TAG ARCHIVES FOR NPRM

21
Dec2015

A Rationale For Pilot Testing

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21 Dec

Comments: 1

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

Who Watches Whom?

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16 Dec

Comments: 5

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

4
Dec2015

Research Ethics Roundup: Developments in the Animal Field, Proposed Changes to the Common Rule, and More

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4 Dec

Comments: 1

From major developments in the animal research field to the new proposed changes to the Common Rule, this week’s Research Ethics Roundup examines new ethical concerns in a changing research landscape.

daydreaming-chimpanzee-1553285-638x477 NIH to Retire All Research Chimpanzees: NIH will send their research chimpanzees to sanctuaries and will begin to phase out their support for research on chimpanzees that they do not own. NIH’s director, Francis Collins, said NIH decided to end their chimpanzee research program because the need for research on chimpanzees had declined [...] Read more

2
Dec2015

Unpacking the NPRM: Single IRB Review and Continuing Review

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2 Dec

Comments: 3

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