TAG ARCHIVES FOR NPRM

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

30
Sep2015

From its inception, one of PRIM&R's goals has been the education of research ethics and oversight professionals. To do this, we host conferences, short courses, webinars, and other offerings, such as PRIM&R’s online and member-only Knowledge Center, to assist our community in their daily work. The newest tool was brought about by our Knowledge Center Advisory Group. It's my pleasure to share PRIM&[...] Read more

3
Sep2015

On September 2, the Office of the Federal Register made available a pre-publication version of a much-anticipated Notice of Proposed Rulemaking (NPRM) that proposes changes to the Federal Policy for the Protection of Human Subjects, or the “Common Rule.”

The release of the NPRM comes four years after the publication of an Advance Notice of Proposed Rulemaking (ANPRM), which first put forward proposals to modernize the regulations governing human subjects research in the United States. The NPRM, which was issued by the Department of Health and Human Services (DHHS), [...] Read more

Page 5 of 512345