February 27, 2024
Several sections of the HRPP Manual have been updated. Included is a summary of the changes.
HRPP Manual 4-9, Designation as Principal Investigator
Revised to allow HRPP managers to review waived PI requests for individuals who are MSU employees, with consultation with the IRB chair, HRPP director, or AVP ORRS if there are any questions
Added “when appropriate” for when approvals by Sponsored Programs are provided to the IRB office
Clarified that a CV is requested if it has not already been provided to the IRB office
Clarified that written recommendations come from the individual’s college and/or their department or academic director as appropriate (process varies by college)
Revised to indicate that the recommendation letter for individuals who have non-employee / no pay appointments should confirm that the activity is being done for MSU
Updated title from Assistant Vice President for Regulatory Affairs to Associate Vice President for the Office of Research Regulatory Support
HRPP Manual 8-2, Expedited Review Procedure
Revised to provide additional flexibility in the reviewer assignment process
Revised to remove “should” when notifying the IRB chair if an IRB reviewer does not respond by the due date
HRPP Manual 8-11, External IRB Submissions
Clarified external IRB submissions may also be assigned to an IRB administrator other than the reliance coordinator
Clarified that the MSU HRPP only needs to be notified of the involvement of non-MSU individual in certain circumstances
Added that consent review includes whether Certificate of Confidentiality or data sharing is applicable
Clarified that if local context language in the consent changes or a consent form is added, MSU HRPP must be notified and sign off before implementation
Clarified events when the MSU HRPP needs to be notified
Revised continuing review follow up process