Professionals engaged in the protection of human and animal subjects felt the tides of change in 2011: The Department of Health and Human Services proposed an overhaul to the regulations governing human subjects protections. Across the country, people provided feedback and comments on the proposed change; the animal care and use community reacted when the National Institutes [...] Read more
TAG ARCHIVES FOR human subjects research
In its December 15 report, the Presidential Commission for the Study of Bioethical Issues (the Commission) makes 14 recommendations to improve the current system of research protections.
One of the most nuanced and interesting parts of the Commission’s 193-page report is the [...] Read more
Welcome to a special installment of our featured member interview series in which we introduce you to our 2011 AER Conference Blog Squad members. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and why they're excited about blogging for PRIM&R!
Today we’d like to introduce you to Dawnett Watkins, IRB coordinator at the University [...] Read more
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