HRPP Manual Section 11-1


Human research protection is a complex process with ever increasing and changing regulations. Because of the complexity and the importance of human research protection to the conduct of effective research and the mission of the university, it is imperative to have a highly trained, experienced, and competent Human Research Protection Program (HRPP) staff, investigators, research staff, and IRB members. Thus, the HRPP requires such individuals to be qualified by training and experience to perform their role and responsibilities. This includes the knowledge of federal, state, and local laws and regulations, relevant professional standards, and the policies and procedures of Michigan State University regarding the protection of research subjects and the conduct of research. The HRPP, working closely with the other university offices, conducts activities designed to enhance the understanding of human research protection subjects or their communities when appropriate. These activities are evaluated on a regular basis. See HRPP Manual 3-3 “Evaluation and Quality Improvement” for a description of evaluation mechanisms.

The HRPP director coordinates communication on human subject protection issues, involving other individuals as appropriate. For a description of how the HRPP director communicates and makes available new or revised HRPP policies and procedures, see HRPP Manual 3-2 “Policy Development and Approval.”

For training requirements and activities specific to individual roles, see the following sections of the HRPP Manual:

11-1-A               Investigators and Research Staff
11-1-B               IRB Member
11-1-C               HRPP Staff

For a description of outreach and engagement policies and procedures, see HRPP Manual 11-2 “Outreach and Engagement.”

Additional Considerations
For research studies subject to the requirements of the U.S. Department of Defense, 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 7-22-2011. Revision 2 approved by Assistant VP Regulatory Affairs on 12-11-2015.

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