Institutional Review Board

What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is a federally required committee that is responsible for overseeing research involving human participants. This administrative body is established to protect the rights and welfare of human subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

The IRB is charged with reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations, university and college policies.

Why is the Institutional Review Board necessary?

In the past, the burden of research was placed on vulnerable populations such as the economically disadvantaged, prisoners, minority groups, individuals with cognitive impairments and the elderly. History is filled with examples of individuals and groups targeted for unethical and cruel research and experimentation.

The recognition of the need for guidelines dealing with human subjects in research emerged following the Nuremberg trials, where the medical experimentation abuses of World War II Nazi doctors came to public attention. This led to the creation of the Nuremberg Code in 1945, the first legal attempt to deal with ethical issues of modern research. The international need for a more specific code of ethics for biomedical research was formulated in the 1964 Declaration of Helsinki.

In the United States, by 1953 the National Institutes of Health required that all proposed clinical research projects at its center obtain approval from a protection of human subjects review panel. In 1966, the United States Public Health Service issued its first set of regulations extending this review requirement to all "extramural" research supported by the agency. These rules were further revised in 1971 and 1974 and led to the establishment of institutional review boards (IRBs) at hundreds of institutions receiving federal funding for research.

Revelations of human subjects’ abuse in the United States culminated in the 1972 public disclosure of the 30-year government supported Tuskegee Syphilis Study, in which 300 Black rural men were left untreated for diagnosed syphilis after effective antibiotics became available. This prompted Public Law 93-348 calling for the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In 1979 the Commission published recommendations, known as the Belmont Report, which served as the basis for revised federal regulations published in the Federal Register in 1979 and subsequently revised several times resulting in the current Code of Federal Regulations Title 45-Part 46 Protection of Human Subjects (45 CFR 46) effective as of 1991.

The Belmont Report established three general ethical principles that continue to be applied to the research of human subjects:

• Beneficence: To maximize benefits for science, humanity, and research participants and to avoid or minimize risk or harm.
• Respect: To protect the autonomy and privacy rights of participants.
• Justice: To ensure the fair distribution among persons and groups of the costs and benefits of research.

Composition of the Institutional Review Board

The IRB consists of six (6) members: two (2) current NCC faculty, two (2) current NCC administrators/staff, one current NCC student, and one (1) individual that is neither a current faculty, administrator/staff nor student. These members represent varying backgrounds, which will enable them to provide a complete and adequate review of human research and its institutional, legal, scientific, and social implications.