Bearing the Brunt of the New Regulations: Minority Populations

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In an ideal world, the new FDA regulations permitting research without consent could have the potential to help hundreds of thousands of people in emergency medical situations. Ideally, those who suffer strokes, drug overdoses, cardiac arrests, and traffic and gunshot wounds would benefit. If able to give consent, most trauma patients would probably want the innovative interventions that investigators propose. For most people, then, emergency medical research without consent presents no ethical dilemma. In an ideal world institutional racism, sexism, and classism would play no part in the selection of research subjects. The benefits and risks of research would be fairly distributed among the population. However, we do not live in an ideal world. Research is not primarily for the benefit of the individual subjects, but rather for scientific knowledge that will benefit people in the future. In the world we live in, researchers have reputations to make; IRBs are not always vigilant in protecting the rights and welfare of the research subjects; individuals are sometimes harmed by experimental medicine; and vulnerable populations--ethnic minorities, children, prisoners, and poor people--have always been fair game for unethical medical research. The new rules will have a significant impact on ethnic minorities, particularly African Americans. For at least three reasons, implementation of research without consent will be problematic for minority populations. First, African Americans, Hispanics, and poor people will be disproportionately the subjects of experimentation without informed consent. Because of the location of trauma centers and because of the disproportionately high rate of certain kinds of trauma, poor people and people of color will probably bear a great deal of the burdens of research. While trauma centers serve people from all walks of life, regardless of race, ethnicity, sex, age, or class, a large proportion of trauma centers are located in public hospitals in or near inner cities. Because public hospitals are often associated with universities, they are also sites for teaching and medical research. For example, the Los Angeles County-University of Southern California Medical Center is the country's largest teaching hospital and also the nation's second largest public health system, caring for 28 percent of all major trauma victims in Los Angeles County.[1] Emergency research will most likely take place in poor communities because that's where the hospitals with sophisticated and well-run trauma centers are located. A disporportionately large number of research subjects will likely be Hispanic and African Americans because of the large number of firearm--related injuries and deaths in minority communities. In 1992, 52,000 U.S. residents had a traumatic brain injury that contributed to their deaths. Forty-four percent of those deaths were caused by firearms--the largest cause of trauma-associated death for Black and Hispanic males.[2] By the year 2003, firearm-related violence is expected to be the leading cause of trauma-related death and disability in the United States.[3] So Blacks and Hispanics will be disproportionately affected by the new regulations. Second, implementation of the new regulations will be difficult in minority populations because of the history of abuse of informed consent. African Americans have historically been subjects of medical experiments without their consent, without benefit to themselves, and often without benefit to science. Many people will wonder what's different about this latest abrogation of informed consent. Is this yet another opportunity to force African Americans to be guinea pigs for white science? Although the Tuskegee experiment is the emblem of experimentation without consent and the source of much African American suspicion of medical science, there are other examples where the principle of informed consent was ignored: research on slave women for finding a cure for urine leakage into the vagina; testing smallpox vaccine on slaves; perfection of the cesarean section on black women. …