Consent for Medical Research
There has been more medical legal scholarship on the conduct of medical research involving human subjects than almost any other consent topic—in interesting contrast to the nearly complete lack of litigation alleging injuries from improperly conducted research. Medical research is controversial because of the abuses that occurred in the not-too-distant past, rather than a current litigation threat. Ranging from the medical experiments conducted by the Nazis to the Tuskegee syphilis experiment [Jones JH. Bad Blood: The Tuskegee Syphilis Experiment. New York: Free Press; 1981.] conducted by the U.S. Public Health Service, these abuses resulted in the promulgation of two major international codes and extensive congressional regulation. [Katz J, Capron AM, Glass ES. Experimentation with Human Beings: The Authority of the Investigator, Subject, Professions, and State in the Human Experimentation Process. New York: Russell Sage Foundation; 1972.] Any patient injured by an experiment that violates these codes or regulations can sue the physician for medical malpractice. More commonly, however, investigators or their institutions are sanctioned by the Department of Health and Human Services (HHS) or the U.S. Public Health Service for not complying with governmental regulations.
In one area, litigation (and criminal investigation) is probable. The growth of joint research agreements between universities and medical businesses, combined with the involvement of medical scientists in for-profit ventures, has put many scientists in violation of laws dealing with conflicts of interest and stock fraud. The Public Health Service has also promulgated rules governing misconduct in science, which could be the basis for fraud-related litigation. Lawsuits asserting financial fraud are not covered by medical malpractice insurance and are especially dangerous to physicians. The physician-scientist must pay the defense costs for such actions and any fines or damages if the defense is unsuccessful.