by Joan Rachlin, JD, MPH, Executive Director
Last week’s Food and Drug Administration approval of Truvada, the first drug to help prevent HIV infection in high-risk populations, was extraordinary, and extraordinarily well-timed. The announcement coincided with the opening of the 2012 International AIDS Conference, which was held in the US for the first time since President Obama lifted a travel and [...] Read more
By Catherine Rogers
Among the esteemed faculty for the 2011 Advancing Ethical Research (AER) Conference is Ann Bonham, PhD. As the chief scientific officer of the American Association of Medical Colleges (AAMC), Dr. Bonham plays a critical role in advancing ethical research. Conference attendees can look forward to her presentation during the pre-conference program The Buck Starts & Stops Here: Investigator Responsibilities for the [...] 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:
