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What Is an IRB Human Subject?

Institutional Review Boards, commonly known as IRBs, are the bodies in universities and institutions which ensure the safe and fair treatment of human research subjects. Their number and influence has multiplied in recent decades, affecting research in medical, scientific and social science fields.

  1. History of IRBs

    • During the Nuremberg trials following World War Two, the general public learned of the horrific medical experiments performed by Nazis. This revelation spurred the creation in 1945 of the Nuremberg Code, the first law to address ethical issues in research. In 1953, the U.S. National Institutes of Health assembled a human subjects review panel at its center in Bethesda. By the 1970s, hundreds of institutions that wished to continue to receive federal funding had set up IRBs.

    The Belmont Report

    • In 1972, the American public learned about the Tuskegee Syphilis Study, which was funded by the government for 30 years. In this study, scientists studied the effects of syphilis on 300 rural black men. Even when antibiotics were available, scientists left the men untreated so they could continue their study. Public outrage led to Public Law 93-348, which established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission published the Belmont Report in 1979, which asserted three ethical principles governing research with human subjects: beneficence, respect and justice.

    Responsibilities and Composition of the IRB

    • Nowadays, stringent rules govern how institutions conduct research. Institutions must provide written assurance that they will obey all the rules and that their projects have been approved by an IRB who will continue to monitor them. Federally conducted or supported research must include a statement of how the institution will carry out its responsibility to protect human research subjects in a principled fashion. They must assemble an IRB of at least five individuals, preferably of diverse race and gender. The IRB must include a mix of members who are in scientific and nonscientific areas, and of people who are affiliated and not affiliated with the institution. Institutions must provide information about the composition of their IRBs to the government.

    The Human Subject

    • The government's definition of a human subject refers to any living human whom a researcher is using to obtain data by interacting with, or from whom the researcher collects identifiable private information. The law requires that subjects are exposed to minimal risk. This means that the research provides no more discomfort or harm than they would expect to encounter in their daily routine.

    Problems with IRBs

    • Despite the good intentions which created IRBs, they have not solved all the problems, and have led to new ones. Some major institutions have suspended all research involving human subjects following violations of human subject requirements in certain biomedical studies. This affects areas outside of those the rules originally were written to govern. For example, the field of oral history, in which people interview consenting adults about their life histories, has fallen under the realm of IRBs. Many oral history studies have been stunted while waiting for an IRB to realize that the interviewer poses no threat to her human subjects.

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