Update: The Office of the Federal Register pre-published the revisions to the Common Rule on January 18.
There has been a lot of anticipation and uncertainty in the research oversight community during the 16 months since the release of the Notice of Proposed Rulemaking to revise the Common Rule. We learned last week that the process is, in the final days of the Obama Administration, officially moving forward.
On January 4, a revised Common Rule Read more
PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on institutional review board (IRB) written procedures. The guidance is “intended for…IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.” Read more
In November 2015, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations. This is the first time the agencies have jointly issued specific guidance on IRB meeting minutes. Read more
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, [...] Read more
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
