request letter for conducting research

Permission Letter To Conduct Research: How To Draft It Right!

In this article, I’ll share my insights and provide you with a step-by-step guide, including a template, to craft your own effective permission letter for research.

Key Takeaways

• Understand the purpose and importance of a permission letter for research.
• Learn the essential components to include in your letter.
• Get a step-by-step guide to writing a compelling permission letter.
• Benefit from a customizable template to streamline your writing process.
• Discover practical tips from my personal experience to enhance your letter.

Understanding the Importance of a Permission Letter for Research

A permission letter for research is a crucial document that formally requests authorization to conduct a study in specific locations or collect data from a particular group. 

It serves as a formal agreement between the researcher and the authority or individuals involved, ensuring that the research is conducted ethically and legally.

Step-by-Step Guide to Writing Your Permission Letter

Step 1: start with contact information and date.

Always begin your letter by stating your contact information at the top, followed by the date. This should include your name, address, phone number, and email address.

Step 2: Address the Recipient Properly

Address the recipient by their proper title and name. If you’re unsure, a general “To Whom It May Concern” can suffice, but personalized greetings are always more impactful.

Step 3: Introduce Yourself and Your Affiliation

Introduce yourself, your position, and your affiliation. This sets the context and establishes your credibility.

Step 4: Clearly State the Purpose of Your Letter

Be clear and concise about your intent to seek permission for research. Mention the research topic and why the specific site or group is essential for your study.

Step 5: Provide Details of Your Research

Explain the scope of your research, the methodology you’ll use, and the expected duration. Transparency is key to gaining trust and approval.

Step 6: Assure Ethical Compliance

Highlight your commitment to ethical standards, including how you’ll ensure participant confidentiality and data protection.

Step 7: Request for Approval

Politely request permission to proceed with your research, expressing your willingness to comply with any required protocols or guidelines.

Step 8: Include Contact Information for Follow-up

Offer your contact information again, encouraging the recipient to reach out with any questions or requests for further details.

Step 9: Close with a Professional Salutation

End your letter with a professional closing, such as “Sincerely,” followed by your name and signature.

Template for a Permission Letter To Conduct Research

[Your Name] [Your Address] [City, State, Zip Code] [Phone Number] [Email Address] [Date]

[Recipient’s Name or Title] [Organization’s Name] [Address] [City, State, Zip Code]

Dear [Recipient’s Name or Title],

I am writing to request permission to conduct research at [location/site/group], as part of my [research project/study] on [topic]. My name is [Your Name], and I am a [Your Position] at [Your Institution or Organization].

The purpose of my research is to [briefly state the objective]. I believe that [location/site/group] is essential for my study because [reason]. The research will involve [describe the methodology], and I anticipate it will take approximately [duration] to complete.

I assure you that all research activities will adhere to the highest ethical standards. Participant confidentiality and data protection will be strictly maintained throughout the research process.

Your approval to conduct this research would be greatly appreciated. I am more than willing to adhere to any specific protocols or requirements you may have. Please feel free to contact me at [Your Phone Number] or [Your Email Address] if you have any questions or need further information.

Thank you for considering my request. I look forward to your positive response.

[Your Name] [Your Signature, if sending a hard copy]

Personal Tips from My Experience

• Personalize Your Letter: Tailoring the letter to the recipient shows respect and attention to detail.
• Be Concise but Thorough: Provide enough detail to inform but not so much that it overwhelms the reader.
• Follow-Up: Don’t hesitate to follow up if you haven’t received a response within a reasonable time frame.
• Show Appreciation: Always express gratitude for the recipient’s time and consideration.

I hope this guide helps you craft an effective permission letter for your research. I’d love to hear about your experiences or any additional tips you might have. Please share your thoughts and questions in the comments below!

Frequently Asked Questions (FAQs)

Q: What is a permission letter to conduct research?

Answer : A permission letter to conduct research is a formal request to obtain permission from an organization or individual to conduct research on a particular topic. This type of letter is commonly used by students, researchers, and scholars who require permission to carry out their research.

Q: Why is a permission letter to conduct research important?

Answer : A permission letter to conduct research is important because it shows that the researcher has obtained the necessary permissions to conduct their research. It also provides a clear understanding of the scope and nature of the research and how it will be conducted, which can help to prevent misunderstandings or legal issues.

Q: Who should I address my permission letter to?

Answer : You should address your permission letter to the individual or organization that has the authority to grant permission for your research. This could be the head of the organization, a department manager, or an individual who is responsible for the area that you wish to conduct research in.

Q: What should I include in my permission letter to conduct research?

Answer : Your permission letter to conduct research should include an introduction that outlines your research topic and objectives, an explanation of why you need permission, an overview of your research methodology, details on the timeline and logistics of your research, and a formal closing that thanks the recipient for their time and consideration.

Q: How do I ensure that my permission letter to conduct research is effective?

Answer : To ensure that your permission letter to conduct research is effective, make sure that it is clear, concise, and polite. Provide detailed information about your research and the nature of your request, and address any potential concerns or objections that the recipient may have. Finally, proofread your letter carefully to ensure that it is free from errors and typos.

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• Application Letter For Permission To Conduct Research In Lab

These four templates serve as formal requests for permission to conduct research in a laboratory setting, addressing various scenarios and academic levels. Whether you are an undergraduate or graduate student seeking to explore your research interests, an external researcher hoping to collaborate with a renowned lab, or any other individual in need of lab access, these templates provide structured, respectful, and well-organized introductions. Each template emphasizes the importance of the research project, highlights the alignment with the lab's expertise, expresses commitment to safety and ethical standards, and kindly requests permission to access the lab facilities. These introductions set the tone for a professional and persuasive application for lab access, showcasing a strong desire to contribute to the scientific community while respecting the lab's protocols and expectations.

