected parties acceptable (ethical, legal, moral, or common sense)? If not, are there circumstances under which those actions would have been acceptable? Who should impose what sanction(s)?
• What other courses of action are open to each of the affected parties? What is the likely outcome of each course of action?
• For each party involved, what course of action would you take, and why?
• What actions could have been taken to avoid the conflict?

Is There a Right Answer?

Acceptable solutions.

Most problems will have several acceptable solutions or answers, but it will not always be the case that a perfect solution can be found. At times, even the best solution will still have some unsatisfactory consequences.

Unacceptable Solutions

While more than one acceptable solution may be possible, not all solutions are acceptable. For example, obvious violations of specific rules and regulations or of generally accepted standards of conduct would typically be unacceptable. However, it is also plausible that blind adherence to accepted rules or standards would sometimes be an unacceptable course of action.

Ethical Decision-Making

It should be noted that ethical decision-making is a process rather than a specific correct answer. In this sense, unethical behavior is defined by a failure to engage in the process of ethical decision-making. It is always unacceptable to have made no reasonable attempt to define a consistent and defensible basis for conduct.

This page was last updated on Friday, July 7, 2023

• Bioethics Cases
• Markkula Center for Applied Ethics
• Focus Areas
• Bioethics Resources

Find case studies on topics in health care and biotechnology ethics, including end-of-life care, clinical ethics, pandemics, culturally competent care, vulnerable patient populations, and other topics in bioethics. (For permission to reprint cases, submit requests to [email protected] .)

Cases can also be viewed by the following categories:

An obstetrician treating a heroin-addicted mother considers whether to comply with state law requiring medical professionals to report drug-addicted pregnant women to law enforcement for child endangerment.

A drug treatment counselor considers whether to allow a patient a second chance in the drug-treatment program, against stated program rules.

A religious cleric considers how to support a member of the community struggling with depression and alcoholism, who declines recommended referral to expert medical treatment.

A primary care physician considers if s/he can competently provide treatment to a patient who may have a serious psychiatric disorder and does not wish to go to another doctor.

A physician considers whether to honor a promising medical student’s request to withhold a diagnosis of depression from her record. The medical student fears a record of depression could hurt her career.

A psychologist considers whether there is a duty to warn a couple whom the jealous patient has expressed a desire to stalk and frighten.

An adolescent medicine physician considers how to help a potentially suicidal non-minor young adult who declines treatment. Potential options include the possibility of petitioning the court to coerce inpatient treatment.

A psychiatrist considers whether to use a placebo (a fake treatment) on a patient whom the clinician thinks might benefit.

While organ donation is necessary to alleviate suffering and save lives, questions of autonomy, coercion, and the yuk factor deserve careful consideration as we seek to increase supply in the face of unrelenting demand.

Is it ethical to eliminate native populations of disease-carrying pests through genetic manipulation?

• More pages:

• Log In Username Enter your ACP Online username. Password Enter the password that accompanies your username. Remember me Forget your username or password ?
• Privacy Policy
• Career Connection
• Member Forums

© Copyright 2024 American College of Physicians, Inc. All Rights Reserved. 190 North Independence Mall West, Philadelphia, PA 19106-1572 800-ACP-1915 (800-227-1915) or 215-351-2600

If you are unable to login, please try clearing your cookies . We apologize for the inconvenience.

Ethics Case Studies & Education Resources

ACP ethics education resources cover a broad range of issues in clinical ethics, professionalism, teaching, research, health care delivery, and other topics. Each resource can be used as a learning activity and completed for free CME/MOC credits as indicated or used as a teaching tool.

• Ethics Case Studies for CME/MOC
• Ethics Manual Activity for CME/MOC
• Position Paper Activities for CME/MOC

Additional Ethics Case Studies

Acp ethics case study series.

Each case study draws on an ethical challenge encountered by physicians in everyday practice, teaching or research. Free CME/MOC credits are available from ACP’s Online Learning Center. Free CME/MOC credits are available for completion of case studies on Medscape as indicated (a free Medscape login is required for access and completion).

• “Why Can’t I Be There?” Ethics Regarding Restrictions on Visitation/Family Caregiver Presence CME/MOC
• Pain Management Near the End-of-Life: What Would Mom Want? CME/MOC
• Ethics, Professionalism, Physician Employment and Health Care Business Practices CME/MOC
• Show Codes, Slow Codes, Full Codes, or No Codes: What Is a Doctor to Do? CME/MOC
• When Resources Are Limited During a Public Health Catastrophe: Nondiscrimination and Ethical Allocation Guidance CME/MOC
• Patient Prejudice? The Patient Said What?... and What Comes Next CME/MOC
• Lab Results Reporting, Ethics, and the 21st Century Cures Act Rule on Information Blocking CME/MOC
• Physician Suicide Prevention: The Ethics and Role of the Physician Colleague and the Healing Community CME/MOC
• Ethics, Electronic Health Record Integrity and the Patient-Physician Relationship CME/MOC
• Ethics, Professionalism, and the Physician Social Media Influencer CME/MOC
• Professional Attire and the Patient-Physician Relationship CME/MOC
• When the Family Caregiver Is a Physician: Negotiating the Ethical Boundaries CME/MOC
• ”Doctor, Can’t You Just Phone a Prescription In?” and Other Ethical Challenges of Telemedicine Encounters CME/MOC
• Serving as an Expert Witness: Is there a Duty? CME  

Ethics Manual (CME/MOC)

The ACP Ethics Manual is the core of College ethics policy. The seventh edition examines issues in medical ethics, reflecting on the ethical tenets of medicine and their application to emerging challenges while also revisiting older issues that are still very pertinent. It helps physicians be prepared to deal with ethical challenges: to identify and reaffirm the fundamentals of medical ethics—such as the patient-physician relationship—and apply principles and reasoned arguments in resolving dilemmas and in debate about ethics topics.

A 25-question quiz module on the seventh edition of the Ethics Manual is available for up to 10 AMA PRA Category 1 Credits TM and MOC Points. The activity is free for ACP members and Annals subscribers.

Annals of Internal Medicine offers the following CME/MOC activity for ACP members and Annals subscribers:

• Ethical and Professionalism Implications of Physician Employment and Health Care Business Practices (Ann Intern Med. published online 15 March 2021) CME/MOC

Additional position papers cover a broad range of health care ethics issues and can be used as a teaching tool.

• Pandemic Treatment Resource Allocation Ethics and Nondiscrimination
• Confidentiality and Privacy: Beyond HIPAA to Honey, Can We Talk?  
• Secret Recordings of Office Visits by Patients  
• Addressing a Colleague's Unprofessional Behavior During Sign-Out  
• Patient Requests for Specific Care: 'Surely You Can Explain to My Insurer That I Need Boniva?'  
• Maintaining Medical Professionalism Online: Posting of Patient Information  
• Banning Harmful Health Behaviors as a Condition of Employment: Where There's Smoke There's Fired?  
• Addressing a Colleague's Sexually Explicit Facebook Post  
• Wellness Programs and Patient Goals of Care  
• Resident Duty Hours: To Hand Over or Gloss Over?
• When an Aging Colleague Seems Impaired  
• Preventive Health Screening, Ethics and the Cognitively Impaired Patient  
• Stewardship of Health Care Resources: Allocating Mechanical Ventilators During Pandemic Influenza  
• Copied and Pasted and Misdiagnosed (or Cloned Notes and Blind Alleys)  
• Stewardship of Health Care Resources: Responding to a Patient’s Request for Antibiotics
• Who Should Get What? Mammography and the Stewardship of Health Care Resources  
• Patient/Physician/Family Caregiver Relationships: When the Family Caregiver Is a Physician  
• Physician Work Stoppages and Political Demonstrations -- Economic Self-Interest or Patient Advocacy? Where Is the Line?  
• To Be or Not to Be: Should I Serve as an Expert Witness?  
• Author! Author! Who Should Be Named in a Published Study? An Ethics Case Study  
• The Difficult Patient: Should You End the Relationship? What Now? An Ethics Case Study  
• Dealing with the "Disruptive" Physician Colleague  
• Must You Disclose Mistakes Made by Other Physicians?
• Providing Care to Undocumented Immigrants
• Twenty-eight additional case studies are published in the book  Ethical Choices: Case Studies for Medical Practice (2nd edition)

For more information on these and other educational content, please contact Lois Snyder Sulmasy, JD, at  [email protected]  or at 215-351-2835.

Ethics Sessions at Internal Medicine Meeting 2020

April 23 – 25, 2020, Los Angeles, CA

Sponsored by the Ethics, Professionalism & Human Rights Committee (EPHRC)

• Ethical Case Challenges: Precision Medicine and Genetics in Primary Care
• Ethics Year in Review
• Spirituality in End-of-Life Care: What is the Physician’s Role?
• Practical Palliative Care: Managing Pain at the End of Life

Ethics education sessions on different topics are offered at the annual Internal Medicine Meeting each year. Information on past Internal Medicine Meeting ethics sessions is available upon request at [email protected] .

Attending the Internal Medicine Meeting is an excellent way to fulfill your state CME relicensure requirements. The ethics sessions may fulfill specific CME content requirements of your state’s licensure renewal. Letters of participation documenting attendance are available online .

For more information on these and other educational content, please contact Lois Snyder Sulmasy, JD, at [email protected] or at 215-351-2835.

• Search Menu

Sign in through your institution

• Browse content in Arts and Humanities
• Browse content in Archaeology
• Anglo-Saxon and Medieval Archaeology
• Archaeological Methodology and Techniques
• Archaeology by Region
• Archaeology of Religion
• Archaeology of Trade and Exchange
• Biblical Archaeology
• Contemporary and Public Archaeology
• Environmental Archaeology
• Historical Archaeology
• History and Theory of Archaeology
• Industrial Archaeology
• Landscape Archaeology
• Mortuary Archaeology
• Prehistoric Archaeology
• Underwater Archaeology
• Urban Archaeology
• Zooarchaeology
• Browse content in Architecture
• Architectural Structure and Design
• History of Architecture
• Residential and Domestic Buildings
• Theory of Architecture
• Browse content in Art
• Art Subjects and Themes
• History of Art
• Industrial and Commercial Art
• Theory of Art
• Biographical Studies
• Byzantine Studies
• Browse content in Classical Studies
• Classical History
• Classical Philosophy
• Classical Mythology
• Classical Literature
• Classical Reception
• Classical Art and Architecture
• Classical Oratory and Rhetoric
• Greek and Roman Epigraphy
• Greek and Roman Law
• Greek and Roman Archaeology
• Greek and Roman Papyrology
• Late Antiquity
• Religion in the Ancient World
• Digital Humanities
• Browse content in History
• Colonialism and Imperialism
• Diplomatic History
• Environmental History
• Genealogy, Heraldry, Names, and Honours
• Genocide and Ethnic Cleansing
• Historical Geography
• History by Period
• History of Agriculture
• History of Education
• History of Emotions
• History of Gender and Sexuality
• Industrial History
• Intellectual History
• International History
• Labour History
• Legal and Constitutional History
• Local and Family History
• Maritime History
• Military History
• National Liberation and Post-Colonialism
• Oral History
• Political History
• Public History
• Regional and National History
• Revolutions and Rebellions
• Slavery and Abolition of Slavery
• Social and Cultural History
• Theory, Methods, and Historiography
• Urban History
• World History
• Browse content in Language Teaching and Learning
• Language Learning (Specific Skills)
• Language Teaching Theory and Methods
• Browse content in Linguistics
• Applied Linguistics
• Cognitive Linguistics
• Computational Linguistics
• Forensic Linguistics
• Grammar, Syntax and Morphology
• Historical and Diachronic Linguistics
• History of English
• Language Acquisition
• Language Variation
• Language Families
• Language Evolution
• Language Reference
• Lexicography
• Linguistic Theories
• Linguistic Typology
• Linguistic Anthropology
• Phonetics and Phonology
• Psycholinguistics
• Sociolinguistics
• Translation and Interpretation
• Writing Systems
• Browse content in Literature
• Bibliography
• Children's Literature Studies
• Literary Studies (Asian)
• Literary Studies (European)
• Literary Studies (Eco-criticism)
• Literary Studies (Modernism)
• Literary Studies (Romanticism)
• Literary Studies (American)
• Literary Studies - World
• Literary Studies (1500 to 1800)
• Literary Studies (19th Century)
• Literary Studies (20th Century onwards)
• Literary Studies (African American Literature)
• Literary Studies (British and Irish)
• Literary Studies (Early and Medieval)
• Literary Studies (Fiction, Novelists, and Prose Writers)
• Literary Studies (Gender Studies)
• Literary Studies (Graphic Novels)
• Literary Studies (History of the Book)
• Literary Studies (Plays and Playwrights)
• Literary Studies (Poetry and Poets)
• Literary Studies (Postcolonial Literature)
• Literary Studies (Queer Studies)
• Literary Studies (Science Fiction)
• Literary Studies (Travel Literature)
• Literary Studies (War Literature)
• Literary Studies (Women's Writing)
• Literary Theory and Cultural Studies
• Mythology and Folklore
• Shakespeare Studies and Criticism
• Browse content in Media Studies
• Browse content in Music
• Applied Music
• Dance and Music
• Ethics in Music
• Ethnomusicology
• Gender and Sexuality in Music
• Medicine and Music
• Music Cultures
• Music and Religion
• Music and Culture
• Music and Media
• Music Education and Pedagogy
• Music Theory and Analysis
• Musical Scores, Lyrics, and Libretti
• Musical Structures, Styles, and Techniques
• Musicology and Music History
• Performance Practice and Studies
• Race and Ethnicity in Music
• Sound Studies
• Browse content in Performing Arts
• Browse content in Philosophy
• Aesthetics and Philosophy of Art
• Epistemology
• Feminist Philosophy
• History of Western Philosophy
• Metaphysics
• Moral Philosophy
• Non-Western Philosophy
• Philosophy of Science
• Philosophy of Action
• Philosophy of Law
• Philosophy of Religion
• Philosophy of Language
• Philosophy of Mind
• Philosophy of Perception
• Philosophy of Mathematics and Logic
• Practical Ethics
• Social and Political Philosophy
• Browse content in Religion
• Biblical Studies
• Christianity
• East Asian Religions
• History of Religion
• Judaism and Jewish Studies
• Qumran Studies
• Religion and Education
• Religion and Health
• Religion and Politics
• Religion and Science
• Religion and Law
• Religion and Art, Literature, and Music
• Religious Studies
• Browse content in Society and Culture
• Cookery, Food, and Drink
• Cultural Studies
• Customs and Traditions
• Ethical Issues and Debates
• Hobbies, Games, Arts and Crafts
• Natural world, Country Life, and Pets
• Popular Beliefs and Controversial Knowledge
• Sports and Outdoor Recreation
• Technology and Society
• Travel and Holiday
• Visual Culture
• Browse content in Law
• Arbitration
• Browse content in Company and Commercial Law
• Commercial Law
• Company Law
• Browse content in Comparative Law
• Systems of Law
• Competition Law
• Browse content in Constitutional and Administrative Law
• Government Powers
• Judicial Review
• Local Government Law
• Military and Defence Law
• Parliamentary and Legislative Practice
• Construction Law
• Contract Law
• Browse content in Criminal Law
• Criminal Procedure
• Criminal Evidence Law
• Sentencing and Punishment
• Employment and Labour Law
• Environment and Energy Law
• Browse content in Financial Law
• Banking Law
• Insolvency Law
• History of Law
• Human Rights and Immigration
• Intellectual Property Law
• Browse content in International Law
• Private International Law and Conflict of Laws
• Public International Law
• IT and Communications Law
• Jurisprudence and Philosophy of Law
• Law and Politics
• Law and Society
• Browse content in Legal System and Practice
• Courts and Procedure
• Legal Skills and Practice
• Primary Sources of Law
• Regulation of Legal Profession
• Medical and Healthcare Law
• Browse content in Policing
• Criminal Investigation and Detection
• Police and Security Services
• Police Procedure and Law
• Police Regional Planning
• Browse content in Property Law
• Personal Property Law
• Study and Revision
• Terrorism and National Security Law
• Browse content in Trusts Law
• Wills and Probate or Succession
• Browse content in Medicine and Health
• Browse content in Allied Health Professions
• Arts Therapies
• Clinical Science
• Dietetics and Nutrition
• Occupational Therapy
• Operating Department Practice
• Physiotherapy
• Radiography
• Speech and Language Therapy
• Browse content in Anaesthetics
• General Anaesthesia
• Neuroanaesthesia
• Browse content in Clinical Medicine
• Acute Medicine
• Cardiovascular Medicine
• Clinical Genetics
• Clinical Pharmacology and Therapeutics
• Dermatology
• Endocrinology and Diabetes
• Gastroenterology
• Genito-urinary Medicine
• Geriatric Medicine
• Infectious Diseases
• Medical Oncology
• Medical Toxicology
• Pain Medicine
• Palliative Medicine
• Rehabilitation Medicine
• Respiratory Medicine and Pulmonology
• Rheumatology
• Sleep Medicine
• Sports and Exercise Medicine
• Clinical Neuroscience
• Community Medical Services
• Critical Care
• Emergency Medicine
• Forensic Medicine
• Haematology
• History of Medicine
• Browse content in Medical Dentistry
• Oral and Maxillofacial Surgery
• Paediatric Dentistry
• Restorative Dentistry and Orthodontics
• Surgical Dentistry
• Medical Ethics
• Browse content in Medical Skills
• Clinical Skills
• Communication Skills
• Nursing Skills
• Surgical Skills
• Medical Statistics and Methodology
• Browse content in Neurology
• Clinical Neurophysiology
• Neuropathology
• Nursing Studies
• Browse content in Obstetrics and Gynaecology
• Gynaecology
• Occupational Medicine
• Ophthalmology
• Otolaryngology (ENT)
• Browse content in Paediatrics
• Neonatology
• Browse content in Pathology
• Chemical Pathology
• Clinical Cytogenetics and Molecular Genetics
• Histopathology
• Medical Microbiology and Virology
• Patient Education and Information
• Browse content in Pharmacology
• Psychopharmacology
• Browse content in Popular Health
• Caring for Others
• Complementary and Alternative Medicine
• Self-help and Personal Development
• Browse content in Preclinical Medicine
• Cell Biology
• Molecular Biology and Genetics
• Reproduction, Growth and Development
• Primary Care
• Professional Development in Medicine
• Browse content in Psychiatry
• Addiction Medicine
• Child and Adolescent Psychiatry
• Forensic Psychiatry
• Learning Disabilities
• Old Age Psychiatry
• Psychotherapy
• Browse content in Public Health and Epidemiology
• Epidemiology
• Public Health
• Browse content in Radiology
• Clinical Radiology
• Interventional Radiology
• Nuclear Medicine
• Radiation Oncology
• Reproductive Medicine
• Browse content in Surgery
• Cardiothoracic Surgery
• Gastro-intestinal and Colorectal Surgery
• General Surgery
• Neurosurgery
• Paediatric Surgery
• Peri-operative Care
• Plastic and Reconstructive Surgery
• Surgical Oncology
• Transplant Surgery
• Trauma and Orthopaedic Surgery
• Vascular Surgery
• Browse content in Science and Mathematics
• Browse content in Biological Sciences
• Aquatic Biology
• Biochemistry
• Bioinformatics and Computational Biology
• Developmental Biology
• Ecology and Conservation
• Evolutionary Biology
• Genetics and Genomics
• Microbiology
• Molecular and Cell Biology
• Natural History
• Plant Sciences and Forestry
• Research Methods in Life Sciences
• Structural Biology
• Systems Biology
• Zoology and Animal Sciences
• Browse content in Chemistry
• Analytical Chemistry
• Computational Chemistry
• Crystallography
• Environmental Chemistry
• Industrial Chemistry
• Inorganic Chemistry
• Materials Chemistry
• Medicinal Chemistry
• Mineralogy and Gems
• Organic Chemistry
• Physical Chemistry
• Polymer Chemistry
• Study and Communication Skills in Chemistry
• Theoretical Chemistry
• Browse content in Computer Science
• Artificial Intelligence
• Computer Architecture and Logic Design
• Game Studies
• Human-Computer Interaction
• Mathematical Theory of Computation
• Programming Languages
• Software Engineering
• Systems Analysis and Design
• Virtual Reality
• Browse content in Computing
• Business Applications
• Computer Security
• Computer Games
• Computer Networking and Communications
• Digital Lifestyle
• Graphical and Digital Media Applications
• Operating Systems
• Browse content in Earth Sciences and Geography
• Atmospheric Sciences
• Environmental Geography
• Geology and the Lithosphere
• Maps and Map-making
• Meteorology and Climatology
• Oceanography and Hydrology
• Palaeontology
• Physical Geography and Topography
• Regional Geography
• Soil Science
• Urban Geography
• Browse content in Engineering and Technology
• Agriculture and Farming
• Biological Engineering
• Civil Engineering, Surveying, and Building
• Electronics and Communications Engineering
• Energy Technology
• Engineering (General)
• Environmental Science, Engineering, and Technology
• History of Engineering and Technology
• Mechanical Engineering and Materials
• Technology of Industrial Chemistry
• Transport Technology and Trades
• Browse content in Environmental Science
• Applied Ecology (Environmental Science)
• Conservation of the Environment (Environmental Science)
• Environmental Sustainability
• Environmentalist Thought and Ideology (Environmental Science)
• Management of Land and Natural Resources (Environmental Science)
• Natural Disasters (Environmental Science)
• Nuclear Issues (Environmental Science)
• Pollution and Threats to the Environment (Environmental Science)
• Social Impact of Environmental Issues (Environmental Science)
• History of Science and Technology
• Browse content in Materials Science
• Ceramics and Glasses
• Composite Materials
• Metals, Alloying, and Corrosion
• Nanotechnology
• Browse content in Mathematics
• Applied Mathematics
• Biomathematics and Statistics
• History of Mathematics
• Mathematical Education
• Mathematical Finance
• Mathematical Analysis
• Numerical and Computational Mathematics
• Probability and Statistics
• Pure Mathematics
• Browse content in Neuroscience
• Cognition and Behavioural Neuroscience
• Development of the Nervous System
• Disorders of the Nervous System
• History of Neuroscience
• Invertebrate Neurobiology
• Molecular and Cellular Systems
• Neuroendocrinology and Autonomic Nervous System
• Neuroscientific Techniques
• Sensory and Motor Systems
• Browse content in Physics
• Astronomy and Astrophysics
• Atomic, Molecular, and Optical Physics
• Biological and Medical Physics
• Classical Mechanics
• Computational Physics
• Condensed Matter Physics
• Electromagnetism, Optics, and Acoustics
• History of Physics
• Mathematical and Statistical Physics
• Measurement Science
• Nuclear Physics
• Particles and Fields
• Plasma Physics
• Quantum Physics
• Relativity and Gravitation
• Semiconductor and Mesoscopic Physics
• Browse content in Psychology
• Affective Sciences
• Clinical Psychology
• Cognitive Neuroscience
• Cognitive Psychology
• Criminal and Forensic Psychology
• Developmental Psychology
• Educational Psychology
• Evolutionary Psychology
• Health Psychology
• History and Systems in Psychology
• Music Psychology
• Neuropsychology
• Organizational Psychology
• Psychological Assessment and Testing
• Psychology of Human-Technology Interaction
• Psychology Professional Development and Training
• Research Methods in Psychology
• Social Psychology
• Browse content in Social Sciences
• Browse content in Anthropology
• Anthropology of Religion
• Human Evolution
• Medical Anthropology
• Physical Anthropology
• Regional Anthropology
• Social and Cultural Anthropology
• Theory and Practice of Anthropology
• Browse content in Business and Management
• Business Strategy
• Business History
• Business Ethics
• Business and Government
• Business and Technology
• Business and the Environment
• Comparative Management
• Corporate Governance
• Corporate Social Responsibility
• Entrepreneurship
• Health Management
• Human Resource Management
• Industrial and Employment Relations
• Industry Studies
• Information and Communication Technologies
• International Business
• Knowledge Management
• Management and Management Techniques
• Operations Management
• Organizational Theory and Behaviour
• Pensions and Pension Management
• Public and Nonprofit Management
• Strategic Management
• Supply Chain Management
• Browse content in Criminology and Criminal Justice
• Criminal Justice
• Criminology
• Forms of Crime
• International and Comparative Criminology
• Youth Violence and Juvenile Justice
• Development Studies
• Browse content in Economics
• Agricultural, Environmental, and Natural Resource Economics
• Asian Economics
• Behavioural Finance
• Behavioural Economics and Neuroeconomics
• Econometrics and Mathematical Economics
• Economic Systems
• Economic Methodology
• Economic History
• Economic Development and Growth
• Financial Markets
• Financial Institutions and Services
• General Economics and Teaching
• Health, Education, and Welfare
• History of Economic Thought
• International Economics
• Labour and Demographic Economics
• Law and Economics
• Macroeconomics and Monetary Economics
• Microeconomics
• Public Economics
• Urban, Rural, and Regional Economics
• Welfare Economics
• Browse content in Education
• Adult Education and Continuous Learning
• Care and Counselling of Students
• Early Childhood and Elementary Education
• Educational Equipment and Technology
• Educational Strategies and Policy
• Higher and Further Education
• Organization and Management of Education
• Philosophy and Theory of Education
• Schools Studies
• Secondary Education
• Teaching of a Specific Subject
• Teaching of Specific Groups and Special Educational Needs
• Teaching Skills and Techniques
• Browse content in Environment
• Applied Ecology (Social Science)
• Climate Change
• Conservation of the Environment (Social Science)
• Environmentalist Thought and Ideology (Social Science)
• Natural Disasters (Environment)
• Social Impact of Environmental Issues (Social Science)
• Browse content in Human Geography
• Cultural Geography
• Economic Geography
• Political Geography
• Browse content in Interdisciplinary Studies
• Communication Studies
• Museums, Libraries, and Information Sciences
• Browse content in Politics
• African Politics
• Asian Politics
• Chinese Politics
• Comparative Politics
• Conflict Politics
• Elections and Electoral Studies
• Environmental Politics
• Ethnic Politics
• European Union
• Foreign Policy
• Gender and Politics
• Human Rights and Politics
• Indian Politics
• International Relations
• International Organization (Politics)
• International Political Economy
• Irish Politics
• Latin American Politics
• Middle Eastern Politics
• Political Methodology
• Political Communication
• Political Philosophy
• Political Sociology
• Political Theory
• Political Behaviour
• Political Economy
• Political Institutions
• Politics and Law
• Politics of Development
• Public Administration
• Public Policy
• Quantitative Political Methodology
• Regional Political Studies
• Russian Politics
• Security Studies
• State and Local Government
• UK Politics
• US Politics
• Browse content in Regional and Area Studies
• African Studies
• Asian Studies
• East Asian Studies
• Japanese Studies
• Latin American Studies
• Middle Eastern Studies
• Native American Studies
• Scottish Studies
• Browse content in Research and Information
• Research Methods
• Browse content in Social Work
• Addictions and Substance Misuse
• Adoption and Fostering
• Care of the Elderly
• Child and Adolescent Social Work
• Couple and Family Social Work
• Direct Practice and Clinical Social Work
• Emergency Services
• Human Behaviour and the Social Environment
• International and Global Issues in Social Work
• Mental and Behavioural Health
• Social Justice and Human Rights
• Social Policy and Advocacy
• Social Work and Crime and Justice
• Social Work Macro Practice
• Social Work Practice Settings
• Social Work Research and Evidence-based Practice
• Welfare and Benefit Systems
• Browse content in Sociology
• Childhood Studies
• Community Development
• Comparative and Historical Sociology
• Economic Sociology
• Gender and Sexuality
• Gerontology and Ageing
• Health, Illness, and Medicine
• Marriage and the Family
• Migration Studies
• Occupations, Professions, and Work
• Organizations
• Population and Demography
• Race and Ethnicity
• Social Theory
• Social Movements and Social Change
• Social Research and Statistics
• Social Stratification, Inequality, and Mobility
• Sociology of Religion
• Sociology of Education
• Sport and Leisure
• Urban and Rural Studies
• Browse content in Warfare and Defence
• Defence Strategy, Planning, and Research
• Land Forces and Warfare
• Military Administration
• Military Life and Institutions
• Naval Forces and Warfare
• Other Warfare and Defence Issues
• Peace Studies and Conflict Resolution
• Weapons and Equipment

