In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published a report “Ethical Principles and Guidelines for the Protection of Human Subjects of Research.” It was named the Belmont Report, for the Belmont Conference Center, where the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research met when first drafting the report. Based on the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Department of Health and Human Services (HHS) revised and expanded its regulations for the protection of human subjects 45 CFR 46 (the Common Rule) in the late 1970’s and early 1980’s.

In its Federalwide Assurance, the University of Wisconsin-Madison cites the Belmont Report as the primary ethical basis for the protection of the rights and welfare of research subjects. The research community, IRB members and staff, as well as institutional officials responsible for the oversight of human subjects research are expected to be knowledgeable of the Belmont Report given the importance of this document.

Summary of the Belmont Report

The Belmont Report identifies three fundamental ethical principles for all human subject research – respect for persons, beneficence, and justice.

1. Respect for Subjects: Respect for persons incorporates at least two ethical convictions: first, individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy. To meet the first moral requirement of respect for persons, researchers would be expected, in most cases, to ensure subjects enter into the research voluntarily and that they are provided adequate information in terms that are easy to understand and when they are not under duress. The Belmont Report makes specific recommendations of the information that should be conveyed to research subjects (i.e., the research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research). In addition, respect for individuals means honoring their privacy and maintaining their confidentiality.
   
   To meet the second moral requirement of respect for persons, the Report discusses how such respect relates to potentially vulnerable populations. Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm them; other persons require little protection beyond making sure they undertake activities freely and with awareness of possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in different situations.

2. Beneficence: Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms. If there are any risks resulting from participation in the research, then there must be benefits, either to the subject, or to humanity or society in general.

3. Justice: The principle of justice means that subjects are selected fairly and that the risks and benefits of research are distributed equitably. Investigators should take precautions not to systematically select subjects simply because of the subjects’ easy availability, their compromised position, or because of racial, sexual, economic, or cultural biases in society. Investigators should base inclusion and exclusion criteria on those factors that most effectively and soundly address the research problem.

The Belmont Report also outlines a method that Institutional Review Board (IRB) members can use to determine if the risks to which research subjects would be subjected are justified by the benefits to be gained. According to this method, those doing the review gather and assess information about all aspects of the research, and consider alternatives systematically and in a non-arbitrary way. The aim is to make the assessment process more rigorous, and the communication between the IRB and the investigator less ambiguous and more factual and precise.