Human Subjects Research
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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.”
McNeese State University’s 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.
All researchers involved in human subjects research must complete an approved human subjects protection education program. The educational program created for the Office of Human Research Protections (OHRP) is one such approved program. It is logistically easy to take this computer-based training module titled “Investigator Responsibilities & Informed Consent” (on HHS.gov website) and requires only 1-1.5 hours to complete. Once complete, a certificate of completion can be downloaded and must be submitted with any IRB application. A copy of this certificate constitutes adequate documentation of training in the protection of human research.
All individuals conducting research that involves human subjects must have their proposed research studies reviewed. Most of these reviews are conducted by the IRB; however, McNeese State University recognizes a small number of exceptions for departments programs that involve undergraduate students in small, course-based research projects and that have departmental review processes. These research projects must meet the “exempt” or “minimal risk” criteria unless external funding is sought or unless the reserach involves a vulnerable population. In those instances, an IRB review is required. The course instructor is expected to understand the concepts of exempt, expedited, and full review; levels of risk; confidentiality; and voluntary participation as defined in the IRB Application Guidelines. Any McNeese State University faculty member, unclassified staff person, or other personnel performing, advising, or supervising research involving human subjects must comply with all McNeese State University IRB requirements and ensure that the students involved comply with the same requirements.