Updates to HRPP Manual

August 8, 2018

HRPP Manual sections have been updated to better reflect use of the Click™ Research Compliance system. For example, Click terminology has been incorporated into the revised sections, such as “modification” instead of “revision”, “submission” instead of “application”, etc. Other changes include updates to form/template names, incorporation of PI proxy, description of the Click system, use of ancillary review, change of Flexibility Exempt category numbers from “7” to “97” and “8” to “98,” etc.

In addition, HRPP Manual 4-9, Designation as Principal Investigator, also includes an update that describes the acceptance of MSU Sponsored Programs approvals for PI exceptions for externally sponsored research, and for non-externally sponsored human research, clarified that an investigator agreement is required for non-MSU individuals.

HRPP Manual Sections that have been updated include:

• 3-1, Michigan State University Human Research Protection Program
• 4-3, Determination of Human Subject Research
• 4-9, Designation as Principal Investigator
• 8-1, Exemptions
• 8-2, Expedited Review Procedure
• 8-3, Committee Review Procedure
• 8-4, 45 CFR 46.118 Designation
• 8-5, Initial Review
• 8-6, Modifications to an Approved Research Study
• 8-7, Renewed Approval
• 8-8, Flexibility Initiative
• 8-8-A, Exemption Category 97
• 8-8-B, Exemption Category 98
• 8-9, Closure