Human-Subject Research
The Direction of Law and Regulation

The news is full of reports about scientific studies of drugs and procedures to treat all kinds of human injuries and illnesses—studies that generally involve testing on human subjects. Despite risks associated with such studies, there is increased demand for access to new products and procedures by individuals with chronic and terminal diseases, and there is increasing opportunity for conflicts of interest where the successful researcher develops a product that can be sold for substantial sums of money. As Kansas City emerges as a national center for biomedical research, we, as citizens and potential research subjects, should become more aware what it means to participate in, oversee and regulate research that involves human subjects.

Until the mid-19th century, medical practice was almost exclusively experimentation. There was not a generally accepted standard of care for patients, so doctors continually tried new treatments in the effort to cure their patients. In 1847, the American Medical Association acknowledged that medical practice must be based on scientific evidence, and it designated as experimental any care not based on established science.

While Germany was the first country to develop guidelines for human research, it also witnessed some of the worst abuses of human subjects in modern times by Nazi doctors. After World War II, as part of the trial of Hitler’s physician, the judges (who were from the United States) wrote the Nuremberg Code to govern human research into the future.

Ironically, while the judges from the U.S. were drafting the Nuremberg Code a study was underway in Tuskegee, Ala., to observe the long-term affects of syphilis in a group of infected African-American men. Despite the availability of drugs for treatment, and representations to the subjects that they were receiving the drugs, the disease was allowed to progress in the subjects untreated.

Congress finally acted after exposure of the “Tuskegee Study,” the Willowbrook study where institutionalized children were intentionally exposed to the hepatitis virus, and the Jewish Chronic Disease Hospital cancer study that involved injection of cancer cells into elderly nursing home residents. As a result, Congress enacted the National Research Act of 1974 that, among other things, required federally funded research institutions to create Institutional Review Boards, or IRBs.

The IRB reviews all human research conducted under the auspices of its institution. It assures there is informed consent from the subject, that the benefits of the study outweigh the risks, that the subject’s privacy is protected, that there are no conflicts of interest and that the subjects are representative of the community’s makeup of races, ethnic groups and genders. The committee must include scientists and non-scientists, persons who reflect the diversity of the community it serves with respect to race, gender and cultural backgrounds, and at least one person who is not affiliated with the institution where the research is conducted. Failure of the IRB to fulfill its function can result in loss of federal-research funding, or fines and other sanctions for the institution or the investigator.

Of course, the research community is concerned that too much regulation could stifle research and the development of new therapies. Persons desperate for treatment are concerned that too much regulation will limit access to experimental programs. At the same time, concerns are raised that pressures to develop new profitable therapies lead to unnecessary risks for human subjects and more regulations are needed.

Human-subjects research, once controlled exclusively by the physician without patient consent or community oversight, is now a highly regulated business that
depends on the willingness of informed citizens to volunteer as research subjects and to participate in its oversights as IRB members.

Mary Beth Blake is a partner with Shook Hardy & Bacon LLC. She can be reached by phone at 816.474.6550 or by e-mail at bblake@shb.com.