protecting study volunteers in research 5th edition

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Protecting Study Volunteers in Research: A Manual for Investigative Sites, Fifth Edition

Product details, are you up to date on developments for protecting your trial participants.

If you’re running trials, relying on outdated knowledge could be putting them at risk. Longstanding principles and practices have been upended by groundbreaking developments in clinical research as well as changes brought about by COVID-19.

Enter the newest edition of what has been the industry’s leading resource on protecting clinical trial participants for more than 20 years: Protecting Study Volunteers in Research: A Manual for Investigative Sites, Fifth Edition .

Throughout this edition, you’ll benefit from the expertise and insights of clinical trial professionals from academia, industry and medical practice. Their 360-degree view of important issues, including genetic research … the ethnicity of participants … requirements of informed consent … and more, will ensure you’re doing right by your trial participants.

Key Manual Highlights:

• Federal regulations related to keeping clinical trial participants safe
• Protection issues related to social science research (behavioral and observational studies)
• Ethics and implications of informed consent
• How accurate publication of trial results protects participants and the public
• The effect of financial conflicts of interest and scientific misconduct on clinical research
• Issues involved in increasing participant diversity
• The impact of HIPAA regulations on clinical trial data
• Issues presented by the growth of genetic research and precision medicine

Bonus! The appendix contains the text of FDA human subject protection regulations; the Common Rule; and a copy of the Belmont Report , on which human subject principles are based.

Protecting Study Volunteers in Research: A Manual for Investigative Sites includes all the developments you must consider to ensure your trial participants are informed, empowered and — above all — as safe as possible. Order your copy today.

About the Contributors

This manual was written by a variety of clinical research professionals — investigators, IRB representatives, medical school professors, former federal officials, sponsor representatives and clinical statisticians — led by primary author Gary Chadwick, PharmD, MPH .

Dr. Chadwick is associate provost at the University of Rochester (retired) and former professor of clinical community and preventive medicine and medical humanities in the university’s School of Medicine and Dentistry. He also directed the school’s Office for Human Subject Protection, which is responsible for the operation and support of the university's IRB system. Dr. Chadwick was a commissioned officer in the U.S. Public Health Service for more than 26 years. He served in the FDA and in the Office for Protection from Research Risks at the NIH. He was the founding chair of the ARENA Council for Certification of IRB Professionals.

Contributing authors to this edition include:

• Angela Branche , associate professor, infectious diseases, University of Rochester School of Medicine and Dentistry
• Nancy Perini Chin , associate professor, undergraduate public health programs, multidisciplinary studies, University of Rochester
• Ann Dozier , professor and chair,   department of public health sciences, University of Rochester School of Medicine and Dentistry
• Joanne Larson , associate director of research, Warner School of Education, University of Rochester
• Kelley O’Donoghue , associate VP for human subject protection, University of Rochester
• Anita Naik , systems integration associate, athenahealth

Contributors: Gary Chadwick, PharmD, MPH; Angela Branche; Nancy Perini Chin; Ann Dozier; Joanne Larson; Kelley O’Donoghue and Anita Naik

ISBN-13: 978-1-60430-132-8

Publication date: Oct. 2021

Page count: 580

CenterWatch Announces Protecting Study Volunteers in Research: A Manual for Investigative Sites, Fifth Edition Training Guide USA - English USA - English

Know everything one needs to protect trial participants? Not without the newest edition of Protecting Study Volunteers in Research. Order today.

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Oct 25, 2021, 14:00 ET

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FALLS CHURCH, Va. , Oct. 25, 2021 /PRNewswire-PRWeb/ -- Protecting Study Volunteers in Research: A Manual for Investigative Sites, Fifth Edition CenterWatch Training Guide https://www.centerwatch.com/products/category/1060-training-guides/product/549-softcover

Don't put study volunteers at risk by using outdated information.

Get comprehensive training in the most up-to-date study volunteer protection regulations, ethics and practices with the fifth edition of the industry's leading resource on protecting clinical trial participants — Protecting Study Volunteers in Research: A Manual for Investigative Sites.

This is the must-have manual for those in clinical research responsible for study volunteers, with material on:

• Federal regulations related to working with clinical trial participants
• Special study volunteer protection issues related to social science research (behavioral and observational studies)
• Ethics and implications of informed consent
• How accurate publication of trial results protects volunteers and the public
• The effect of financial conflicts of interest and scientific misconduct on clinical research
• Issues involved in increasing participant diversity
• The impact of HIPAA regulations on clinical trial data
• Issues presented by the growth of genetic research and precision medicine

Protecting Study Volunteers in Research: A Manual for Investigative Sites includes all the developments one must consider to ensure study volunteers are informed, empowered and — above all — as safe as possible.

Training Guide Details: Protecting Study Volunteers in Research: A Manual for Investigative Sites, Fifth Edition CenterWatch Training Guide https://www.centerwatch.com/products/category/1060-training-guides/product/549-softcover

Easy Ways to Order: Online: https://www.centerwatch.com/products/category/1060-training-guides/product/549-softcover By phone: 888.838.5578 or 703.538.7600

About CenterWatch: Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.

Media Contact

Michelle Butler , CenterWatch, 703.538.7600, [email protected]

SOURCE CenterWatch

Related Links

https://www.centerwatch.com/

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PROTECTING STUDY VOLUNTEERS IN RESEARCH: A MANUAL FOR INVESTIGATIVE SITES

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A manual for investigative sites, by cynthia mcguire dunn , cynthia, md mcguire-dunn , and gary l. chadwick.

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Protecting study volunteers in research - softcover, cynthia mcguire dunn ; m.d. ; gary chadwick ; pharm.d. ; mph ; cip.

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• Publisher CenterWatch LLC
• Publication date 2012
• ISBN 10  1930624646
• ISBN 13  9781930624641
• Binding Paperback
• Edition number 4
• Number of pages 554

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Protecting Study Volunteers in Research, Third Edition 3rd Edition

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• ISBN-10 1930624441
• ISBN-13 978-1930624443
• Edition 3rd
• Publisher CenterWatch
• Publication date April 1, 2004
• Language English
• Dimensions 5.75 x 0.75 x 8.75 inches
• Print length 382 pages
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• Publisher ‏ : ‎ CenterWatch; 3rd edition (April 1, 2004)
• Language ‏ : ‎ English
• Paperback ‏ : ‎ 382 pages
• ISBN-10 ‏ : ‎ 1930624441
• ISBN-13 ‏ : ‎ 978-1930624443
• Item Weight ‏ : ‎ 1.4 pounds
• Dimensions ‏ : ‎ 5.75 x 0.75 x 8.75 inches
• #538 in Medical Research (Books)
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