Guiding Ethical Principles and Explanation

The fair and equitable selection of research subjects is rooted in the ethical principle of justice. “Justice” as defined by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the Belmont Report is actually what is commonly called “distributive justice” and requires the equitable distribution of both the benefits and the burdens of the research. This principle comes into play when there are not enough benefits to go around and burdens must be borne by some but not all members of a population. Unequal distribution must be justified according to “morally relevant” criteria. The morally relevant criterion identified as the most important by the National Commission is “vulnerability.” Vulnerability is defined as a substantial inability to protect one’s own interest.

In general, the principle of justice calls for the selection of subjects according to the following three criteria. First, subjects are to be representative of the population required for study, i.e., they are not selected because of convenience or ease. Second, subjects are to belong to a group that is likely to benefit from the results of the research. And third, vulnerable subjects may participate only when special criteria for their selection have been satisfied (See Module #7 for additional information on vulnerable subjects). In summary, the principle of justice guides the investigator to equitably select subjects while balancing the benefits and burdens of the research with regard to certain individuals or groups.

Additional information on the ethical principles guiding research with human subjects is located in Module #1.