Protecting individuals who participate in research, although a requirement for federal research grantees for over twenty years, is suddenly a hot topic in some Washington circles. The renewed attention is the fallout from a recent series of events--some tragic and some trivial. For those who thought that the days of the Tuskegee syphilis study and Willowbrook were long gone, more recent events, although not of the same magnitude, have reminded policymakers that not all is well in the world of biomedical and behavioral research.
In 1998, the Inspector General of the Department of Health and Human Services sounded a warning that the twenty-year-old system of protecting research subjects, based on regulations and embodied in institutional review boards (IRBs), had not adapted sufficiently to the changing research environment (see HCR, July-August 1998). Subsequent reports from the same office declared that the system was simply overwhelmed; IRBs were crushed by the volume and complexity of research needing review and lacked the financial, administrative, and educational resources necessary to do the work. These findings echoed those of a 1996 report from the General Accounting Office, which also warned of the growing tendency of IRBs to rely on investigators' willingness to comply with the regulatory requirements.
Unfortunately, government reports have a way of sitting on shelves. Scandal, however, is always a tremendous motivator in Washington. Thus the most recent round of public scrutiny followed the death of eighteen-year-old Jesse Gelsinger during a gene transfer study at the University of Pennsylvania. Before that was the revelation that researchers with the Department of Veterans Affairs in West Los Angeles were performing risky research without obtaining subjects' consent, and in the background were shutdowns of federally funded research at seven major research universities. Although no one had died at these research sites, the suspensions, meted out by the federal Office for Protection from Research Risks (OPRR), were a red flag that a pattern of disregard for the regulations existed that had to be corrected.
These events have sparked a re-examination of human subjects research projections. The biomedical research community was alarmed by the OPRR actions and charged that the office was going too far, suspending entire research programs for violations that were sometimes purely administrative. Congress, always quick to smell smoke, also began asking questions about the oversight of human subjects research. …