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&R’s newest resource: an annotated version of 45 CFR 46.
This interactive tool connects users to, and provides information about, correspondence, guidance, frequently asked questions, and related resources made available by the Office for Human Research Protections. Anyone whose work is governed by the regulations at 45 CFR 46 will find this tool useful for fostering greater understanding of those regulations.
Additionally, with the recent release of a Notice of Proposed Rulemaking (NPRM), which proposes changes to the “Common Rule,” this resource is especially timely. While considering the proposals in the NPRM, we encourage you to use the annotated version to reflect on the current regulations and the guidance issued by OHRP over the years, in order to assess which issues have been appropriately addressed by the proposed changes, and which issues remain unresolved.
We welcome your thoughts and feedback as you make use of PRIM&R’s annotated 45 CFR 46, as this is an ongoing effort which will see further additions and refinements as in the months to come.
Also, if you’re attending the 2015 Advancing Ethical Research Conference (AER15) and/or the 2015 Social, Behavioral, and Educational Research Conference (SBER15), please plan to join members of the Knowledge Center Advisory Group, who will demonstrate the annotated version of 45 CFR 46 and showcase the breadth of resources available in the Knowledge Center. More details about these demonstrations are available on the respective conference websites, or onsite.
I wish to extend a warm thanks to Lauren Solberg, JD, MTS; Michael Leary, MA, CIP; Lois Brako, PhD; and the other members of the Knowledge Center Advisory Group for their work developing this tool.
by Melissa A. Epstein, PhD, MBE, CIP, administrator for the IRB at the Albert Einstein College of Medicine; member of PRIM&R’s Knowledge Center Advisory Group and chair of its Annotated Regulations Subgroup