The Institutional Review Board and Protecting Human Subjects: 10 Frequently Asked Questions

Abstract

It is essential that anyone involved in research involving human subjects be familiar with the purpose and role of institutional review boards. Institutional review boards are designed, first and foremost, to protect human research subjects by overseeing the implementation of federal regulations regarding protection of human subjects. The federal government requires institutional review board approval for any human subject research that receives federal funding, and many scholarly journals require proof of institutional review board approval of the research before publication. In this article, the answers to 10 frequently asked questions about the role of institutional review boards highlight the important contributions made by institutional review boards to the conduct of ethically sound research. The aim is to generate a working knowledge of the institutional review board's function that can be used by every researcher contemplating working with human research subjects. This is the first in a series of 3 articles examining common issues in research ethics.

Get full access to this article

View all access options for this article.

References

Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10.

Nuremberg, October 1946-April 1949. Washington, DC: US Government Printing Office; 1949–1953. Available at: http://ohsr.od.nih.gov/guidelines/nuremberg.html. Accessed April 27, 2005.

World Medical Association . World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. May 2002. Available at: http://www.wma.net/e/policy/b3.htm. Accessed April 27, 2005.

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research . The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: Department of Health and Human Services; 1979. Available at: http://ohsr.od.nih.gov/guidelines/belmont.html. Accessed April 27, 2005.

National Institutes of Health . Code of Federal Regulations. Title 45: Public Welfare. Part 46: Protection of Human Subjects (2001) (codified at 45 CFR §46). Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed April 27, 2005.