Institutional Review Board

Institutional Review Board
Name	Institutional Review Board
Founded	0 1974
Founder	United States Congress
Location	United States
Focus	Research ethics, Human subject research

Institutional Review Board. An Institutional Review Board is a committee formally designated by an institution to review, approve, and monitor biomedical research and behavioral research involving human subjects. Its primary purpose is to protect the rights and welfare of the people participating as subjects in research studies. The authority and mandate of these boards are derived from federal regulations, primarily the Common Rule, which is enforced by agencies like the Department of Health and Human Services and the Food and Drug Administration.

History and purpose

The modern concept emerged in direct response to historical ethical breaches in research, most notably the Tuskegee Syphilis Study and the atrocities revealed during the Nuremberg Trials. Public outrage over the Willowbrook State School experiments and other scandals led the United States Congress to pass the National Research Act in 1974, which mandated the establishment of local review boards. The foundational ethical guidance for these boards was provided by the Belmont Report, issued in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The core purpose is to ensure that research adheres to ethical principles, minimizes risk to participants, and that informed consent is properly obtained and documented, thereby maintaining public trust in the scientific enterprise.

Composition and structure

These boards are required to have at least five members with varying backgrounds to promote complete and adequate review of research activities. The membership must include both men and women, as well as at least one member whose primary concerns are in nonscientific areas, such as law, philosophy, or theology. There must also be at least one member who is not otherwise affiliated with the institution, often referred to as a community member. Boards reviewing research involving vulnerable populations, such as prisoners or children, must include additional members with specific expertise or experience regarding those groups. They operate under written procedures and are often administered through an office at institutions like Harvard University or the Mayo Clinic.

Ethical principles and regulations

The ethical framework is anchored by the three principles outlined in the Belmont Report: respect for persons, beneficence, and justice. These principles are operationalized through federal regulations codified in Title 45, Part 46 of the Code of Federal Regulations, known as the Common Rule. Key regulatory requirements include the assessment of risks and potential benefits, the equitable selection of subjects, and the process of obtaining and documenting informed consent. Additional protections are mandated for specific populations by subparts of the regulations, covering research involving pregnant women, fetuses, neonates, and prisoners. The Food and Drug Administration enforces similar regulations for research involving drugs, devices, or biologics.

Review process and types of review

The review process involves a detailed examination of the research protocol, informed consent documents, and recruitment materials. Boards can conduct several types of review: full board review, expedited review, or review for projects that qualify for exemption. Full board review, required for higher-risk studies, involves a convened meeting of a quorum of members. Expedited review, for minimal risk research, can be carried out by the chair or a designated member. The board has the authority to approve, require modifications to secure approval, or disapprove research. Ongoing approved research is subject to continuing review at least annually, and investigators must report any adverse events or proposed changes to the approved protocol.

Criticisms and controversies

Critics argue that the system can be overly bureaucratic, creating delays and administrative burdens that stifle low-risk research in fields like sociology or education. There are concerns about inconsistent interpretations of regulations across different institutions, leading to variability in decisions. Some controversies have arisen from perceived conflicts of interest, particularly when boards at prestigious institutions like Johns Hopkins University or the University of Pennsylvania review research sponsored by large pharmaceutical companies. High-profile cases, such as the death of Jesse Gelsinger in a gene therapy trial, have sparked debates about the adequacy of risk assessment and the transparency of the review process.

International equivalents

Many countries have established similar ethical review systems, though their names and specific governance structures differ. In the European Union, research ethics committees operate under the Clinical Trials Directive and the General Data Protection Regulation. In Canada, the equivalent body is typically called a Research Ethics Board, governed by the Tri-Council Policy Statement. In the United Kingdom, review is conducted by a National Health Service Research Ethics Committee. Other international frameworks include the Council for International Organizations of Medical Sciences guidelines and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, which influence standards in countries like Japan and Australia.

Category:Research ethics Category:Human subject research Category:Medical research organizations