On March 1, 2017, PRIM&R held a day-long Ethics of Data Access, Use, and Sharing for Human Subjects Research Workshop in partnership with the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (MRCT Center). I am pleased to announce that the proceedings and other information from the day are now available on PRIM&R’s website. Read more
TAG ARCHIVES FOR public policy
On December 13, 2016, President Obama signed into law the 21st Century Cures Act. Passed as the Cures Act, the sweeping law aims to foster innovation, reduce administrative burdens, and otherwise enhance the nation’s approach to healthcare, medicine, and research. Read more
Update: The Office of the Federal Register pre-published the revisions to the Common Rule on January 18.
There has been a lot of anticipation and uncertainty in the research oversight community during the 16 months since the release of the Notice of Proposed Rulemaking to revise the Common Rule. We learned last week that the process is, in the final days of the Obama Administration, officially moving forward.
On January 4, a revised Common Rule Read more
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for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on institutional review board (IRB) written procedures. The guidance is “intended for…IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.” Read more
In November 2015, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations. This is the first time the agencies have jointly issued specific guidance on IRB meeting minutes. Read more