Institutional Review Board

What is an Institutional Review Board (IRB)?

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.

  1. Respect for Persons
  • Individuals should be treated as free thinking people and are capable of making their own informed decisions
  • Persons with reduced free thinking abilities are entitled to protection
  1. Beneficence
  • Do not harm
  • Make the most of benefits while reducing risks
  1. Justice
  • That no one group is singled out either to exclude them with no cause from research (such as children or women) or to include them because they are more accessible than other populations.

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.