The basic ethical principles on which the federal regulations for the protection of human subjects are founded are set forth in The Belmont Report developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
The report sets forth three principles that are basic to the protection of human subjects: Respect for Persons, Beneficence, and Justice.
Involves the recognition of the personal autonomy and dignity of individuals, and the need for special protections of individuals with diminished autonomy. Under this principle, individuals must be given sufficient information to decide whether to participate in a study, they must be able to comprehend the information, and their consent must be given voluntarily and free from coercion and undue influence. Respect for Persons also means honoring the subjects' privacy and confidentiality.
IRBs are expected to be particularly sensitive to these factors when vulnerable subjects are involved, and ensure that extra measures are taken to protect the immature and incapacitated. IRBs may even require that they be excluded from participating in certain research.
Entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. This principle requires assessing the nature and scope of the risks and benefits. All possible harms must be considered; not just physical and psychological injury. All possible benefits including societal benefits that might be gained from research must also be considered. Benefits to the subjects, or generalizable knowledge to be gained from the research should always outweigh the risks.
In assessing the risks and benefits, the appropriateness of involving vulnerable populations is considered.
Requires that the benefits and burdens of research be distributed fairly. Subjects must be fairly selected and may not be selected either because they are favored by a research or held in disdain. Social justice requires an order of preference in selection of classes of subjects, for example, adults before children. The principle cautions that researchers should not systematically select subjects because of their easy availability, their compromised position, or their social, racial, sexual, or economic position, or because of cultural biases institutionalized in society. Investigators should base inclusion criteria on those factors that most appropriately address the research problem.
View our Standard Operating Procedures.