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Maas Family Chair in Bioethics, Director, Center for Bioethics, University of Minnesota, Minneapolis, MN 55455-0346
2To whom correspondence should be addressed. E-mail: kahnx009{at}umn.edu.
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ABSTRACT |
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 TOP ABSTRACT |
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KEY WORDS: • informed consent • vulnerable populations • risks • benefits
History of research protections
Many of the research protection policy programs that we have in place are really driven by a history of exploitation of subjects. There are numerous examples that I could walk you through. The so-called Tuskegee Syphilis Study is a very important and well-known example. The Willowbrook Study is another example but involved children in an institutionalized setting. The value of recounting these historical shortcomings is that what we came to live with and currently do live with are research protection policies that were driven by a sense that we have to protect people from being exploited at the hands of researchers, at the hands of government, at the hands of those who are in control. In Tuskegee, Alabama, it was about deceiving subjects into participating. At Willowbrook, it was taking advantage of the parents of children who needed to be institutionalized and effectively saying: You can have a spot for your child in our institution if you agree to their being used in research. That is not meaningful, voluntary informed consent in the sense that we expect. These examples and others come from the late 1960s and early 1970s, which is exactly when we started to think about regulations. What is interesting about those dates is that we were certainly doing much more research before 1972, which is when the Tuskegee Study first came to public attention. So from that history came policies that were driven by a commitment to provide some level of protection for those deemed to be "vulnerable." Vulnerability is understood in this context in terms of assuring the fair distribution of the risks of research. In concrete terms, that would mean making sure we do not place all the burdens of research onto one community or one group of people when the benefits go mostly to others. Only more recently have we come to pay attention to how the benefits of research are distributed.
Anybody who performs research on human subjects has a love–hate relationship with their institutional review board (IRB). We know there is a requirement for prospective review and that there are good reasons for requiring approvals in advance of research going forward. Before 1966, in the United States, there was no requirement for written informed consent on the part of research subjects. In 1966, the first policy requiring written informed consent was implemented but only for research performed at the NIH Clinical Center in Bethesda, MD. The federal-wide requirement came along only in the late 1970s. So the requirement of informed consent, which we take to be obvious and now part of the landscape, is really quite a recent construct. In addition, special protections were crafted for so-called vulnerable subjects. Those vulnerable subgroups that were identified in our federal regulations are prisoners, children, and pregnant women. Why? Because there has been a history of exploitation of these groups: children coming out of the Willowbrook experience; and prisoners, because almost all pharmaceutical research was being done in prisons in that period. Prisoners were prized research subjects because they are excellent research subjects—they are willing to participate and should be easy to keep in research. The obvious ethical concern is that they are not exactly free to make decisions on their own. So, early in the development of protection policies, prisoners were deemed to deserve special protections. Similarly, children get special protections, because they cannot decide for themselves. Pregnant women were included in the list for a complicated set of political reasons, including the raging debate over abortion in the early 1970s. What is interesting about the regulations is what is missing—there are no subparts speaking to protections for communities, nothing for those who are decisionally impaired, and nothing about those who are economically disadvantaged, for example.
A shift in protection policies
In the late 1980s and early 1990s, there was a policy shift in protection of human subjects. We saw a shift toward increasing emphasis on access to participation in research. Rather than focusing on the risks that research carries, the focus had switched to making sure that there is fair distribution of the benefits that research offers. This is about assuring inclusion in research, driven largely by efforts on the part of those who were involved in HIV/AIDS advocacy, as well as those working in cancer advocacy groups. The best evidence of how the thinking changed is in a quote from the HIV/AIDS advocacy group ACT-UP, from the early stages of HIV/AIDS epidemic. Demonstrators marched in major cities around the United States with placards that said: "Clinical trials are health care too." Why? Because the only way to get cutting-edge treatment if you were HIV-infected in the early days of the epidemic was to be in a clinical trial.
This represents the other side of protection policies. It is not protection from risk, but protection in terms of our rights to access research participation because of the benefits that it offers to subjects. We can see the effects of the lack of inclusion in areas such as women’s health. Women were largely excluded from research, first if they were pregnant because of the protections that I mentioned before. That notion of protection was then expanded to women who could be "potentially pregnant," which had the effect of barring a whole class of individuals from research. To address this shortcoming, we saw an increasing emphasis on the benefits that research has to offer individuals in research. But much more importantly, it goes to the benefits to categories of individuals, whether they are communities or groups of individuals, such as women. We now have policies that require inclusion, whereas in the past we required exclusion. In the past, we restricted research access because of protection. Now we have the flip side, requiring researchers as a matter of NIH policy to justify why they are not going to include minorities and women in research—the expectation has switched from exclusion to inclusion.
