The Basic Principles of Research Ethics

Through the 1940s little explicit attention had yet been paid to issues of research ethics, but at the end of the decade the Nuremberg War Crime Trials changed that.

Nazi physicians and soldiers were brought to trial before an international tribunal for atrocities committed in the Holocaust. The defendants justified their actions as scientific research. The Nuremberg Code was developed to serve as a set of 10 standards in judging that defense (Nuremberg Code, 1949). The code insisted that the free and informed consent of human subjects was essential to all ethical research. It also addressed the prevention of suffering by subjects and the necessity that researchers be qualified and their research well designed.

Several years later, the Helsinki Code described ethically important differences between clinical and nonclinical human research (World Medical Association, 1964). Research intended to be therapeutic for subjects is different from that in which the subjects are primarily a means to the welfare of others. That distinction moved the ethics of nontherapeutic research into the mainstream: misuse of research subjects did not have to be at the level of a Nazi atrocity to be unethical. The Helsinki Code proposed also that research consent by a proxy (a substitute decision-maker) might in some cases be ethical. The Helsinki Code has since then undergone several revisions, but consensus had begun to build about the fundamental ethical principles of human research ethics.

Soon after, the disclosure of several instances of research abuse in the United States made it clear that the recently articulated principles would have to become more specific and be embodied in policy and regulation. The Tuskegee Syphilis Study (Mitford, 1972), the Willowbrook Studies (Ramsey, 1970), and the Jewish Chronic Disease Hospital study (Langer, 1966) all used subjects whose free and informed consent to participate was at best questionable in studies in which potential harm to the subjects was disproportionate to the potential benefit. Federal committees and task forces worked throughout the 1970s to make clear and precise what is ethical in the use of human subjects in research. The most significant of their outputs was the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). That report is the basis for much informed dialogue about research ethics, the IRB process, and FDA and other government regulations.

The authors of the Belmont Report proposed three broad principles as fundamental to ethical human subjects research: respect for persons, beneficence, and justice.

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These general principles would not by themselves solve particular ethical problems. Instead, they ''provide an analytical framework that will guide the resolution of ethical problems.''

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