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Human Subjects Research Compliance

Human Subjects Research Compliance

Date enacted or revised: 
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The McNeese State University adheres to the 1991 Federal Policies for the Protection of Human Subjects (called the "common rule") adopted by the Federal government and set forth in 45 CFR 46 (rev. March 1983) and as revised August 1991 (Final Common Rule. Federal Register, June 18, 1991). These guidelines apply to "all research involving human subjects" except research that meets the criteria for being "exempt" (see below).

McNeese State University Institutional Review Board (MSU IRB) functions to assure that research involving human subjects is carried out in an ethical manner. To this end, the principles and applications discussed in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979) are applied to guide researchers in formulating informed consent, assessing risks and benefits, and selecting subjects. The principles of respect for persons, beneficence, and justice will prevail in IRB review of research involving human subjects. These documents are available from the Research Office or from the chair of the IRB.

It is recommended that all researchers involved in human subjects research complete an approved human subjects protection education program. The educational program created for the National Institute of Health's institutional investigators is such an approved program. It is logistically easy to take this computer-based training course (on NIH's web site), requires only 1-1.5 hours to complete, and a certificate of completion can be directly generated on your personal computer following the conclusion of this course. A copy of this certificate constitutes adequate documentation of training in the protection of human research.

All individuals conducting research that involves human subjects are expected to have their research proposal reviewed by the McNeese State University Institutional Review Board (IRB) with the following exceptions:

Undergraduate class research projects/pilot studies involving human subjects may be certified by departmental Human Subjects Institutional Review Board Committee if the project is either exempt or of minimal risk and forego IRB review, unless the research is externally funded, uses the following vulnerable populations as primary subjects: minors, prisoners or other institutionalized populations, pregnant women, physically and/or mentally handicapped/disabled persons, economically or educationally disadvantaged persons, fetuses, or is a study involving human in vitro fertilization.

The instructor is expected to understand the concepts of exempt, expedited, and full review; levels of risk; confidentiality; and voluntary participation as defined in the "McNeese State University IRB Guidelines".

Any McNeese State University faculty member, unclassified staff person, or other personnel performing, advising, or supervising research involving human subjects must comply with McNeese State University IRB guidelines.