The shift has been endorsed throughout government, with prominent endorsements from people like the former director of the National Cancer Institute (NCI), Richard Klausner, who went before Congress in 2000, arguing for large increases in the NIH budget request. One of the arguments made on the part of the NCI was that the funding was necessary to ensure that all people who wish to participate in a cancer clinical trial are able to do so. This rhetoric is part of a sense that research has great benefit; we need government funding to make sure that the commitment to research participation can be lived out through a right that we are creating to have access to clinical trials. This is an amazing statement, particularly in a country where we do not have a similar commitment to assuring access to basic health care.
What do we have to do differently or think about differently in terms of the context of this switch to commitments to access to research? We have to make sure that we do not overemphasize the benefits, and we need to make sure that a balance is correctly struck. And that is about the fact that research inherently carries risks. Risk is about uncertainty. We do not know if harm will befall research subjects, and we cannot predict whether and how research participation will benefit individual subjects.
Protecting communities vs. individuals
Why do we think about protecting communities as somehow separate or different from individuals? In the context of informed consent, as I said before, communities are made up of groups of individuals, and there are strong parallels in protection of individuals and the processes we use. We are getting much more sophisticated about consent not only at the individual level but also for groups and communities as well. The risk-benefit balancing has to be thought about not only for individuals in research but for the communities of which they are a part.
There may be risks and benefits for the community separate from the individuals that make them up. There are informed consent issues to be thought about more broadly.
We also can argue about whether communities per se benefit from being in research. Who gets to consent on the part of groups or communities? Part of the problem is that we talk about community consent, but we know that it does not make sense as a concept. A community cannot consent, because there is no entity that is the community. It is representatives of the community or individuals who reside within the community. In the end, what we are really after is partnership. Through partnerships, we want commitments between researchers and institutions and the people we are asking to participate in our research from these groups. We will not be successful in research unless we partner with the communities in which we are asked to do the research, from the very beginning, in everything from research design to recruitment of subjects to dissemination of research results.
Trust and the future of research
What are the implications of the evolution of research protections? We have to make sure that when we talk about oversight that we are balancing protection—protection of individuals and protection of the communities with access to participation in research. That is the responsibility of the oversight process of institutions. We have to make sure that we focus on the process of informed consent rather than signatures on consent forms as being meaningful informed consent. It is especially important for research within communities, because mere pieces of paper are not going to be sufficient in any context and more so in the context of communities. We have to admit and to understand that partnership has implications for the entire process of research. Those who do it, those who oversee it, the institutions at which it is done, and the relationships created with the communities that were asked to participate in research.
This all comes out in trust. Adequate protections will never be achieved unless there is a trust relationship between the researchers, their institutions, and the people whom we are asking to participate, along with the groups that they represent. This includes trust in investigators, trust in institutions, and trust in the processes for those oversight protections. Unfortunately, we have had far too many examples where there have been reasons to not fully trust in the people who are doing research. This undermines the entire process and comes back to haunt everybody. Without trust, there is no willingness on the part of potential subjects to participate in research. In conclusion, we must remember that research is a privilege. We need to ask people to join us in the research enterprise, working with them to make sure that they are committed in the way that we are, that they understand and are partners with us as we go forward. If we violate the trust of those we ask to participate in research, then we are likely to see more media coverage such as the cover of Time magazine from April 22, 2002, in which a woman was portrayed dressed in a hospital gown crouching in a cage, with the caption "How Medical Research Has Made Millions of Us into Human Guinea Pigs." Nobody wants to be turned into a human guinea pig, and any representation of research in this light can only undermine the public’s trust in what we do. The charge to us is to redouble our efforts to earn and preserve that trust so that we can serve the public through all the benefits research has to offer, while protecting the rights and the interests of those who join us as partners in the endeavor.
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FOOTNOTES |
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This article has been cited by other articles:
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  A. M. Ferris and G. S. Marquis Bioethics in Scientific Research: Conflicts between Subject's Equitable Access to Participate in Research and Current Regulations J. Nutr., April 1, 2005; 135(4): 916 - 917. [Full Text] [PDF]
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