The Oxford Textbook of Clinical Research Ethics

• Cite Icon Cite
• Permissions Icon Permissions

The Oxford Textbook of Clinical Research Ethics is the first systematic and comprehensive reference on clinical research ethics. Under the editorship of experts from the National Institutes of Health of the United States, the book offers a wide-ranging and systematic examination of all aspects of research with human beings. Considering historical triumphs of research as well as tragedies, the textbook provides a framework for analysing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the textbook examines issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent as well as focused consideration of international research ethics, conflicts of interests and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research with human beings.

Personal account

• Sign in with email/username & password
• Get email alerts
• Save searches
• Purchase content
• Activate your purchase/trial code
• Add your ORCID iD

Institutional access

Sign in with a library card.

• Sign in with username/password
• Recommend to your librarian
• Institutional account management
• Get help with access

Access to content on Oxford Academic is often provided through institutional subscriptions and purchases. If you are a member of an institution with an active account, you may be able to access content in one of the following ways:

IP based access

Typically, access is provided across an institutional network to a range of IP addresses. This authentication occurs automatically, and it is not possible to sign out of an IP authenticated account.

Choose this option to get remote access when outside your institution. Shibboleth/Open Athens technology is used to provide single sign-on between your institution’s website and Oxford Academic.

• Click Sign in through your institution.
• Select your institution from the list provided, which will take you to your institution's website to sign in.
• When on the institution site, please use the credentials provided by your institution. Do not use an Oxford Academic personal account.
• Following successful sign in, you will be returned to Oxford Academic.

If your institution is not listed or you cannot sign in to your institution’s website, please contact your librarian or administrator.

Enter your library card number to sign in. If you cannot sign in, please contact your librarian.

Society Members

Society member access to a journal is achieved in one of the following ways:

Sign in through society site

Many societies offer single sign-on between the society website and Oxford Academic. If you see ‘Sign in through society site’ in the sign in pane within a journal:

• Click Sign in through society site.
• When on the society site, please use the credentials provided by that society. Do not use an Oxford Academic personal account.

If you do not have a society account or have forgotten your username or password, please contact your society.

Sign in using a personal account

Some societies use Oxford Academic personal accounts to provide access to their members. See below.

A personal account can be used to get email alerts, save searches, purchase content, and activate subscriptions.

Some societies use Oxford Academic personal accounts to provide access to their members.

Viewing your signed in accounts

Click the account icon in the top right to:

• View your signed in personal account and access account management features.
• View the institutional accounts that are providing access.

Signed in but can't access content

Oxford Academic is home to a wide variety of products. The institutional subscription may not cover the content that you are trying to access. If you believe you should have access to that content, please contact your librarian.

For librarians and administrators, your personal account also provides access to institutional account management. Here you will find options to view and activate subscriptions, manage institutional settings and access options, access usage statistics, and more.

Our books are available by subscription or purchase to libraries and institutions.

• About Oxford Academic
• Publish journals with us
• University press partners
• What we publish
• New features  
• Open access
• Rights and permissions
• Accessibility
• Advertising
• Media enquiries
• Oxford University Press
• Oxford Languages
• University of Oxford

Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide

• Copyright © 2024 Oxford University Press
• Cookie settings
• Cookie policy
• Privacy policy
• Legal notice

This Feature Is Available To Subscribers Only

Sign In or Create an Account

This PDF is available to Subscribers Only

For full access to this pdf, sign in to an existing account, or purchase an annual subscription.

• Technical Support
• Find My Rep

You are here

Clinical Ethics

Preview this book.

• Description
• Aims and Scope
• Editorial Board
• Abstracting / Indexing
• Submission Guidelines

Devoted to the application of ethics in clinical practice, research and policy.

Devoted to the discussion of key issues surrounding the application of ethics in clinical practice, research and policy this journal features original peer-reviewed research papers on issues in clinical ethics, case studies with extensive commentary from experts and updates on important legal developments. Clinical Ethics continues to focus on the needs of professionals who are actually engaged in making difficult ethical decisions in health care. With an international editorial board, it features increasing coverage of developments around the globe.

This journal is a member of the Committee on Publication Ethics (COPE)

Clinical Ethics is an important journal devoted to the discussion of key issues surrounding the application of ethics in clinical practice, research and policy. Published quarterly, the journal publishes peer-reviewed articles under the headings of Case Studies, Public Policy and Law, Empirical Ethics and Papers. Additional material is included to help develop cross-disciplinary debate and increase the understanding of the complex ethical issues confronting providers and recipients of health care.

• Academic Search - Premier
• Academic Search Alumni Edition
• Academic Search Elite
• EBSCO: Sales & Marketing Source
• EBSCOhost: Academic Search Complete
• EBSCOhost: Current Abstracts
• Health Policy Reference Center

Manuscript submission guidelines can be accessed on Sage Journals .

• Read Online
• Sample Issues
• Current Issue
• Email Alert
• Permissions
• Foreign rights
• Reprints and sponsorship
• Advertising

Individual Subscription, Combined (Print & E-access)

Institutional Subscription, E-access

Institutional Subscription, Combined (Print & E-access)

Individual, Single Print Issue

Institutional, Single Print Issue

To order single issues of this journal, please contact SAGE Customer Services at 1-800-818-7243 / 1-805-583-9774 with details of the volume and issue you would like to purchase.

Clinical Researcher

Lessons Learned from Challenging Cases in Clinical Research Ethics

Clinical Researcher April 12, 2024

Clinical Researcher—April 2024 (Volume 38, Issue 2)

RESOURCES & REVIEWS

Lindsay McNair, MD, MPH, MSB

[A review of Challenging Cases in Clinical Research Ethics . 2024. Wilfond BS, Johnson L-M, Duenas DM, Taylor HA (editors). CRC Press (Boca Raton, Fla.)]

Challenging Cases in Clinical Research Ethics may not be a book you take to the beach for a light read, but if you have a role, or an interest, in how we analyze the complex ethical challenges that are an integral part of conducting clinical research, it may be a good book for you. This is a reference book, a teaching tool, and, in some ways, a historical record.

While healthcare institutions have long had ethics committees or even trained clinical ethicists to provide consultation to staff and families during difficult situations in clinical care settings, the specialized practice of clinical research ethics consultation is much more recent. As described in the foreward of the book, the development of this kind of resource was spurred by the National Institutes of Health’s (NIH’s) Clinical and Translational Science Awards (CTSA) program, a funding mechanism which supports a network of almost 60 medical institutions across the United States to facilitate collaboration that expedites the design and dissemination of new medical advances. Since a requirement of the funding program is that the institutions must have ethical support services, the CTSA-funded institutions created ethics consultation services that focused on the research ethics issues likely to arise from the CTSA-funded work.

In 2014, the leaders of the clinical research consultation services across the organizations formed a group to share information and best practices, called the Clinical Research Ethics Consultation Collaborative (CRECC). The CRECC continues to be an active group, and membership is open to anyone who is in a role related to clinical research ethics practice, including representatives not just from the CTSA-funded institutions, but also from biopharmaceutical companies and independent contributors.

This book arose from the work of the CRECC. The cases discussed in the book are real situations at research institutions across the U.S. for which the persons involved sought advice from their local consultation services, and the consultants brought the case to CRECC for discussion. The editors make a point of saying that by the time of the finished case discussion, each case involved 30 to 50 consultants, and they recognize almost 170 contributors to the book, including most of the best-known and most well-respected research bioethicists.

Each year, the American Journal of Bioethics has published up to four of these case presentations, along with two to four commentaries on the case from different ethicists to provide a variety of approaches, perspectives, and opinions. These cases and the accompanying commentaries comprise this book.

The editors have organized the book around the ethical principles for research ethics that were described in a seminar paper by Emanuel, Wendler, and Grady in 2000,{1} resulting in five main sections focused on collaborative partnerships, respect for participants, fair participant selection, favorable risk-benefit ratio, and informed consent. Because they also recognize that there were many possible ways to organize the material and that someone looking for discussion of a specific topic may want to be able to search in more detail, the book includes three separate appendices; one that lists cases by primary and secondary ethical principles involved, one that lists cases by topic keywords (e.g., pediatrics, Phase I trials, social media), and one that lists cases by values relevant to the discussion (social value, equity, and trustworthiness), as well as a standard index which lists topics, people, policies, and keywords and the pages on which the terms appear or are discussed.

In each section, an editor presents a brief description of the unifying theme of that section, and then short summaries of each of the five to eight cases under that theme. The section then delves into each case in more detail with an introduction that includes any necessary background context (disease details, standard of care framing, existing policy), a case description (often just a page or two), references, and then one to four commentaries.

The commentaries, each by different authors, approach different considerations or aspects of the case, together providing a variety of opinions and a well-rounded discussion. For example, there is a case focused on a request from a study team to unblind a participant’s treatment assignment after an adverse event (to help determine relationship to study drug and whether other participants were also at risk, or whether the event was a symptom of the underlying condition). The commentaries are presented by two ethicists from a sponsor company discussing the ethical issues of unblinding and the impact on study data; an ethicist from the NIH discussing considerations of a data monitoring committee in making decisions that will impact studies; and an ethicist involved in health monitoring programs for chronic illness who discusses issues of community trust and communication. The editors and commentators are careful to focus on the relevant ethical issues and conflicts, and not on operational or regulatory requirements, although they do address those considerations.

Although the cases all stem from situations that developed at research institutions, almost all of the content is relevant to other audiences in the clinical research ecosystem, including situations encountered in biopharmaceutical-sponsored studies that industry leaders have to think about. For example, there are cases that discuss ethical implications of advertising for research participants on social media, whether compensation for participation can (or should) be withheld from a participant who was intentionally deceptive to get enrolled in the study, how extensive the “alternative options” presented in a consent form should be, and whether a patient with advanced cancer must exhaust all possible treatment options before being allowed to enroll in a Phase I study of a new immunotherapy.

There are a number of ways that teachers, trainers, and leaders could use the content of this book both for education, and as the basis for case-based discussions. Overall, I would recommend this book as a resource for anyone in a training or leadership role, both for personal education and as a useful tool for developing training content that will likely prompt thoughtful discussion.

• Emanuel EJ, Wendler D, Grady C. 2000. What makes clinical research ethical? JAMA 283(20):2701–11. doi:10.1001/jama.283.20.2701. PMID:10819955.

Lindsay McNair, MD, MPH, MSB, is a physician, research ethicist, and Founder and Principal Consultant of Equipoise Consulting LLC, which provides consulting for projects related to the scientific and ethical conduct of research studies and drug development programs. She joined the Clinical Research Ethics Collaboration Collective, from which the authors of the reviewed book drew their case discussions, in 2023, when the book was already in the process of publication.

Sorry, we couldn't find any jobs that match your criteria.

Barriers to Clinical Trial Enrollment: Focus on Underrepresented Populations

Using Simulation to Teach Research

An Approach to a Benefit-Risk Framework

Jobs in the acrp career center.

• Clinical Research Coordinator
• Clinical Research Coordinator 182825
• Clinical Research Coordinator - 223996

• Open access
• Published: 03 August 2023

Raising concerns on questionable ethics approvals – a case study of 456 trials from the Institut Hospitalo-Universitaire Méditerranée Infection

• Fabrice Frank   ORCID: orcid.org/0000-0002-6524-4570 1 ,
• Nans Florens   ORCID: orcid.org/0000-0002-0960-6055 2 ,
• Gideon Meyerowitz-katz   ORCID: orcid.org/0000-0002-1156-9345 3 ,
• Jérôme Barriere   ORCID: orcid.org/0000-0003-1113-8948 4 ,
• Éric Billy   ORCID: orcid.org/0000-0002-8859-0089 5 ,
• Véronique Saada   ORCID: orcid.org/0000-0001-8021-9050 6 ,
• Alexander Samuel   ORCID: orcid.org/0000-0003-4547-5280 7 ,
• Jacques Robert   ORCID: orcid.org/0000-0003-4380-1476 8 &
• Lonni Besançon   ORCID: orcid.org/0000-0002-7207-1276 9  

Research Integrity and Peer Review volume  8 , Article number:  9 ( 2023 ) Cite this article

16k Accesses

2 Citations

1638 Altmetric

Metrics details

The practice of clinical research is strictly regulated by law. During submission and review processes, compliance of such research with the laws enforced in the country where it was conducted is not always correctly filled in by the authors or verified by the editors. Here, we report a case of a single institution for which one may find hundreds of publications with seemingly relevant ethical concerns, along with 10 months of follow-up through contacts with the editors of these articles. We thus argue for a stricter control of ethical authorization by scientific editors and we call on publishers to cooperate to this end.

We present an investigation of the ethics and legal aspects of 456 studies published by the IHU-MI (Institut Hospitalo-Universitaire Méditerranée Infection) in Marseille, France.

We identified a wide range of issues with the stated research authorization and ethics of the published studies with respect to the Institutional Review Board and the approval presented. Among the studies investigated, 248 were conducted with the same ethics approval number, even though the subjects, samples, and countries of investigation were different. Thirty-nine (39) did not even contain a reference to the ethics approval number while they present research on human beings. We thus contacted the journals that published these articles and provide their responses to our concerns. It should be noted that, since our investigation and reporting to journals, PLOS has issued expressions of concerns for several publications we analyze here.

This case presents an investigation of the veracity of ethical approval, and more than 10 months of follow-up by independent researchers. We call for stricter control and cooperation in handling of these cases, including editorial requirement to upload ethical approval documents, guidelines from COPE to address such ethical concerns, and transparent editorial policies and timelines to answer such concerns. All supplementary materials are available.

Peer Review reports

There are over 27 million scientific articles listed on the National Health Institute Platform PubMed. Previous investigations have shown that about 2% of scientists admitted to have fabricated, falsified or modified data or results at least once [ 1 ]. The business of scientific publication has surged during the last decade, including a staggering growth in the number of articles submitted and finally accepted for publication [ 2 ]. The peer review process is crucial for assessing the quality of hypotheses, methods, reliability of the data, and identifying any obvious ethical shortcomings. The Covid-19 pandemic was a stress test for the academic publishing system and unveiled several failures in processes evaluating quality of scientific publications [ 3 , 4 , 5 , 6 , 7 ]. Neglected or non-existent review procedures [ 3 , 6 ], editorial conflicts of interests combined with expeditive peer review [ 3 ], inconsistent publications with, e.g., missing data [ 8 ], failure to retract or delayed retractions [ 6 , 7 ], and irregularities in legal permissions are among the most common concerns seen in biomedical publications relating to the COVID-19 pandemic. The latter is particularly critical as it can directly put study participants at risk.

Regulation of clinical research became gradually an issue after the crimes perpetrated by the Nazis during World War II [ 9 ]. Later, these issues were reinforced by notoriously unethical studies conducted in the following decades, such as the Tuskegee Syphilis Study [ 10 ]. In the 1950 and 1960 s, the thalidomide adverse effects scandal reinforced this tendency by defining vulnerable groups such as, pregnant women [ 11 ]. More recently, ethics has evolved with new concerns for the protection of healthy volunteers following the TGN1412 disaster [ 12 ].

To prevent these ethical quandaries, countries have different governance system for ensuring appropriate moral conduct in clinical research. This commonly includes both legal requirements for conducting research, as well as guidelines for the oversight into and approval of ethical research. In France, this is done through the legislative framework. In this context, the French legislation was updated in 2016 with the Jardé Law on good practices in clinical research [ 13 ]. It should be noted that the legislative framework encountered in France is not the same as in other countries which may have other governance instead. French regulation requires that any experimentation on human beings must be approved by an independent ethics committee and depending on the complexity of the protocol, additional authorizations are required, especially regarding the collection of body fluids such as stool, vaginal secretions or urine.

In this paper, we present an investigation into papers published by the Institut Hospitalo-Universitaire Méditerranée Infection (IHU-MI ), a large clinical and research center in the city of Marseilles in the south of France. The IHU-MI employs over 700 people, covering a range of research topics related to infectious disease including basic biomedical research, epidemiological work, clinical trials,

This center has been the subject of research controversy since the advent of the COVID-19 pandemic, largely due to the actions of Professor Didier Raoult, former head of the institute. The original notoriety of the IHU-MI came from the now-infamous promotion of hydroxychloroquine, an anti-malarial medication, in combination with azithromycin for the treatment of COVID-19 [ 14 ]. This regimen was promoted as the most effective treatment for COVID-19 based on the results of a small, poorly-controlled observational study that has been described as having “major methodological shortcomings which make it nearly if not completely uninformative” and “fully irresponsible” in an independent review commissioned by the parent publishing company Elsevier [ 15 , 16 , 17 , 18 ]. This study also elicited negative peer-review comments on PubPeer, an independent review site that collates commentary on scientific studies, and from the French authorities [ 19 ]. The hydroxychloroquine/azithromycin regimen has remained popular in some minds despite increasingly robust evidence that it is ineffective in the treatment of COVID-19 and furthermore may increase the risk of death [ 18 ], demonstrating once more the danger of problematic and potentially unethical research [ 20 ]. Of note, IHU-MI has had previous retractions for alleged data fabrication, but thus far not due to ethical concerns [ 20 ].

Concerns on ethical approvals from IHU-MI have been raised outside scientific journals [ 21 ]. In August 2021, Elisabeth Bik pointed out issues about ethical approvals including research on vulnerable populations like homeless study participants [ 22 ]. These initial reports prompted us to further investigate potential concerns about ethics in the published literature from the institute. We have found and report below about highly worrying data in IHU-MI publications.

For post-publication critiques, the Committee on Publication Ethics (COPE) recommends referring to the journal or publisher policy [ 23 ], depending on the availability of an editorial policy for the reported issue. In case editorial policy does not take post-publication critiques into account, this policy should be amended. We can thus hope that the critiques formulated here might be helpful for journals to improve their peer reviewing policies. This is the whole meaning of our approach.

