A sneak peek from the APR/MAY 2006 issue of Seed:
Credit: Mikhail Tolstoy
In the 1980s, AIDS patients protested in Washington and other major US cities to loosen restrictions on drug research, marching with placards that said “Clinical Trials are Health Care Too!” When you’re dying of a disease for which there is only an experimental therapy with unknown effectiveness, waiting on research results can be the equivalent of a death sentence. The argument that people are being protected for their own good can seem empty and patronizing at best.
In fact, there is a growing trend: Many now see participation in medical research as a right, rather than a risk. Right now, the US Department of Health and Human Services is considering loosening restrictions on who can volunteer for participation, and in January, the EPA decided, for the first time, to accept data from studies that intentionally expose humans to pesticides. As our culture’s stance on the role of human research shifts, we need to remember that human experimentation—for all its value—is not an unmitigated good. It’s time to take stock of what benefits the controls we have in place have brought us, and where they need to change. I believe that investing billions of our public dollars in the hope of reaping the benefits of state-of-the-art research brings an obligation to invest in state-of-the-art protections for the rights and welfare of human subjects.
As a member of the Clinton administration’s presidential commission investigating government-sponsored radiation research on American citizens during the Cold War, I was deeply affected: How could our country have condoned—let alone supported—research that involved the injection of plutonium into unwitting cancer patients? The goal of research is to advance knowledge, but that cannot come at the expense of the rights (and sometimes health) of our fellow citizens. This not-so-distant history has informed my thinking about how we must behave in the future.
When they were drafted in the 1970s, the federal regulations on human subjects in research (now known as “The Common Rule”) contained extra protections for three groups of subjects termed “vulnerable” populations: children, pregnant women and fetuses, and prisoners. Some clearly required protection (children) while for others it was less obvious (women, prisoners). The hope was to prevent the exploitation of the past—wherein some groups were viewed as expendable for the greater good of medical research—from ever happening again. Children were protected for their inability to consent, prisoners because of the constraints of their living environment, and in a well-intentioned but overly paternalistic effort, women were excluded from research to protect their unborn and future children.
Not only were the early protections questionable in their underlying ethical justifications, but we may have overprotected some populations. The prime example is women, who as a result of the regulations have been prevented from realizing the benefits of research. Public protests by HIV/AIDS advocacy groups like ACT UP and others further argued that the sick should have more access to experimental drugs and treatments. Protection efforts came full circle with federal policies requiring access to research for women and minorities in the early 1990s. The pendulum swung from emphasizing protection, to guaranteeing access for these groups.
The financial tangle among sponsors, researchers and the institutions where research is performed is an escalating problem that’s only now finally beginning to receive the attention it requires. These potential conflicts have yet to be well understood, let alone well managed; as the conflicts in relationships and interests among those involved in research become more complex, it only complicates our understanding of the risks and benefits this research presents.
It is time to end the longstanding lack of oversight of private research. The regulations that we’re so carefully revising apply to only a portion of actual studies; the rules’ reach is limited to federally-funded research, research at federally-funded institutions, and research for submission to the FDA. That leaves subjects in some privately-funded research without any required oversight or protections. The most worrisome part is that we have no idea how much private research is slipping through the cracks. Congress should pass legislation to remedy this obvious shortcoming that has existed far too long.
Evaluating the risks and benefits posed by research on human subjects has always been a difficult task. Balancing the two has been even harder. Today, the landscape and culture of scientific research is more vast and complex than at any time in our history. But if we are to preserve the kind of society we hope will benefit from our many experiments, we must continue to rise to the challenge.
Jeffrey Kahn, PhD, MPH, is director and Maas Family Endowed Chair in Bioethics at the University of Minnesota Center for Bioethics, and co-editor of two books, Beyond Consent: Seeking Justice in Research and Policies for Human Subjects Research.
Originally published March 20, 2006