When an institution engages in research that is conducted or supported by the federal government, it must provide the Department of Health and Human Services (HHS) Office of Human Research Protection (OHRP) with written assurance that the research will be carried out in accordance with federal regulations for the protection of humans as research subjects. Under such regulations, oversight of research is facilitated at each institution by a designated committee called the Institutional Review Board (IRB). IRB oversight also is required for clinical trials that are submitted to the Food and Drug Administration (FDA) in support of applications for the marketing of drugs and devices.
Excerpt from Nancy C. LeGros, Institutional Review Board Update, Annual Meeting (American Health Lawyers Association June 2007).
An IRB is a board, committee or other group designated by a healthcare institution to review, to approve the initiation of, and to conduct periodic reviews of clinical research studies involving human subjects. The IRB is an “agent of [its] own institution, not a branch office of any regulatory agency.” See Robert J. Levin, Ethics & Regulation of Clinical Research 326 (1986). An IRB derives its power from “the institution’s legal authority to regulate any investigations it sponsors or funds.” Id. The IRB should be established and operated in conformance with the federal regulations. Understanding the reporting structure of the IRB is key to representing an IRB. In some instances, the IRB will report to an administration liaison who reports directly to the governing board of the institution.
The primary purpose of the IRB is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. The IRB is charged primarily with balancing the risks and benefits of the research, ensuring an equitable selection of human subjects, and obtaining valid informed consent of the human subjects. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.
Excerpt from Teresa M. Williams et al., INSTITUTIONAL REVIEW BOARDS: A PRIMER 21-22 (2007).
Each IRB is required to have at least five members of diverse professional and cultural backgrounds. There must be at least one member who is not otherwise affiliated with the research institution, as well as at least one member whose primary concerns are with nonscientific areas. If research is being conducted on subjects within one of several “vulnerable” populations (e.g., prisoners), the IRB must include at least one member with special knowledge about such persons. Finally, “every nondiscriminatory effort must be made” to include members of both sexes on the IRB. Most reviews by the IRB must take place with a quorum present, including at least one non-scientist member.