TAG ARCHIVES FOR Common Rule

13
Jan2017

Update: The Office of the Federal Register pre-published the revisions to the Common Rule on January 18.

There has been a lot of anticipation and uncertainty in the research oversight community during the 16 months since the release of the Notice of Proposed Rulemaking to revise the Common Rule. We learned last week that the process is, in the final days of the Obama Administration, officially moving forward.

On January 4, a revised Common Rule Read more

6
Jan2017

Much of my AER16 schedule focused on risks in vulnerable populations. For me, an important backdrop for these topics was presented in the Plenary Session A New Framework for Human Subjects Research? An Update from NAS, moderated by Alexander Capron. The presenters, Barbara Bierer, MD, Steven Joffe, MD, MPH, and Heather Pierce, JD, MPH, did not discuss research risks or vulnerable populations, but they discussed how the current regulatory and policy framework fits with current research practices. Read more

28
Dec2015

Elisa HurleyOn September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects, or "Common Rule." If adopted, the proposals in the NPRM will result in the most substantive revisions to the core regulation governing federally funded human subjects research in the United States since 1981.

In earlier posts, we explored a new category of activities that would be excluded from oversight under the Common Rule and proposed [...] Read more

21
Dec2015

Many thanks to my Blog Squad colleague Courtney Zweig for exploring the proposed changes to the Common Rule involving single IRB review processes. That particular proposal is Issue #6 of 19 of the Office of Human Research Protections’ (OHRP) summary of the proposed regulatory changes in ANPRM.

If you’re reviewing the other proposed changes as well, don’t miss Issue #5 of 19 involving informed consent. According to the OHRP, modifications may be necessary because consent documents are currently "too long and hard to understand." Under the proposed regulations, these documents would be "shorter, more readily understood [and] less [...] Read more

2
Dec2015

On September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects, or "Common Rule." If adopted, the proposals in the NPRM will result in the most substantive revisions to the core regulation governing federally funded human subjects research in the United States since 1981.

In earlier posts, we explored a new category of activities that would be excluded from oversight under the Common Rule and proposed changes to the category of Read more

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