TAG ARCHIVES FOR Common Rule

23
Nov2011

by Elisa Hurley, PhD


Last  week, the Presidential Commission for the Study of Bioethical Issues held its seventh public meeting in Boston. This was the final meeting devoted to President Obama’s charge to assess how well current regulations protect human subjects in research. The President’s instruction came in response to the revelation last year that from 1946 to 1948 the US Public Health [...] Read more

26
Oct2011

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

19
Oct2011

Welcome to another installment of our featured member interviews where we introduce you to our members—individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Lisandra V. González, MPH, an HRPP integrity and education specialist at Baystate Health Medical Center in Springfield, MA.

When and why did [...] Read more

5
Oct2011

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

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