Template Formal Research Lab Permission Request

[Your Name] [Your Address] [City, State, Zip Code] [Email Address] [Phone Number] [Date]

[Lab Supervisor's Name] [Lab Name] [Institution Name] [Institution Address] [City, State, Zip Code]

Dear [Lab Supervisor's Name],

Subject: Request for Permission to Conduct Research in Your Lab

I hope this letter finds you in good health and high spirits. I am writing to seek your permission to conduct research in your esteemed laboratory for my [Your Research Topic] project. I am a [Your Academic Level] student at [Your University] and have a strong interest in [Relevant Research Area].

My research aims to [Briefly Describe Your Research Objectives] and is an integral part of my academic pursuits. I believe that your lab, with its state-of-the-art equipment and expertise, would provide an ideal environment for me to carry out this research effectively.

I assure you that I will adhere to all lab protocols, safety guidelines, and ethical standards. I am willing to participate in any necessary training and orientation programs to ensure the responsible and safe conduct of my research.

I kindly request your permission to access the lab facilities and materials required for my research from [Proposed Start Date] to [Proposed End Date]. I understand that lab availability may vary, and I am flexible with scheduling to accommodate the needs of the lab and its ongoing research projects.

I am more than willing to discuss this request further at your convenience and provide any additional information or documentation you may require. Your guidance and mentorship would be invaluable to the success of my research project.

Thank you for considering my request. I look forward to the opportunity to contribute to the research conducted in your lab and to learn from the experts in the field.

[Your Name] [Your University ID (if applicable)]

Template Permission Request for Lab Research (Graduate Student)

I hope this message finds you well. I am writing to formally request your permission to carry out my graduate research in your laboratory. As a [Your Academic Level] pursuing a degree in [Your Program] at [Your University], my research topic is centered around [Briefly Describe Your Research Objectives], which aligns closely with the work being done in your lab.

I am impressed by the innovative research being conducted at [Lab Name] and believe that the resources and expertise available there would greatly enhance the quality and impact of my research. I am committed to upholding the highest standards of safety, ethics, and professionalism while working in the lab.

I kindly request permission to access your lab facilities and collaborate with your research team from [Proposed Start Date] to [Proposed End Date]. I am more than willing to accommodate the lab's schedule and contribute to its ongoing projects in any way possible.

I would appreciate the opportunity to meet with you to discuss this request further and address any questions or concerns you may have. Your mentorship and guidance in this research endeavor would be invaluable to me.

Thank you for considering my request. I eagerly await your response and the potential opportunity to conduct research in your esteemed lab.

Template Research Lab Access Request (Undergraduate Student)

I trust this letter finds you in good health. I am writing to request your permission to conduct research in your laboratory as part of my undergraduate academic journey. I am currently enrolled in the [Your Program] program at [Your University] and am passionate about exploring [Relevant Research Area].

My research project focuses on [Briefly Describe Your Research Objectives], and I believe that your lab's facilities and the expertise of your team would significantly contribute to the success of my research. I am committed to following all lab protocols and safety guidelines diligently.

I kindly request permission to access your lab facilities and work under your guidance from [Proposed Start Date] to [Proposed End Date]. I am flexible and willing to accommodate the lab's operational hours and ongoing projects.

I would greatly appreciate the opportunity to meet with you to discuss this request in more detail and address any questions or concerns you may have. Your mentorship and support would be instrumental in my academic and research pursuits.

Thank you for considering my request. I look forward to the possibility of conducting research in your lab and contributing to the scientific advancements of the institution.

Template Lab Research Permission Request (External Researcher)

[Your Name] [Your Affiliation/Institution] [Your Address] [City, State, Zip Code] [Email Address] [Phone Number] [Date]

Subject: Request for Permission to Conduct Research in [Lab Name]

I hope this message finds you well. I am writing to request permission to conduct research in your laboratory as an external researcher. My research interests align closely with the work being carried out at [Lab Name], and I believe that collaborating with your team would be mutually beneficial.

My research project, [Briefly Describe Your Research Objectives], requires access to specialized equipment and expertise that I understand your lab can provide. I am committed to adhering to all lab protocols, safety measures, and ethical standards during my research activities.

I kindly request permission to access your lab facilities and collaborate with your research team from [Proposed Start Date] to [Proposed End Date]. I am open to discussing any scheduling or resource-sharing arrangements that may be necessary.

I would be grateful for the opportunity to meet with you to discuss this request further and explore potential avenues of collaboration. Your guidance and support would be invaluable in advancing the goals of my research project.

Thank you for considering my request. I look forward to the possibility of conducting research in your esteemed lab and contributing to the scientific community.

[Your Name] [Your Affiliation/Institution]

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Dissertation Format and Submission

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Instrument Permission documents

Instrument Permissions FAQ

Download a pdf of this faq  , download the template permission letter, permissions to use and reproduce instruments in a thesis/dissertation frequently asked questions, why might i need permission to use an instrument in my thesis/dissertation.

• Determine whether you need permission
• Identify the copyright holder
• Ask for permission
• Keep a record
• What if I can't locate the copyright holder?

If you want to use surveys, questionnaires, interview questions, tests, measures, or other instruments created by other people, you are required to locate and follow usage permissions. The instrument may be protected by copyright and/or licensing restrictions.

Copyright Protection

Copyright provides authors of original creative work with limited control over the reproduction and distribution of that work. Under United States law, all original expressions that are “fixed in a tangible medium” are automatically protected by copyright at the time of their creation. In other words, it is not necessary to formally state a declaration of copyright, to use the © symbol, or to register with the United States Copyright Office.

Therefore, you must assume that any material you find is copyrighted, unless you have evidence otherwise. This is the case whether you find the instrument openly on the web, in a library database, or reproduced in a journal article. It is your legal and ethical responsibility to obtain permission to use, modify, and/or reproduce the instrument.

If you use and/or reproduce material in your thesis/dissertation beyond the limits outlined by the “fair use” doctrine, which allows for limited use of a work, without first gaining the copyright holder’s permission, you may be infringing copyright.

Licensing/Terms of Use

Some instruments are explicitly distributed under a license agreement or terms of use. Unlike copyright, which applies automatically, users must agree to these terms in order to use the instrument. In exchange for abiding by the terms, the copyright holder grants the licensee specific and limited rights, such as the right to use the instrument in scholarly research, or to reproduce the instrument in a publication.

When you ask a copyright holder for permission to use or reproduce an instrument, you are in effect asking for a license to do those things.

How do I know if I need permission to use instruments in my thesis/dissertation research? (Adapted from Hathcock & Crews )

Follow the four-step process below:

1. Determine whether you need permission

There are different levels of permissions for using an instrument:

a)  No permission required

i. The copyright holder has explicitly licensed the use of instrument for any purpose, without requiring you to obtain permission.

ii. If you are only using a limited portion of the instrument, your use may be covered under the Fair Use Doctrine. See more here:  https://uhcl.libguides.com/copyright/fairuse .

iii. If the instrument was developed by the federal government or under a government grant it may be in the public domain, and permission is therefore not required.

iv. If the document was created before 1977, it may be in the public domain, and permission is therefore not required. See the Stanford Public Domain Flowchart at https://fairuse.stanford.edu/wp-content/uploads/2014/06/publicdomainflowchart.png .

b)  Non-commercial/educational use: The copyright holder has licensed the instrument only for non-commercial research or educational purposes, without requiring you to obtain the permission of the copyright holder. Any other usage requires permission.

Sample Permission for Educational Use:

Test content may be reproduced and used for non-commercial research and educational purposes without seeking written permission. Distribution must be controlled, meaning only to the participants engaged in the research or enrolled in the educational activity. Any other type of reproduction or distribution of test content is not authorized without written permission from the author and publisher. Always include a credit line that contains the source citation and copyright owner when writing about or using any test.

Source: Marta Soto, “How Permissions Work in PsycTests,” APA Databases & Electronic Resources Blog. American Psychological Association. http://blog.apapubs.org/2016/12/21/how-permissions-work-in-psyctests/ .

Even if you are not required to obtain permission to use the instrument, consider contacting the author for ideas on how to administer and analyze the test. Authors often welcome further use of their work, and may request you send them a copy of your final work.

c)  Permission required:  Instruments that require you to obtain the permission of the copyright holder, regardless of whether the use is for educational or commercial purposes. This may be because the copyright holder

• has important directions for how the test must be administered and analyzed
• wants to make sure the most current version is being used
• charges users a fee in order to administer the test

If you cannot locate the permissions, you are required to identify the copyright holder and contact them to ask about permission to use the instrument.

2. Identify the copyright holder  (Adapted from Crews )

The next step is to identify who owns the copyright. The copyright holder is usually the creator of the work. If the copyright owner is an individual, you will need to do the usual Internet and telephone searches to find the person. Be ready to introduce yourself and to explain carefully what you are seeking.

Some authors transfer copyright to another entity, such as a journal publisher or an organization. In these cases, you must obtain permission from that entity to use or reproduce the instrument. You can often identify the owner by locating a © copyright notice, but as mentioned above, not all copyrighted works have a notice.

Check the following sources to locate instruments, their copyright holders, and their permission statements:

• Mental Measurements Yearbook: https://uhcl.idm.oclc.org/login?url=https://search.ebscohost.com/login.aspx?authtype=ip,uid&profile=ehost&defaultdb=mmt
• PsycTESTS: https://uhcl.idm.oclc.org/login?url=https://search.ebscohost.com/login.aspx?authtype=ip,uid&profile=ehost&defaultdb=pst
• Neumann Library Tests & Measures help: https://uhcl.libguides.com/PSYC/tests
• Library assistance e-mail: [email protected]

​You may need to contact the author or publisher directly to find out who owns the copyright. Publishers often have websites that prescribe a method for contacting the copyright owner, so search the publisher website for a permissions department or contact person. Be sure to confirm the exact name and address of the addressee, and call/e-mail the person or publishing house to confirm the copyright ownership.

• The copyright owner may prefer or require that permission requests be made using a certain medium (i.e. fax, mail, web form, etc.). If you do not follow instructions, you may not get a reply.
• Telephone calls may be the quickest method for getting a response from the owner, but they should be followed up with a letter or e-mail in order to document the exact scope of the permission. E-mail permissions are legally acceptable in most cases, but getting a genuine signature is usually best.
• The request should be sent to the individual copyright holder (when applicable) or permissions department of the publisher in question. Be sure to include your return address, telephone and fax numbers, e-mail address, and the date at the top of your letter or message. If you send the permission request by mail, include a self-addressed, stamped return envelope.
• Make the process easy for the copyright owner. The less effort the owner has to put forth, the more likely you will get the permission you need. If you are using conventional mail, include a second copy of your request for the owner’s records.
• State clearly who you are, your institutional affiliation (e.g., University of Houston-Clear Lake), and the general nature of your thesis/dissertation research.

