An Institutional Review Board (IRB) is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. In accordance with federal regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
Capitol College is committed to ensuring that all human subject research in which it is engaged is conducted in accordance with the ethical principles stated in the Belmont Report. The Belmont Report, published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, provides the ethical foundation for the federal regulations for the protection of human research subjects.
Three fundamental principles are articulated:
Respect for Persons. Individuals should be treated as autonomous agents afforded the right to make decisions for themselves. Those with diminished autonomy (e.g. minors, prisoners, persons who are mentally disabled) are entitled to additional protections. Application of this principle requires that human subjects are enrolled into research studies only under the conditions of effective informed consent. This involves a process in which participation in the research is acknowledged by the research subject (or by a legally authorized representative) as a voluntary act free from coercion or undue influence from the investigator or members of the research team. Exceptions to this informed consent requirement must be outlined in the federal regulations and subsequently approved by the Capitol College IRB.
Beneficence. The research study must be designed and implemented so as to maximize possible benefits and minimize possible harms. Application of this principle involves a risk/benefit analysis in which the risks to subjects must be reasonable compared to the potential for benefit either to subjects directly or to society. Risk evaluation must include the consideration of both the probability and magnitude of harm, including psychological, physical, legal, social, and economic harm.
Justice. The possibility for benefits and the potential burdens of the research should be equitably distributed among the potential research subjects. Application of this principle requires the close scrutiny of the enrollment process to ensure that particular classes (welfare patients, traditionally underserved populations, or persons confined to institutions) are not selected for their compromised position or convenience to the research investigator.
The IRB adheres to the following regulations and policies for human subject research activities that fall under its authority:
The Federal Policy regulations for the protection of human research subjects (45 CFR Part 46; “Common Rule”).
When research involves articles subject to regulation by the FDA, the FDA regulations for the protection of human subjects (21 CFR Parts 50) and Institutional Review Boards (21 CFR Parts 56).
Research is defined by the U.S. Department Health and Human Services as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46)