The Price of Perfection: Individualism and Society in the Era of Biomedical Enhancement

14. Research on Enhancement

u Chapter 14 Research on Enhancement Because by far the best way to ensure that biomedical enhancements promote the public good is to make them as safe and effective as possible, it is critical that good information be available about their risks and benefits. Good information includes knowledge about the chemical formulation of the drug or the electrical and mechanical design of the device, as well as data about the effects that the enhancement produces in laboratory and animal testing. But by far the most important information comes from human experiments. The United States, along with other nations and international organizations , has developed an elaborate system of ethical norms and legal rules to govern biomedical research using human subjects. The principles they embody were developed to safeguard against abuses such as the Nazi medical experiments that came to light following World War II; indeed, the first set of rules to protect human subjects was adopted by military judges at Nuremberg as part of their verdict against the Nazi doctors. But the Nazis were not the only ones who conducted unethical medical experiments. In the early 1960s, mentally disabled children in a state school on Staten Island were deliberately infected with hepatitis, some of it extracted from feces, to test the efficacy of treatment with gamma globulin. Around the same time, patients at Jewish Research on Enhancement 231 Chronic Disease Hospital in New York were unknowingly injected with live cancer cells to learn about organ transplant rejection. But next to the abuses of the Germans and Japanese during World War II, the most infamous case is the U.S. Public Health Service syphilis experiment at Tuskegee. Begun in 1932, the study involved 410 African-American syphilitic men in rural Alabama. The purpose of the study was to follow the course of the untreated disease. Subjects were not informed what was wrong with them, and they were not treated, even in the 1950s after penicillin had been recognized as standard, effective therapy. In fact, U.S. public health officials actively discouraged treatment by local physicians, the state health department, and the army. Subjects were offered a $50 burial subsidy to stay in the study, and in 1958, each survivor was given $25 and a certificate of appreciation. The first paper describing the study appeared in the medical literature in 1936, and reports continued to be published through the 1960s. In 1969, a committee of the U.S. Centers for Disease Control and Prevention (CDC) reviewed the experiment and authorized it to continue. By the time the press exposed the study in 1972 and halted it, only 74 men remained alive. Revulsion against the experiment at Tuskegee led Congress to enact the National Research Act of 1974. This created the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, which in turn produced the Belmont Report, the primary source of ethical principles for human subjects research, which forms the basis for the so-called Common Rule, the federal regulations governing human experimentation. The Common Rule requires experiments to be approved by institutional review boards (IRBs), committees created by the institutions that conduct the research and comprised primarily of employees of those institutions who perform their duties as an uncompensated add-on to their regular jobs. (Experiments funded by the government or intended to be submitted to the FDA also must obtain government approval.) To approve the proposed experiment, the IRB reviewers must satisfy themselves that the benefits are maximized and the risks minimized and that the risks are reasonable in relation to the anticipated benefits, including benefits to subjects and the importance of the knowledge to be gained.1 Furthermore , the reviewers must ensure that the investigators will obtain the informed consent of the subjects. This requires that the subjects be given a description of the proposed experiment, together with information about reasonably foreseeable risks and any benefits to the subject 232 the price of perfection or to others that may reasonably be expected from the research.2 Additional requirements kick in for obtaining informed consent for specific populations (e.g., pregnant women, fetuses and newborns; prisoners; and children).3 Special safeguards may also be imposed to protect other populations deemed “vulnerable to coercion or undue influence, such as . . . mentally disabled persons, or economically or educationally disadvantaged person.”4 It is open to question how well these protections work. In a 2004 critique in...