Protecting Human Subjects

Institutional Review Boards, or IRBs, are mandated by the Office for Human Research Protection of the U.S. Department of Health and Human Services; the Food and Drug Administration has a similar requirement. An IRB—such as the Duke University Health System (DUHS) IRB—has responsibility for the review of research involving human subjects. In clinical trials, human-subject protections are an ethically minded element of research protocols, which are carefully structured written plans that outline the aims, methodology, schedule, and costs of the trial.

The DUHS IRB has thirteen full-time and thirteen part-time employees. The parttimers include the chairs and vice chairs of the individual IRBs, many of whom are active clinicians and researchers in the School of Medicine. Other members of the individual IRBs are drawn from various disciplines across DUHS and the larger Triangle community. There are nine individual IRBs, with a total of some 200 members. Typically, eight of them meet once a month; the ninth is a Rapid Response IRB for emergency issues.

Generally it takes thirty calendar days from the time that a new research protocol involving human subjects is proposed until it receives an IRB review. In a standard review, the full IRB reviews the protocol. In an expedited review, which is applied to minimal-risk studies, the IRB chair and vice chair review the protocol.

Every year, the DUHS IRB reviews about 5,000 protocols, with oncology the most active area in seeking IRB oversight. The DUHS IRB also is responsible for issuing declarations of exemption for projects using human samples or data that may not meet the federal definitions of “research” or “research with human subjects.”