Human Research Protections: Time for Regulatory Reform?

Ever greater numbers of us will be asked at some point in our lives to participate in a research study. We might be invited to participate in surveys and focus groups, asked to let researchers conduct studies with our tissue or medical information, or recruited for clinical trials that test whether drugs, medical devices, or biologics—like vaccines and genetic materials—are safe or effective. One company involved in recruiting human subjects estimated that the number of participants needed to fill industry-sponsored trials grew from 2.8 million in 1999 to 19.8 million in 2005.¹ There is also a growing need for children, the elderly, and people with certain diseases to enroll in studies that test interventions targeted to those populations.

The very fact that record numbers of people are being recruited for research makes thoughtful attention to how we safeguard human subjects of the utmost importance. On top of that, though, there are problems with the current regulatory system. Some requirements may be overprotective and excessively bureaucratic. And yet there are also gaps that may leave many research participants without adequate protection. Some of the gaps exist because regulations have not kept pace with recent developments, such as stem cell and other biotech research, and the globalization of clinical trials. Increasing numbers of American-based trials are being conducted abroad, and participants in those trials may be less well protected than participants in trials conducted domestically. There are also gaps in the empirical data about the research enterprise, including such basic information as the number of adults and children who enroll in trials.

Other gaps are caused by disagreements about the extent to which research with humans should be regulated. Thus, there are no specific rules for research with persons who are cognitively impaired, even though several advisory bodies have recommended them, and there are significant exceptions to the requirements for informed consent and prior approval of studies. Today these exceptions are widely accepted, yet there have been and continue to be dissenters. As Robert Veatch has noted, researchers often wanted to pursue research unhindered, and the authors of the regulations listened.²

Many commentators are now calling for regulatory reform, and the Department of Health and Human Services' Secretary's Advisory Committee for Human Research Protections is considering whether changes are needed and where. The challenge is to start from the solid foundation of ethical principles and to identify both the regulatory gaps that should be filled and the regulatory overburden that does not meaningfully protect research participants.

The Foundations

Until the late twentieth century, research with humans was not subject to federal regulations. Informal scientific norms guided researchers as to whether and how they should conduct experiments with humans. The medical norm to "do no harm" and the notion of the "virtuous researcher" justified the scientific community's preference for self-regulation and its resistance to government oversight. In the 1970s, Congress enacted legislation that resulted in limited federal regulation in response to the public outcry over several unethical research studies. Scientists had conducted research on children and sick adults without obtaining consent or under coercive circumstances. The United States Public Health Service's Tuskegee Syphilis Study was perhaps the best known of these studies.

Today, regulations issued by the Department of Health and Human Services and the Food and Drug Administration spell out the rules researchers must follow when conducting human studies. Although the DHHS regulations apply only to federally funded studies, many institutions conducting federally sponsored human research apply the DHHS rules to all of their research with humans, regardless of the source of funding. Since many medical institutions and universities conduct human research using federal dollars, the DHHS regulations are applied to a wide range of clinical trials and other types of research with humans. Although not in full harmony with the DHHS rules, FDA regulations apply to research involving drugs, biological agents, or devices that are subject to FDA approval.

Both sets of regulations include two key rules. The first demands that an institutional review board review and approve studies before individuals are asked to enroll in them. Under...