Institutional Review Board (IRB)

Institutional review boards (IRBs) are committees charged with the review and monitoring of research (including surveys) involving human participants. The basic principles of human research protection used today in the United States were outlined in the Nuremberg Code and were developed in response to the Nazi atrocities. Voluntary informed consent to research participation is at the core of that code. In response to research participant abuse in the first half of the 20th century, IRBs were mandated in the United States by the Research Act of 1974. In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research submitted the Belmont Report, which recommended the basic ethical principles underlying the acceptable conduct of research involving human participants. Those principles are (a) respect for persons (autonomy), (b) beneficence, and (c) justice. These basic principles continue to form the foundation for ethical conduct of research involving human participants.

Since 1974, all research funded by the Department of Health and Human Services has been required to undergo review to ensure ethical treatment of research participants. Most organizations receiving federal funding have assurance agreements that extend this ethical review to all research conducted by the institution. Although not yet enacted, in recent years, several federal legislators have expressed interest in expanding these protections to all public and private research—irrespective of funding source.

The constitution and utilization of IRBs were included in the regulations that were codified in Title 45 (Public Welfare—Department of Health and Human Services) Code of Federal Regulations (C.F.R.) Part 46 (Protection of Human Subjects). The regulations require that IRBs have a minimum of five members of varying experience and expertise as well as broad demographic representation. At least one member must have scientific expertise and at least one member must be from a nonscientific area. One member of the IRB must be from outside the institution. IRBs are also allowed to invite individuals with special expertise or knowledge to provide consultation and information on individual protocols, where needed.

Review of research activities typically involves the submission of a detailed overview of the research protocol utilizing a submission form. The form asks specific questions regarding how participants will be recruited, what they will be asked to do, details of the research design, and how the data will be transmitted, stored, and disseminated. The IRB reviews this information and performs a risk-benefit analysis to assure that any risks to the participants are offset by benefits to the participants or society. The review includes the following seven components: (1) identification of risks associated with the research participation; (2) identification of probable benefits of the research; (3) to the extent possible, assurance that risks are minimized; (4) determination of whether risks are proportionate to benefits; (5) assurance that participants are given accurate and complete information about the [Page 339]potential risks and potential benefits; (6) determination of the adequacy of privacy and confidentiality protections; and (7) determination of the best review intervals and any necessary monitoring of data collection.

The IRB has the authority to approve a protocol, to disapprove a protocol, or to ask for revisions or modifications of a protocol before approving the protocol. The IRB's decision and any required modifications are made in writing to the investigator. If a project is disapproved, the investigator is notified of the rationale and is provided with an opportunity to respond to the IRB regarding the disapproval.

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