CAREB-ACCER’s response to the U.S. Notice of Proposed Rulemaking (NPRM) – Federal Policy for the Protection of Human Subjects

In September, 2015, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced proposed revisions to the U.S. regulations for protection of human subjects in research. The proposed changes are intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, and public comment sought on the proposal

Attached is CAREB-ACCER’s response to the “Federal Policy for the Protection of Human Subjects” incorporating comments submitted from members and respectfully submitted to the Office for Human Research Protections (OHRP) on January 5, 2016.

File: CAREB-ACCER NPRM response, January 5, 2016

File: CAREB-ACCER NPRM response, January 5, 2016 French