by Elisa Hurley, PhD, PRIM&R education director
On October 26, 2011, PRIM&R submitted to the Office for Human Research Protections (OHRP) comments in response to the Advance Notice of Proposed Rulemaking (ANPRM) titled, "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators," published in the Federal Register on July 26, 2011.
In its comments, PRIM&R addressed many of the specific proposals and 74 questions embedded in the ANPRM. We also took this opportunity to highlight some broad themes that cut across specific regulatory proposals, including:
- There is a need for more robust [...] Read more
by Wendy Tate, PSM, CIP
By this time almost everyone is familiar with the advance notice of proposed rulemaking (ANPRM) that recommends vast changes to the human subject regulations known as the “Common Rule.” As I read the memorandum, table of changes, and 92-page document, one thing kept popping into my mind: What about the subparts?
Being “in the trenches” at a university that supports both medical and social/behavioral research, I find it frustrating to apply subpart B (research involving pregnant women) to non-biomedical research and/or minimal risk biomedical research. Granted, subpart B is not technically part of the “Common Rule,” and as such is not included in the recent ANPRM. [...] Read more