Institutional Review Board

Department of Health and Human Services (DHHS) regulations require that institutions conducting research activities on humans and receiving federal funds must appoint a specialized review and oversight committee called the institutional review board (IRB). The IRB is mandated by the federal law 45 CFR 46—Protection of Human Subjects. The IRB system is a direct result of the need to provide structure, review, oversight, and public accountability for federally funded research activities involving humans as subjects. The overarching responsibility for IRBs is to protect the rights and welfare of persons recruited as human subjects in research conducted in the affiliated institution. While fortunately somewhat rare, questions about human subjects protections can become prominent news items, and science communicators should be familiar with the basic requirements; university-based science communication researchers, like all other researchers who use human subjects in their research for any purpose, are also bound by these rules.

Throughout history, inquisitive minds have searched for ways to improve the human condition. In the 4th century BCE, Hippocrates is credited with the dictum: “First, do no harm.” Despite this early cautionary treatment principle, there are numerous historical accounts of egregious abuses of human beings used as research subjects. Revelations of inhumane experimentation by Nazi researchers during World War II resulted in the creation of the Nuremberg Code. Developed to assist the prosecuting Military Tribunal, it featured 10 ethical principles for the conduct of research involving humans.

In the United States, the infamous Tuskegee study observed untreated syphilis infection in dis-advantaged minority populations who were denied treatment that was available to the general public. This study is an example of serious violations of moral and ethical principles in government-sponsored research. To increase accountability, in 1974 the government convened the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In 1979, the commission produced the Belmont Report, a unifying review of research and medical ethics involving humans as subjects. Although federal laws provide the regulations for IRBs, the Belmont Report provides the ethical and moral base for human subjects research and still serves as the essential reference for IRB policies.

The Belmont Report delineates three “basic ethical principles” that remain the basis for all human subjects research: respect for persons, beneficence, and justice. The principle of respect for persons involves the ethical conviction that all individuals must be free to make an independent assessment and judgment of their ability and willingness to participate as a research subject in a defined activity. Not all persons are capable of or empowered to make self-determination, and some cases may require special considerations or protections. Examples include the young, mentally disabled, incarcerated, or those susceptible to coercion. Informed consent—the process of ensuring that participants understand the research and willingly volunteer—is the key application of respect for persons.

The second principle is beneficence. This principle obligates researchers not only to try to protect research participants from harm, but also to seek to secure their well-being. The IRB must attempt to ensure that subjects receive maximum possible benefits and minimum possible harms. Regulating research that poses a degree of risk but has no immediate prospect for benefit to the actual participant involves consideration of beneficence in IRB evaluations. The performance of a comprehensive risk-benefit assessment is critical to the application of the principle of beneficence.

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