Investigation

Due to a great deal of national interest following publicization of poor research practices at IHU-MI, the French government investigated the unit and then launched legal actions in early September 2022. This followed a damning report from IGAS (Inspection Générale des Affaires Sociales) on the ethics and conduct of research taking place at IHU-MI during the period of investigation [ 24 ]. The seriousness of the accusations reported, combined with previous reports of questionable conduct and publication ban [ 20 ], made us question whether current academic editorial processes could have caught such concerns regarding the legal framework implemented at IHU-MI when conducting clinical trials. This paper provides the results of a detailed review covering the work of researchers at IHU-MI, analyzing published ethical statements.

After noticing that some Institutional Review Board (IRB) identification numbers were identical in several publications from the IHU-MI, we started by screening studies on IRB numbers on “Google Scholar”. We found several repetitions, and we finally noticed that one of the IRB approval numbers (09–022) appeared in hundreds of publications while the publications’ topics and the patients involved in studies were significantly different. We then used “Google Scholar” to identify all occurrences of this approval number.

We then decided to further investigate the bibliography of this institute by screening PubPeer reports and analyzing them. We did not contact directly IHU-MI since their answer to the PubPeer posts showed they were already aware of the concerns reported here. Furthermore, cyber and legal harassment made any direct contact with this institute more difficult than it should have been [ 21 , 25 , 26 ]. We only recently contacted Prof. Didier Raoult, former head of IHU-MI, since he was listed as editor-in-chief of the journals where some of the articles we report here were published but received no answer to this day. This list has also been reported to French Health Authority, namely the “Agence Nationale de Sécurité du Médicament” (ANSM), in charge of the evaluation of the legality of clinical studies, in July 2022. These publications were only evaluated regarding ethics criteria and our findings have no significance regarding the validity of their content.

We attempted to conduct a relatively systematic review of all recent biomedical research published by key authors at the IHU-MI, using “Google Scholar” profiles and PubPeer. This involved searching the bibliographies of senior scholars (i.e., Professors) at the institute, however given the sheer number of studies, we limited the search parameters to those published in the last 25 years. Screening on PubPeer was conducted by searching author names, and reviewing the resulting comments on papers. The results from PubPeer were then used to complete the data obtained from analysis of “Google Scholar” results. Frequently-repeating IRB-approval numbers were entered into “Google Scholar” to list of all their occurrences.

Request for the official IRB approval

We qualitatively determined whether IRB approval was likely to have been granted for different studies. This was done by discussion among the authors, and we present the tabulated findings in the results of the number of separate published works that use the same IRB approval number.

Contact of editors

While papers have been retracted in the past for issues concerning ethical approval [ 27 ], most of the Retraction Watch database entries seem to contain only Expressions of Concern (EOCs) or retractions relating to “ethical violations by author” or “lack of IRB/IACUC approval.” As such, it is not surprising that COPE did not provide guidelines on reporting and investigating IRB approval duplications such as what we have found. Indeed, current COPE guidelines on issues on ethics approval only focus on handling concerns at the time of submission of a manuscript [ 28 ] and not after publication or for cases of potentially fraudulent duplication of IRB approval numbers. As a result, we have further analysed the dataset to append the journal Editor-in-Chief’s name and email after screening the journals websites for information. In some cases, such as discontinued journals, the last known editor-in-chief was contacted. When no contact form or mail was available on the journal’s page, we contacted the editor-in-chief directly through academic mail found on the university affiliation’s website.

We thus contacted all editors of journals that published papers for which our analysis could raise concerns. The number of editors we contacted may seem very low compared to the number of publications we report, but many of them have been published in the same journal: for example “New Microbes and New Infections” published 135 of the studies we report. The low number of answers (despite reminder emails) led us to contact some publishers including Elsevier, for “New Microbes and New Infections”, without any satisfactory answer to this day. It should be noted that some of the authors of the papers we investigated are in many cases on the editorial team of the journals which have published the papers. Such concerns had already been highlighted with respect to this institute and some of their COVID-19 papers which had been peer-reviewed under 24 h in journals in which the authors presented with editorial conflicts of interest [ 3 ]. Related to our concerns, the journal “New Microbes and New Infections” is famous for being closely related to the team whose work we investigated [ 29 ] and had many members of the IHU-MI on the editorial board [ 30 ]. As such, editorial contact to report on the issues we have identified was indeed difficult.

At the time of writing, we have not approached the STM integrity hub. We have only contacted the ethics officer at Elsevier, since this publisher counts for most of the articles we report; from some answers of the editor-in-chief, we have no doubt that they did not intend to take any action.

After cleaning, we noticed that the IRB approval number 09–022 had been used 248 times over 12 years (between 2009 and 2021). Reusing approvals is allowed if results are from samples originally approved by the committee and in compliance with local laws related to clinical research. However, we found that those 248 publications covered a large variety of samples (stool, vaginal secretions, urine, samples taken during surgical procedures), a wide array of populations (adults, children, healthy volunteers, obese patients, etc.) and countries (France, Senegal, Niger, Gabon, Saudi Arabia, etc.) as depicted in Fig.  1 (see the Additional file 2 “Table S1 – Studies_with_09–022_IRB.csv”). Among the 248 studies identified, we have found at least one that was conducted after the Jardé Law was implemented, as well as many more published after 2016 with no dates of patient enrollment identifiable.

Various subjects, samples, and countries for the 248 studies with the IRB number 09–022

Further investigation in the bibliography from IHU-MI showed a total of 456 studies that could have ethical and legal concerns of the same type: multiple and different studies with the same IRB, absence of legal authorization, recruitment starting before authorization was obtained, etc. (see Additional file 2 Table S2 “Table S2-Clinical_Research_Papers_With_Ethical_Concerns.csv”).

In biomedical research, researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Most, if not all, scientific publishing companies have subscribed to the declaration of Helsinki [ 31 , 32 , 33 , 34 ], which is also recommended by COPE [ 35 ].

We could not access the original file with the IRB number 09–022, even after requesting this document from French authorities. However, we obtained a copy of the outline of the document (see Additional file 3 ). Based on our analysis, this form does not allow such a wide variety of samples, clinical conditions, and geographical origin to be documented. We could not find any reasonable explanation for such a multiplicity of identical occurrences in the literature. The original document should mention all those samples, conditions, and countries. If amendments have been made, they have not been explicitly mentioned in the articles from IHU-MI cited herein.

Contact of the editors

An overview of the journals that have published most of these articles is available in Fig.  2 .

Journals involved in the 456 studies with legal authorization concerns

Out of the 85 journals that we contacted, 19 editorial teams have responded to our email while 66 have not replied to us yet. A complete list of the journals, dates at which they have been contacted, as well as date and summary of the response is available in Additional file 2 (“Table S3 – Editors contact.csv”).

In summary, among the studies we have investigated, 248 were conducted with the same ethics approval number, even though the subjects, samples, and countries of investigation were different. Thirty-nine (39) of the manuscripts we considered did not even contain a reference to the ethics approval number although they contained research on human beings. We have contacted the 85 journals that published these articles and only 19 of them have replied to our queries so far. However, a publisher, PLOS [ 36 ], has issued expressions of concerns for several publications we have analyzed over ethical concerns.

Taking French legal framework into account, we made a rapid analysis and this showed these studies could include different categories of research involving human beings (RIPH) i.e. 6 RIPH 1, 67 RIPH 2 and 202 RIPH 3 for which no legally-required authorization has been reported by the authors.

Since we have reached out to editors, PLOS Biology has issued a wide expression of concern for 49 articles published by this institute, including 12 for which we have reported concerns on ethics approval. Out of these 12 articles, ten use the same ethics approval number, namely 09–022. Given that we have not raised concerns about the remaining 37 articles, there appears to be some concern at the editorial level of the work done by IHU-MI more broadly than this investigation identified. Thus, our figures should serve as a baseline estimate of the total number of papers which may have issues that are associated with IHU-MI. To our best knowledge, no other public editorial decision has been made from other publishing venues yet, although we hope that the concerns from PLOS Biology will help either obtaining clarifications from the authors on such concerns, or drive other journals to publicly respond too.

Editorial practices in verifying ethics and lawfulness of clinical research are still very heterogeneous and all journal are not members of COPE. We wish to initiate a conversation to improve the ethical controls at the editorial level across published academic research, and for changes to facilitate post-hoc investigations in future work, despite not suggesting any mean of enforcing these controls.

While some publishers already require the upload of ethics approval, this is not a largely adopted requirement. We thus argue that the practice should become more widely and rigorously adopted, or that, at the very least, ethics approval numbers are provided as metadata along a submission such that post-hoc analysis could be done in a more systematically fashion through mining of submission’s metadata. This metadata could be made available through PubMed along with a basic description of the study and its targeted population, intervention(s), and country of study.

We argue that submission processes should be amended to require the potentially confidential upload of ethical documents linked to clinical research, and that editorial procedures should pay attention to the international (and potentially local) ethical framework for research by including, for instance, basic verification steps. This responsibility should absolutely not be placed on reviewers whose primary mission is to ensure the scientific robustness of the research as well as its relevance for publication. Indeed, much of this process could be easily automated by publishing companies such as Elsevier to avoid precisely the issues identified in this review. Placing the weight on an editorial responsibility would also facilitate further verification. Indeed, as we have ourselves experienced, independent researchers investigating the adequacy of ethical documents are not likely to obtain an answer from IRBs or ethical committees, while editors and publishers would have an easier and more legally anchored claim to request those documents. In conclusion, there is an urgent need for publishers to require clinical research approvals. This could be done by requesting validation from the sponsoring organization or from the authority that issued the IRB number. There is also a critical need for COPE to provide clear guidelines on how to report (for researchers) and how to handle (for editors and journals) issues with ethics approval in published manuscript. While we are aware that further editorial verifications could create additional and potentially difficult to navigate publication steps, we however believe that the recommendations we put forward here could easily be put in place without an increased bureaucratic cost. Indeed, our most drastic recommendation would be to normalize the upload of IRB documents for which IRB and publishers could easily implement regulations based on existing policies from journals which already implement such requirements.

We finally argue that editorial responses within a strict timeline should be put in place, such that journals and editorial teams have a responsibility to respond to ethical queries from researchers within a reasonable time [ 7 ] as well as disclose reasonable concerns that have been publicly raised on articles, and this even before reaching out to authors.

Since we cannot ask every editor to know every framework of every country for every type of clinical research, this would of course not solve all the problems, but we think that this might be a step forward to a better respect of ethics and thus of patient rights. While additional editorial constraints are unlikely to eliminate fraud or questionable practices altogether, they can help limit them, raise awareness about them, and facilitate their detection. We believe that the new editorial policies on ethics and IRB approval that we suggest would advance scientific processes in the same way that requiring the publication of clinical trials registration has facilitated research on the spin of medical research [ 37 , 38 ], the prevalence of outcome switching, and other questionable reporting practices and likely help reduce these practices and adopt new standards to produce more robust and ethical research.

We have presented a case study of 456 trials from the Institut Hospitalo-Universitaire Méditerranée Infection. Our investigation has revealed serious concerns on the ethics approvals of these trials ranging from the re-use of the same ethics approval number 248 times on trials with significantly different subjects, samples, and countries of investigation, to potential lack of local ethics approval for studies conducted abroad. To the best of our knowledge, our investigation is the first to reveal concerns over the potentially inappropriate reuse of ethics approval numbers on such a massive scale. While our concerns have been acted on by one publisher (PLoS), most publishers are either still investigating the issue or have not yet responded to us. This investigation thus highlights the needs for guidelines and processes for readers, reviewers, and editorial teams, to report and respond to ethics approval misuse and concerns.

Availability of data and materials

The datasets supporting this article are available.

Abbreviations

Institut Hospitalo-Universitaire.

IHU Méditerannée Infection.

Institutional Review Board.

Hydroxychloroquine.

Agence Nationale de Sécurité du Médicament.

Recherche impliquant la personne humaine i.e. research involving human subjects.

Fanelli D. How many scientists fabricate and falsify Research? A systematic review and Meta-analysis of Survey Data. PLoS ONE. 2009;4:e5738. https://doi.org/10.1371/journal.pone.0005738 .

Article   Google Scholar  

Bornmann L, Haunschild R, Mutz R. Growth rates of modern science: a latent piecewise growth curve approach to model publication numbers from established and new literature databases. Humanit Soc Sci Commun. 2021;8. https://doi.org/10.1057/s41599-021-00903-w .

Besançon L, Peiffer-Smadja N, Segalas C, et al. Open science saves lives: lessons from the COVID-19 pandemic. BMC Med Res Methodol. 2021;21. https://doi.org/10.1186/s12874-021-01304-y .

Fraser N, Brierley L, Dey G, et al. The evolving role of preprints in the dissemination of COVID-19 research and their impact on the science communication landscape. PLoS Biol. 2021;19:e3000959. https://doi.org/10.1371/journal.pbio.3000959 .

Lawrence JM, Meyerowitz-Katz G, Heathers JAJ, et al. The lesson of ivermectin: meta-analyses based on summary data alone are inherently unreliable. Nat Med. 2021;27:1853–4. https://doi.org/10.1038/s41591-021-01535-y .

Barrière J, Frank F, Besançon L, et al. Scientific Integrity requires Publishing Rebuttals and Retracting Problematic Papers. Stem Cell Rev and Rep. 2022. https://doi.org/10.1007/s12015-022-10465-2 .

Besançon L, Bik E, Heathers J, et al. Correction of scientific literature: too little, too late! PLoS Biol. 2022;20:e3001572. https://doi.org/10.1371/journal.pbio.3001572 .

Mehra MR, Ruschitzka F, Patel AN. Retraction-hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. Lancet. 2020;395:1820. https://doi.org/10.1016/S0140-6736(20)31324-6 .

Kim WO. Institutional review board (IRB) and ethical issues in clinical research. Korean J Anesthesiol. 2012;62:3–12. https://doi.org/10.4097/kjae.2012.62.1.3 .

Corbie-Smith G. The continuing legacy of the Tuskegee syphilis study: considerations for clinical investigation. Am J Med Sci. 1999;317:5–8. https://doi.org/10.1016/S0002-9629(15)40464-1 .

Waggoner MR, Lyerly AD. Clinical trials in pregnancy and the “shadows of thalidomide”: revisiting the legacy of Frances Kelsey. Contemp Clin Trials. 2022;119:106806. https://doi.org/10.1016/j.cct.2022.106806 .

Attarwala H. TGN1412: from discovery to disaster. J Young Pharm. 2010;2:332–6. https://doi.org/10.4103/0975-1483.66810 .

French legal approach to clinical research. Anaesthesia Critical Care & Pain Medicine.2018;37:607–14. https://doi.org/10.1016/j.accpm.2018.10.013.

Gautret P, Lagier J-C, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020;56:105949. https://doi.org/10.1016/j.ijantimicag.2020.105949 .

Rosendaal FR. Review of: “Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial Gautret et al. Int J Antimicrob Agents. 2020;56:106063. https://doi.org/10.1016/j.ijantimicag.2020.106063 .

Oransky I. French hydroxychloroquine study has “major methodological shortcomings” and is “fully irresponsible,” says review, but is not being retracted. Retraction Watch 2020. https://retractionwatch.com/2020/07/19/french-hydroxychloroquine-study-has-major-methodological-shortcomings-and-is-fully-irresponsible-says-review-but-is-not-being-retracted/ . Accessed 19 Jan 2022.

Machiels JD, Bleeker-Rovers CP, ter Heine R, et al. Reply to Gautret et al: hydroxychloroquine sulfate and azithromycin for COVID-19: what is the evidence and what are the risks? Int J Antimicrob Agents. 2020;56:106056. https://doi.org/10.1016/j.ijantimicag.2020.106056 .

Axfors C, Schmitt AM, Janiaud P, et al. Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials. Nat Commun. 2021;12. https://doi.org/10.1038/s41467-021-22446-z .

Contrôle de l’IHU Méditerranée infection - IGAS. - Inspection générale des affaires sociales. https://www.igas.gouv.fr/spip.php?article861 . Accessed 19 Jan 2022.

6 Mary C. Didier Raoult profile. Sound and fury in the microbiology lab. Science 2012;335:1033–5. https://doi.org/10.1126/science.335.6072.1033 .

Schneider L. Didier Raoult fraud: “Je ne regrette rien.” For Better Science 2021. https://forbetterscience.com/2021/03/23/didier-raoult-fraud-je-ne-regrette-rien/ . Accessed 21 Feb 2023.

Concerns about Marseille’s IHU-MI/AMU papers – part 2. Science Integrity Digest 2021. https://scienceintegritydigest.com/2021/08/31/concerns-about-marseilles-IHU-MI-amu-papers-part-2/ . Accessed Feb 21 2023.

Handling of post-publication critiques. Committee on Publication Ethics. ; 2021. https://doi.org/10.24318/o1VgCAih . Accessed 19 Feb 2022.

IHU de Didier Raoult. Une information judiciaire ouverte à Marseille suite au rapport de l’ANSM. Ouest-france.fr. https://www.ouest-france.fr/sante/ihu-de-didier-raoult-une-information-judiciaire-ouverte-a-marseille-suite-au-rapport-de-l-ansm-7d300800-2ddd-11ed-82ab-ca288831284e#:~:text=de%20Didier%20Raoult.-,Une%20information%20judiciaire%20ouverte%20%C3%A0%20Marseille%20suite%20au%20rapport%20de,%C3%A9tait%20dirig%C3%A9%20par%20Didier%20Raoult . Accessed 15 Feb 2023.

Besançon L, Samuel A, Sana T, Rebeaud ME, Guihur A, Robinson-Rechavi M, Berre NL, Mulot M, Meyerowitz-Katz G, Hervé, Maisonneuve, Brian A, Nosek. (2021). “Open Letter: Scientists Stand up to Protect Academic Whistleblowers and Post-publication Peer Review.” OSF Preprints. May 18. doi: https://doi.org/10.31219/osf.io/2awsv .

Else H. Scientific image sleuth faces legal action for criticizing research papers. Nature. 2021;594:17–8. https://doi.org/10.1038/d41586-021-01430-z .

Marcus A. 250th COVID-19 retraction is for faked ethics approval. Retraction Watch. 2022. https://retractionwatch.com/2022/07/21/250th-covid-19-retraction-is-for-faked-ethics-approval/ (Accessed 28 Feb 2023).

What to do if you suspect an ethical problem. Committee on Publication Ethics. 2006. https://publicationethics.org/sites/default/files/ethical-problem-in-submitted-manuscript-cope-flowchart.pdf . Accessed 28 Feb 2023.

Locher C, Moher D, Cristea IA, et al. Publication by association: how the COVID-19 pandemic has shown relationships between authors and editorial board members in the field of infectious diseases. BMJ Evid Based Med. 2022;27:133–6. https://doi.org/10.1136/bmjebm-2021-111670 .

Editorial Board - New Microbes and New Infections - Journal – Elsevier. Archived 04. August 2021. https://web.archive.org/web/20210804233115/https://www.journals.elsevier.com/new-microbes-and-new-infections/editorial-board .

Mandatory author declaration. https://www.elsevier.com/__data/promis_misc/JBMTauthor_declaration.pdf . Accessed 19 Jan 2022.

Research Ethics | Nature Portfolio. https://www.nature.com/nature-portfolio/editorial-policies/ethics-and-biosecurity . Accessed 19 Jan 2022.

Best Practice Guidelines on Research Integrity and Publishing Ethics. https://authorservices.wiley.com/ethics-guidelines/index.html . Accessed 19 Jan 2022.

Research involving human. participants, their data or biological material. https://www.springer.com/gp/editorial-policies/research-involving-human-and-or-animal-participants . Accessed 19 Jan 2022.

Code of conduct and best practice guidelines for, journal editors. https://publicationethics.org/files/Code_of_conduct_for_journal_editors_Mar11.pdf . Accessed 19 Jan 2022.

PLOS flags nearly 50 papers by controversial French COVID researcher for ethics concerns. https://retractionwatch.com/2022/12/13/plos-flags-nearly-50-papers-by-controversial-french-covid-researcher-for-ethics-concerns/ . Accessed 19 Jan 2022.

Austin J, Smith C, Natarajan K, et al. Evaluation of spin within abstracts in obesity randomized clinical trials: a cross-sectional review: spin in obesity clinical trials. Clin Obes. 2019;9:e12292. https://doi.org/10.1111/cob.12292 .

Jellison S, Roberts W, Bowers A, et al. Evaluation of spin in abstracts of papers in psychiatry and psychology journals. BMJ Evid Based Med. 2019;25:178–81. https://doi.org/10.1136/bmjebm-2019-111176 .

Download references

The authors received no specific funding for this work.

Author information

Authors and affiliations.

Independent researcher, Essaouira, Morocco

Fabrice Frank

Department of Nephrology, Hôpitaux Universitaires de Strasbourg, Université de Strasbourg, Strasbourg, France

Nans Florens

School of Health and Society, University of Wollongong, Wollongong, Australia

Gideon Meyerowitz-katz

Medical Oncology Department, Polyclinique Saint-Jean, Cagnes-sur-Mer, France

Jérôme Barriere

Independent researcher, Strasbourg, France

Biopathology department, Gustave Roussy Anti-Cancer Center, Villejuif, France

Véronique Saada

Independent researcher, Nice, France

Alexander Samuel

Université de Bordeaux, INSERM Unité 1312, Bordeaux, France

Jacques Robert

Media and Information Technology, Linköping University, Norrköping, Sweden

Lonni Besançon

You can also search for this author in PubMed   Google Scholar

Contributions

Conceptualization: FF, NF, LB. Methodology: FF, NF, LB. Investigation: FF. Writing – original draft: FF, NF, EB. Writing – review & editing: FF, NF, GMK, JB, EB, VS, AS, LB, JR. The author(s) read and approved the final manuscript.

Corresponding author

Correspondence to Lonni Besançon .

Ethics declarations

Ethics approval and consent to participate.

Not applicable.

Consent for publication

Competing interests.

No competing interest. EB is a full-time Novartis employee. Views are his own.

Additional information

Publisher’s note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Additional file 1: figure 1..

Various subjects, samples, and countries for the 248 studieswith the IRB number 09-022.  Figure 2. Journals involved in the 444 studies with legal authorization concerns.

Additional file 2: Table S1.

 Studies_with_09–022_IRB.  Table S2. Clinical_Research_Papers_With_Ethical_Concerns.  Table S3.  Editors contact.

Additional file 3:

 Outline of IRB approval.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ . The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Cite this article.

Frank, F., Florens, N., Meyerowitz-katz, G. et al. Raising concerns on questionable ethics approvals – a case study of 456 trials from the Institut Hospitalo-Universitaire Méditerranée Infection. Res Integr Peer Rev 8 , 9 (2023). https://doi.org/10.1186/s41073-023-00134-4

Download citation

Received : 13 February 2023

Accepted : 22 May 2023

Published : 03 August 2023

DOI : https://doi.org/10.1186/s41073-023-00134-4

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Clinical research
• Scientific publications
• Scientific publishing
• IRB (Institutional Review Board)

Research Integrity and Peer Review

ISSN: 2058-8615

• Submission enquiries: [email protected]
• General enquiries: [email protected]

• Clinical Ethics Services
• Ethical AI Services
• Custom Workshops
• Medical Student Education
• In the News
• Impact Videos and Stories
• Frequently Asked Questions
• Policies, Disclosures and Reports

Case Study – Clinical Research Involving Children

Print this case study here:  Case Study – Clinical Research Involving Children

Case Study: Clinical Research Involving Children

By Ralph E. Kauffman, MD

T.J. is a seven-year-old boy who was diagnosed with asthma at three years of age. His asthma is of moderate severity and is well controlled with medications most of the time, although he has occasional (two or three times per year) exacerbations requiring a visit either to his physician or to the emergency room. Otherwise, he is healthy, attends school regularly, and participates in age appropriate sports. T.J.’ s asthma medications include daily use of a corticosteroid inhaler and use of a bronchodilator inhaler as needed for worsening of his asthma symptoms or before physical exertion.

