Research Integrity and Assurance

Human Subjects

Human subjects

Research may involve human subjects to make advances in science or increase our understanding of human behaviors. When considering using human subjects in research, you must consider the following principles from the Belmont Report (1979):

  • Respect for persons: “Respect for persons incorporates at least two ethical convictions: first, that 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.”

    Respecting the autonomy of individuals means acknowledging that they have a right to make decisions for themselves, given adequate information to make an informed decision. To withhold information from a participant when there isn’t a justification to do so would not respect the autonomy of the individual.

  • Beneficence: the obligation to maximize benefit and reduce harm whenever possible. For some types of research, merely participating poses a risk. The benefit may not be to the individual but to society at large in the information that is gained from the study.

  • Justice: The principle of justice is the sense of “fairness in distribution.” Fair and balanced samples should be used unless there is a justified, scientific reason not to. An example of unfair sampling is described in the Belmont Report: “in the 1940s, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population.”

Human subject research oversight

Federal regulations require institutions that receive federal funds to have an Institutional Review Board (IRB) to oversee human subjects research. IRBs consider the principles of the Belmont report during their review of the research to determine whether:

  • subjects are selected equitably, and if not, whether there is justification
  • risks are minimized where possible
  • risk is reasonable in relation to the benefit
  • informed consent is sought and documented appropriately
  • the data protection plan is adequate

The IRB membership must include at least one scientist, one non-scientist and one person who is not affiliated with the institution. Generally, IRBs have more than one scientist and include a variety disciplines to achieve diversity in opinions. The community member is required to provide input on the views and sentiments of the community-at-large.

More information about the IRB can be found on the Human subjects home page.

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