IRBs- The Basics
Madeleine M. Jester, RN, JD

Abstract

The Department of Health and Human Services has developed a regulatory apparatus that oversees biomedical research in the United States, and is responsible for seeing that individual researchers and institutions comply with federal laws and regulations for protecting human subjects. This regulatory apparatus has been put into place to counter breakdowns in the protection of human subjects rights that have taken place in recent years in the United States.¹

The FDA is the government entity responsible for the oversight of the human protection system for the products it regulates. Most research done in the United States is subject to the regulations pertaining to human subject protection, and is reviewed by local committees called institutional review boards (IRBs).²

These community-based committees make sure that the research conducted within that locality is consistent with community ethics, and that the rights of the research subjects involved in the study are protected. The efforts of local IRBs have helped to heighten the research community’s awareness of ethical conduct standards.

The Makeup of the IRB

An IRB is a duly constituted group that has been formally charged with reviewing and monitoring biomedical human subject research.³

IRBs must have at least five members with diversity of race, gender and cultural backgrounds, as well as sensitivity to the issues surrounding human subject research. The IRB membership must also be aware of the attitude within the local community towards research in general. In order for the pronouncements of the IRB to carry sufficient weight, the members of the IRB must be qualified to review specific research activities. At least one member of the IRB should be from outside the institution where the committee is located, and each IRB should have one member primarily interested in scientific issues and one concerned with nonscientific issues.⁴

Many institutions, especially those that conduct a great deal of research, have their own IRBs. An institutional or an individual investigator may use an IRB at another institution, as long as that IRB has the appropriate membership, and is also aware of local community attitudes toward research. There are a number of commercial, free standing or regional IRBs, that have been duly constituted, and review studies that are to be conducted in other geographic locations. Although this type of IRB review is permitted by the FDA, there may sometimes be a question as to whether or not the IRB is truly able to be sensitive to local community attitudes.⁵

The Function of the IRB

Although the FDA is responsible for general oversight of the human subject protection system it is the IRBs, sometimes also known as committees for the protection of human subjects or institutional review committees, that are primarily responsible for looking at research protocols, consent forms, and ongoing studies.

The IRB has the power to approve/disapprove or require changes to research plans and consent forms. The ultimate purpose of IRB review is to assure that the rights and welfare of participants in human subject research are protected. This is done through a group review process, during which research protocols and other related materials such as the informed consent document are discussed by the committee.

The IRB conducts this review with certain criteria in mind. Risks to research subjects must be minimized, so as part of its review the IRB assesses the risk-benefit ratio to the subject. The IRB makes sure that there has been no bias in selecting subjects for participation in the research. It also looks at the informed consent document to be used in a particular study to make sure the form complies with regulations and contains the basic required elements.⁶ The IRB is also responsible for making sure that there is adequate monitoring by the sponsor of the safety data generated in the study, that the privacy of research subjects is protected, the data is kept confidential, and that appropriate safeguards are in place to protect vulnerable populations such as prisoners and children.⁷

IRBs are expected to comply with the Code of Federal Regulations. They must have adequate written procedures for their functions and operations, and are required to conduct initial and continuing review of ongoing research studies. Research is to be reviewed at convened meetings with a majority of the members present. The IRB must maintain adequate records of actions taken at meetings with respect to the reviews that are done, and must notify investigators in writing of decisions to approve, deny or require modifications to proposed research activities.⁸

The IRB must determine if each study can be reviewed on an annual basis (the minimum), or if the nature of the risks to subjects in a particular study is such that the review must take place more frequently. It is also the job of the IRB to ensure that investigators report any significant changes in their research protocols to the IRB, so that the changes can be reviewed and approved prior to being initiated.⁹

IRBs must keep a list of IRB members, and maintain copies of all documentation related to each research proposal reviewed, of correspondence with investigators, and information on significant new findings given to subjects. These records must be kept for three years after research is completed, and they are subject to inspection by authorized government representatives.¹⁰

IRBs have a very serious and vital job to do, in assuring that research conducted within the local community is consistent with proper ethics and protects the rights of the research subjects. The effort of local IRBs working in concert with the federal agencies concerned with human subject protection have been instrumental in heightening the research community’s awareness of ethical conduct standards.

See also Balancing Benefit and Risk in Clinical Research , IRBs-Are They Still Working?

References

1. A History of Informed Consent, Risk Review, February 1998

2. Scientific Research - Continued Vigilance Critical to Protecting Human Subjects, Statement of Sarah F. Jaggar, Director Health Financing and Public Health Issues, Health, Education, and Human Services Division, before the Committee on Governmental Affairs, March 12, 1996, GAO/T-HEHS-96-102, Chapter 0.1

3. . FDA Document, Frequently Asked Questions, I. Institutional Review Board Regulations, p1, internet at http://www.fda.gov

4. Code of Federal Regulations, section 21 CFR 56.107

5. Letter Report to the Ranking Minority Member, Committee on Governmental Affairs, U.S. Senate, Scientific Research: Continued Vigilance Critical to Protecting Human Subjects, 3/8/96, GAO/HEHS-96-72, p 2, 5.1

6. The Basic Requirements of Informed Consent, Risk Review, February, 1998

7. Code of Federal Regulations, section 21 CFR 56.111

8. Code of Federal Regulations, section 21 CFR 56.108

9. Id.

10. Code of Federal Regulations, section 21 CFR 56.115

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