T.J. and his parents have been approached about his participation in a clinical study of a new medication for asthma to assess its safety and efficacy in treating children with asthma. This medication is taken as a flavored chewable tablet once daily by mouth and works by a totally different mechanism than the inhaled medications T.J. currently is taking. It has not yet been studied in children, but three studies have been completed in 550 adult patients with asthma. The preliminary evidence from the adult studies is that the new experimental drug does improve asthma in some patients and has very few side effects. The side effects so far in adults have been limited to occasional nausea, headache, and dizziness. However, these side effects occurred at about the same frequency in adults whether they were taking the experimental drug or a placebo.

If T.J. participates in this study, he will be on the study protocol for a total of fourteen weeks. During the first two weeks he will be stabilized on his standard therapy to assure he is well controlled at the time he enters the experimental phase. During weeks three through fourteen, he will be randomized to receive either his standard treatment, the experimental drug plus the bronchodilator inhaler as needed, or a placebo plus his bronchodilator inhaler as needed. Neither T.J., his parents, or his doctor will know which medication he is receiving during the study. In other words, the study is blinded. While he is on the study, he may not use any drugs for asthma other than those mentioned above. He will be seen at regular and frequent intervals during the study to assess his response to treatment and evaluate for any adverse events. This evaluation will require six additional visits to the physician’s office. Along with other safety monitoring, he will be evaluated for linear growth, bone metabolism, and any eye lens abnormalities (some drugs are associated with formation of cataracts). During each office visit, breathing tests will be done and blood will be drawn for safety laboratory tests and to measure the amount of study drug in his blood.

T.J.’ s family will not be responsible for the costs of the study-related office visits or testing. All medications will be provided free of charge. In addition, transportation costs for the required office visits will be covered. In addition, T.J. will receive $40 for each office visit- a total of $240 if he completes the entire protocol. The details of the study have been explained to T.J. and his parents and they have been asked if they and T.J. will agree for him to enroll in this study.

• What are the possible risks (if any) to T.J. if he were to enroll in this study?
• What are the possible benefits (if any)? To T.J.? To his parents? To other children with asthma?
• What are the risks of not including children in research?
• Since T.J. is only seven years old, he is not allowed by law to independently consent to medical care or agree to be in a study. What right do his parents have to volunteer him to be in a clinical trial? What are their responsibilities if they choose to do so? If they choose not to?
• What rights does T.J. have? Should he have the right to volunteer even if his parents refuse their permission? Should he have the right to refuse even if his parents agree for him to be in the study?
• Can it be ethically justified to withhold medications from a child for conducting a study?
• Can the use of placebos be ethically justified in research involving children? If so, under what circumstances?
• If T.J. were your child, would you give permission for him to be in this study?

SELECTED READING

American Academy of Pediatrics Committee on Drugs. 1995. “Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations.” Pediatrics 95:286-294.

Kauffman, R.E. 1994. “Drug Trials in children: Ethical, legal, and practical issues.” Journal of Clinical Pharmacology 34:296-299. –.

1998. “Drug safety, testing, and availability for children.” Children’s Legal Rights Journal. 18(2): 27-34.

2000. “Clinical Trials in Children: Problems and Pitfalls.” Paediatric Drugs Nov-Dec 2(6): 411- 418.

Clinical Trials, Ethics, and Human Protections Policies

• Reference work entry
• First Online: 20 July 2022
• Cite this reference work entry

• Jonathan Kimmelman 3  

426 Accesses

1 Altmetric

Clinical trials raise two main sets of ethical challenges. The first concerns protecting human beings when they are used in scientific experiments. The second concerns protecting the welfare of downstream users of medical evidence generated in trials. The present chapter reviews core ethical standards and principles governing the conception, design, conduct, and reporting of clinical trials. This review concludes by suggesting that even the most technical decisions about design and reporting embed numerous moral judgments about how to serve the interests of research subjects and downstream users of medical evidence.

Clinical trials are experiments on human beings. They involve two elements that make them ethically sensitive undertakings. First, the very reagent used in the experiment – the human being – has what philosophers call moral status. That is, human beings are sentient and self-aware, they have preferences and plans, and they have a capacity for suffering. Human beings are thus entitled to having their interests respected and protected when they are themselves the research reagents. Second, clinical trials are aimed at supporting decision-making in health care. Life and death decisions are ultimately based on the evidence we generate from human experiments. Human beings who use that evidence deserve protection from scientific findings that are misleading, incomplete, or biased.

In what follows, I provide a very condensed overview of the ethics of clinical trials. Most writings on the ethics of clinical trials have centered on the protection of human volunteers, treating issues of research integrity as an afterthought, if at all. Two core claims ground this review – claims that perhaps differentiate it from similar overviews of human research ethics. The first is that scientific integrity is a complement to human protections; even the most technical decisions about design and analysis are laden with implicit ethical judgments. The second is that clinical trials present ethical challenges across their full life cycle – not merely in the brief window when a trial is open for enrollment, and where human protection regulations are directed. This review is thus organized according to the life cycle of a clinical trial.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

• Available as PDF
• Read on any device
• Instant download
• Own it forever
• Available as EPUB and PDF
• Durable hardcover edition
• Dispatched in 3 to 5 business days
• Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Al-Lamee R, Thompson D, Dehbi H-M et al (2018) Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet 391:31–40. https://doi.org/10.1016/S0140-6736(17)32714-9

Article   Google Scholar  

Andersen M, Kragstrup J, Søndergaard J (2006) How conducting a clinical trial affects physicians’ guideline adherence and drug preferences. JAMA 295:2759–2764. https://doi.org/10.1001/jama.295.23.2759

Annas GJ, Grodin MA (eds) (1995) The Nazi doctors and the Nuremberg Code: human rights in human experimentation, 1st edn. Oxford University Press, New York

Google Scholar  

Appelbaum PS, Roth LH, Lidz CW et al (1987) False hopes and best data: consent to research and the therapeutic misconception. Hast Cent Rep 17:20–24

Azar M, Riehm KE, Saadat N et al (2019) Evaluation of journal registration policies and prospective registration of randomized clinical trials of nonregulated health care interventions. JAMA Intern Med. https://doi.org/10.1001/jamainternmed.2018.8009

Bauchner H, Golub RM, Fontanarosa PB (2016) Data sharing: an ethical and scientific imperative. JAMA 315:1238–1240. https://doi.org/10.1001/jama.2016.2420

Beecher HK (1966) Ethics and clinical research. N Engl J Med 274:1354–1360. https://doi.org/10.1056/NEJM196606162742405

Bothwell LE, Kesselheim AS (2017) Thereal-world ethics of adaptive-design clinical trials. Hast Cent Rep 47:27–37. https://doi.org/10.1002/hast.783

Boutron I, Altman DG, Hopewell S et al (2014) Impact of spin in the abstracts of articles reporting results of randomized controlled trials in the field of cancer: the SPIIN randomized controlled trial. J Clin Oncol 32:4120–4126. https://doi.org/10.1200/JCO.2014.56.7503

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, Secretariat on Responsible Conduct of Research (Canada) (2018) Tri-Council policy statement: ethical conduct for research involving humans

Carlisle B, Federico CA, Kimmelman J (2018) Trials that say “maybe”: the disconnect between exploratory and confirmatory testing after drug approval. BMJ 360:k959. https://doi.org/10.1136/bmj.k959

Chalmers I, Nylenna M (2014) A new network to promote evidence-based research. Lancet 384:1903–1904. https://doi.org/10.1016/S0140-6736(14)62252-2

Crouch RA, Arras JD (1998) AZT trials and tribulations. Hast Cent Rep 28:26–34. https://doi.org/10.2307/3528266

DeMets DL, Furberg CD, Friedman LM (eds) (2005) Data monitoring in clinical trials: a case studies approach, 2006 edition. Springer, New York

Dickmann LJ, Schutzman JL (2017) Racial and ethnic composition of cancer clinical drug trials: how diverse are we? Oncologist. https://doi.org/10.1634/theoncologist.2017-0237

Dixon-Woods M, Jackson C, Windridge KC, Kenyon S (2006) Receiving a summary of the results of a trial: qualitative study of participants’ views. BMJ 332:206–210. https://doi.org/10.1136/bmj.38675.677963.3A

Elahi M, Eshera N, Bambata N et al (2016) The Food and Drug Administration Office of Women’s Health: impact of science on regulatory policy: an update. J Women’s Health 25:222–234. https://doi.org/10.1089/jwh.2015.5671

Faden RR, Beauchamp TL (1986) A history and theory of informed consent. Oxford University Press, New York

Federico CA, Wang T, Doussau A et al (2019) Assessment of pregabalin postapproval trials and the suggestion of efficacy for new indications: a systematic review. JAMA Intern Med 179:90–97. https://doi.org/10.1001/jamainternmed.2018.5705

Fergusson D, Glass KC, Hutton B, Shapiro S (2005) Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding? Clin Trials 2:218–232. https://doi.org/10.1191/1740774505cn085oa

Flory J, Emanuel E (2004) Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA 292:1593–1601. https://doi.org/10.1001/jama.292.13.1593

Flory JH, Kitcher P (2004) Global health and the scientific research agenda. Philos Public Aff 32:36–65. https://doi.org/10.1111/j.1467-6486.2004.00004.x

Flory JH, Mushlin AI, Goodman ZI (2016) Proposals to conduct randomized controlled trials without informed consent: a narrative review. J Gen Intern Med 31:1511–1518. https://doi.org/10.1007/s11606-016-3780-5

Freedman B (1987) Equipoise and the ethics of clinical research. N Engl J Med 317:141–145. https://doi.org/10.1056/NEJM198707163170304

General Assembly of the World Medical Association (2014) World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent 81:14–18

Ghare MI, Chandrasekhar J, Mehran R et al (2019) Sexdisparities in cardiovascular device evaluations: strategies for recruitment and retention of female patients in clinical device trials. JACC Cardiovasc Interv 12:301–308. https://doi.org/10.1016/j.jcin.2018.10.048

Glickman SW, McHutchison JG, Peterson ED et al (2009) Ethical and scientific implications of the globalization of clinical research. N Engl J Med 360:816–823. https://doi.org/10.1056/NEJMsb0803929

Goldbeck-Wood S (1998) Denmark takes a lead on research ethics. BMJ 316:1185. https://doi.org/10.1136/bmj.316.7139.1185j

Grant RW, Sugarman J (2004) Ethics in human subjects research: do incentives matter? J Med Philos 29:717–738. https://doi.org/10.1080/03605310490883046

Hakala A, Kimmelman J, Carlisle B et al (2015) Accessibility of trial reports for drugs stalling in development: a systematic assessment of registered trials. BMJ 350:h1116. https://doi.org/10.1136/bmj.h1116

Halperin H, Paradis N, Mosesso V et al (2007) Recommendations for implementation of community consultation and public disclosure under the Food and Drug Administration’s “exception from informed consent requirements for emergency research”: a special report from the American Heart Association Emergency Cardiovascular Care Committee and Council on Cardiopulmonary, Perioperative and Critical Care: endorsed by the American College of Emergency Physicians and the Society for Academic Emergency Medicine. Circulation 116:1855–1863. https://doi.org/10.1161/CIRCULATIONAHA.107.186661

Halpern SD, Karlawish JHT, Berlin JA (2002) The continuing unethical conduct of underpowered clinical trials. JAMA 288:358–362

Hawkins JS (2004) The ethics of Zelen consent. J Thromb Haemost 2:882–883. https://doi.org/10.1111/j.1538-7836.2004.00782.x

Hey SP, Kimmelman J (2014) The questionable use of unequal allocation in confirmatory trials. Neurology 82:77–79. https://doi.org/10.1212/01.wnl.0000438226.10353.1c

Hope T, McMillan J (2004) Challenge studies of human volunteers: ethical issues. J Med Ethics 30:110–116. https://doi.org/10.1136/jme.2003.004440

Horng S, Grady C (2003) Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB 25:11–16

International Council for Harmonisation (1996) Guideline for good clinical practice. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf

Kane PB, Kim SYH, Kimmelman J (2020) Whatresearch ethics (often) gets wrong about minimal risk. Am J Bioeth 20:42–44. https://doi.org/10.1080/15265161.2019.1687789

Kasenda B, Schandelmaier S, Sun X et al (2014) Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications. BMJ 349:g4539. https://doi.org/10.1136/bmj.g4539

Kimmelman J (2005) Medical research, risk, and bystanders. IRB Ethics Hum Res 27:1

Kimmelman J (2020) What is human research for? Reflections on the omission of scientific integrity from the Belmont Report (accepted). Perspect Biol Med 62(2):251–261

Kimmelman J, Federico C (2017) Consider drug efficacy before first-in-human trials. Nature 542:25–27. https://doi.org/10.1038/542025a

Kimmelman J, Weijer C, Meslin EM (2009) Helsinki discords: FDA, ethics, and international drug trials. Lancet 373:13–14. https://doi.org/10.1016/S0140-6736(08)61936-4

King NMP (2000) Defining and describing benefit appropriately in clinical trials. J Law Med Ethics 28:332–343. https://doi.org/10.1111/j.1748-720X.2000.tb00685.x

Lantos JD, Feudtner C (2015) SUPPORT and the ethics of study implementation: lessons for comparative effectiveness research from the trial of oxygen therapy for premature babies. Hast Cent Rep 45:30–40. https://doi.org/10.1002/hast.407

Levine C, Faden R, Grady C et al (2004) “Special scrutiny”: a targeted form of research protocol review. Ann Intern Med 140:220–223

Loder E, Groves T (2015) The BMJ requires data sharing on request for all trials. BMJ 350:h2373. https://doi.org/10.1136/bmj.h2373

London AJ (2007) Clinical equipoise: foundational requirement or fundamental error? In: The Oxford handbook of bioethics. Oxford University Press, Oxford, pp 571–596

London AJ, Kimmelman J, Emborg ME (2010) Beyond access vs. protection in trials of innovative therapies. Science 328:829–830. https://doi.org/10.1126/science.1189369

London AJ, Kimmelman J, Carlisle B (2012) Rethinking research ethics: the case of postmarketing trials. Science 336:544–545. https://doi.org/10.1126/science.1216086

Mathieu S, Boutron I, Moher D et al (2009) Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 302:977–984. https://doi.org/10.1001/jama.2009.1242

Mello MM, Francer JK, Wilenzick M et al (2013) Preparing for responsible sharing of clinical trial data. N Engl J Med 369:1651–1658. https://doi.org/10.1056/NEJMhle1309073

Mello MM, Lieou V, Goodman SN (2018) Clinical trial participants’ views of the risks and benefits of data sharing. N Engl J Med. https://doi.org/10.1056/NEJMsa1713258

Menikoff J, Kaneshiro J, Pritchard I (2017) Thecommon rule, updated. N Engl J Med 376:613–615. https://doi.org/10.1056/NEJMp1700736

Nasser M, Clarke M, Chalmers I et al (2017) What are funders doing to minimise waste in research? Lancet 389:1006–1007. https://doi.org/10.1016/S0140-6736(17)30657-8

Palmowski A, Buttgereit T, Palmowski Y et al (2018) Applicability of trials in rheumatoid arthritis and osteoarthritis: a systematic review and meta-analysis of trial populations showing adequate proportion of women, but underrepresentation of elderly people. Semin Arthritis Rheum. https://doi.org/10.1016/j.semarthrit.2018.10.017

Partridge AH, Winer EP (2002) Informing clinical trial participants about study results. JAMA 288:363–365. https://doi.org/10.1001/jama.288.3.363

Phillips R, Hazell L, Sauzet O, Cornelius V (2019) Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ Open 9:e024537. https://doi.org/10.1136/bmjopen-2018-024537

Polman CH, Reingold SC, Barkhof F et al (2008) Ethics of placebo-controlled clinical trials in multiple sclerosis: a reassessment. Neurology 70:1134–1140. https://doi.org/10.1212/01.wnl.0000306410.84794.4d

Richardson HS, Belsky L (2004) The ancillary-care responsibilities of medical researchers. An ethical framework for thinking about the clinical care that researchers owe their subjects. Hast Cent Rep 34:25–33

Savulescu J, Chalmers I, Blunt J (1996) Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ 313:1390–1393. https://doi.org/10.1136/bmj.313.7069.1390

Sox HC, Rennie D (2008) Seeding trials: just say “no”. Ann Intern Med 149:279–280

Turner L, Shamseer L, Altman DG et al (2012) Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev 11:MR000030. https://doi.org/10.1002/14651858.MR000030.pub2

U.S. Department of Health and Human Services (2016) 42 CFR 11: clinical trials registration and results information submission

U.S. Department of Health and Human Services, Food and Drug Administration (2005) Guidance for industry: how to comply with the Pediatric Research Equity Act

U.S. Department of Health and Human Services, Food and Drug Administration(2009) Good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices

U.S. Department of Health and Human Services, Food and Drug Administration(2016) Collection of race and ethnicity data in clinical trials

Vedula SS, Li T, Dickersin K (2013) Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin. PLoS Med 10:e1001378. https://doi.org/10.1371/journal.pmed.1001378

Weijer C, Miller PB (2004) When are research risks reasonable in relation to anticipated benefits? Nat Med 10:570. https://doi.org/10.1038/nm0604-570

Weijer C, Grimshaw JM, Taljaard M et al (2011) Ethical issues posed by cluster randomized trials in health research. Trials 12:100. https://doi.org/10.1186/1745-6215-12-100

Wolf SM, Paradise J, Caga-anan C (2008) The law of incidental findings in human subjects research: establishing researchers’ duties. J Law Med Ethics 36(361–383):214. https://doi.org/10.1111/j.1748-720X.2008.00281.x

World Health Organization, Council for International Organizations of Medical Sciences (2017) International ethical guidelines for health-related research involving humans. CIOMS, Geneva

Yordanov Y, Dechartres A, Porcher R et al (2015) Avoidable waste of research related to inadequate methods in clinical trials. BMJ 350:h809. https://doi.org/10.1136/bmj.h809

Download references

Author information

Authors and affiliations.

Biomedical Ethics Unit, McGill University, Montreal, QC, Canada

Jonathan Kimmelman

You can also search for this author in PubMed   Google Scholar

Corresponding author

Correspondence to Jonathan Kimmelman .

Editor information

Editors and affiliations.

Department of Surgery, Division of Surgical Oncology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

Steven Piantadosi

Department of Epidemiology, School of Public Health, Johns Hopkins University, Baltimore, MD, USA

Curtis L. Meinert

Section Editor information

Professor of Epidemiology & Population Health, and Medicine, Stanford University School of Medicine, Stanford, CA, USA

Steven N. Goodman MD, MHS, PhD

School of Medicine, The Johns Hopkins University, Baltimore, MD, USA

Karen A Robinson Ph.D

The Johns Hopkins Center for Clinical Trials and Evidence Synthesis, Johns Hopkins University, Baltimore, MD, USA

Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

Rights and permissions

Reprints and permissions

Copyright information

© 2022 Springer Nature Switzerland AG

About this entry

Cite this entry.

Kimmelman, J. (2022). Clinical Trials, Ethics, and Human Protections Policies. In: Piantadosi, S., Meinert, C.L. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52636-2_238

Download citation

DOI : https://doi.org/10.1007/978-3-319-52636-2_238

Published : 20 July 2022

Publisher Name : Springer, Cham

Print ISBN : 978-3-319-52635-5

Online ISBN : 978-3-319-52636-2

eBook Packages : Mathematics and Statistics Reference Module Computer Science and Engineering

Share this entry

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Publish with us

Policies and ethics

• Find a journal
• Track your research

Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Case Study: Research Ethics

Short-course Zidovudine Compared to What? A Trial to Prevent Mother-to-Infant HIV Transmission is a classroom-based interactive case study that addresses ethical and scientific issues in research. The research example used in this case study is a randomized controlled trial of zidovudine to prevent mother-to-child transmission of HIV in developing countries after its effectiveness had been established in developed countries. The case study focuses on ethical issues, particularly the appropriateness and selection of a comparison (placebo) group, the review process, and informed consent.

Learning Objectives

After completing this case study, the participant should be able to:

• Discuss the principle of equipoise and its relevance in designating an appropriate comparison group in a randomized controlled trial (RCT)
• Describe the role of an Institutional Review Board
• List the required elements of informed consent and discuss key considerations in using informed consent in developing countries
• Describe the ethical rationale for conducting an interim analysis of a clinical trial

The case study is intended to be used in the classroom, with students reading text and responding to questions under the facilitation of an instructor. The instructor should provoke discussion and exchange of ideas among participants.

Instructor and participant versions are available. The participant’s version includes all text and questions and space for answers. The instructor’s version includes all of the text and questions, plus teaching points and responses for each question.

FETP Case Study ZVD Instructor Guide [435K, 24 pages]

FETP Case Study ZVD Participant Guide [342K, 22 pages]

To receive updates about this page, enter your email address:

• Global Health
• CDC and the Global Health Security Agenda
• Global HIV/AIDS
• Global Vaccines and Immunization

Exit Notification / Disclaimer Policy

• The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website.
• Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website.
• You will be subject to the destination website's privacy policy when you follow the link.
• CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website.

• Open access
• Published: 29 September 2021

Defining ethical challenge(s) in healthcare research: a rapid review

• Guy Schofield   ORCID: orcid.org/0000-0002-9055-292X 1 , 3 ,
• Mariana Dittborn   ORCID: orcid.org/0000-0003-2903-6480 2 ,
• Lucy Ellen Selman   ORCID: orcid.org/0000-0001-5747-2699 3 &
• Richard Huxtable   ORCID: orcid.org/0000-0002-5802-1870 1  

BMC Medical Ethics volume  22 , Article number:  135 ( 2021 ) Cite this article

21k Accesses

15 Citations

11 Altmetric

Metrics details

Despite its ubiquity in academic research, the phrase ‘ethical challenge(s)’ appears to lack an agreed definition. A lack of a definition risks introducing confusion or avoidable bias. Conceptual clarity is a key component of research, both theoretical and empirical. Using a rapid review methodology, we sought to review definitions of ‘ethical challenge(s)’ and closely related terms as used in current healthcare research literature.

Rapid review to identify peer-reviewed reports examining ‘ethical challenge(s)’ in any context, extracting data on definitions of ‘ethical challenge(s)’ in use, and synonymous use of closely related terms in the general manuscript text. Data were analysed using content analysis. Four databases (MEDLINE, Philosopher’s Index, EMBASE, CINAHL) were searched from April 2016 to April 2021.

