Add like
Add dislike
Add to saved papers

On Improving Oversight and Enhancing Protections.

IRB 2017 November
For this theme issue, "Reflections on the Revised Common Rule," we invited leading experts and scholars in research ethics to identify and comment on some of the important changes that the U.S. Department of Health and Human Services made to the Common Rule in a final regulation the agency released in January 2017. The authors draw on their experience as institutional leaders, members of national research ethics advisory bodies and institutional review boards, and scholars with deep knowledge of the ethical issues that human biomedical and behavioral research raises. Carl Coleman addresses some of the implications of the definitional ambiguities that remain in the revision, including the distinction between research and quality assessment and quality assurance activities. Barbara Bierer argues that the generalizable knowledge definition of research should not be the criterion for distinguishing research from clinical care. Holly Fernandez Lynch, Emily Largent, and Deborah Zarin raise important issues about what kind of research could be conducted on and with the consent forms that the revised Common Rule requires be posted on a publicly accessible website. And Suzanne Rivera identifies several concerns about the new blanket requirement that multisite studies cede authority to one single IRB to review the protocols for all the study sites.

Full text links

We have located links that may give you full text access.
Can't access the paper?
Try logging in through your university/institutional subscription. For a smoother one-click institutional access experience, please use our mobile app.

For the best experience, use the Read mobile app

Mobile app image

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app

All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.

By using this service, you agree to our terms of use and privacy policy.

Your Privacy Choices Toggle icon

You can now claim free CME credits for this literature searchClaim now

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app