The first task of a board reviewing human subject research is to decide whether

What Is an Institutional Review Board (IRB)?

An IRB is a committee within a university or other organization receiving federal funds to conduct research that reviews research proposals. The IRB reviews the proposals before a project is submitted to a funding agency to determine if the research project follows the ethical principles and federal regulations for the protection of human subjects. The IRB has the authority to approve, disapprove or require modifications of these projects.

Who Serves on an IRB?

An IRB consists of at least five members of varying backgrounds. IRB members should have the professional experience to provide appropriate scientific and ethical review. An IRB must have at least one scientist member and at least one member whose primary concerns are nonscientific. Additionally, there must be one member who is not otherwise affiliated with the institution (a community representative). The IRB should strive for appropriate representation in gender and racial and cultural heritage as well.

Where Does an IRB Get Its Authority?

In 1974, the Department of Health Education and Welfare promulgated the regulations on the Protection of Human Subjects that established the IRB. IRBs are administered on a federal level by the Office for Human Research Protections (OHRP), an office within the Department of Health and Human Services. OHRP assists IRBs in their work and receives and investigates claims of inappropriate research practices.

The institution that the IRB serves provides administrative support for its activities including designation of an individual within the institution to oversee research and IRB functions. The institution also files an "Assurance" with the federal government that describes the procedures and guidelines that the IRB must follow.

What Kind of Research Projects Do IRBs Review?

IRBs are charged with reviewing all federally funded research projects involving human subjects with a few exceptions (e.g., reviews of records or surveys in which subjects cannot be individually identified or when disclosure of subjects' responses could not place them at risk of criminal or civil liability and is not damaging to subjects financially, vocationally or socially). However, based on the procedures set forth in the Institutional Assurance, the IRB may review all research projects, regardless of the source of funding.

How Does an IRB Make Its Decisions?

Before an investigator can receive federal funds to conduct a research project, the protocol (research procedures) is reviewed by the IRB. The researcher provides the IRB with all the necessary materials to conduct their review including a full description of the proposed project, materials the subjects will use (surveys, questionnaires, tests, etc.), a description of the manner in which subjects will be recruited and provide consent to participate in the project (including a consent form), and how the subjects' confidentiality will be maintained.

The IRB examines all these materials to determine if the research participants are adequately protected. The IRB's consideration is based primarily on weighing the risks and benefits of the research. Risks may be physical, psychological, social or economic. Benefits include both those to the individual research participant and to society as a whole. The IRB also considers the population being studied — Does it require additional protections? Would this population assess the risks and benefits differently?

What Does An IRB Do After Reviewing the Project?

After examining the materials the researcher provides to the IRB, they must decide if the benefits of the research have been maximized and the risks minimized, and make a final determination whether the benefits justify the risks to the subjects. If the IRB finds that this is the case, they may approve the protocol. Alternatively, the IRB may request that the researcher make specific changes to the procedures and approve the protocol contingent on these changes or ask that the protocol be revised and resubmitted. Finally, the IRB may decide to disapprove of the project. Institutional officials may disapprove research protocols that have IRB approval, but they may not grant approval of research projects that have been disapproved by the IRB.

In addition to reviewing new research protocols, IRBs also review continuing projects or those that have changes in their procedures. Continuing projects are reviewed yearly (or more often if the IRB feels it is necessary).

How Does an IRB Protect Special Populations?

The Code of Federal Regulations requires that IRBs give special consideration to some classes of subjects: children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons. The IRB carries out this charge in a number of ways. In many cases, the IRB may approve of research with these subjects only when it involves minimal risk or when the benefits apply to the subject directly. Additionally, if the IRB frequently reviews protocols involving one of the special groups, they may have a community member whose primary interests are with one of these groups.

Who Has Access to IRB Records?

The institution and the IRB maintain records of IRB activities including copies of the research protocols reviewed, minutes from meetings and correspondence. All records must be made available for review by OHRP.

Date created: September 2017

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