393 records were screened, with 72 studies eligible and included: 53 empirical studies, 17 structured reviews and 2 review protocols. 12/72 (17%) contained an explicit definition of ‘ethical challenge(s), two of which were shared, resulting in 11 unique definitions. Within these 11 definitions, four approaches were identified: definition through concepts; reference to moral conflict, moral uncertainty or difficult choices; definition by participants; and challenges linked to emotional or moral distress. Each definition contained one or more of these approaches, but none contained all four. 68/72 (94%) included studies used terms closely related to synonymously refer to ‘ethical challenge(s)’ within their manuscript text, with 32 different terms identified and between one and eight different terms mentioned per study.

Conclusions

Only 12/72 studies contained an explicit definition of ‘ethical challenge(s)’, with significant variety in scope and complexity. This variation risks confusion and biasing data analysis and results, reducing confidence in research findings. Further work on establishing acceptable definitional content is needed to inform future bioethics research.

Peer Review reports

Methodological rigour within research is a cornerstone in the production of high-quality findings and recommendations. Across the range of empirical methodologies, a broad collection of protocol development tools, methodology guidelines, and reporting guidelines have been developed and evidence of their use is increasingly required by journals [ 1 , 2 , 3 , 4 , 5 , 6 ]. Within both empirical bioethics and descriptive ethics, there has been an accompanying increase in the acknowledgment of the importance of methodological rigour in the empirical elements, including within the recent consensus statement on quality standards in empirical bioethics research by Ives et al. [ 7 , 8 , 9 ]. Aligned with this aim for rigour, definitional clarity of key terms used within a research project is a component of research quality [ 10 , 11 ]. Improving the quality of empirical bioethics is also itself an ethical imperative [ 9 ].

We recently conducted a systematic review examining ‘ethical challenges’ as reported by specialist palliative care practitioners [ 12 ]. Our review, alongside our initial scoping search findings and reading of the literature, suggested that, although many authors use the term ‘ethical challenge(s)’ in empirical ethics research, there appeared to be no commonly described or accepted definition. Furthermore, papers retrieved rarely defined ‘ethical challenge(s)’ explicitly , which has also been noted by other researchers examining other topic areas [ 13 , 14 , 15 ]. Our review further suggested that authors frequently use terms closely related to ‘ethical challenge(s)’—such as ‘moral dilemmas’ or ‘ethical issues’—interchangeably with ‘ethical challenge(s)’ throughout manuscripts, rather than staying with the original term. Research shows that non-philosophers may understand these related terms in heterogeneous ways which may additionally affect understanding of texts across different readerships [ 16 , 17 ].

Without a clear definition of an ethical challenge, each researcher must use individual judgement to ascertain whether they have identified an instance of one within their dataset. This potentially generates an unnecessary source of bias, particularly if multiple researchers are involved in data collection, extraction, or analysis. This risks generating misleading ethical analyses, evaluations, or recommendations. Additionally, and more broadly, if primary studies do not define the term, then work based on these—such as systematic reviews of individual studies or those undertaking secondary data analysis—may unknowingly compare different phenomena without a mechanism for mitigating the effects this introduces.

In the hope of prompting a debate on this topic, we therefore undertook a rapid review, which aimed to explore existing definitions of “ethical challenge(s)” and the use of other closely related terms within recent empirical healthcare ethics literature.

We conducted a rapid review examining the usage of the term ‘ethical challenge(s)’ over the last 5 years in published research articles, in order to identify and summarise if, and how, the term was defined. As a secondary aim, we examined authors’ uses of closely related alternative terms within the included article texts separate to their use within any explicit definitions that may be present.

Rapid reviews use abridged systematic review methodology to understand the evidence base on a particular topic in a time and resource efficient manner [ 18 , 19 , 20 , 21 , 22 ]. Comparative reviews of topics in which both a rapid review and a systematic review had been undertaken demonstrated that the overall conclusions were similar, although rapid reviews were less likely to contain social and economic data, and systematic reviews contained more detailed recommendations [ 18 , 19 , 20 , 23 , 24 ]. The Cochrane Rapid Review Methods Group has recently released interim methodological guidelines for undertaking rapid reviews [ 6 ], advising authors to describe where their protocol deviates from a systematic review and detail any biases that these deviations may introduce [ 18 , 19 , 21 ]. We have followed the Cochrane recommended methodology [ 6 ]. A rapid review reporting guideline is currently under development [ 25 ] and this review is therefore reported based on the PRISMA 2020 statement for systematic reviews, with justifications provided where our approach deviated [ 26 ].

Prospective review protocol registration on the PROSPERO database is the current gold standard, but, at the time of writing, PROSPERO does not accept records for rapid reviews [ 27 ]. The protocol was therefore not published in advance.

Eligibility criteria

The inclusion and exclusion criteria are summarised in Table 1 . We used Strech et al.’s Methodology, Issues, Participants (MIP) structure for our eligibility criteria, which is recommended for systematic reviews in ‘empirical bioethics’ [ 28 ]. The criteria reflect three assumptions. First, that the inclusion of ‘ethical challenge(s)’ in the title would increase the likelihood that this was the authors’ preferred term for the concept under investigation, and therefore increase the probability of a definition being provided. Second, that studies aiming to describe empirical data and identify ethical challenges in real-world contexts are most likely to contain a definition to guide researchers in identifying these challenges as they collect and analyse data. Third, that structured reviews of studies of ethical challenges are likely to include a definition to allow researchers to reliably recognise an ethical challenge in retrieved records. We used a 5-year timeframe as a date restriction. This reflected a balance between adequately covering recent use of the term and time and resource restrictions of the rapid review.

Information sources

The search strategy was as follows:

‘ethical challenge’.ti OR ‘ethical challenges’.ti.

We searched Medline (Ovid interface), Philosopher’s Index (OVID interface), EMBASE (OVID interface), and CINAHL (Cumulative Index to Nursing and Allied Health Literature, EBSCO interface) for studies indexed over a five-year period between April 2016 and April 2021. These resources cover the breadth of healthcare research. Including Philosopher’s Index increased coverage of the bioethics literature. We did not search the grey literature [ 6 ]. The search strategy was tested by successfully retrieving three sentinel studies known to the research team.

Study selection

Retrieved studies were imported into Endnote X9.2 [ 29 ]. Records unavailable through institutional subscriptions were requested from corresponding authors. If unavailable 14 days after the request, the record was excluded. A random sample of 20% of records were dual screened at the title/abstract level by GS/MD. After discussion, the remainder were screened by GS. At full-text screening, a further 20% were dual screened by GS/MD and, again after discussion, the remaining studies were screened by GS.

Data extraction and analysis

Data extraction was undertaken using a pre-piloted form, with the first 5 records dually extracted by GS and MD. Data from the remaining included studies was then extracted by GS, with correctness and completeness checked by MD. We collected data on date of publication, authors, journal, country (for primary studies), methodology, definition of ‘ethical challenge(s)’ (present (yes/no)) and (where offered) the definition provided, and any closely related terms used, with counts of all terms used in each article. For closely related terms, data was extracted from the authors’ text, but not from direct quotations from qualitative research. Where definitions of ‘ethical challenge(s)’ were offered and/or related terms were identified, these were categorised and counted following the principles of summative content analysis [ 30 ]. Summative content analysis combines both the quantitative counting of specific content or words/terms with latent content analysis to identify and categorise their meanings. We identified keywords (‘ethical challenge(s)’ and closely related terms) deployed by the authors of the included papers, both prior to and during data analysis, and analysed the retrieved definitions. This approach allowed for exploration of both the content of definitions and development of insights into the use of related terms.

Risk of bias assessment

The focus of the rapid review was the definition of the term ‘ethical challenge(s)’ within retrieved records. We therefore did not undertake quality assessment for the included studies and reviews.

831 records were retrieved, reduced to 393 after de-duplication. 238 records were excluded after reviewing the title and/or abstract. 157 records were identified for full text screening, with 3 unavailable [ 31 , 32 , 33 ]. 82 records were excluded at full text stage and 72 records were included for analysis. See Fig.  1 for the PRISMA flowchart.

PRISMA flow diagram of record identification

Record characteristics

Of the 72 included records, 53 were empirical studies [ 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 ], 10 non-systematic reviews [ 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 ], 7 systematic reviews [ 12 , 13 , 14 , 97 , 98 , 99 , 100 ], 1 systematic review protocol [ 101 ], and 1 non-systematic review protocol [ 102 ]. Of the 53 empirical studies, 42 (79%) were qualitative studies [ 34 , 35 , 36 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 47 , 48 , 50 , 51 , 52 , 54 , 55 , 56 , 57 , 58 , 60 , 62 , 63 , 64 , 65 , 66 , 67 , 69 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 79 , 80 , 81 , 83 , 84 , 85 , 86 ], 6 (12%) used a mixed methods approach [ 45 , 46 , 53 , 59 , 61 , 68 ], and 5 (10%) were quantitative [ 37 , 49 , 70 , 78 , 82 ]. 7/56 empirical studies, all qualitative interview studies, recruited participants internationally with no specific location stated [ 40 , 54 , 55 , 58 , 60 , 63 , 73 ]. Of the remaining studies, all but one were single-country studies: Botswana [ 75 ], Canada [ 41 , 65 ], China [ 57 ], Denmark [ 39 , 43 ], Dominican Republic [ 44 ], Germany [ 51 , 84 ], India [ 61 ], Iran [ 38 , 46 , 49 , 68 , 70 , 71 , 72 , 78 , 82 , 98 ], Italy [ 45 ], Mexico [ 87 ], the Netherlands [ 76 ], New Zealand [ 47 ], Norway [ 42 , 52 , 56 , 64 , 80 , 81 , 83 ], Saudi Arabia [ 34 , 35 , 36 , 37 ], Tanzania [ 69 , 74 ], Uganda [ 67 ], UK [ 86 ], and USA [ 50 , 53 , 59 , 62 , 66 , 77 , 79 , 85 , 85 ]. The remaining study was undertaken in both Sierra Leone and the UK [ 48 ]. See Table 2 for a summary.

12/72 (17%) of retrieved studies offered an explicit definition for ‘ethical challenge(s)’ [ 12 , 13 , 14 , 48 , 50 , 56 , 57 , 66 , 69 , 81 , 98 , 101 ]. Definitions were more likely to be found in more recent publications, with 4/12 included studies published in 2016–2018 [ 14 , 48 , 56 , 81 ], and 8/12 published in 2019–2021 [ 12 , 13 , 50 , 57 , 66 , 69 , 98 , 101 ]. The included study locations were evenly distributed, matching the overall pattern of retrieved studies, with studies from high- [ 48 , 50 , 56 , 66 , 81 ], middle- [ 57 , 98 ], and low-income settings [ 48 , 69 ]. The identified studies included eight qualitative studies [ 48 , 50 , 56 , 57 , 66 , 69 , 81 , 98 ], 3 systematic reviews [ 12 , 13 , 14 ], and 1 systematic review protocol [ 101 ]. Two of these records were the systematic review protocol and the report from our group, which accordingly contained the same definition [ 12 , 101 ], leaving 11 unique definitions. Definitions of ‘ethical challenge(s)’ identified in included studies are provided in Table 3 . Additionally, 68/72 (94%) reports used closely related terms synonymously in place of ‘ethical challenge(s)’ throughout their manuscript text, with between 1 and 8 different terms used within each report, and 32 different terms were identified. This occurred in both those reports that contained a definition and those that did not. See Table 4 for terms and frequencies.

Those records that offered explicit definitions used four approaches: (1) definition through concepts [ 12 , 57 , 66 ]; (2) reference to moral conflict, moral uncertainty or difficult choices [ 13 , 14 , 48 , 57 , 69 , 98 ]; (3) definition by study participants [ 12 , 48 , 50 , 56 ]; or (4) challenges as linked to their ability to generate emotional or moral distress within healthcare practitioners [ 14 , 14 , 66 , 81 ]. Each definition was associated with one or more of the identified elements, although none covered all four approaches. We describe these approaches below.

Approach 1: definition through concepts

This approach involves primarily defining ‘ethical challenge(s)’ in terms of related concepts. All three definitions using this approach defined ‘ethical challenge(s)’ as a summative collection of related concepts, including ‘ethical dilemmas’, ‘moral dilemmas’, ‘moral challenges’, ‘ethical issues’, and ‘ethical conflicts’ [ 12 , 57 , 66 ], for example:

‘The expression “ethical challenges” mainly refers to ethical dilemmas and ethical conflicts as well as other scenarios where difficult choices have to be made’ [ 57 ] p34

Only one went on to define the other concepts they utilised, ‘ethical dilemmas’ and ‘ethical conflicts’:

‘Ethical dilemmas are described as situations that cannot be solved; decisions made between two options may be morally plausible but are equally problematic due to the circumstances. Ethical conflicts, on the contrary, arise when one is aware of the necessity of proper actions but he or she may have trouble exercising these actions because of certain internal or external factors.’ [ 57 ] p34

Approach 2: moral conflict, moral uncertainty or difficult choices

This approach anchors an ethical challenge to the requirement for an agent to make a (difficult) choice in a situation where moral principles conflict, or there is moral uncertainty as to the ‘right’ way forward.

‘In this context, ethical challenge refers to the situation whereby every alternative is morally wrong and still one has to make a choice’ [ 69 ] p676 ‘An ethical challenge occurs when one does not know how to behave and act in the best way…’ [ 14 ] p93

Approach 3: definition by study participants

Four of the definitions involved research participants themselves defining something as an ‘ethical challenge’ [ 12 , 48 , 50 , 56 ], with three studies explicitly stating that participants would lead this definitional work [ 48 , 50 , 56 ]. Draper & Jenkins offer a starting definition, adopted from Schwartz et al. [ 103 ] with which to prime participants, while Forbes and Phillips [ 50 ] and Jakobsen and Sørlie [ 56 ] left the definition fully with their participants (Table 3 ). Finally, Schofield et al. proposed a very broad definition (Table 3 ), alongside the specific statement that either participants or researchers could nominate something as an ‘ethical challenge’ [ 12 ].

Approach 4: emotional or moral distress

This final approach was to tie ethical challenges to situations where participants feel ‘discomfort’, emotional distress or more specifically moral distress or moral residue [ 14 , 66 , 81 ]. Larkin et al. are clear that this distress must be tied to moral causes, but Hem et al. and Storaker et al. also refer more broadly to ‘discomfort’ [ 14 ] and ‘emotional stress’ [ 81 ] respectively. For example:

‘In this article, ethical challenges refer to values that entail emotional and moral stress in healthcare personnel.’ [ 81 ] p557

To the authors’ knowledge, this is the first rapid review to examine the use of the term ‘ethical challenge(s)’ in empirical healthcare research literature. Notably, only 12/72 (17%) of included studies published in the last 5 years contained a definition for ‘ethical challenge(s)’, despite this being the focus of the research being reported. The definitions identified were found in qualitative studies and systematic reviews and were evenly distributed geographically across high-, middle- and low-income settings. Definitions contained one or more of the identified approaches, although none contained elements from all four. Taken together, these findings suggest that a clear definition of ‘ethical challenge(s)’, and consistent use thereof, is currently lacking.

The four approaches indicate the diverse approaches to understanding ‘ethical challenge(s)’. Approaches 1 and 2 explore the concept from opposite viewpoints, with approach 1 looking from the conceptual perspective, through terms such as ‘dilemmas’ and ‘conflict’, and approach 2 from a participant perspective, specifically in those situations in which someone is trying to make a decision in circumstances where the preferred option is not possible or when they perceive there to be clash in values they feel are important. Within the concept-led definitions (approach 1), the use of a plurality of terms highlights a potential risk of bias, as different readers may interpret these differently. For example, some terms, such as ‘moral dilemma’, have relatively well understood specific meanings for some readers, particularly those with philosophical training [ 104 , 105 , 106 ]. The presence in the literature of specific and multiple meanings for some related terms highlights the importance of empirical studies providing a definition of these additional terms alongside their primary definition for ‘ethical challenge(s)’. This is more likely to be relevant where an a priori definition is used, but may be relevant to any prompting text for studies using a participant-led process, as in the study by Draper and Jenkins [ 48 ]. This clarity is important for both readers and future researchers who may undertake a secondary analysis of the data.

Approach 3 involves facilitating participants to nominate something as an ethical challenge [ 12 , 48 , 50 , 56 ]. This speaks to an important question about who, in a research context, is permitted to define or describe the object of interest, in this case ‘ethical challenge(s)’. Restricting the identification of ‘ethical challenge(s)’ to researchers alone may introduce bias by excluding input from those without bioethical ‘expertise’, but with important lived experience of the context under investigation. There is evidence that although clinicians can be sensitive to major ethical dilemmas, they can be less sensitive to small everyday ethical elements in clinical practice, and that ethical awareness varies between individuals [ 107 , 108 ]. Additionally, there is evidence in healthcare ethics research that patients and carers identify ethical challenges in situations that healthcare workers do not [ 109 ]. Therefore, relying entirely on a particular stakeholders’ perspectives (such as clinicians’) may risk missing important ethical challenges present in a scenario (assuming, of course, that we can settle what counts as an ‘ethical challenge(s)’).

In Approach 4, ethical challenges were linked to situations in which participants felt discomfort [ 14 ], emotional stress [ 81 ], moral distress or moral residue [ 66 ]. These concepts are themselves defined in quite varied ways (see, for example, definitions of ‘moral distress’ in a systematic review by Morley et al. [ 110 ]), potentially leading to additional conceptual confusion. Identifying triggers for moral distress is important, as high levels of moral distress are known to have negative impacts on work environments and lead to increased levels of compassion fatigue, increased staff turnover rates and poorer patient outcomes [ 110 , 111 , 112 ]. However, it is also possible that the requirement that, to be identified as an ethical challenge, the situation must invoke stress or distress might result in the under-identification of ethical challenges. We anticipate that many practitioners will daily manage multiple low-level ethical challenges, many of which will not generate moral distress or leave a moral residue. As such, the presence of moral distress may not be sufficient or even necessary in order to label a moral event an ‘ethical challenge’. However, the relationship between ‘ethical challenge(s)’ and moral distress is complex, and some might argue that the latter has an important relationship to the former. For example, moral distress, as conceived by Jameton and others [ 110 , 113 , 114 ], is linked to the after-effects of having to handle ethical challenge(s), so some researchers might view the generation of moral distress as relevant to identifying ethical challenges.

Although our review revealed these four approaches, the wider literature indicates there may be alternative approaches available. For example, other potential approaches would define ethical challenges as events that interact with moral principles, such as autonomy, beneficence, non-maleficence or justice, as proposed by Beauchamp and Childress [ 115 ], or as events in which those principles clash, for example as used by Klingler et al. in their research focusing on ethical issues in health surveillance [ 116 ]. However, these approaches were not seen amongst our included papers.

Returning to our included papers, the high rates of use of closely related terms within included manuscript texts may add to difficulties in understanding the exact object of interest if these terms are being used as synonyms for ‘ethical challenge(s)’. This may be particularly the case if terms used include those such as ‘moral dilemma’, which (as shown above) will have specific meanings for some readers. Interchangeable, undefined usage of these terms by study authors within study texts risks further exacerbating the problems caused by a lack of definitional clarity.

Strengths and limitations

This rapid review is the first systematic attempt to describe the definitions of ‘ethical challenge(s)’ available within the recent published literature.

There are, however, five limitations to note. First, the review only includes results from the past 5 years, which inevitably means that older publications, which may have contained further definitions of ‘ethical challenge(s)’, were excluded. The focus on the previous 5 years does, however, allow for an assessment of the term’s use(s) within a reasonable period of time and was felt to be appropriate given the aims and resources available to this project.

Second, our three assumptions listed in the methodology section may have excluded some records that contained a relevant definition. However, these assumptions, and the resulting focus on two search terms, allowed for a balance between retrieved record numbers and team resources.

Third, the four databases searched were chosen for their focus on the healthcare ethics literature; we may therefore may have missed relevant usage in other fields or disciplines. Similarly, we did not search the grey literature, which might have excluded relevant research.

Fourth, for resource reasons, the assessment as to whether a related term was being used interchangeably in the text was undertaken by a single researcher (GS). This subjective assessment risks miscalculating both the number of interchangeable terms identified and the frequency counts.

Finally, we did not review the theoretical literature for conceptual definitions of ‘ethical challenge(s)’, hence the definitions we identified might not match completely conceptual understandings of the term. However, our review shows how the term is currently being used in the research literature. Indeed, if there are strong conceptual definitions within the theoretical literature, then it is clear that they are currently not reaching the researchers whose work was identified by our review.

This review is the first, to our knowledge, to identify and describe definitions (and uses) of the widely-utilised concept of ‘ethical challenge(s)’ within healthcare research. Only 17% (12/72) of retrieved papers presented an explicit definition of ‘ethical challenge(s)’ before beginning to investigate this concept in context. The definitions found contained one or more of four identified approaches, with significant cross-reference to related terms and concepts which themselves have variation in their accepted meanings. We recommend that researchers define the phenomenon of interest—in this case, ‘ethical challenge(s)’—to help ensure clarity. This should either be a priori, or, if using an approach that includes participant participation in the generation of the definition, reporting their final working definition a posteriori. The choice of definition should be justified, including the decision as to whether to include participants in this process. Additionally, if a definition references other conceptual terms, then consideration should be given to defining these as well.

The results of this rapid review suggest that a common conceptual understanding of the term ‘ethical challenge(s)’ is lacking within empirical bioethical research and that there is a need for researchers in this area to consider what conceptual formulations might be most useful. Again, failure to use definitions of crucial research concepts within empirical bioethics research potentially generates confusion and avoidable bias within research outputs, risking misleading ethical analyses, evaluations, and resulting recommendations. We therefore hope this review will help stimulate debate amongst empirical bioethics researchers on possible definitional content for such a commonly used term and prompt further discussion and research. Additionally, given the central role of patient and public partnership and involvement in research, further thought should be given to who should be involved in nominating something as a challenge worthy of study.

Following on from this work, there would be value in conducting an empirical bioethical project combining a full systematic review of definitions of ‘ethical challenge(s)’ (and related terms) integrated with an exploration of the conceptual literature to generate recommendations for approaches towards the content of potential definitions, perhaps related to the identified approaches above. Such a project could also ask authors who currently use the term ‘ethical challenge(s)’ in their research how they conceptualise this. Furthermore, work to better understand the benefits of including study participants in the definition process is also important. Finally, whilst researchers should justify whatever approach they choose to take, there may be merit in examining whether anything is lost if studies lack a robust or agreed definition, or whether doing so affords a flexibility and openness that allows for a broader range of ethical challenges to be identified.

Availability of data and materials

All data is presented in this manuscript.

Critical Appraisal Skills Programme. CASP Qualitative Checklist. 2018. https://casp-uk.net/wp-content/uploads/2018/01/CASP-Qualitative-Checklist.pdf . Accessed 16 Aug 2018.

Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups | The EQUATOR Network. https://www.equator-network.org/reporting-guidelines/coreq/ . Accessed 2 Apr 2020.

Standards for reporting qualitative research: a synthesis of recommendations | The EQUATOR Network. https://www.equator-network.org/reporting-guidelines/srqr/ . Accessed 2 Apr 2020.

Lewin S, Booth A, Glenton C, Munthe-Kaas H, Rashidian A, Wainwright M, et al. Applying GRADE-CERQual to qualitative evidence synthesis findings: introduction to the series. Implement Sci. 2018;13:2.

