TAG ARCHIVES FOR NPRM

17
Nov2015

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

6
Nov2015

Heather-Kim-resizedWelcome to the latest installment in our series of featured member interviews. This series highlights individuals within our membership who are making an impact on the research ethics field through their work. This month, we hear from Heather Kim, a senior regulatory compliance auditor in Quality Management for Copernicus Group IRB.

Elise Davis (ED): When and why did you join the field?
Heather Kim (HK): I had just begun my Masters in Regulatory Affairs when we covered the IRB in a basic Part 50 and 56 overview. Around that time, I was looking for [...] Read more

29
Oct2015

By Elisa A. Hurley, PhD, and Avery Avrakotos

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 an earlier post, we explored the rationale for the proposed changes, as well as a new category of [...] Read more

13
Oct2015

By Elisa A. Hurley, PhD, and Avery Avrakotos

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. Over the next few weeks, we will be exploring the proposals put forward in the NPRM, including some of the questions that have already emerged about the potential impact of the [...] Read more

9
Oct2015

By Lauren Solberg, JD, MTS
Member, Knowledge Center Advisory Group

PRIM&R’s Knowledge Center Advisory Group recently developed an online tool that connects users to Office for Human Research Protections (OHRP) materials that can be used to understand the regulations at 45 CFR 46 Subpart A.  In developing and finalizing this educational resource, we realized that while we frequently use terms like “statutes,” “regulations,” and “guidance,” it isn’t always clear what they mean or how they differ.  This summary should clarify these differences and help you to use the annotated regulations tool effectively.

[...] Read more

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