University of Michigan Medical School Policy on Requirement to Use MICHR MIAP Services

The purpose of this policy is to ensure that any University of Michigan Medical School (UMMS) personnel and University of Michigan personnel using the Institutional Review Board of the UMMS (IRBMED) who serve or are seeking to serve as a United States Food and Drug Administration (FDA)-recognized Sponsor or Sponsor-Investigator (S-I; i.e., IND or IDE holder) receive expert support and oversight from the Michigan Institute for Clinical and Health Research (MICHR) Investigational New Drug / Investigational Device Exemption (IND/IDE) Investigator Assistance Program (MIAP) in order to reduce noncompliance risk.

It is the policy of the UMMS to require that any university personnel holding or seeking to hold an FDA IND or Significant Risk Device IDE in conjunction with his or her university appointment receive oversight and support from the MICHR MIAP.

1. Prior to initiating an IND or IDE application to the FDA, personnel must notify MICHR MIAP to arrange for support and oversight (fees may apply).
2. MICHR MIAP support and oversight includes:
   1. training on Sponsor and S-I requirements;
   2. document preparation and retention, application review, and IND/IDE maintenance reports; and
   3. monitoring by the MICHR Study Monitoring Unit (for non-oncology studies), or other professional monitoring unit (at study expense) as deemed suitable by MIAP.
3. Abbreviated IDE Sponsors or Sponsor-Investigators are exempt from this policy. The UMMS Executive Vice Dean for Research and Associate Dean for Regulatory Affairs, or their delegates, will jointly consider other exceptions to this requirement on a case-by-case basis.
4. Failure to adhere to this policy may result in restriction to conduct certain or all FDA-regulated research.

UM Human Research Protection Program (HRPP) Operations Manual (OM) Part 8 section VII.B.

FDA regulations at 21 CFR 312.50-59 and 21 CFR 812.40-47

1. This policy is effective January 1, 2020.
2. Original policy approval date: November 21, 2019
3. Policy revisions: updated by Ann Curtis, per Pat Ward, May 3, 2021.
4. Approver: Steven L. Kunkel, PhD, Executive Vice Dean for Research