Article   Google Scholar  

The EQUATOR Network | Enhancing the QUAlity and Transparency of Health Research. https://www.equator-network.org/ . Accessed 2 Apr 2020.

Garritty C, Gartlehner G, Nussbaumer-Streit B, King VJ, Hamel C, Kamel C, et al. Cochrane Rapid Reviews Methods Group offers evidence-informed guidance to conduct rapid reviews. J Clin Epidemiol. 2021;130:13–22.

Singh I. Evidence, epistemology and empirical bioethics. In: Cribb A, Ives J, Dunn M, editors. Empirical bioethics: theoretical and practical perspectives. Cambridge: Cambridge University Press; 2016. p. 67–83. https://doi.org/10.1017/9781139939829.006 .

Chapter   Google Scholar  

Ives J, Dunn M, Molewijk B, Schildmann J, Bærøe K, Frith L, et al. Standards of practice in empirical bioethics research: towards a consensus. BMC Med Ethics. 2018;19:68.

Mertz M, Inthorn J, Renz G, Rothenberger LG, Salloch S, Schildmann J, et al. Research across the disciplines: a road map for quality criteria in empirical ethics research. BMC Med Ethics. 2014;15:17.

Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4:1.

Cronin P, Ryan F, Coughlan M. Concept analysis in healthcare research. Int J Ther Rehabil. 2010;17:62–8.

Schofield G, Dittborn M, Huxtable R, Brangan E, Selman LE. Real-world ethics in palliative care: a systematic review of the ethical challenges reported by specialist palliative care practitioners in their clinical practice. Palliat Med. 2021;35:315–34.

Heggestad AKT, Magelssen M, Pedersen R, Gjerberg E. Ethical challenges in home-based care: a systematic literature review. Nurs Ethics. 2020;28:628–44.

Hem MH, Gjerberg E, Husum TL, Pedersen R. Ethical challenges when using coercion in mental healthcare: a systematic literature review. Nurs Ethics. 2018;25:92–110.

Lillemoen L, Pedersen R. Ethical challenges and how to develop ethics support in primary health care. Nurs Ethics. 2013;20:96–108.

Saarni SI, Halila R, Palmu P, Vänskä J. Ethically problematic treatment decisions in different medical specialties. J Med Ethics. 2008;34:262–7.

Self D, Skeel J, Jecker N. A comparison of the moral reasoning of physicians and clinical medical ethicists. Acad Med. 1993;68:852–5.

Ganann R, Ciliska D, Thomas H. Expediting systematic reviews: methods and implications of rapid reviews. Implement Sci IS. 2010;5:56.

Cameron A. Rapid versus full systematic reviews: an inventory of current mathods and practice in health technology assessment. Stepney: Royal Australasian College of Dental Surgeons; 2007.

Google Scholar  

Tricco AC, Antony J, Zarin W, Strifler L, Ghassemi M, Ivory J, et al. A scoping review of rapid review methods. BMC Med. 2015;13:224.

Haby MM, Chapman E, Clark R, Barreto J, Reveiz L, Lavis JN. What are the best methodologies for rapid reviews of the research evidence for evidence-informed decision making in health policy and practice: a rapid review. Health Res Policy Syst. 2016;14:83.

Gough D, Thomas J, Oliver S. Clarifying differences between review designs and methods. Syst Rev. 2012;1:28.

Watt A, Cameron A, Sturm L, Lathlean T, Babidge W, Blamey S, et al. Rapid reviews versus full systematic reviews: an inventory of current methods and practice in health technology assessment. Int J Technol Assess Health Care. 2008;24:133–9.

Khangura S, Konnyu K, Cushman R, Grimshaw J, Moher D. Evidence summaries: the evolution of a rapid review approach. Syst Rev. 2012;1:10.

Stevens A, Garritty C, Hersi M, Moher D. Developing PRISMA-RR, a reporting guideline for rapid reviews of primary studies (Protocol). 2018. https://www.equator-network.org/wp-content/uploads/2018/02/PRISMA-RRprotocol.pdf . Accessed 6 Oct 2019.

Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.

PROSPERO: International prospective register of systematic reviews. https://www.crd.york.ac.uk/prospero/ . Accessed 10 June 2021.

Strech D, Synofzik M, Marckmann G. Systematic reviews of empirical bioethics. J Med Ethics. 2008;34:472–7.

The Endnote Team. Endnote X9.2. Philadelphia, PA: Clarivate Analysis; 2013.

Hsieh H-F, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15:1277–88.

Khalili M. Iranian nurses’ ethical challenges in controlling children’s fever. Int J Pharm Res. 2018;10:337–40.

Rezaee N. Ethical challenges in cancer care: a qualitative analysis of nurses’ perceptions. Res Theory Nurs Pract. 2019;33:169–82.

Bartnik E. Ethical challenges in genetics. J Med Liban. 2019;67:138–40.

Alahmad G, Aljohani S, Najjar MF. Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC Med Ethics. 2020;21:1–7.

Alahmad G, Al-Kamli H, Alzahrani H. Ethical challenges of pediatric cancer care: interviews with nurses in Saudi Arabia. Cancer Control. 2020;27:1073274820917210.

Alahmad G, Richi H, BaniMustafa A, Almutairi AF. Ethical challenges related to the novel coronavirus (COVID-19) outbreak: interviews with professionals from Saudi Arabia. Front Med. 2021. https://doi.org/10.3389/fmed.2021.620444 .

Alahmad G, AlSaqabi M, Alkamli H, Aleidan M. Ethical challenges in consent procedures involving pediatric cancer patients in Saudi Arabia: an exploratory survey. Dev World Bioeth. 2021. https://doi.org/10.1111/dewb.12308 .

Bijani M, Mohammadi F. Ethical challenges of caring for burn patients: a qualitative study. BMC Med Ethics. 2021;22:1–10.

Bladt T, Vorup-Jensen T, Sædder E, Ebbesen M. Empirical investigation of ethical challenges related to the use of biological therapies. J Law Med Ethics. 2020;48:567–78.

Boulanger RF, Komparic A, Dawson A, Upshur REG, Silva DS. Developing and implementing new TB technologies: key informants’ perspectives on the ethical challenges. J Bioeth Inq. 2020;17:65–73.

Bourbonnais A, Rousseau J, Lalonde M-H, Meunier J, Lapierre N, Gagnon M-P. Conditions and ethical challenges that could influence the implementation of technologies in nursing homes: a qualitative study. Int J Older People Nurs. 2019;14:e12266.

Brodtkorb K, Skisland AV-S, Slettebø Å, Skaar R. Preserving dignity in end-of-life nursing home care: some ethical challenges. Nord J Nurs Res. 2017;37:78–84.

Bruun H, Lystbaek SG, Stenager E, Huniche L, Pedersen R. Ethical challenges assessed in the clinical ethics Committee of Psychiatry in the region of Southern Denmark in 2010–2015: a qualitative content analyses. BMC Med Ethics. 2018;19:62.

Canario Guzmán JA, Espinal R, Báez J, Melgen RE, Rosario PAP, Mendoza ER. Ethical challenges for international collaborative research partnerships in the context of the Zika outbreak in the Dominican Republic: a qualitative case study. Health Res Policy Syst. 2017;15:82.

Carnevale F, Delogu B, Bagnasco A, Sasso L. Correctional nursing in Liguria, Italy: examining the ethical challenges. J Prev Med Hyg. 2018;59:E315.

Delpasand K, Nazari Tavakkoli S, Kiani M, Abbasi M, Afshar L. Ethical challenges in the relationship between the pharmacist and patient in Iran. Int J Hum Rights Healthc. 2020;13:317–23.

Donnelly S, Walker S. Enabling first and second year doctors to negotiate ethical challenges in end-of-life care: a qualitative study. BMJ Support Palliat Care. 2021. https://doi.org/10.1136/bmjspcare-2020-002672 .

Draper H, Jenkins S. Ethical challenges experienced by UK military medical personnel deployed to Sierra Leone (operation GRITROCK) during the 2014–2015 Ebola outbreak: a qualitative study. BMC Med Ethics. 2017;18:77.

Ebrahimi A, Ebrahimi S. Pediatric residents’ and attending physicians’ perspectives on the ethical challenges of end of life care in children. J Med Ethics Hist Med. 2018;11:16.

Forbes S, Phillips C. Ethical challenges encountered by clinical trials nurses: a grounded theory study. Oncol Nurs Forum. 2020;47:428–35.

Gágyor I, Heßling A, Heim S, Frewer A, Nauck F, Himmel W. Ethical challenges in primary care: a focus group study with general practitioners, nurses and informal caregivers. Fam Pract. 2019;36:225–30.

Haugom W, Ruud E, Hynnekleiv T. Ethical challenges of seclusion in psychiatric inpatient wards: a qualitative study of the experiences of Norwegian mental health professionals. BMC Health Serv Res. 2019;19:879.

Hawking M, Kim J, Jih M, Hu C, Yoon JD. “Can virtue be taught?”: a content analysis of medical students’ opinions of the professional and ethical challenges to their professional identity formation. BMC Med Educ. 2020;20:380.

Hyder A, Krubiner C. Ethical challenges in designing and implementing health systems research: experiences from the field. AJOB Empir Bioeth. 2016;7:209–17.

Jackson C, Gardy JL, Shadiloo HC, Silva DS. Trust and the ethical challenges in the use of whole genome sequencing for tuberculosis surveillance: a qualitative study of stakeholder perspectives. BMC Med Ethics. 2019;20:43.

Jakobsen R, Sørlie V. Ethical challenges: trust and leadership in dementia care. Nurs Ethics. 2016;23:636–45.

Jia Y, Chen O, Xiao Z, Xiao J, Bian J, Jia H. Nurses’ ethical challenges caring for people with COVID-19: a qualitative study. Nurs Ethics. 2021;28:33–45.

Kalkman S, van Thiel GJMW, Grobbee DE, Meinecke A-K, Zuidgeest MGP, van Delden JJM, et al. Stakeholders’ views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs. Trials. 2016;17:419.

Kasper J, Mulye A, Doobay-Persaud A, Seymour B, Nelson BD. Perspectives and solutions from clinical trainees and mentors regarding ethical challenges during global health experiences. Ann Glob Health. 2020;86:34.

Kelley MC, Brazg T, Wilfond BS, Lengua LJ, Rivin BE, Martin-Herz SP, et al. Ethical challenges in research with orphans and vulnerable children: a qualitative study of researcher experiences. Int Health. 2016;8:187–96.

Kemparaj VM, Panchmal GS, Kadalur UG. The top 10 ethical challenges in dental practice in indian scenario: dentist perspective. Contemp Clin Dent. 2018;9:97.

Klitzman R. Unconventional combinations of prospective parents: ethical challenges faced by IVF providers. BMC Med Ethics. 2017;18:18.

Komparic A, Dawson A, Boulanger RF, Upshur REG, Silva DS. A failure in solidarity: ethical challenges in the development and implementation of new tuberculosis technologies. Bioethics. 2019;33:557–67.

Laholt H, McLeod K, Guillemin M, Beddari E, Lorem G. Ethical challenges experienced by public health nurses related to adolescents’ use of visual technologies. Nurs Ethics. 2019;26:1822–33.

Laliberté M, Williams-Jones B, Feldman DE, Hunt M. Ethical challenges for patient access to physical therapy: views of staff members from three publicly-funded outpatient physical therapy departments. Narrat Inq Bioeth. 2017;7:157–69.

Larkin ME, Beardslee B, Cagliero E, Griffith CA, Milaszewski K, Mugford MT, et al. Ethical challenges experienced by clinical research nurses: a qualitative study. Nurs Ethics. 2019;26:172–84.

Mbalinda SN, Bakeera-Kitaka S, Amooti DL, Magongo EN, Musoke P, Kaye DK. Ethical challenges of the healthcare transition to adult antiretroviral therapy (ART) clinics for adolescents and young people with HIV in Uganda. BMC Med Ethics. 2021;22:1–14.

Mehdipour Rabori R, Dehghan M, Nematollahi M. Nursing students’ ethical challenges in the clinical settings: a mixed-methods study. Nurs Ethics. 2019;26:1983–91.

Mlughu TS, Anaeli A, Joseph R, Sirili N. Voluntary HIV counseling and testing among commercial motorcyclist youths: an exploration of ethical challenges and coping mechanisms in Dar es Salaam. HIVAIDS - Res Palliat Care. 2020;12:675–85.

Moeini S, Shahriari M, Shamali M. Ethical challenges of obtaining informed consent from surgical patients. Nurs Ethics. 2020;27:527–36.

Naseri-Salahshour V, Sajadi M. Ethical challenges of novice nurses in clinical practice: Iranian perspective. Int Nurs Rev. 2020;67:76–83.

Naseri-Salahshour V, Sajadi M. From suffering to indifference: reaction of novice nurses to ethical challenges in first year of clinical practice. Iran J Nurs Midwifery Res. 2019;24:251.

Nicholls SG, Carroll K, Zwarenstein M, Brehaut JC, Weijer C, Hey SP, et al. The ethical challenges raised in the design and conduct of pragmatic trials: an interview study with key stakeholders. Trials. 2019;20:765.

Pancras G, Shayo J, Anaeli A. Non-medical facilitators and barriers towards accessing haemodialysis services: an exploration of ethical challenges. BMC Nephrol. 2018;19:342.

Sabone M, Mazonde P, Cainelli F, Maitshoko M, Joseph R, Shayo J, et al. Everyday ethical challenges of nurse-physician collaboration. Nurs Ethics. 2020;27:206–20.

Seekles W, Widdershoven G, Robben P, van Dalfsen G, Molewijk B. Inspectors’ ethical challenges in health care regulation: a pilot study. Med Health Care Philos. 2017;20:311–20.

Segal AG, Frasso R, Sisti DA. County jail or psychiatric hospital? Ethical challenges in correctional mental health care. Qual Health Res. 2018;28:963–76.

Shayestefar S, Hamooleh MM, Kouhnavard M, Kadivar M. Ethical challenges in pediatrics from the viewpoints of Iranian pediatric residents. J Compr Pediatr. 2018. https://doi.org/10.5812/compreped.62747 .

Sinow C, Burgart A, Char DS. How anesthesiologists experience and negotiate ethical challenges from drug shortages. AJOB Empir Bioeth. 2020;12:84–91.

Slettebø Å, Skaar R, Brodtkorb K, Skisland A. Conflicting rationales: leader’s experienced ethical challenges in community health care for older people. Scand J Caring Sci. 2018;32:645–53.

Storaker A, Nåden D, Sæteren B. From painful busyness to emotional immunization: nurses’ experiences of ethical challenges. Nurs Ethics. 2017;24:556–68.

Taebi M, Bahrami R, Bagheri-Lankarani N, Shahriari M. Ethical challenges of embryo donation in embryo donors and recipients. Iran J Nurs Midwifery Res. 2018;23:36.

Tønnessen S, Solvoll B-A, Brinchmann BS. Ethical challenges related to next of kin - nursing staffs’ perspective. Nurs Ethics. 2016;23:804–14.

Ullrich A, Theochari M, Bergelt C, Marx G, Woellert K, Bokemeyer C, et al. Ethical challenges in family caregivers of patients with advanced cancer—a qualitative study. BMC Palliat Care. 2020;19:1–13.

Verma A, Smith AK, Harrison KL, Chodos AH. Ethical challenges in caring for unrepresented adults: a qualitative study of key stakeholders. J Am Geriatr Soc. 2019;67:1724–9.

Morley G, Ives J, Bradbury-Jones C. Moral distress and austerity: an avoidable ethical challenge in healthcare. Health Care Anal. 2019;27:185–201.

Ayala-Yáñez R, Ruíz-López R, McCullough LB, Chervenak FA. Violence against trainees: urgent ethical challenges for medical educators and academic leaders in perinatal medicine. J Perinat Med. 2020;48:728–32.

Binns C, Lee M, Kagawa M. Ethical challenges in infant feeding research. Nutrients. 2017;9:59.

Čartolovni A, Habek D. Guidelines for the management of the social and ethical challenges in brain death during pregnancy. Int J Gynecol Obstet. 2019;146:149–56.

Hofmann B. Informing about mammographic screening: ethical challenges and suggested solutions. Bioethics. 2020;34:483–92.

Hunt M, Pal NE, Schwartz L, O’Mathúna D. Ethical challenges in the provision of mental health services for children and families during disasters. Curr Psychiatry Rep. 2018;20:60.

Johnson S, Parker M. Ethical challenges in pathogen sequencing: a systematic scoping review. Wellcome Open Res. 2020;5:119.

MacDonald S, Shemie S. Ethical challenges and the donation physician specialist: a scoping review. Transplantation. 2017. https://doi.org/10.1097/TP.0000000000001697 .

Saigle V, Racine E. Ethical challenges faced by healthcare professionals who care for suicidal patients: a scoping review. Monash Bioeth Rev. 2018;35:50–79.

Saigle V, Séguin M, Racine E. Identifying gaps in suicide research: a scoping review of ethical challenges and proposed recommendations. IRB Ethics Hum Res. 2017;39:1–9.

Wilson E, Kenny A, Dickson-Swift V. Ethical challenges in community-based participatory research: a scoping review. Qual Health Res. 2018;28:189–99.

Martins Pereira S, Hernández-Marrero P. Ethical challenges of outcome measurement in palliative care clinical practice: a systematic review of systematic reviews. Ann Palliat Med. 2018;7:S207–18.

Saghafi A, Bahramnezhad F, Poormollamirza A, Dadgari A, Navab E. Examining the ethical challenges in managing elder abuse: a systematic review. J Med Ethics Hist Med. 2019. https://doi.org/10.18502/jmehm.v12i7.1115 .

West E, Stuckelberger A, Pautex S, Staaks J, Gysels M. Operationalising ethical challenges in dementia research—a systematic review of current evidence. Age Ageing. 2017;46:678–87.

Ewuoso C, Hall S, Dierickx K. How do healthcare professionals respond to ethical challenges regarding information management? A review of empirical studies. Glob Bioeth. 2021;32:67–84.

Schofield G, Brangan E, Dittborn M, Huxtable R, Selman L. Real-world ethics in palliative care: protocol for a systematic review of the ethical challenges reported by specialist palliative care practitioners in their clinical practice. BMJ Open. 2019;9:e028480.

Sun W, Wilson MG, Schreiber D, Wang RH. Ethical challenges related to assistive product access for older adults and adults living with a disability: a scoping review protocol. Syst Rev. 2017;6:24.

Schwartz L, Sinding C, Hunt M, Elit L, Redwood-Campbell L, Adelson N, et al. Ethics in humanitarian aid work: learning from the narratives of humanitarian health workers. AJOB Prim Res. 2010;1:45–54.

McConnell T. Moral Dilemmas. In: Zalta EN, editor. The Stanford Encyclopedia of Philosophy. Fall 2018. Metaphysics Research Lab, Stanford University; 2018. https://plato.stanford.edu/archives/fall2018/entries/moral-dilemmas/ . Accessed 30 Oct 2019.

Tessman L. Moral failure: on the impossible demands of morality. New York, NY: Oxford University Press; 2014. http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=859724 . Accessed 5 Nov 2019.

Ejder Apay S, Gürol A, Gür EY, Church S. Midwifery students’ reactions to ethical dilemmas encountered in outpatient clinics. Nurs Ethics. 2020;27:1542–55.

Milliken A, Ludlow L, DeSanto-Madeya S, Grace P. The development and psychometric validation of the Ethical Awareness Scale. J Adv Nurs. 2018;74:2005–16.

Truog RD, Brown SD, Browning D, Hundert EM, Rider EA, Bell SK, et al. Microethics: the ethics of everyday clinical practice. Hastings Cent Rep. 2015;45:11–7.

Woods S, Beaver K, Luker K. User’s views of palliative care services: ethical implications. Nurs Ethics Int J Health Care Prof. 2000;7:314–26.

Morley G, Ives J, Bradbury-Jones C, Irvine F. What is ‘moral distress’? A narrative synthesis of the literature. Nurs Ethics. 2017;26:646–62.

Epstein EG, Hamric AB. Moral distress, moral residue, and the crescendo effect. J Clin Ethics. 2009;20:330–42.

Mason VM, Leslie G, Clark K, Lyons P, Walke E, Butler C, et al. Compassion fatigue, moral distress, and work engagement in surgical intensive care unit trauma nurses: a pilot study. Dimens Crit Care Nurs DCCN. 2014;33:215–25.

Jameton A. Nursing practice: the ethical issues. Englewood Cliffs: Prentice-Hall; 1984.

Tigard DW. The positive value of moral distress. Bioethics. 2019;33:601–8.

Beauchamp TL, Childress JF. Principles of biomedical ethics. New York: Oxford University Press; 1979.

Klingler C, Silva DS, Schuermann C, Reis AA, Saxena A, Strech D. Ethical issues in public health surveillance: a systematic qualitative review. BMC Public Health. 2017;17:295.

Solvoll B-A, Hall EO, Brinchmann BS. Ethical challenges in everyday work with adults with learning disabilities. Nurs Ethics. 2015;22:417–27.

Download references

Acknowledgements

Not applicable.

GS is supported by a Wellcome Trust Research Award for Health Professionals (208129/Z/17/Z). LES is funded by a Career Development Fellowship from the National Institute for Health Research. RH is part-funded by the Wellcome Trust (209841/Z/17/Z) and the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. He serves on various local, regional, and national ethics committees and related groups. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research, the Department of Health, or any of the other organisations with and for whom the authors work.

Author information

Authors and affiliations.

Centre for Ethics in Medicine, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK

Guy Schofield & Richard Huxtable

Paediatric Bioethics Centre, Great Ormond Street Hospital, London, WC1N 3JH, UK

Mariana Dittborn

Palliative and End of Life Care Research Group, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK

Guy Schofield & Lucy Ellen Selman

You can also search for this author in PubMed   Google Scholar

Contributions

GS, MD and RH conceived of the idea for the review; LES, GS, MD and RH designed the review protocol; GS and MD conducted the literature searching, screening, data extraction and led on data interpretation but all authors were involved; GS led on drafting the manuscript; all authors critically revised the manuscript for content and approved the version to be published. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Guy Schofield .

Ethics declarations

Ethics approval and consent to participate, consent for publication, competing interests.

The authors declare that there are no conflicts of interests.

Additional information

Publisher's note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ . The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Cite this article.

Schofield, G., Dittborn, M., Selman, L.E. et al. Defining ethical challenge(s) in healthcare research: a rapid review. BMC Med Ethics 22 , 135 (2021). https://doi.org/10.1186/s12910-021-00700-9

Download citation

Received : 10 June 2021

Accepted : 03 September 2021

Published : 29 September 2021

DOI : https://doi.org/10.1186/s12910-021-00700-9

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Ethical challenges
• Rapid review
• Empirical bioethics
• Moral dilemmas

BMC Medical Ethics

ISSN: 1472-6939

• General enquiries: [email protected]

• Technical Help
• CE/CME Help
• Billing Help
• Sales Inquiries

The Collaborative Institutional Training Initiative (CITI Program) is dedicated to serving the training needs of colleges and universities, healthcare institutions, technology and research organizations, and governmental agencies, as they foster integrity and professional advancement of their learners.

