The last few months have been a bit of blur. The long-awaited NPRM to revise the Common Rule was released in September, setting off something of a firestorm of commentary, concern, and clamor around what was in the proposal, and what wasn’t; what might work, and what wouldn’t; and of course, how it would all look in the "real world" of ethical research oversight. Here at PRIM&R we spent a good deal of time over the three-month comment period crafting our response to the NPRM, and [...] Read more
TAG ARCHIVES FOR biospecimens
by László M. Szabó, Esq., director of the Office of Research Regulatory Affairs at Rutgers, The State University of New Jersey
More than six months after the 2013 Advancing Ethical Research (AER) Conference, members of the PRIM&R Blog Squad are still benefiting from the experiences they had in Boston. With the opening of registration for the 2014 AER Conference around the corner, we’re pleased to share a few of their reflections.
by László M. Szabó, Esq., Director of the Office of Research Regulatory Affairs at Rutgers, The State University of New Jersey
On Monday, March 4, PRIM&R hosted a webinar titled PRIM&R’s Primer on the HIPAA/HITECH Act Omnibus Final Rule. Emily Chi Fogler, JD, senior legal counsel in the Office of General Counsel at Partners HealthCare System, and Jennifer Geetter, JD, partner in the law firm of McDermott Will & Emery LLP, participated as speakers, with P. Pearl O’Rourke, MD, as moderator. Following the webinar, we connected with Emily Chi Fogler, and she kindly answered a few more questions that came in from webinar participants, for <[...] Read more