Do not send permissions letters to all possible rightsholders simultaneously. Taking the time to find the person who most likely holds the copyright will better yield success. If you do not have much information about who actually owns the copyright, be honest with your contacts, and they may be able to help you find the right person.

3. Ask for permission  (Adapted from  Crews )

Once you have identified the copyright holder, you must determine the scope of your permission request. Some copyright owners furnish their own permission form that you may download from their website.

If the copyright owner does not provide a permission agreement form, you may write your own letter ( click here to download a template ). Requests should be made in writing; e-mail is fine for this purpose. A most effective letter will include detailed information concerning your request for permission to use the work. Include the following information:

• Who: Introduce yourself. Tell who you are, your degree program, and a brief overview of your research.
• Why: Tell why you are contacting that person or entity for permission.
• What: Be as specific as possible when you cite and describe the instrument you wish to use. Include whether you plan to use the entire instrument, or if you plan on modifying or adapting any of the questions.
• How: Tell how you plan to use the instrument. Specify the parameters of your research study, and include any important information about the way you will administer the instrument and/or analyze the results.
• When: Expected length of the project and time to complete the thesis/dissertation.

Important : Obtaining permission to use an instrument is not the same as obtaining permission to reproduce the instrument in your appendix. If you intend on providing a copy of the instrument in an appendix, ask for separate permissions to do that.

Click here to download a template letter . Feel free to modify and adapt this template for your purposes.

4. Keep a record

After securing permission to use and/or reproduce the instrument, save a copy of the correspondence and the agreement. Documentation allows you to demonstrate to others that you have the legal right to use the owner's work. In the unlikely event that your use of the work is ever challenged, you will need to demonstrate your good faith efforts. That challenge could arise far in the future, so keep a permanent file of the records. Moreover, you might need to contact that same copyright owner again for a later use of the work, and your notes from the past will make the task easier.

Upload a copy of your permission letter in Vireo with your thesis/dissertation, or include it as an appendix in the document itself.

What if I can't locate the copyright holder?  (Adapted from Hathcock  & Crews & Pantalony )

In some cases, you may never get a response from the copyright holder or you may never even be able to identify who they are or how to contact them. It can be difficult to know how to proceed when you reach a dead end. Unfortunately, no matter how diligently you have tried to get permission, these efforts cannot completely eliminate the risk of infringement should you proceed to use the work.

Assuming you have diligently investigated your alternatives, do not want to change your project, and remain in need of the elusive copyright permission, the remaining alternative is to explore a risk-benefit analysis. You need to balance the benefits of using that particular material in your given project against the risks that a copyright owner may see your project, identify the materials, and assert the owner’s legal claims against you. Numerous factual circumstances may be important in this evaluation. The “benefit” may depend upon the importance of your project and the importance of using that particular material. The “risks” may depend upon whether your project will be published or available on the Internet for widespread access—as theses and dissertations will. You ought to investigate whether the work is registered with the U.S. Copyright Office and weigh the thoroughness of your search for the copyright owner and your quest for appropriate permission.

Undertaking this analysis can be sensitive and must be advanced with caution and with careful documentation. You may be acting to reduce the risk of liability, but you have not eliminated liability. A copyright owner may still hold rights to the material. Members of the University of Houston-Clear Lake community should consult with their chair or the Neumann Library to discuss their options.

Portions of this FAQ are used and adapted from:

Crews, Kenneth and Rina Elster Pantalony. “Special Cases.” Columbia University Copyright Advisory Services. https://copyright.columbia.edu/basics/special-cases.html . Licensed under Creative Commons Attribution 4.0 International (CC BY 4.0).

Crews, Kenneth. “Asking for Permission.” Columbia University Advisory Services. https://copyright.columbia.edu/basics/permissions-and-licensing.html . Licensed under Creative Commons Attribution 4.0 International (CC BY 4.0).

Hathcock, April. “Getting Permission.” NYU Libraries Copyright Library Guide, https://guides.nyu.edu/c.php?g=276785&p=1845968 . Licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0).

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Sample consent and permission forms

General consent form to participate in research (DOC)

Two stage project consent form (DOC)

Parent permission form for research with child (DOC)

Child assent form (DOC)

Multiple consent form including audio-recording and quotations (DOC)

Photo and video consent form (DOC)

Video-recording consent form (DOC)

Re-contact agreement form (DOC)

Post-debriefing consent form (DOC)

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• v.14(2); 2018 Jun

How to obtain informed consent for research

1 University of Messina, “G. Martino” Hospital, Messina, Italy

Amelia Licari

2 University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Current biomedical research on human subjects requires clinical trial, which is defined as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions [ i.e. drugs, cells or other biological products, surgical procedures, devices] to evaluate the effects on health outcomes” [1]. In our modern ethical conception, all research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent, which is a process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”, as stated in the International Council for Harmonisation Good Clinical Practice guidelines [2]. Informed consent is documented by means of a written, signed and dated informed consent form. This form is required in the following cases: 1) when the research involves patients, children, incompetent/incapacitated persons, healthy volunteers, immigrants or others ( e.g. prisoners); 2) when the research uses/collects human genetic material, biological samples or personal data [3].

Short abstract

The process of obtaining informed consent for clinical trials is tightly regulated; complications arise in circumstances when consent may be waived, or when needed from vulnerable populations http://ow.ly/rEMe30j5MVq

Current biomedical research on human subjects requires clinical trial, which is defined as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions [ i.e. drugs, cells or other biological products, surgical procedures, devices] to evaluate the effects on health outcomes” [ 1 ]. In our modern ethical conception, all research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent, which is a process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”, as stated in the International Council for Harmonisation Good Clinical Practice guidelines [ 2 ]. Informed consent is documented by means of a written, signed and dated informed consent form. This form is required in the following cases: 1) when the research involves patients, children, incompetent/incapacitated persons, healthy volunteers, immigrants or others ( e.g. prisoners); 2) when the research uses/collects human genetic material, biological samples or personal data [ 3 ].

The informed consent form must be written in language easily understood by the subjects, it must minimise the possibility of coercion or undue influence, and the subject must be given sufficient time to consider participation. However, informed consent is not merely a form that is signed, but is a process in which the subject has an understanding of the research and its risks, and it is tightly described in ethical codes and regulations for human subject research [ 2 ].

Educational aims

• To provide a comprehensive overview of issues in obtaining informed consent in clinical research.
• To describe the process of obtaining informed consent in clinical trials.
• To highlight the circumstances under which informed consent can be waived.
• To review the setting of obtaining informed consent from “vulnerable populations”.

The informed consent process

The voluntary expression of the consent by a competent subject and the adequate information disclosure about the research are critical and essential elements of the informed consent process [ 4 ]. Competent subjects able to comprehend the research-related information should personally decide and provide the consent on research participation. Conditions posing practical challenges in obtaining informed consent from the real subject may include situations of medical emergency or obtaining consent from “vulnerable” subjects and/or children [ 5 ].

Research-related information must be presented to enable people to voluntarily decide whether or not to participate as a research subject. For an ethically valid consent, information provided to a research subject should include, but not be limited to: information about the health condition for which the research is proposed; details of the nature and purpose of the research; the expected duration of the subject’s participation; a detailed description of study treatment or intervention and of any experimental procedures (including, in the case of randomised clinical trials (RCTs), also blinding and randomisation); a statement that participation in research is voluntary; probable risks and benefits associated with research participation; details of the nature of the illness and possible outcome if the condition is left untreated; availability, risks and benefits of alternative treatments; information about procedures adopted for ensuring data protection/confidentiality/privacy, including duration of storage of personal data; details about the handling of any incidental findings of the research; description of any planned genetic tests; details of insurance coverage in case of injury; reference contacts for any further answers to pertinent questions about the research and the subject’s rights and in case of any research-related injury to the subject; and any other information that seems necessary for an informed decision to be taken by the subject. Of particular importance, a statement offering the subject the opportunity to withdraw at any time from the research without consequences must be provided during the information disclosure [ 2 ]. Specific information should be provided in case of research projects involving children, incapacitated adults not able to give informed consent, illiterate populations, etc. (as will be described later in this article).

The information about the research should be given by a physician or by other individuals ( i.e.  researchers) with appropriate scientific training and qualifications [ 6 ]. Furthermore, the location where the informed consent is being discussed, and the subject’s physical, emotional and psychological capability, must be taken into consideration when taking consent from a human subject.

Informed consent: when is it not necessary?

After institutional review board (IRB) or independent ethics committee approval is achieved, obtaining informed consent from each human subject prior to his/her participation in clinical trial is mandatory [ 5 ]. However, when specific circumstances occur, the informed consent can be waived, and “research without consent” is possible, which allows enrolment of patients without their consent, under strict regulation [ 7 ]. In order that research without consent is considered justifiable, the following three conditions have to be met: 1) it is impracticable to obtain consent, 2) the research does not infringe the principle of self-determination, and 3) the research provides significant clinical relevance [ 8 ].

The first condition, of “impracticability”, occurs when obtaining informed consent is burdened by high impact in terms of time and economic resources or could compromise the study’s validity [ 8 ]. The second condition means that, although physicians are requested to ensure that the patient has understood the aim of the research and the risks and/or benefits associated with study participation, the researchers are also advised to respect the patient’s decision-making capacity, not interfering with his/her decisions and acting always in the patient’s best interest [ 9 ]. The third condition leads to justification of waiving consent when the clinical relevance and public health importance are potentially high [ 8 ].

The formal literature identifies different types of RCTs and classifies them into three macro-areas: 1) RCTs based on infeasibility of informed consent; 2) RCTs that omit informed consent only for control groups; and 3) RCTs that omit informed consent entirely.

RCTs based on infeasibility of informed consent

Emergency clinical studies, involving critically ill subjects, represent an exception to the requirement of informed consent. The investigated life-saving therapy and the medical intervention may be required immediately, not permitting the researchers to wait and respect all procedures of obtaining informed consent. Within this context, the researchers will be able to proceed with patient recruitment, also without the subject’s consent to treatment, when, prior to the study, the IRB has ascertained the presence of mandatory conditions ( table 1 ) [ 10 ].

Table 1

Conditions to be met in emergency clinical study

Cluster randomised studies include cluster-cluster and individual-cluster research [ 11 ]. In cluster-cluster designs ( e.g. studies on infectious disease prevention), the intervention involves the entire target community, so that single subjects cannot refuse it [ 12 ]. Conversely, in individual-cluster designs ( e.g. studies on primary care), although the intervention involves all the selected community, the right to refuse treatment is allowed. Under this circumstance, the omission of informed consent is justified only when the treatment refusal undermines the validity of the research study and/or procedures [ 13 ].

RCTs that omit informed consent only for control groups

In Zelen’s single-consent model ( e.g. RCTs in infectious or oncological diseases), randomisation occurs prior to any consent, and informed consent is sought only from individuals assigned to experimental treatment [ 14 ]. In the control group, the physicians do not make substantial changes in routine patient care, so informed consent is not required for patient enrolment [ 8 ].