Explore Our Featured Courses

• Professional
• Other Offerings

This role-based course provides the practical know-how to monitor clinical research sites effectively.

Learn to recognize fraud, waste, and abuse.

Foundational overview of clinical research meant to prepare medical residents and fellows to conduct their own research and work on research teams.

Provides information on risks and threats to the global research ecosystem — and the knowledge and tools necessary to protect against these risks.

A systematic approach to preparing for and adjusting to risks associated with wilderness field research.

Examines mentorship in biomedical and behavioral research, which is critical to advancing science.

Browse all of the courses and series available from CITI Program.

Learn strategies for promoting equity, diversity, and inclusivity in clinical research participation.

A role-based course that provides practical know-how to effectively lead or participate on data monitoring committees.

Reviews best practices and challenges for navigating collaborative research partnerships in a global environment.

Learn ways to manage conflicts with your dissertation chair and committee.

Provides research administrators with strategies to build, improve, and retain employees.

Learn how grant stewardship obligations are a part of responsible conduct of research.

An introduction for students to the meaning of academic integrity and plagiarism.

Discusses ways to improve diversity and equity among clinical trial participants.

Explores the importance of ethics for AI companies and its impact on public trust and profitability.

This course provides learners with a review of contemporary bioethics issues.

This course focuses on developing the knowledge and skill base necessary for being a successful healthcare ethics committee member.

This course covers the core norms, principles, regulations, and rules governing the practice of research.

Explores various types of noncompliance and their impact.

Discusses the FDA’s approach to inspecting GMP facilities and the ways that facilities can prepare for inspections.

Discusses steps that investigators and clinical sites can take to understand and respond to an FDA Form 483.

A general overview of FMLA and special considerations for grant-funded research.

Provides learners with practical tips to make ADA, Section 504, and accommodations in the 21st century more accessible and equi...

Explores the use of drones in research and the regulations and requirements researchers and administrators need to know.

Helps develop leadership skills to meet today’s changing, diverse, and dynamic environments.

Discusses the importance of CRA soft skills in building productive relationships with sites and sponsors.

Introduces regulations and their application as they relate to subrecipient monitoring.

Provides learners with an overview on the state of faculty and staff mental health while explaining the role an institution can...

Provides instruction on how to improve your teaching and training skills in a variety of settings.

Provides an overview of conflict, types of conflict, conflict styles, communication styles, and intervention strategies.

N2 is a not-for-profit alliance of Canadian research networks and organizations working to enhance national clinical research capability and capacity.

BIC Study Foundation is a resource for those who want to take CITI Program courses in Korean. They are a certified training provider by the Korean FDA/MAFRA for HRPP and ACU Programs.

A complete research compliance suite that supports IRB, IACUC Conflict of interest, Bio Safety Export Control, and more.

HRP Consulting provides customized services for your research program, including temporary staffing, IRB/IACUC assistance, accreditation support, program evaluations, training/education and more.

CTrials helps grow sponsored research programs by taking on the many administrative challenges inherent in managing clinical trials.

Informed Consent Builder is a cloud-based platform that streamlines the process of managing and generating informed consent forms.

Protocol Builder is an online protocol writing and collaboration platform that also speed up your pre-review turnaround times.

Join Over 2,500 Subscribing Organizations

Highlighted below are just a few select subscribers & collaborators.

Meet A Few Of Our Expert Authors and Presenters

Our courses are built by over 150 highly qualified experts and rigorously peer reviewed to incorporate various perspectives and ensure accuracy, completeness, and overall quality.

William Hinchcliffe, MS

Bill Hinchcliffe serves as Radiation Safety Officer and Assistant Radiation Safety Officer for Bridgeport Hospital and Yale New Haven Hospital (YNHH), respectively. He has both his BS and MS in Health Physics from Purdue University and Idaho State University. Bill has been serving in his role at YNHH since 2010.

Sukrit Venkatagiri, PhD

Sukrit Venkatagiri is an Assistant Professor in the Department of Computer Science at Swarthmore College. His research interests are in social computing and mis/disinformation studies, where he explores the ethical design of technology.

Amber Grove, Esq

Since November 2022, Amber Grove has served as Title IX Coordinator at Pennsylvania State University. Previously a practicing attorney, she got her start in higher education in residence life and began assisting with Title IX investigations. She went on to serve in compliance oversight roles at private and public institutions.

Sarah Melton, PhD

As the Head of Digital Scholarship at Boston College, Sarah led a group that teaches technical topics. Her team facilitated data-driven research, project creation, and digital publishing. Now Sarah consults on topics related to digital scholarship, such as open access publishing. ​Sarah received her PhD from Emory University in 2017.

In Our Learners' Words

PhD Student

The course was short and well divided into sub-themes that were easy to understand and retain.

Clinical Research Assistant

Courses are great and very informative.

DSW Graduate Student

I enjoyed the comprehensive coverage of topics related to informed consent in the 21st century, including the use of technology in the consent process and federal guidance on multimedia tools and electronic consent forms.

Postdoctoral Associate

I thought that the videos dramatizing various possible scenarios added a great deal to the written material. I also appreciated the inclusion of references to relevant philosophical and historical scholarship on research and methodological ethics.

Courses Approved by Top Continuing Education Accreditors

CITI Program courses are approved for CME credits through the Albert Einstein Montefiore Continuing Professional Development Center (CPDC) . Albert Einstein College of Medicine-Montefiore Medical Center (Einstein) is accredited by the Joint Accreditation for Interprofessional Continuing Education to provide continuing education activities for healthcare professionals. Einstein is accredited to offer continuing education credit for the following professions: medicine, nursing, psychology, pharmacy, dentistry, optometry, social work, nutritional science, and athletic training.

CITI Program is also accredited by the International Accreditors for Continuing Education and Training (IACET) and offers IACET CEUs for its learning events that comply with the ANSI/IACET Continuing Education and Training Standard. IACET is recognized internationally as a standard development organization and accrediting body that promotes quality of continuing education and training.

Recent News & Articles

New Course and Series Available on Fraud, Waste, and Abuse

This new series combines our Federal Fraud and Abuse Laws course with a new course: Combating Medicare Parts C and D Fraud, Waste, and Abuse.

How HIPAA and FERPA Rules Affect School-Based Health Clinics

Overview Understanding the ins and outs of compliance with federal privacy and data protection regulations can be complicated for even the savviest of school administrators....

Free Live Webinar – At Risk Survey Research Design: Remaining Diligent

This webinar examines online survey research design considerations and risks from the perspectives of IRB members and researchers.

Privacy Overview

• Open access
• Published: 31 May 2024

Public involvement and engagement in scientific research and higher education: the only way is ethics?

• Claire Nollett 1 ,
• Matthias Eberl 2 , 3 ,
• Jim Fitzgibbon 4 ,
• Natalie Joseph-Williams 5 , 6 &
• Sarah Hatch 7  

Research Involvement and Engagement volume  10 , Article number:  50 ( 2024 ) Cite this article

580 Accesses

33 Altmetric

Metrics details

Involving and engaging the public in scientific research and higher education is slowly becoming the norm for academic institutions in the United Kingdom and elsewhere. Driven by a wide range of stakeholders including regulators, funders, research policymakers and charities public involvement and public engagement are increasingly seen as essential in delivering open and transparent activity that is relevant and positively impacts on our society. It is obvious that any activities involving and engaging members of the public should be conducted safely and ethically. However, it is not clear whether conducting activities ethically means they require ethical approval from a research ethics committee.

Although there is some guidance available from government organisations (e.g. the UK Health Research Authority) to suggest ethical approval is not required for such activities, requests from funders and publishers to have ethical approval in place is commonplace in the authors’ experience. We explore this using case studies from our own institution.

We conclude that any public-facing activity with the purpose to systemically investigate knowledge, attitudes and experiences of members of the public as research and as human participants requires prior approval from an ethics committee. In contrast, engaging and involving members of the public and drawing on lived experience to inform aspects of research and teaching does not. However, lack of clarity around this distinction often results in the academic community seeking ethical approval ‘just in case’, leading to wasted time and resources and erecting unnecessary barriers for public involvement and public engagement. Instead, ethical issues and risks should be appropriately considered and mitigated by the relevant staff within their professional roles, be it academic or a professional service. Often this can involve following published guidelines and conducting an activity risk assessment, or similar. Moving forward, it is critical that academic funders and publishers acknowledge the distinction and agree on an accepted approach to avoid further exacerbating the problem.

Plain English summary

Involving and engaging members of the public is recognised best practice in university research and teaching. Involvement and engagement activities (for instance, working with the public to design a research study) continue to increase in priority and are an important part of an academic’s role. However, there is often confusion amongst researchers and educators around whether involving the public in these activities requires prior ethical approval, similar to what would be the case when inviting members of the public to participate in a clinical research study, or to donate samples such as blood for experiments. As an example, sometimes researchers are asked for ethical approval by scientific journals when trying to publish the findings from their public involvement and engagement work, when in fact this is not needed. The ongoing uncertainty about the difference between actual research on one hand and public involvement and engagement on the other hand wastes precious time and resources, and is a barrier for scientists to working with the public. We have developed guidance for academic staff on when ethical approval is and is not required, using examples from our own experience. We wrote this article to bring awareness to this problem; share our views with the wider academic community; encourage discussion around the problem and possible solutions; and ultimately contribute to educating on when research ethics approval is needed, and when not.

Peer Review reports

Public involvement (PI) is ‘important, expected and possible in all types of health and social care research’ [ 1 ]. It is now commonly embedded and reported in health research papers in the UK, with approximately half mentioning public involvement activities [ 2 ]. Public engagement (PE) is also encouraged and recognised by funders and other stakeholders across the higher education sector to raise awareness, increase trust and transparency, share knowledge, foster learning and deliver positive impact to society [ 3 ].

In 2019, the UK Standards Partnership published the UK Standards for Public Involvement ‘to help researchers and organisations improve the quality and consistency of public involvement in health and care research’ [ 4 ], and a large knowledge base is developing around how to do public involvement well. However, PI is not without its challenges, as identified both in the literature e.g [ 5 ]. and through our own experience as academic researchers, professional services staff and members of several national public involvement committees. Key issues include how to efficiently pay and reimburse public contributors within organisations, how to effectively evaluate the impact, and how to provide inclusive opportunities and reach under-served groups to increase the diversity of those involved [ 6 ].

The Research Excellence Framework (REF) 2029, the UK’s national assessment of the quality of research produced by its higher education institutions held every 6–7 years, will see a 25% weighting of returns with respect to the social, economic and political influence of the research conducted. The 2029 round will in fact be the first REF assessment where impact will be measured as “ Engagement and Impact” (our emphasis), alongside an accompanying statement to evidence engagement and impact activity beyond case studies [ 7 ]. As with PI, researchers face challenges in delivering PE including achieving the inclusion of under-served communities [ 8 ] and how to evaluate impact [ 3 ].

With individual researchers and their host institutions increasingly embracing PI and PE as part of their research and scholarship activities, there is one issue that we have found particularly contentious with researchers, employers, funders and publishers across both involvement and engagement and that is the focus of this commentary: the role of ethical approval in PI and PE activity.

Public involvement, sometimes referred to as Patient & Public Involvement (PPI) in health and social care research, is defined as ‘research being carried out ‘with’ or ‘by’ members of the public, rather than ‘to’, ‘about’ or ‘for’ them’ [ 9 ]. PE, adopting the UK’s National Coordinating Centre for Public Engagement’s definition, is a ‘myriad of ways in which the activity and benefits of higher education and research can be shared with the public’ [ 10 ]. PE is by definition a two-way process, involving interaction and listening, with the goal of generating mutual benefit. Both PI and PE are distinct from human participation in research whereby a member of the public agrees via informed consent to be a participant in research, e.g. receiving a study intervention, donating samples or sharing lived experiences. Whilst health and social care research involving human participants requires approval from a research ethics committee (REC), PI and PE activities typically do not.

In the UK, ethical approval is granted by a REC under the auspices of the National Health Service (NHS) for research on patients or healthcare professionals, or a local review committee or panel for research that does not include NHS patients. In academic research, this would usually be a university or school REC (referred to here as an Institutional Review Board, IRB). Other countries may use different approaches but the general need for RECs to approve research with human participants is ubiquitous. With regard to public involvement, the UK Health Research Authority (HRA) that is responsible for all NHS RECs explicitly states that ‘You do not need to submit an application to a Research Ethics Committee in order to involve the public in the planning or the design stage of research, even if the people involved are patients’ [ 11 ]. This advice would also apply to university ethics committees. However, despite this clear distinction, we have encountered and become aware of situations in which investigators were asked to acquire ethical approval for activities with the public – including PI, PE and impact activities. This highlights a potential misunderstanding of the nature of PI and PE, and their role alongside research. Whilst either activity can raise ethical considerations for the individuals involved, the requests to acquire research ethics approval for PI and PE need to be challenged within the academic community to increase awareness, understanding of and best practice around these activities. Seeking unnecessary approval adds a heavy additional burden on researchers which effectively acts as a barrier to carrying out PI and PE; can significantly delay timely activities; and uses valuable resources.

We propose that the requests to gain ethical approval for PI and PE activities stem largely from three main issues.

Firstly, ‘grey’ areas, such as a blurring of the boundary between qualitative research and PI and PE activities, including confusion amongst the research community over the differences between research involvement, engagement and participation.

Secondly, a perception amongst the research community that it is best to seek ethical approval ‘just in case’ or to ‘be on the safe side’, e.g. if asked by journal editors when trying to publish, rather than complete appropriate risk assessments to address any ethical considerations when carrying out PI and PE.

And finally, lack of knowledge of an alternative recognised process on how to evidence that PI and PE activities with the public have been conducted in an ethical manner, if not approved by an NHS REC or local IRB.

Despite guidance indicating other ways to address ethical concerns in PI and PE [ 12 , 13 , 14 , 15 , 16 , 17 , 18 ], researchers, funders and publishers appear to be turning increasingly to university IRBs as the (perceived) ultimate arbiters of deciding ethical issues related to PI and PE activities. We see the need to highlight this as a growing problem and suggest ways the issues above can be overcome. We will firstly explore in more detail the distinction between qualitative research and PI and PE activities before outlining examples from our own experience around the three issues identified, and then proceeding to make recommendations for moving forwards.

Public involvement and engagement vs. qualitative research

Distinguishing between whether activities with members of the public constitute PI and PE or qualitative research (and therefore require ethical approval) is a particularly ‘grey’ area [ 19 ]. This is especially true when consulting with a number of people at one time in what is usually referred to as a ‘focus group’. Going forward, it may be helpful to distinguish between ‘focus groups’, which are used for research, and ‘discussion groups’ used for PI and PE [ 20 ].

Several authors and organisations have described the difference between the two activities and developed useful side-by-side comparisons [ 19 , 20 ]. In focus groups which are part of research, people attending are research participants who receive a standard Participant Information Sheet and provide informed consent. Their input will usually be recorded via an audio device, transcribed verbatim, treated as ‘data’, and systematically be analysed to answer a research question. For this, ethical approval is usually required. On the other hand, the contributions of people attending PI discussion groups will be recorded only as key points (e.g. a list of key themes emerging or key priorities discussed by the group in relation to a specific topic) to help shape and guide the research itself, such as agreeing which research outcome measures to use, helping to shape the intervention or the development of data collection materials like participant information sheets or interview guides. PI discussion groups do not require ethical approval but should be conducted in an ethical manner. Those involved should still be provided with information about the activity up front to ensure they are clear what their involvement will entail, and they may be asked to provide agreement or consent, but not in the formally documented way required for research. This is discussed in more detail in the recommendations.

Another grey area concerns whether direct quotes gathered from people in a discussion group can be used in a publication. Whilst ethical approval is not required for this, we do advise gaining documented agreement if you wish to do this, e.g. an email from the group member agreeing to quotes being used in a publication to illustrate the key points identified (not as data). In some cases, researchers will need to combine PI activities with a qualitative research approach and there may be confusion regarding which activities require approval. For example, an investigator may wish to interview new mothers as research participants to get their views on motherhood (research participation). This would require ethical approval. But prior to interviews, they may want to involve a separate group of new mothers in a discussion to help shape the topic guide for the interviews (PI). This would not need ethical approval [ 21 ].

The extent of the problem - examples from our own experience

Through requesting examples from colleagues on their experiences, we uncovered many different situations within our own institution highlighting a difference of opinion on whether research ethics should be sought for PI and PE activity. We here outline three examples, giving the background to the project, the activity undertaken and the issues encountered.

Writing a training program with charity service users and staff – request from charity and publication to seek ethical approval from the university IRB for the project .

This project involved service users and charity staff in writing a mental health training curriculum for staff to identify depression in service users. Staff and service user input was sought through online meetings and email feedback. The attendees gave their opinions (based on their lived experience) on what should be included in the curriculum, and the key points were summarised to inform curriculum development. The information they gave was not treated as data to answer a research question and was not systematically analysed using qualitative methods. In this respect, HRA state that ’if you are collecting opinions rather than study data, your activity is likely an involvement activity’ [ 22 ].

Regardless of the above considerations, the project lead was asked by third sector organisations to seek university IRB approval, to ensure the service users would be treated in an ethical manner. An academic colleague agreed this was a good idea ‘just in case’ it was questioned by others, in particular by a journal editor when seeking to publish (which indeed it was). However, we view this as unnecessary given the activity was not classed as research and therefore not in the remit of the IRB. The IRB provided written agreement that ethical review was not required for this project and the project team agreed a standard engagement risk assessment would consider and address any ethical issues.

Co-producing an educational online resource for school children – request from publication to seek ethical approval for the project .

This co-production project working with researchers, a PI and PE professional, school teachers and web designers aimed to develop an educational online resource for school age children and their teachers. This interdisciplinary team of experts were involved in four online workshops to support the delivery and development of a website that would support teachers and enhance learning. All individuals involved fully signed up to the coproduction focus of the project and provided verbal agreement to take part in the workshops and off-line discussions. However, when trying to publish the co-production process, the journal editor stressed that according to journal policy ‘research involving human subjects, human material or human data must have been approved by an appropriate ethics committee’.

The authors explained that the project did not involve human subjects, human material or human data (as it was not research) and therefore in their opinion did not require ethical approval. The journal editor disagreed, arguing that the project was a research study that collected and analysed data, and that the teachers and web designers involved in this project were human participants of the study and data had been generated of their opinions. The editor recommended seeking either retrospective ethical approval or else removing all human data. The team saw no alternative but to withdraw their original manuscript and submit the work elsewhere.

Co-production project involving people from minority ethnic backgrounds in discussion about inclusive health research – project investigators not comfortable including quotes from public contributors due to lack of informed consent.

This project involving researchers, an artist, charity project workers serving the most ethnically diverse ward in Wales and local residents aimed to answer the question: ‘How can people from minority ethnic backgrounds influence health research in terms of both what and how this research is done?’ Eight co-production workshops drawing on the participatory democracy approach were held and delivered a set of recommendations for the health research community. In advance of these workshops, a university IRB Chair helped to clarify that ethical approval was not needed.

When publishing this work, researchers did not include quotes obtained from the workshops as informed consent had not been sought (as it was not research) [ 23 ]. On reflection, the authors would like to have gained agreement for the residents’ quotes to be used, in the absence of the requirement for documented informed consent.

Identified exceptions

Whilst PI and PE activities do not generally require ethical approval, there are at least two example scenarios where approval is required. Firstly, for example, when systematically comparing two methods of involvement and/or engagement to understand which is better i.e. answering a research question about PI/PE to produce generalisable or transferable findings. Secondly, when public members come into direct contact with study participants or their data e.g. if assisting with conducting research interviews or analysing the transcripts. In this situation, ethical approval is required because human participants are involved in the research.

Recommendations for moving forwards

We encourage the research community, including researchers, publishers, reviewers, funders and ethics committees to better appreciate the difference between PI and PE and research involving human participants; to recognise that all involved stakeholders operate within professional boundaries; and to work together to agree an alternative accepted approach when the PI and PE activity raises ethical considerations (e.g. when working with vulnerable groups or publishing of public contributor quotes). The responsibility of determining whether research ethic approval is required falls on the individuals/team planning the activity. We understand that it is tempting to seek research ethical approval for PI and PE activity ‘just in case’ or ‘to be on the safe side’, but we do believe this is detrimental for several reasons including:

Sustains the confusion between qualitative research and PI and PE activity, and the different purposes of each.

Wastes valuable researcher and committee time and resources.

Undermines the importance of the research ethics approval process.

Delays PI and PE activities in the research process, potentially leading to missing out on the benefits of earlier involvement.

Undermines coproduction principles such as equality and shared responsibility between researchers and members of the public. The process of acquiring ethical approval itself asserts a hierarchy whereby a researcher is identified as Chief/Principal investigator, and other members of the team are listed below an identified leader.

Acts as an additional barrier and disincentive to researchers carrying out PI and PE activity.

Simple flow diagram to support researchers to decide on the need for research ethical approval via an IRB

There is a need to address this growing problem, via education and generating solutions acceptable to the community as a whole, providing confidence in decisions made and assurances that the health and safety and any risks associated with the proposed PI and PE activity have been carefully considered and approved. Here we present key recommendations for those conducting public involvement and engagement activities based on our internal guidance (Appendix 1) for alternative courses of action moving forwards when faced with these challenges.

Purpose - Consider the purpose of the activity. Is it to answer a scientific or clinical question (research) or help shape, guide or disseminate the research (PI/PE)? If you are unsure if your project is research, you can consult the UK Health Research Authority’s ‘Is my study research’ decision tool. Following response to three questions, (1. Are the participants in your study randomised to different groups? 2. Does your study protocol demand changing treatment/care/services from accepted standards for any of the patients/service users involved? 3. Is your study designed to produce generalisable or transferable findings? ) The tool confirms if your study would be considered as research. This result can be downloaded and further advice can be sought [ 24 ]. The HRA table ‘Defining Research’ can also help provide clarification [ 25 ].

Internally, a simple flow diagram (Fig.  1 ) has been created to support researchers in making a decision on the need for research ethics approval when carrying out public involvement activity.

Risk assessment – To ensure PI and PE activities are conducted in a safe and ethical manner, particularly when engaging and/or involving ‘vulnerable’ groups, refer to published guidance on conducting ethical PI&E [ 12 , 13 , 14 , 15 , 16 ], consider completing a specifically designed PI and PE risk assessment (See Appendix 2 for an example) or using the PIRIT tool [ 26 ]to assess your planned activities and undertake adequate training (See Appendix 2 for an example). Use the same considerations as you might for research or teaching e.g. what to do if an individual becomes upset in a discussion group, how to support them, where to refer them. Also consider safety, protection of anonymity and confidentiality of personal data. Use the UK Standards on Public Involvement [ 4 ] to guide your thinking around accessibility and inclusivity when completing the assessment. If possible, involve a public contributor and have this signed off by a senior academic/responsible member of staff in your organisation.

Adequate information and agreement to take part – Ensure that public members being invited to take part in PI and PE activity agree for you to use their anonymous quotes in any output. But understand that standard Participant Information Sheets and Informed Consent Forms are not required as formal consent is not required.

