At Law: Time for New Rules on Human Subjects Research?

An era of relative contentment with the federal rules on human subjects research appears to have ended. Beginning with the 1995 Final Report of the Advisory Committee on Human Radiation Experiments,1 a growing array of federal officials and advisory groups have raised concerns about the state of human studies oversight. The latest assessment and the most detailed to date comes from the Department of Health and Human Services Inspector General, which in June 1998 presented four reports based primarily on a review of federal records and committee reports and on the literature on human subjects protection. The IG's overarching conclusion is that the long-established system for protecting human subjects has vulnerabilities that threaten its effectiveness.2 To address those vulnerabilities, the IG proposed numerous revisions in the federal requirements governing human subjects research. According to the IG, the IRB system's effectiveness is jeopardized by a series of recent developments in the research environment. The reports emphasize six such developments. First, to recruit subjects, researchers rely more and more on advertising that stresses the financial and potential therapeutic benefits of participating in the research. Second, IRBs review a substantially increased volume of research proposals, some of which, such as those involving genetic testing, raise novel ethical questions. Third, IRBs fail to re-examine studies carefully after the initial approval process. A related problem is that IRBs are not getting the information they need from data safety and monitoring boards and from the existing method of adverse incident reporting. Fourth, greater reliance on commercially sponsored research in both academic and independent health centers can lead to pressure on IRBs to issue speedy and accommodating decisions. Although nonscientist and unaffiliated IRB members could in theory mitigate such pressure, most IRBs do not have enough such members to make a difference. The two remaining problems affecting the quality of IRB review concern the oversight of IRBs themselves. One is that research facilities and their IRBs fail to offer investigators and IRB members sufficient instruction on the ethics and regulations relevant to human subjects protection. Another is that there is no system for evaluating IRB performance. Because IRBs and federal agency officials neither observe the actual research process nor seek information from subjects during and after research, the adequacy of human subjects protection remains unclear. IG Recommendations The reports offer numerous recommendations to address these problems. Some of them will be welcomed by IRB members and administrators; others could be somewhat unsettling. Many would require changes in current federal regulations. For example, the IG says the National Institutes of Health and the FDA should hold IRBs more accountable for protecting human subjects but should at the same time give IRBs more freedom to determine how they carry out their mission. The reports suggest that current requirements for annual IRB review of all approved protocols impose significant administrative burdens on IRBs without necessarily advancing human subjects protection. Subjects would be better served if IRBs were able to devote less time to low-risk studies and more time to in-depth inquiries on projects that present the highest risk to subjects. Such inquiries could incorporate the use of consent observers or intermediaries, announced or unannounced site visits, and discussions with subjects. To reduce the burdens on IRBs, the IG also indicated that it might be appropriate to permit IRBs to review studies only after they have been funded. On a similar note, the IG recommended that the NIH abandon its requirement for lengthy and detailed institutional assurances in favor of an institutional attestation to conform to the IRB requirements set forth in Federal regulations. …