The MICHR Regulatory Support Program (RSP) operates under the leadership of Ray Hutchinson, MD and Michael Geisser, PhD. The RSP interdisciplinary team consists of University of Michigan regulatory leadership and highly experienced individuals committed to accomplishing five key aims. The program provides pre- and post-award regulatory services and consultation directly to researchers.
The program's five aims are to:
- Provide academic leadership in regulatory affairs by reducing regulatory barriers for translational researchers as well as developing, disseminating, and implementing best practices within a complex and ever-changing regulatory environment.
- Increase and expand knowledge about human subject protection by providing regulatory education and training to investigators, staff, and the community at large; by collaborating with other CTSA programs to develop an interdisciplinary and methodologically innovative approach to training and education; and by educating lay persons about translational research with the goal of increasing community involvement.
- Expand the Regulatory Support Program to provide relevant services such as: individualized consultation on protocol development and E-Research applications, informed consent document assistance, development of data and safety monitoring plans, planning and formation of data and safety monitoring boards, cGMP customization, consultation on IND/IDE submissions, and technology transfer.
- Establish and study novel ways of conducting regulatory reviews by forming a demonstration IRB to conduct a concurrent regulatory and scientific review of protocols and by examining other novel methods for streamlining the ethical review of translational research protocols.
- Enhance regional and national leadership through participation in the U-M and NIH CTSA consortium and other national initiatives relevant to regulatory issues.
- IRB regulatory support
- IRB-related regulatory support, including coordination of multi-site IRB submissions
- Informed Consent preparation assistance
- Protocol preparation assistance
- Case Report Forms (CRF) preparation assistance
- Clinical data integrity assurance support
- Regulatory guidance, updates, and education services
- Assistance determining the need for an FDA-approved IND or IDE application
- Regulatory assistance regarding FDA, NIH, HHS and other federal and state agencies
Raymond Hutchinson, MD
Regulatory Support Program Director
Michael Geisser, PhD
Manager, Project Management and Monitoring
For more information on MICHR please contact us at 734.998.7474 or email UMfirstname.lastname@example.org
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