Institutional Review Board

Since 1947, when guidelines for research with human participants were promulgated, there has been increasingly widespread recognition of the need for voluntary and informed consent and a scientifically valid design of experiments involving human participants.

Over time, this recognition has evolved into a rigorous and formalized system of regulations and guidelines, which were codified in governmental policies on human participant research, and were included in the former Department of Health, Education and Welfare's regulations in 1974, Title 45 Code of Federal Regulations 46. In 1991, 16 agencies formally adopted the core of these regulations in a common Federal Policy for the Protection of Human Participants. This Policy requires that all research protocols involving human participants be reviewed by an Institutional Review Board. This review ensures that:

(1) risks are minimized and reasonable in relation to anticipated benefits

(2) there is informed consent

(3) the rights and welfare of the participants are maintained (56 Fed. Reg. 28003 (June 18, 1991))

The policies and procedures governing the McKendree University Institutional Review Board (IRB) are adopted from this common Federal Policy for the Protection of Human Participants. The policy is available at *. The source of the information at this government website is the June 18, 1991 issue of the Federal Register (56 FR 28003).

* Office for Human Research Protection, Office of Public Health and Science, Department of Health and Human Services.