What are the regulations that underlie the IRB policies?
The Scientific Committees (IRBs) for Bureau affiliates are bound by the regulations of two federal agencies: the Food and Drug Administration , which oversees trials of new drugs and devices, and the Office for Human Research Protection (OHRP, formerly OPRR) , which oversees subject protections in federally-funded research. The regulations maintained by these agencies are spelled out in the Code of Federal Regulations (45 CFR 46, 21 CFR 50, 21 CFR 56 ). Although the FDA and OHRP have jurisdiction over only a portion of the research conducted at within the Bureau, it is Bureau policy to apply the same standards for all research projects, regardless of the funding source. In addition to the federal regulations, JCAHO has standards and the State of Illinois has statutes which govern the protection of research subjects in health facilities.
