Faculty Handbook

Human Research Protection Program


The Michigan State University (MSU) Human Research Protection Program's (HRPP) primary mission is the protection of individuals who are the subjects of research and/or clinical investigations. MSU is committed to follow the ethical standards described in the Belmont Report, and all applicable federal, state, local, and university requirements. The HRPP at MSU has developed the structure, and requirements to implement this mission and commitment. The processes of training, review, and monitoring described in the HRPP Manual serve to ensure the safe and ethical conduct of research and/or clinical investigations. (See HRPP Manual 3-1, MSU Human Research Protection Program Plan.)

The Vice President for Research and Graduate Studies (VPRGS) has been designated as the Institutional Official for MSU's HRPP. (See HRPP Manual 4-4, Institutional Official.) The HRPP office is organized under the Office of Regulatory Affairs in the Office of the VPRGS. The HRPP includes the offices of the Institutional Review Board (IRB) and Compliance and provides support to the MSU IRBs. The HRPP encompasses not only the IRB requirements for the protection of human subjects, but other additional areas of human research regulatory oversight that are broader than the IRB requirements (e.g., U.S. Food and Drug Administration regulations, protected health information, clinicaltrials.gov, clinical research billing compliance that provide protection for human subjects. (See HRPP Manual for requirements.)

MSU HRPP requirements apply to all of MSU's human subject research and/or clinical investigations related activities regardless of funding support or location where the research and/or clinical investigation will be conducted (i.e. domestic, international), including activities of its Institutional Review Boards (IRBs). These requirements apply to human subject research and/or clinical investigation 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 and/or clinical investigations at entities that have a formal written agreement with MSU for review and approval of their human subject research and/or clinical investigation. An investigator planning to conduct human subject research and/or a clinical investigation must submit an application to the MSU HRPP.

Investigators should contact the IRB office with any questions regarding whether an activity constitutes research involving human subjects, or whether the activity is a clinical investigation involving human subjects. HRPP staff will determine whether the activity meets the definition of human subject research and/or clinical investigation based on federal regulatory definitions. See HRPP Manual 4-3, Determination of Human Subject Research. Human subject research and/or clinical investigations must be approved by an IRB or determined to be exempt from IRB review prior to any human research and/or clinical investigation activity, including interacting or intervening with subjects and obtaining or analyzing identifiable private information about subjects. (See HRPP Manual 4-1, Applicability, for more information.)

Any individual who is involved in conducting a human subject research and/or clinical investigation study that is under the jurisdiction of the MSU HRPP is responsible for, including but are not limited to, carrying out sound ethical research consistent with research plans approved by an IRB, following MSU requirements, and complying with all applicable laws, regulations, and grants policy. This includes IRB requirements as well as other applicable regulatory requirements such as the U.S. Food and Drug Administration regulations for investigational drugs and devices, protected health information under the Health Insurance Portability and Accountability Act of 1996, clinicaltrials.gov requirements, and clinical research billing compliance. These responsibilities extend to all individuals (e.g., all investigators, research staff, employees, students) engaged in research and/or clinical investigations with human subjects. (See HRPP Manual 4-6, Responsibilities of Investigators.)

The principal investigator (PI) has overall responsibility for the conduct of human subject research and/or clinical investigation studies, including but not limited to the hiring of qualified staff, ensuring that the staff have training appropriate for their role in the study and for the protection of human subjects, following the IRB-approved study and complying with the IRB approval and any applicable regulatory requirements, promptly reporting events (e.g. any non-compliance, unanticipated problems), maintaining IRB approval throughout the duration of the human research and/or clinical investigation, and maintaining oversight over the conduct of the study including following proper recruitment, consent, and research procedures, and maintaining security and storage of research data. (See HRPP Manual 4-9, Designation as Principal Investigator.)

Individuals are encouraged to contact the HRPP office by phone: (517) 355-2180 or email: irb@msu.edu with any questions, such as whether an activity requires IRB review. Additional information, including the HRPP Manual, can be found at the HRPP website: www.hrpp.msu.edu.

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