Institutional Review Boards

Although universities and hospitals began establishing committees to review re- search ethics in the 1960s, such committees did not become common until the 1970s. In the aftermath of the Tuskegee scandal, Congress in 1974 created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission’s reports laid the groundwork for current guidelines regarding research ethics. That same year, the National Research Act mandated the development of institutional review boards (IRBs), charging them with reviewing all federally funded research projects involving human sub- jects. Such boards now exist at all universities and other research institutions, and they monitor both social science and medical research.

In recent years, though, pharmaceutical research has increasingly shifted from federally funded projects in hospitals and universities to for-profit projects funded by pharmaceutical companies and conducted by research organizations, individual doctors, or the pharmaceutical companies themselves. To oversee this research, for- profit, commercial IRBs have emerged, run by or under contract with pharmaceu- tical companies or other research organizations.

The conflict of interest involved in such IRBs is obvious. When employees of a pharmaceutical company review their company’s research, they know that their company’s success depends on getting that research approved. Similarly, those who work for commercial IRBs know that they are unlikely to get future contracts from pharmaceutical companies unless they approve those companies’ research proposals.