In order to improve study recruitment, Zelen developed the double-consent design. Specifically, informed consent is requested for subjects to be involved in the study but not for the randomisation, preventing psychological distress [ 14 ].

In follow-up studies, the nested consent model ( e.g. for single cohort studies) or cohort multiple RCTs model ( e.g. for multiple cohort studies) is applied. In these variants, patients give their consent for prospective follow-up; however, they remain blinded to any randomised experimental interventions [ 15 ].

In trials using the model of “consent to postponed information”, the informed consent process is carried out after the study is completed [ 16 ].

All these RCT types aim to avoid unnecessary stress in patients who will not receive the new promising experimental treatment. Moreover, these clinical study designs do not affect the standard therapeutic approach or infringe the rights of the patients in the control group; therefore, the clinical trial can proceed without obtaining informed consent [ 8 ].

RCTs that omit informed consent entirely

Based on the fact that patients are assigned to standard care interventions, no informed consent is sought either in low-risk pragmatic RCTs [ 17 ] or in prompted optional randomisation trials [ 18 , 19 ]. However, in a low-risk pragmatic RCT, patients do not have the possibility to choose one of the two standard treatments, whereas in a prompted optional randomisation trial, both the researchers and the enrolled patients can choose one type of treatment over another, despite the randomisation results [ 6 ].

Special needs: vulnerable patients

A “vulnerable population” is defined as a disadvantaged community subgroup unable to make informed choices, protect themselves from inherent or intended risks, or keep their own interests safeguarded [ 20 ]. In the health domain, “vulnerable populations” refers to physical vulnerability ( e.g. pregnant women, fetuses, children, orphans, students, employees, prisoners, the military, and those who are chronically or terminally ill), psychological vulnerability (cognitively and intellectually impaired individuals) and social vulnerability (those who are homeless, from ethnic minorities, are immigrants or refugees) [ 20 ].

Due to a compromised free will and inability to make conscious decisions, several ethical dilemmas (related to communications, privacy and treatment) often arise when research involves these populations. Guaranteeing protection of rights, safety, data privacy and confidentiality of vulnerable subjects are prerogatives of good clinical practice, and law dispositions are regulated and strictly monitored by the applicable authorities [ 21 ].

Physical vulnerability

For a long time, pregnant women were excluded from clinical research because of their “vulnerability”. Although pregnant women are able to make informed and conscious choices, they have been considered “vulnerable” due to the potential risks to the fetus, who is also considered as a “patient” [ 22 ]. More recently, with the consideration of pregnant women as “scientifically complex” rather than “vulnerable” subjects, it has been permitted to involve this category in research trials [ 23 ]. The “scientific complexity” reflects both ethical and physiological complexity. The ethical aspects are secondary to the need to find a balance between interests of the fetus and the mother. The physiological aspects are strictly related to the pregnancy status [ 24 ].

Research studies involving pregnant women and fetuses have to satisfy specific federal regulations ( table 2 ). The following appropriate precautions should be taken in research studies involving pregnant women: no pregnant woman may be involved as a subject in a human clinical research project unless the purpose of the research is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or the risk to the fetus is minimal [ 25 ].

Table 2

Conditions to be met in research studies involving pregnant women and fetuses

Researchers can enrol pregnant women only when the mother and/or the father are legally competent. In fact, the consent to participate in research may be either self-directed (only the mother’s consent is required) or made with the guidance of the woman’s partner. However, the father’s consent need not be obtained when: 1) the research activity is directed to the health needs of the mother; 2) the father’s identity is doubtful; 3) the father is absent; or 4) a pregnancy from rape has occurred [ 26 ]. The consent signature requirements from the mother and father are summarised in table 3 . Once the informed consent is obtained, the pregnant women will be included into any phase of the study unless the research project will be compromised or the patient’s health (mother and/or fetus) will be in danger.

Table 3

Consent signature requirements for pregnant women and children

# : consent requirements are the same whether the risk is “no more than minimal” or “more than minimal”.

Medical students and employees, who take part in numerous aspects of patient care in primary, secondary and tertiary care settings, are often invited to participate in human studies as volunteers. Frequently, the requesting researcher is their supervisor or instructor, who may push them to participate in the study, which can negatively influence their decision and also violate the consent legitimacy. Therefore, in order to protect these subjects against “coercion” or “undue influence”, when an investigator wishes to recruit medical students or employees, they must first obtain IRB approval for inclusion in the study of these vulnerable subgroups [ 27 ].

Prisoners, defined as any individual involuntarily confined or detained in a penal institution, are considered as “vulnerable” because they may be coerced into study participation, and also, due to both cognitive and psychiatric disorders, they can show an impaired ability to provide voluntary informed consent [ 28 ]. To protect this population, the Office for Human Research Protections has stipulated federal regulations according to which the only studies that may involve prisoners are those with independent and valid reasons for involving them ( table 4 ) [ 25 ].

Table 4

Studies that may involve prisoners

Due to the context of war in which they work, as well as the critical care setting in which they are treated, military subjects often receive medical care and/or participate in biomedical research under an “implied consent” condition. Moreover, the superior–subordinate relationship contributes to favour coercion or undue influence, making this population vulnerable [ 29 ]. To curb this phenomenon and to ensure that participation is truly voluntary, the US Dept of Defense agencies have adopted requirements similar to those that govern medical research that applies to the civilian population. Accordingly, the medical research recruitment session happens in the absence of superiors, and the informed consent is obtained prior to participating in a medical research study. The presence of an ombudsman guarantees and verifies that the participation is voluntary and that the information provided during recruitment is complete, accurate and clear. A payment as an incentive is acceptable but it must not be used to legitimise a coercive interference. Additional protection is provided to students at service academies, especially those aged <18 years. However, when emergency research is conducted or the research study advances the development of a medical product needed by the armed forces, informed consent will not be required [ 29 ].

