TAG ARCHIVES FOR NPRM

25
Jan2016

The last few months have been a bit of blur. The long-awaited NPRM to revise the Common Rule was released in September, setting off something of a firestorm of commentary, concern, and clamor around what was in the proposal, and what wasn’t; what might work, and what wouldn’t; and of course, how it would all look in the "real world" of ethical research oversight. Here at PRIM&R we spent a good deal of time over the three-month comment period crafting our response to the NPRM, and [...] Read more

6
Jan2016

Dahron_JohnsonBefore we get too far into the new year, I wanted to take an opportunity to sneak in a few last reflections on the recent Advancing Ethical Research conference. As I prepared to leave Tennessee for Boston and AER15, I projected two goals: first and most basically, a renewal of knowledge; and second, the more lofty aspiration, to gain insight into the pragmatic relationships formed during the research process. Given the amorphous nature of both, I could argue I either achieved everything I could have hoped for, or, that [...] 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

23
Dec2015

PRIM&R recently completed a draft of our comments to the Department of Health and Human Services (DHHS) in response to their Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects , If adopted, the proposals in the NPRM will result in the first revision to the Common Rule since 1991, and the most substantive revisions to the core regulations governing federally funded human subjects research in the United States since 1981.PRIM&R believes that, without question, an improved and modernized [...] Read more

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