TAG ARCHIVES FOR PRIMR comments

4
Feb2016

PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on meeting minutes for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations. Read more

17
Oct2012

by Amy Davis, JD, MPH, Senior Director for Programs and Publications

PRIM&R recently sent comments to Congressman Edward Markey, (D-MA), senior member of the House Energy and Commerce Committee, on a bill called the Trial and Experimental Studies Transparency (TEST) Act of 2012. The goal of the bill is to increase transparency of clinical trials by expanding reporting [...] Read more

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