Research Support Units

MICHR Regulatory Support

• MICHR Regulatory Support
• MICHR Regulatory Services

The MICHR Regulatory Support Program (RSP) operates under the leadership of Ray Hutchinson, M.D. and Michael Geisser, Ph.D. 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. See Regulatory Services.

The Program's five aims are to:

• Provide academic leadership in regulatory affairs by: reducing regulatory barriers for translational researchers, 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 on 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 UM and NIH CTSA consortium and other national initiatives relevant to regulatory issues.

Contact

Kevin Weatherwax
Project Management and Monitoring Program Manager
kweath@umich.edu
(734) 998-6275

Raymond Hutchinson, MD
http://www2.med.umich.edu/departments/mott/index.cfm...
Regulatory Support Program Director
rhutchin@umich.edu

Michael Geisser, Ph.D.
http://www.med.umich.edu/painresearch/staff/index.htm#geisser
mgeisser@umich.edu

Kay Fuller, RAC
IND/IDE Project Manager
kfull@umich.edu
(734)-998-6059

Jan Kosmyna, MIS, RN, ACRN
Regulatory Consultant
jkosmyna@umich.edu
(734) 936-8083

For more information on MICHR please contact us at (734) 998-7474 or email um-michr@umich.edu

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