Institutional Review Boards: Requiring Sponsors and Investigators to Inform IRBs of Any Prior IRB Reviews

摘要

The Food and Drug Administration (FDA) is considering whether to amend its institutional review board (IRB) regulations to require sponsors and investigators to inform IRBs about any prior IRB review decisions. These disclosures could help ensure that sponsors and clinical investigators who submit protocols to more than one IRB will not be able to ignore an unfavorable IRB review decision and that IRBs reviewing a protocol will be aware of what other IRBs reviewing similar protocols have concluded. FDA seeks information on IRB practices to determine whether it should draft a regulation and, if a regulation is to be drafted, to help determine the regulation's contents.