Belmont Report

The Belmont Report was conceived in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Both the report and the commission were mandated by the National Research Law (Public Law 93-348), promulgated on July 12, 1974. The report identifies and provides relevant applications for the three ethical principles that must be followed by investigators who must conceive and conduct, and for institutional review boards (IRBs) who must review and assess, research involving human participants. The Belmont Report provides the basis for the federal regulations governing the protection of human participants (Code of Federal Regulations at Title 45, Public Welfare, Part 46, Protection of Human Subjects; 45 CFR 46).

The ethical principle of “beneficence” requires that the investigator “Do no harm.” Although this end is ultimately desired, it is not necessarily guaranteed in a research setting. It may, in fact, be the variable being tested, as when an investigator is assessing adverse effects of an experimental drug that is being administered to a human participant for the first time. The Belmont Report allows for this and extends the “Do no harm” principle to research by expanding the concept to one of “Minimize risk and maximize benefit.”

The ethical principle of “justice” requires that the decision of who should be included and who should be excluded from a particular research activity should not be done arbitrarily and should make ethical sense, given the aims of the research activity. The report speaks of social justice, that is, there should be some order of preference for inclusion, based on the vulnerability of a subject population. For example, adults should be included in the research before children, as should nonpregnant women before pregnant women.

The ethical principle of “respect for persons” speaks to consideration of the subject as an individual, not as a means to collect data. One of the most basic ways to respect the subject as an individual is to provide that person with all the information needed to make the decision regarding whether or not to be in the research study, that is, to allow for self-determination. An ethical and noncoercive informed consent process is one of the critical tenets of principles governing human subjects research. Another aspect of this principle is the requirement to protect subjects who cannot by themselves make the decision to participate. An example of this type of “vulnerable” subject is a minor, who is considered too immature to make such a decision. IRBs must ensure that additional protections are in place to protect such a population, for example by ensuring parental permission and minor assent where applicable.