Language – To avoid confusion for reviewers and publishers, think carefully about the language you use to describe your PI and PE activities. For example, use the term ‘discussion group’ rather than ‘focus group’; refer to members of the public as ‘attendees’ not ‘participants’ and input as ‘contributions’ rather than ‘data’; and ‘summarising key points or themes’ as opposed to ‘thematic analysis’ when describing your activities (if that is indeed what you are doing).

Written confirmation – Some institutions have established infrastructure to support researchers through a self-assessment process for governance and ethics, providing a confirmatory statement as to whether ethical approval is required if challenged by funders and publishers [ 27 ]. However, not all institutions have this facility and until this area of contention is resolved, some individuals may wish to seek written confirmation from their local IRB. In our experience, a letter confirming approval is not required is acceptable by journal editors. Liaise with your local IRB to determine if this is within their remit.

Training – The development and inclusion of training for researchers and support staff is required on when to seek ethical approval and how to effectively manage ethical, risks, and health and safety aspects of PI and PE in a considered, widely accepted and non-burdensome way.

Conclusions

Our experience suggests that ambiguity remains in the academic community about whether ethical approval is needed for PI and PE activities. We believe this stems from (1) the grey area between qualitative research and PI and PE activities; (2) seeking approval ‘just in case’ they are requested by funders, publishers or authorities (based on previous experience) (3) funders, publishers and authorities not being clear in the distinction and equally asking for approval ‘just in case’ and (4) a lack of an alternative recognised way to evidence that ethical issues have been considered and mitigated against. We have used real world examples to demonstrate the issues encountered in a single institution and make several recommendations aimed at researchers for addressing this area of contention going forward. We appreciate that our views may be framed by our experience of conducting PI&E in a healthcare context and in the UK, and the experiences of researchers in other disciplines and countries may vary significantly.

We hope this commentary triggers debate in the community to highlight, educate and clarify the position surrounding research ethics and PI and PE activity amongst researchers, funders and journal editors. Our experience shows that this issue is effectively acting as a barrier to researchers conducting PI and PE activity and publishing PI and PE learning. An alternative recognised process needs to be established by the community to resolve this growing detrimental development.

Data availability

Not applicable.

Abbreviations

Health Research Authority

Institutional review board

• Public engagement
• Public involvement

Research Ethics Committee

Research Excellence Framework

Health Research Authority. Putting people first - embedding public involvement in health and social care research 2023 [ https://www.hra.nhs.uk/planning-and-improving-research/best-practice/public-involvement/putting-people-first-embedding-public-involvement-health-and-social-care-research/

Lang I, King A, Jenkins G, Boddy K, Khan Z, Liabo K. How common is patient and public involvement (PPI)? Cross-sectional analysis of frequency of PPI reporting in health research papers and associations with methods, funding sources and other factors. BMJ Open. 2022;12:e063356.

Article   PubMed   PubMed Central   Google Scholar  

Eberl M, Joseph-Williams N, Nollett C, Fitzgibbon J, Hatch S. Overcoming the disconnect between scientific research and the public. Immunol Cell Biol. 2023;101(7):590.

Article   PubMed   Google Scholar  

UK Public Involvement Standards Development Partnership. UK Standards for Public Involvement 2019 [ https://drive.google.com/file/d/1U-IJNJCfFepaAOruEhzz1TdLvAcHTt2Q/view

Staniszewska S, Denegri S, Matthews R, Minogue V. Reviewing progress in public involvement in NIHR research: developing and implementing a new vision for the future. BMJ Open. 2018;8(7):e017124.

Hatch S, Fitzgibbon J, Tonks AJ, Forty L. Diversity in patient and public involvement in healthcare research and education—realising the potential. Health Expect. 2023;27(1):e13896.

Research Excellence Framework. Research Excellence Framework 2029 2024 [ https://www.ref.ac.uk/

Nguyen Thanh H, Cheah P, Chambers M. Identifying ‘hard-to-reach’ groups and strategies to engage them in biomedical research: perspectives from engagement practitioners in Southeast Asia. Wellcome Open Res. 2019;4(102).

National Institute for Health and Care Research. Briefing notes for researchers-public involvement in NHS, health and social care research. 2021.

National Co-ordinating Centre for Public Engagement. Introducing Public Engagament 2024 [ https://www.publicengagement.ac.uk/introducing-public-engagement

Health Research Authority. What do I need to do? 2020 [ https://www.hra.nhs.uk/planning-and-improving-research/best-practice/public-involvement/what-do-i-need-do/

Pandya-Wood R, Barron D, Elliott J. A framework for public involvement at the design stage of NHS health and social care research: time to develop ethically conscious standards. Res Involv Engagem. 2017;3(3).

Canadian Institutes of Health Research. Ethics Guidance for Developing Partnerships with Patients and Researchers 2020 [ https://cihr-irsc.gc.ca/e/51910.html#2

Hersh D, Israel M. C. S. The ethics of patient and public involvement across the research process: towards partnership with people with aphasia. Aphaisology. 2021.

Abma T, Groot B, Widdershoven B. The Ethics of Public and Service User Involvement in Health Research: the need for participatory reflection on everyday ethical issues. Am J Bioeth. 2019;19:23–5.

Groot B, Abma T. Ethics framework for citizen science and public and patient participation in research. BMC Med Ethics. 2022;23.

National Institute for Health and Care Research. Ethical dimensions of community engagement and involvement in global health research 2021 [ https://www.nihr.ac.uk/documents/ethical-dimensions-of-community-engagement-and-involvement-in-global-health-research/28258#references

Martineau JT, Minyaoui A, Boivin A. Partnering with patients in healthcare research: a scoping review of ethical issues, challenges, and recommendations for practice. BMC Med Ethics. 2020;21.

Hanley B, Staley K, Stewart D, Barber R. Qualitative research and patient and public involvement in health and social care research: What are the key differences? 2019 [ https://www.learningforinvolvement.org.uk/content/resource/qualitative-research-and-patient-and-public-involvement-in-health-and-social-care-research-what-are-the-key-differences/

Doria N, Condran B, Curtis Maillet LB, Dowling D, Levy L. A. Sharpening the focus: differentiating between focus groups for patient engagement vs. Qualitative Res Res Involv Engagem. 2018;4.

Morgan H, Thomson G, Crossland N, Dykes F, Hoddinott P, ‘BIBS’ study team. Combining PPI with qualitative research to engage ‘harder-to-reach’ populations: service user groups as co-applicants on a platform study for a trial. Res Involv Engagem. 2016;24(7).

Health Research Authority. Accessing study support and advice services 2024 [ https://www.hra.nhs.uk/planning-and-improving-research/research-planning/access-study-support-advice-services/

Bridges S, Lamont-Robinson C, Herbert A, Din M, Smith C, Ahmed N et al. Talking trials: an arts-based exploration of attitudes to clinical trials amongst minority ethnic members of the South Riverside Community of Cardiff Health expectations. 2023(26):3.

Health Research Authority. Is my study research? 2024 [ https://www.hra-decisiontools.org.uk/research/

Health Research Authority. Defining Research Table 2022 [ https://www.hra-decisiontools.org.uk/research/docs/DefiningResearchTable_Oct2022.pdf

Marie Curie Research Centre. Public Involvement in Research Impact Toolkit (PIRIT) [ https://www.cardiff.ac.uk/marie-curie-research-centre/patient-and-public-involvement/public-involvement-in-research-impact-toolkit-pirit

University of Surrey. Ethics Guide 2022 [ https://issuu.com/universityofsurrey/docs/surrey_ethics_cop_v20_single?fr=sNDM5NzUwNzU0OTI

Download references

Acknowledgements

We are grateful to our colleagues Martina Svobodoba, Sarah Bridges and Dr Vicky Shepherd for providing useful insights and resources from their experiences and to Dr Emma Yhnell for her helpful review and comment on the first draft.

Author information

Authors and affiliations.

Centre for Trials Research, Cardiff University, 7th Floor, Neuadd Meirionnydd, Heath Park Campus, Cardiff, UK

Claire Nollett

Division of Infection and Immunity, School of Medicine, Cardiff University, Cardiff, UK

Matthias Eberl

Systems Immunity Research Institute, Cardiff University, Cardiff, UK

School of Medicine, Lead Public Contributor, Cardiff University, Cardiff, UK

Jim Fitzgibbon

Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK

Natalie Joseph-Williams

Health and Care Research Wales Evidence Centre, Cardiff, UK

Public Involvement and Engagement Team, School of Medicine, Cardiff University, Cardiff, UK

Sarah Hatch

You can also search for this author in PubMed   Google Scholar

Contributions

CN and SH drafted the first version; CN, SH, ME and NJW added case studies; ME, NJW and JF contributed to revised versions and all authors read and approved the final manuscript.

Corresponding authors

Correspondence to Claire Nollett or Sarah Hatch .

Ethics declarations

Ethics approval and consent to participate.

Not applicable – no participants involved.

Consent for publication

Competing interests.

The authors declare that they have no competing interests.

Authors information

CN is Academic Lead for Public Involvement and Engagement in the Centre for Trials Research, Cardiff University. SH is the Public Involvement and Engagement Manager for the School of Medicine, Cardiff University, alongside researchers ME and NJW who are the Joint Academic Leads for Public Involvement and Engagement in the School of Medicine, Cardiff University. ME is also the Engagement Lead for the Systems Immunity Research Institute at Cardiff University and the Engagement Secretary for the British Society for Immunology. JF was the Lead Public Contributor in the School of Medicine at the time of writing.

Additional information

Publisher’s note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary Material 1

Supplementary material 2, rights and permissions.

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ . The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Cite this article.

Nollett, C., Eberl, M., Fitzgibbon, J. et al. Public involvement and engagement in scientific research and higher education: the only way is ethics?. Res Involv Engagem 10 , 50 (2024). https://doi.org/10.1186/s40900-024-00587-x

Download citation

Received : 15 February 2024

Accepted : 24 May 2024

Published : 31 May 2024

DOI : https://doi.org/10.1186/s40900-024-00587-x

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Research ethics committee
• Ethical approval

Research Involvement and Engagement

ISSN: 2056-7529

• General enquiries: [email protected]

Ethical Considerations in Clinical Research

Researchers have an ethical obligation to provide clinical trial participants with a robust explanation of the trial. This ensures that participants can make an informed choice about their participation.

Table of Contents:

Informed Consent Challenges

Informed consent in pediatric clinical trials, informed consent and cultural competency.

Medical research is a partnership between investigators and study participants. When individuals volunteer for clinical trials, they are entitled to understand the science behind the trial and what their participation means for themselves and their families.

Researchers need to give study participants a complete picture when they agree to enroll in a study. Before a participant commits to the study, the researchers will explain what they will be expected to do and answer all questions. This process is called informed consent and is one of the most important ethical considerations in clinical research .

All potential trial participants need to fully understand what will happen during the trial before they can give consent. Informed consent isn't just signing a waiver. Researchers will need to talk with participants, answer their questions, and address any concerns they may have.

Certain challenges may complicate getting informed consent, but researchers can anticipate them before they become problems.

• Language Barriers: The staff running a clinical trial may not speak the same language as the prospective participants. Researchers should have translators available to ensure no miscommunications due to language differences.
• Participant Expectations: Participants may worry they won't get all the information they want during the trial. They may also have unrealistic expectations about the outcomes of the experiment. Researchers and participants should have honest conversations before the trial begins to manage expectations.
• Religious Practices: Religious beliefs and practices may not align with clinical trial requirements. Study designers should ensure that the trial doesn't conflict with religious holidays, dietary rules, and beliefs regarding the acceptance of blood products and medical procedures. Participants can help researchers accommodate their religious beliefs by being open about them.
• Vulnerable People and Groups: Researchers should be careful when enrolling vulnerable people in studies. They should ensure that the rights and well-being of individuals with cognitive disabilities or other special needs are considered when they enroll in clinical trials. Study researchers may ask caregivers for proof of power of attorney or guardianship. This ensures that everyone is acting in the participant's best interest.

Research involving children is important for obtaining accurate data and developing the best therapies for them. However, because children are more vulnerable than adults, they need extra protection. When researchers recruit people under 18 for research studies, all ethical issues in clinical research with adults must also be considered. There are also additional concerns that children and families have to consider when enrolling in a clinical trial.

Under FDA regulations, children in clinical trials receive extra protections. These rules limit the potential risks children can be exposed to unless there's a direct benefit to them. Researchers must also get permission from caregivers and, when suitable, assent from the children themselves.

Parents or guardians can give or withhold consent for minors to participate. However, the adult caregiver isn't the final word on informed consent. Children over 7 may need to assent to participate in trials depending on certain factors. Adults also need to make sure the child doesn't have any misconceptions about the possible results of the trial.

Recruiting healthy children for control groups in studies is another complicated matter. Not all families want to commit their children to a trial with no direct benefit to them. Researchers may rely on clinicians with strong doctor-patient relationships to encourage participation.

Sometimes, researchers have to look for trial participants in multiple locations. They may recruit participants from different countries or minority groups. Sometimes, cultural differences may hinder getting informed consent. Ideally, researchers partner with people from the communities where they hope to recruit participants. Ensuring cultural competence gives the researchers and participants a better understanding of one another before beginning a clinical trial.

Clinical trial participants are critical partners in medical research, so researchers must be committed to upholding ethical standards. Connect with Studypages to learn the latest news in medical research.

WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects

Adopted by the 18 th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the: 29 th WMA General Assembly, Tokyo, Japan, October 1975 35 th WMA General Assembly, Venice, Italy, October 1983 41 st WMA General Assembly, Hong Kong, September 1989 48 th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 52 nd WMA General Assembly, Edinburgh, Scotland, October 2000 53 rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added) 55 th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added) 59 th WMA General Assembly, Seoul, Republic of Korea, October 2008 64 th WMA General Assembly, Fortaleza, Brazil, October 2013

1.         The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.

2.         Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.

General Principles

3.         The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”

4.         It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.

5.         Medical progress is based on research that ultimately must include studies involving human subjects.

6.         The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.

7.         Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.

8.         While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.

9.         It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.

10.       Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

11.       Medical research should be conducted in a manner that minimises possible harm to the environment.

12.       Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.

13.       Groups that are underrepresented in medical research should be provided appropriate access to participation in research.

14.       Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.

15.       Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

Risks, Burdens and Benefits

16.       In medical practice and in medical research, most interventions involve risks and burdens.

Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

17.       All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.

Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.

18.       Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.

When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.

Vulnerable Groups and Individuals

19.       Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm.

All vulnerable groups and individuals should receive specifically considered protection.

20.       Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

Scientific Requirements and Research Protocols

21.       Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.

22.       The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol.

The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.

In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.

Research Ethics Committees

23.       The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.

The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions.

Privacy and C onfidentiality

24.       Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

Informed Consent

25.       Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.

26.       In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.

After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

All medical research subjects should be given the option of being informed about the general outcome and results of the study.

27.       When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.

28.       For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.

29.       When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.

30.       Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research  group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.

31.       The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never adversely affect the patient-physician relationship.

32.       For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee.

Use of Placebo

33.       The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:

Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or

Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention

and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

Extreme care must be taken to avoid abuse of this option.

Post-Trial Provisions

34.       In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.

Research Registration and Publication and Dissemination of Results

35.       Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.

36.       Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

Unproven Interventions in Clinical Practice

37.       In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.

Policy Types

Archived versions.

• » DoH-Jun1964
• » DoH-Oct1975
• » DoH-Oct1983
• » DoH-Sept1989
• » DoH-Oct1996
• » DoH-Oct2000
• » DoH-Oct2004
• » DoH-Oct2008

Related WMA Policies

Wma declaration of venice on end of life medical care, wma international code of medical ethics.

Transforming the understanding and treatment of mental illnesses.

Información en español

Celebrating 75 Years! Learn More >>

• Health Topics
• Brochures and Fact Sheets
• Help for Mental Illnesses
• Clinical Trials

Clinical Trials – Information for Participants

Esta página también está disponible en español .

What are clinical trials?

Clinical trials are research studies that look at ways to prevent, detect, or treat diseases and conditions. They are critical to understanding and treating mental illnesses. Clinical trials are the primary way researchers determine if a new treatment is safe and effective in people.

Clinical trials can study:

• New drugs or combinations of drugs.
• New medical procedures (such as a new blood test or scan).
• New medical devices (such as a  brain stimulation device ).
• New therapies or behavioral interventions, which help people change their behaviors, thoughts, and feelings to improve their mental health
• New ways to prevent health conditions or find a disease early, sometimes even before symptoms occur.

Watch these videos to learn more about clinical trials

Why are clinical trials important.

Clinical trials are the foundation of most medical advances. Without clinical trials, many of the medical treatments and cures we have today wouldn’t exist.

By testing new treatments and interventions in a carefully designed and controlled way, researchers learn more about the underlying mechanisms of disease and develop new ways to diagnose, treat, and prevent illness.

The results of clinical trials help inform medical decision-making and provide evidence-based information about the benefits and risks of different treatments or interventions. Researchers and doctors use this information to decide which treatments should be recommended and which require more study.

Why should I participate in a clinical trial?

People volunteer for clinical trials for many reasons. Some people join clinical trials to help doctors and researchers learn more about a disease and improve health care. Other people, such as those with health conditions, join to try treatments that aren’t widely available.

Researchers usually study people who have a specific health condition. Researchers sometimes need to compare data from volunteers with no health conditions to data from people with specific health conditions so they can use that information to learn more about the disease.

Participating in a clinical trial is entirely up to you. If you volunteer for a clinical trial and later decide it’s not right for you, you can withdraw anytime.

Clinical Research Trials and You: Questions and Answers

Find more information about the risks and benefits of joining a clinical trial, how your safety is protected, and what happens when a clinical trial ends.

Download this free fact sheet about clinical trials

What is it like to participate in a clinical trial?

During a clinical trial, you will see a team of researchers, sometimes called a study team, clinical trial team, or clinical research team, who will monitor your health closely.

You may have more tests and medical exams than you would if you were getting mental health care but not participating in a clinical trial. The study team may also ask you to do other tasks, such as keeping a log about your health or filling out forms about how you feel.

Clinical trials occur in medical centers, doctors’ offices, and community-based organizations nationwide. You may need to travel or stay in a hospital to participate in a clinical trial.

Are clinical trials safe?

Clinical trials are generally safe. Though there are risks to participating in clinical research, clinical trials are designed to minimize risks and keep you safe.

Before a clinical trial can start, it must be reviewed and approved by an institutional review board (IRB) for U.S.-based studies or an independent ethics committee outside the U.S. This review ensures that it is safe and that the potential benefits of the trial are worth the potential risks. The study team will also make sure you meet certain requirements and that it is safe for you to participate.

Clinical studies might make you feel a little uncomfortable for a short time, but how much risk you face depends on the type of study you join. For instance, if you are participating in a study testing a new drug, the medication might make you feel sick or tired when you first start taking it. In some studies, instead of trying a new medicine, you might take computer-based tests or have a non-invasive magnetic resonance imaging (MRI) done, which carries different risks. The research team and the IRB continuously monitor studies to ensure ongoing safety.

Speak with the study team to understand the risks involved in a particular study. Potential risks are included in the informed consent process, and the research team will be able to explain anything you don’t understand.

Are clinical trials paid?

Some clinical trials pay participants, including some trials that take place at the National Institutes of Health (NIH) Clinical Center in Bethesda, MD.

The amount of money you get paid depends on things like how long the trial takes, how much time you need to give, and what kind of trial it is. Sometimes, the trial may also cover your travel, lodging, and food costs. Not all clinical trials are paid, and you should consider all aspects of the study, including risks and benefits, before making a final decision.

How do I find a clinical trial?

The National Institute of Mental Health (NIMH) is the lead federal agency for research on mental disorders. NIMH supports clinical trials at the NIH campus in Bethesda, MD and across the United States.

Find a study at the NIH campus

NIMH researchers conduct many clinical trials at the NIH Clinical Center  . Located on the NIH campus in Bethesda, Maryland, the Clinical Center is the largest research hospital in the world.

Learn more about how to join an NIMH clinical trial at the NIH Clinical Center. These studies enroll volunteers from the local area and across the nation.

Find NIMH clinical trials for adults and children that are currently accepting volunteers:

• Join a Research Study: Adults
• Join a Research Study: Children
• Frequently Asked Questions About Participating in NIMH Research Studies for Adults & Children

You can also subscribe to receive  email updates   about clinical trials conducted at NIH.

Find other studies around the United States

NIMH also funds many studies that are currently recruiting people around the country on different mental health disorders, including:

• Anxiety Disorders
• Attention-Deficit/Hyperactivity Disorder (ADHD)
• Autism Spectrum Disorder (ASD)
• Bipolar Disorder
• Borderline Personality Disorder
• Eating Disorders
• Generalized Anxiety Disorder
• Obsessive-Compulsive Disorder (OCD)
• Panic Disorder
• Post-Traumatic Stress Disorder (PTSD)
• Schizophrenia
• Social Anxiety Disorder
• Studies Recruiting Only Men
• Studies Recruiting Only Women
• Conditions Related to Mental Disorders

Other ways to find a clinical trial

• Search  clinicaltrials.gov   , a database of privately and publicly funded clinical studies conducted worldwide.
• Talk to your health care provider  about studies that may be right for you. You can also learn about studies in newspapers, TV, or online.
• Join a national registry of research volunteers , such as  ResearchMatch   . ResearchMatch is a nonprofit program funded by NIH that helps connect people interested in research studies with researchers from medical centers across the United States.
• Join the  NIH  All of Us  Research Program   ,  which is enrolling a large group of people that reflects the diversity of the United States. The program aims to build a diverse database that can inform thousands of studies on various health conditions.

How do I sign up to participate in a clinical trial?

After you find a clinical trial you're interested in, contact the study team to learn more about it. You can usually find the study teams’ contact information in the trial’s description. The staff can give you information that will help you decide whether to participate.

Check out this resource from the U.S. Department of Health and Human Services (HHS) for a list of specific questions to ask about volunteering for a research study  .

Let your health care provider know if you decide to join a clinical trial. They may want to talk to the study team to help coordinate your care and ensure the trial is safe for you.

How can I learn more about participating in a clinical trial?

Federal resources

• Clinical Trials  : The National Institute on Aging offers articles about how clinical trials work and how to participate about clinical trials.
• NIH Clinical Research Trials and You  : Answers from the NIH to many common questions about participating in a clinical trial
• Clinical Trials  (MedlinePlus - also en español)  : Information about clinical trial protocols and institutional review boards
• Federal Government Health Insurance Programs  : Information about federal programs that help pay the costs of care in clinical trials
• NIH Clinical Research Trials and You: Personal Stories  : Stories about volunteers and researchers
• Videos sobre la investigación clínica  : Spanish-language videos about participating in research
• What is a clinical trial?   
• Should I participate in a clinical trial? What’s in it for me? 
• What should I know to participate in a clinical trial? 
• HHS: Human Research Volunteer Informational videos  : Basic information about research, including questions to ask and what to think about when deciding whether to participate in a study

Last reviewed : April 2024

Unless otherwise specified, the information on our website and in our publications is in the public domain and may be reused or copied without permission. However, you may not reuse or copy images. Please cite the National Institute of Mental Health as the source. Read our copyright policy to learn more about our guidelines for reusing NIMH content.