MSU HRPP Manual Section 4-1

4-1, Applicability

The policies and procedures included in the Michigan State University (MSU) Human Research Protection Program (HRPP) and this Manual apply to all of MSU’s human subject research activities regardless of funding support or location where the research will be conducted (i.e. domestic, international), and to all activities of its Institutional Review Boards (IRBs).  These policies and procedures apply to the human subject research activities conducted by employees of MSU (faculty and staff), by students of MSU, by agents of MSU (i.e. individuals engaged by MSU to conduct human subject research on behalf of MSU), or by individuals conducting research at entities that have a formal written agreement with MSU for review and approval of their human subject research. The MSU HRPP does not apply to adjunct or clinical faculty who are not employees or agents of MSU (volunteer faculty), unless they have a formal written agreement to conduct human subject research on behalf of MSU or are conducting research at an entity that does have such an agreement.

When a planned activity meets the definitions of “research” involving a “human subject,” the HHS regulations (45 CFR 46) regarding the protection of human subjects apply, with limited exceptions specified in HRPP Manual 8-8 “Demonstration Projects.” When a planned activity meets the definitions of “clinical investigation” involving a “human subject,” the FDA regulations (e.g., 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812) regarding the protection of human subjects apply, as applicable. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of the FDA regulations. 21 CFR 56.102 (c). In instances when both HHS and FDA regulations apply and conflict, the stricter regulatory requirement must be followed.   See HRPP Manual 4-3 “Determination of Human Subject Research” for policies and procedures on how the determination of whether an activity is human subject research is made. For additional guidance on activities considered outside of the scope of IRB review, see HRPP Manual 4-3-A “Clinical Case Reports,” 6-9-A “Student Classroom Research,” and 12-1 “Quality Assurance, Quality Improvement, or Program Evaluation.”

An investigator planning to conduct human subject research must submit an application to the MSU HRPP, with limited exceptions specified in HRPP Manual 1-1, “Federal Wide Assurance” (i.e. reliance on a non-MSU IRB as the IRB of record). All human subject research submitted to the MSU HRPP will be assigned to the appropriate IRB (i.e. Biomedical and Health IRB, Social Science / Behavioral / Education IRB). Human subject research must be approved by an IRB or determined to be exempt from IRB review prior to any human research activity, including interacting or intervening with subjects and obtaining or analyzing identifiable private information about subjects.

The Biomedical and Health IRB (BIRB) and Social Science / Behavioral/ Education IRB (SIRB) review applications based primarily on the Principal Investigator's college or unit affiliation.

In general, the BIRB reviews human subject research studies for investigators in the biomedical and clinical departments or units. These colleges include but are not limited to the College of Engineering, College of Human Medicine, College of Nursing, College of Osteopathic Medicine, and College of Veterinary Medicine.

In general, the SIRB reviews non-biomedical human subject research studies from the non-biomedical or non-clinical departments or units. These colleges and units include but are not limited to the College of Agriculture and Natural Resources, College of Arts and Letters, College of Education, Eli Broad College of Business, College of Communication Arts and Sciences,  James Madison College, College of Music, College of Natural Science, College of Social Science, College of Urban Affairs Program, MSU Libraries, MSU Museum, Women’s Resource Center, Residence Life, Counseling Center, International Studies and Programs, and Career Services and Placement.

However, some individual departments in a college reviewed by the SIRB may be reviewed by the BIRB, and vice-versa (e.g., Department of Kinesiology in the College of Education is typically reviewed by BIRB, not SIRB). For a listing of such exceptions, see the HRPP website (hrpp.msu.edu). Research studies from a department reviewed by the SIRB that involve the use of drugs, medical devices, or medical interventions (e.g. fMRI) may be reviewed by the BIRB. The IRB chair will be consulted if there is question of which IRB has the appropriate IRB member expertise to review the research. The BIRB and SIRB chair will then consult with each other as needed to determine which IRB has the expertise to review the project. Additional expertise will be obtained as needed (e.g. obtain expertise from a member of the other MSU IRB). See HRPP Manual 5-4 “Additional Expertise.” Research subject to FDA regulations must be reviewed by the BIRB.

Additional Considerations
For additional federal requirements, see the following sections of the HRPP Manual:

2-2-A            U.S. Department of Defense
2-2-B            U.S. Environmental Protection Agency
2-2-C            U.S. Department of Justice
2-2-D            U.S. Department of Education
2-2-E            U.S. Department of Energy

This policy and procedure supersedes those previously drafted.

Approved By: Vice President for Research and Graduate Studies, 4-21-2005; Revision 1 approved by the VP Research & Graduate Studies on 11-2-2005. Revision 2 approved by VP Research & Graduate Studies on 3-9-2008. Revision 3 approved by VP Research & Graduate Studies on 5-6-2008. Revision 4 approved by VP Research & Graduate Studies on 9-3-2009. Revision 5 approved by the VP Research & Graduate Studies on 7-21-2011. Revision 6 approved by Assistant VP Regulatory Affairs on 12-10-2015.

Related HRPP Manual Sections

Approved PDF Version

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