MSU HRPP Manual Section 4-4

4-4, Institutional Official

Michigan State University (MSU) delegates the responsibility for the Human Research Protection Program (HRPP) to an official with sufficient standing, authority, and independence to ensure implementation and maintenance of the program. MSU has designated Dr. Stephen Hsu, Vice President for Research and Graduate Studies, as the only Institutional Official (IO) for the protection of human research subjects under its Federal Wide Assurance (FWA) #00004556 with the U.S. Department of Health and Human Services, Office for Human Research Protections (OHRP).

In this federally mandated role, Dr. Hsu shares responsibility with the MSU HRPP, the Institutional Review Boards (IRB), and researchers for the protection of human research subjects. As the IO, Dr. Hsu is responsible for ensuring that all human subject research at MSU, regardless of source of support, will follow the ethical principles as stated in the Belmont Report and, as appropriate, will follow the laws and regulations governing human subjects research, including 45 CFR 46 and all its subparts.  He is also responsible for fostering open communication with regard to, and a culture of respect for, human subjects at the university.

The IO has the authority and responsibility to support IRBs for the review of human subjects research, to educate the IRB, researchers, and staff on the ethical conduct of human subjects research, to monitor the human research protection program, and to delegate responsibilities to others as needed to carry out these duties. 

The IO and other MSU officials may further review, approve, or disapprove human subjects research that has been approved by an MSU IRB as appropriate. However, they may not approve the research if it has not been approved by an MSU IRB. 45 CFR 46.112, 21 CFR 56.112

The IO will evaluate the HRPP in accordance with HRPP Manual 3-3 “Evaluation and Quality Improvement.” MSU, through the IO, ensures that the HRPP has resources sufficient to protect the rights and welfare of research subjects for the research activities that MSU conducts or oversees, including meeting space and sufficient staff to support the IRB's review and recordkeeping duties. 46 CFR 103(b)(2).

The IO is authorized to review and sign U.S. Department of Defense addendums, to review and sign updates or renewals to the OHRP FWA or IRB registration, to review and sign IRB authorization agreements, and to sign individual investigator agreements. The IO may delegate authority to sign documents when appropriate. See HRPP Manual 2-2-A “U.S. Department of Defense.”

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 7-21-2011. Revision 2 approved by VP Research & Graduate Studies on 11-19-2012. Revision 3 approved by Assistant VP Regulatory Affairs on 11-18-2015.

Related HRPP Manual Sections

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