An Institutional Review Board (IRB) is a committee made up of individuals who have training in scientific areas, individuals who have expertise and training in non-scientific areas, and members of the community who may represent people who would participate as subjects in research studies. An IRB provides an independent review of research studies that propose to use human subjects in answering a research question. The IRB is concerned with the research being conducted in an ethical manner, with protecting the rights and welfare of the human subjects, and with adherence to federal regulations, state laws, or other requirements that may govern how research is conducted. Not all research must be reviewed by an IRB. If the researcher or the entity for whom they work received funding from the federal government for any research involving human subjects, then they must have their research reviewed and approved by an IRB before it can begin. Also, any research that would involve products regulated by the federal Food and Drug Administration (FDA) must be reviewed by an IRB.
History of the Institutional Review Board (IRB)
The IRB began in 1974 when the National Research Act was signed into law, the Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission was charged with identifying the basic ethical principles that underlie the conduct of Biomedical and Behavioral research and to develop guidelines for research involving human subjects. Human subject research provides many societal benefits, but it also brings some troubling ethical questions due to reported abuses of human subjects. These abuses were most egregious during the Second World War, but other cases occurred such as the U.S. Tuskegee Syphilis trial in which rural black men with syphilis were not told they were participating in research and were subsequently denied treatment for their disease when penicillin became a known cure.
The Nuremberg Code was drafted from the Nuremberg War Crimes trials of Nazi physicians and scientist who had conducted atrocious biomedical experimentation on concentration camp prisoners. The Code comprises certain basic principles that must be observed in order to satisfy the moral, ethical and legal requirements for the conduct of human research, and has become the prototype of many later codes. Another set of guidelines is the Declaration of Helsinki, authored by the World Medical Association, which allows for research on subjects with the diminished capacity to participate in research provided consent is obtained from their legal guardian.
IRB Review of Research
The Belmont Report was drafted in response to numerous clinical trial violations. The three basic ethical principles identified in the Belmont Report are used to review proposed research involving human subjects.
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The IRB at Washington University
The Washington University in St. Louis’s Human Research Protection Office (HRPO) is the Institutional Review Board (IRB) that serves Washington University, Barnes-Jewish Hospital and St. Louis Children’s Hospital.
Washington University IRB Committee Information
The Washington University IRB reviews new and renewal applications, reportable events, and modifications to research studies. Committee meetings occur each week. Our committee members include; physicians, non-physician scientists, researchers, clinicians, nurses, pharmacists, occupational therapists, physical therapists (among other members of the medical community), lawyers, clergy, and lay people from the St. Louis community.
Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects. The purpose of IRB review 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. 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. Institutional Review Board Questions: Contact the Office of Good Clinical Practice, 301-796-8340, or
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Selected US Regulatory Requirements for IRBs (Paraphrased)
| Regulation | Requirements |
| Membership (45CFR.46 107; 21CFR.56.107) | At least 5 members of varying backgrounds, both sexes, and > 1 profession |
| At least 1 scientific member, 1 nonscientific member, and 1 unaffiliated member | |
| Members sufficiently qualified through diverse experience and expertise to safeguard subjects’ rights and welfare and to evaluate research acceptability related to laws, regulations, institutional commitments, and professional standards | |
| At least 1 member knowledgeable about any regularly researched vulnerable groups | |
| Members report and recusal for conflicts of interest | |
| Ad hoc experts as needed | |
| Functions/operations (45CFR.46 108; 21CFR.56.108) | Follow written procedures for initial and continuing review and for any changes and amendments |
| Written procedures for reporting unanticipated problems, risks, and noncompliance | |
| Quorum of majority at convened meetings. Approval requires majority vote | |
| Review (45CFR.46 109; 21CFR.56.109) | Authority to approve, require modifications of, or disapprove research |
| Require informed consent and documentation (or approve a waiver1) | |
| Notify investigators in writing | |
| At least annual continuing review | |
| Criteria for approval (45CFR.46 111; 21CFR.56.111) | IRB should determine that risks are minimized; risks are reasonable in relation to anticipated benefits, if any, and the importance of the expected knowledge; subject selection is equitable and attention to vulnerable populations; informed consent will be sought and documented; adequate provisions for monitoring; adequate provisions to protect confidentiality; additional safeguards for subjects vulnerable to coercion or undue influence |
| Authority (45CFR.46. 113; 21CFR.56.113) | Institutional officials cannot approve research that is disapproved by the IRB (45CFR.46 only) |
| The IRB can suspend or terminate research for serious harm or noncompliance | |
| Records (45CFR.46. 115, 21CFR.56.115) | Records of research proposals, meetings, actions, correspondence, members, and so forth |