Psychological vulnerability

Mental disability may compromise the self-determination and decision-making capacities [ 30 ]. Researchers interested in enrolling individuals with cognitive disorders are invited to apply different strategies to promote a better understanding of information-gathering processes. Simplifying the questions and content, adopting supportive technologies, using a more simple language, and spending more time for the information process have been suggested as useful and valid measures. When all these strategies prove to be insufficient, the investigators are required to obtain consent from a legally authorised representative [ 30 ].

Social vulnerability

Similarly to other vulnerable populations, research involving the homeless, ethnic minorities, immigrants and refugees is regulated by laws and specific procedures. Cultural and language differences, “undocumented” migrant status, and the precarious legal positions of these subjects raise several ethical issues, such as whether the participation is truly voluntary, or there are unrealistic expectations, or any benefits for their “status”.

Obtaining informed consent in these groups is extremely complex. A friendly procedure has been identified as the best way to adequately involve these vulnerable groups. A health centre or community building could represent an accessible location. The reimbursement of travel expenses for applicants can be a valid solution to obtain a representative sample for the clinical research. Clear and simple language, emphasising confidentiality, with the help of professional interpreters, can tempt migrants to sign the consent form. Lastly, the possibility of receiving something back in return for their contribution may enable successful enrolment of migrants in research [ 31 ].

Special needs: children

Because of their young age as well as their limited emotional and intellectual abilities, children are considered to be legally incompetent to give valid informed consent; thus, to enrol a child in a research study, the permission by at least one parent or legal representative is mandatory ( table 3 ). For subjects aged <18 years, biological or adoptive parents or legal guardians (persons having both legal capacity and responsibility) can give consent on behalf of their child, exercising free power of choice without any form of coercion. While married mothers and fathers both have parental responsibility, unmarried parents can exert parental responsibility only if they are named individually on the child’s birth certificate. Also, divorced parents maintain parental responsibility, but it is necessary to know to whom the child’s custody has been assigned [ 32 ]. However, on this matter, the European laws and regulations are not harmonised and several discrepancies are present in each country [ 33 ].

Despite potential benefits for the research subjects, the failure of parents to give consent (or their refusal to give consent) is not a rare circumstance [ 34 ]. It can be the case that researchers are dealing with underage parents, so that, although underage parents are responsible for representing their children, as minors themselves they are not considered to be sufficiently mature; therefore, they will be not able to give valid consent. Literacy and socioeconomic levels have been identified as the most common reasons for parental non-response [ 34 ]. Clarity and adequate explanation of research information materials should be part of effective planning to overcome language and social barriers.

In clinical studies in which the adopted methodology constitutes “less than minimal risks” for children, passive parental consent represents a possible way to more easily obtain informed parental consent [ 34 ]. Furthermore, parents can be informed with regard to a possible study involving their children, and, at the time of data collection, only the child’s assent is required. In fact, although the child’s decision-making capacity and understanding of the research project in which he/she will be involved may be limited, the Medical Research Council have shown that, when study details are provided and communicated in a clear and adequate manner, the child can be able to reach a decision and participate consciously in the research [ 35 ]. “Assent” is the term coined to express the child’s willingness to participate in clinical trials despite their young age. The “assent” should include and respect the following key points: 1) helping the child to acquire disease awareness; 2) explaining the potential impact of the experimental treatment; 3) evaluating the child’s ability to understand and adapt to new situations or challenges; and 4) positively influencing the patient’s willingness to participate in clinical trials [ 36 ]. Although the “assent” is not mandatory for research offering a direct benefit for the child, it arises from the need to respect paediatric research subjects [ 37 ]. The evaluation of the capacity to provide the “assent” is based on developmental stage, intellectual abilities and life or disease experience. Usually, the cut-off age of 7 years is used for the beginning of logical thought processes and rational decision making [ 38 ]. However, “assent” for children aged <7 years can be also required once the ability to read and write has been verified [ 32 ]. Figures 1 and ​ and2 2 summarise the parental and assent permission requirements, respectively.

Flow chart of parental permission requirements.

Flow chart of child assent requirements.

When conducting clinical research, the obtaining of informed consent is required. Informed consent is a procedure through which a competent subject, after having received and understood all the research-related information, can voluntarily provide his or her willingness to participate in a clinical trial. However, when it is impracticable to obtain consent, and the research does not infringe the principle of self-determination and also provides significant clinical relevance, the researcher is legally authorised to proceed without informed consent. Furthermore, in order to preserve the self-determination and decision-making rights, specific law dispositions are applied when vulnerable populations are enrolled in clinical trials.

Self-evaluation questions

• a) Diagnosis
• b) Risks and benefits of treatment
• c) Alternatives to treatment
• d) Family’s wishes
• a) When a minor is considered as emancipated
• b) When a patient is found to be incompetent
• c) When immediate treatment is necessary to prevent death or permanent impairment
• d) When the subject is aged >18 years
• a) Minor is married or divorced
• b) Minor on active duty in the US armed forces
• c) Minor is considered self-sufficient by a court
• d) Minor having a son

Suggested answers

• All research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent.
• Voluntary expression of consent and adequate information disclosure about the research are critical and essential elements of the informed consent process.
• When specific circumstances occur, informed consent can be waived: if it is impracticable to obtain consent, if the research does not infringe the principle of self-determination, and if the research provides significant clinical relevance.
• Participation of vulnerable patients in clinical trials is regulated by specific law dispositions.

