What Is “Key Information”? Consideration of the Reasons People Do or Do Not Take Part in Research-Reference-Cited by-同舟云学术

What Is “Key Information”? Consideration of the Reasons People Do or Do Not Take Part in Research

Published:2024-04-17 Issue:3 Volume:46 Page:26-33
ISSN:2578-2355
Container-title:Ethics & Human Research
language:en
Short-container-title:Ethics & Human Research

Author:

Berwanger Kara¹,Merz Jon F.²

Affiliation:

1. Clinical research coordinator of medical ethics and health policy at the Perelman School of Medicine at the University of Pennsylvania

2. Associate professor of medical ethics and health policy at the Perelman School of Medicine at the University of Pennsylvania

Abstract

ABSTRACTWe performed a qualitative review of 50 consent forms posted on Clinicaltrials.gov, examining the content of key information sections. We found that key information disclosures are typically focused on procedures, risks, potential benefits, and alternatives. Drawing upon reviews of the large literature examining the reasons people do or do not take part in research, we propose that these disclosures should be based more directly on what we know to be the real reasons why people choose to take part or refuse participation. We propose key information language for consideration by researchers and institutional review boards.

Publisher

Wiley

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/eahr.500210

Reference28 articles.

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2. Department of Health and Human Services “Human Subjects Research Protections.”

3. Federal Policy for the Protection of Human Subjects;Department of Health and Human Services;Federal Register,2015

4. Ibid. 53970.

5. Ibid. 54052 section 116 (italics added).