TAG ARCHIVES FOR regulations

3
Sep2019

From the Director: The Promise and Puzzle of the Key Information Requirement

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3 Sep
Comments: 3

Some of the most significant changes in the revised Common Rule involve the provisions around informed consent, including the new requirement that informed consent begin with a “concise and focused presentation of key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research” [46.116(a)(5)(i)]—the “key information requirement,” for short. I welcome the key information requirement and think it has the potential to greatly improve informed consent, but it is bringing with it several complexities. Read more

1
Mar2019

How to Operationalize the Revised Common Rule

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1 Mar
No comments

After over five years of discussion—from the advance notice of proposed rulemaking and two implementation delays—the revised Common Rule finally went into effect on January 21, 2019. The delays in implementation, while frustrating at times, also gave institutions more time to plan and discuss best practices. Through all this discussion, however, many areas of ambiguity were identified including challenges on how to implement the changes. To help address these issues, PRIM&R held a panel on Operationalizing the Revised Common Rule at the 2018 Advancing Ethical Research Conference (AER18). While change can be challenging, working together to share ideas and best practices can help ensure the transition goes as smoothly as possible. Read more

19
Nov2018

2018 IRB Administrator Boot Camp: IRB Administrator 201 Impressions

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19 Nov
No comments

The IRB Administrator 201 portion of PRIM&R’s IRB Administrator Boot Camp was very insightful and provides a good opportunity to apply critical thinking skills to real life scenarios faced by other IRBs. The presentations on implementation of the revised Common Rule and single IRB review considerations are particularly relevant with regard to the anticipated changes. A great deal of templates and samples were provided as examples of how other institutions are attempting to navigate the Common Rule changes and this is certainly an area in which IRBs can learn from each other. Read more

11
Sep2018

From the Director: Taking a look at the National Academies’ report on returning individual research results to participants

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11 Sep
Comments: 5

In July of this year, the National Academies of Science, Medicine, and Engineering (NASEM) released a report titled, “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm.” It’s a comprehensive report that raises many important considerations and proposes a number of thoughtful recommendations on this very timely topic. I won’t be able to do justice to all of its details and nuance here. Instead, I’ll share what I take to be some key themes and takeaways, including for IRBs. Read more

11
Aug2017

AER16 Blog Squad: Since the conference, how have things changed?

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11 Aug
No comments

PRIM&R invites members of our conference Blog Squads to reflect on the conference they attended in an additional post six months after the event. In this post, AER16 Blog Squad member Seth Hall reflects on how he's applied what he learned at AER16 to his day-to-day work. Read more