Conflict of interest: None declared.

As the nation’s largest public research university, the Office of the Vice President for Research (OVPR) aims to catalyze, support and safeguard U-M research and scholarship activity.

The Office of the Vice President for Research oversees a variety of interdisciplinary units that collaborate with faculty, staff, students and external partners to catalyze, support and safeguard research and scholarship activity.

ORSP manages pre-award and some post-award research activity for U-M. We review contracts for sponsored projects applying regulatory, statutory and organizational knowledge to balance the university's mission, the sponsor's objectives, and the investigator's intellectual pursuits.

Ethics and compliance in research covers a broad range of activity from general guidelines about conducting research responsibly to specific regulations governing a type of research (e.g., human subjects research, export controls, conflict of interest).

eResearch is U-M's site for electronic research administration. Access: Regulatory Management (for IRB or IBC rDNA applications); Proposal Management (eRPM) for the e-routing, approval, and submission of proposals (PAFs) and Unfunded Agreements (UFAs) to external entities); and Animal Management (for IACUC protocols and ULAM).

Sponsored Programs manages the post-award financial activities of U-M's research enterprise and other sponsored activities to ensure compliance with applicable federal, state, and local laws as well as sponsor regulations. The Office of Contract Administration (OCA) is also part of the Office of Finance - Sponsored Programs.

Ethics & Compliance

You are here, parent permission letter sample.

(Word).  Sample of informed consent permission letter addressed to the parents of a child being recruited for participation in a human subjects study.  

Educator Resources

Conducting Research

Here is a sample letter for guiding your own request to the National Archives and Records Administration. Remember, the more specific your request, the better.

[Return Address] [Date]

Dear Archivist:

I am a student participating in National History Day. My topic is Amelia Earhart. According to entry 237.2 in the Guide to Federal Records at the National Archives , textual records related to this topic exist in the Records of the Aeronautics Branch and the Bureau of Air Commerce, 1922-38, of the Federal Aviation Administration.

I would like more information about these records. I know that the textual records in this group occupy over 1,500 cubic feet of space and that a finding aid entitled Preliminary Inventory of the Records of the Civil Aeronautics Administration NC6 (1962) exists. Unfortunately, I do not have access to this publication. Could you look at it for me and describe the records that exist pertaining to Amelia Earhart? I also need to know how much the National Archives charges for photocopies. When I determine which records will be useful for my project, I will be back in touch.

Thank you for your attention to this request.

[Your name]

National History Day Student

Now it is your turn:

Dear Archivist at the National Archives:

I am a student participating in National History Day. My topic is _________________. According to entry number __ ( cite number ) ____in the ______________ ( cite reference source ) ___________, records related to this topic exist in the Records of the _______ ( cite name of record group ) _______.

[ If your search for information led you to a specific item, cite the item and ask for information about obtaining a copy. If your search for information led you to a series of records that contain or may contain information of interest to you, ask for a search of those records for documentation pertaining to your topic. The more specific your request the better the chances of locating documentation useful to you. For example, instead of asking for records about the U.S. Navy during World War II, ask for the log of a specific ship (including ship name or hull number) for a specific date span. Rather than requesting records documenting the nation's Westward Expansion, ask for maps of the Oregon Trail, architectural drawings of Fort Laramie, photographs or drawings from the Hayden expedition, etc. ]

[ If your search for information produced no helpful results then phrase a request for documentation that is as specific as possible. Specific requests read like the following: I would like a VHS videotape copy of motion picture footage of the lift-off and splashdown of Apollo 13; I would like copies of photographs of the Yalta Conference during World War II; I would like copies of maps of the battlefield at Gettysburg; I would like audiocassette copies of sound recordings of the oral arguments before the Supreme Court in Roe v. Wade, October 11, 1972; I would like copies of nautical charts and soil erosion maps of the area surrounding Point Lookout, MD, for a specific date span; I would like copies of documentation pertaining to the awarding of the Congressional Medal of Honor to Sgt. Alvin York in World War I; or I would like copies of aerial photographs of Salt Lake City, UT around 1940. ]

[Your Name]

________________________

You can send your letter to the addresses you found during Activities 1, 2, 3, 4,or 5. If you don't have a specific address, the general address for reference requests is National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001, or you can e-mail it to [email protected] .

Sample Research Survey and Interview Request Letter

Sample Research Survey and Interview Request Letter (to the School Principal) Content

We, the Grade 12 Accounting, Business, and Management (ABM) senior high school students of AcadShare State University, are currently conducting a pre-feasibility study on a scented decorative candle with built-in speaker, an innovative and marketable product that targets teacher consumers as it has a special stress-relief feature.

With this, we would like to request your good office a consent allowing us to conduct a structured interview and/or survey with a number of randomly selected teachers in your school. In particular, the interview will focus on the teacher respondents’ stress levels, stress management practices, and perceived acceptability and marketability of the developed product. Equally, we also request that you allow us to conduct a video shoot for the online promotion of such product within the schedule of our visit in the school.

Furthermore, participation in our interview and/or survey and video shoot is entirely voluntary and does not pose any known or anticipated risk or issue. All information gathered will be dealt with utmost integrity and confidentiality.

Your approval of this request will be highly appreciated. Should you have further concerns and clarifications, please let us know.

Thank you very much.

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