During its first meeting of the year, scheduled for March 22-23, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will review a Government Accountability Office (GAO) report that faulted both the Food...more
On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more
Today, the Office for Human Research Protections (OHRP) will publish a notice in the Federal Register that its “Guidance on Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018...more