TAG ARCHIVES FOR NPRM

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

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

16
Dec2015

By the end of the post, I may call into question my own particular existence. In the meantime, though, let’s talk about research ethics (the two are related, I assure you).

As the 2015 Advancing Ethical Research (AER) Conference wound through its days, a theme of sorts began to emerge. It found its clearest statement in the conference’s final session, a discussion of the various reports and inquires that have come forth regarding the state of research ethics oversight at the University of Minnesota. The recent headlines about this—"Why the U. of Minnesota Research Scandal Threatens [...] Read more

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