University of Michigan Medical School
Regulatory Affairs: Regulatory Resources
Research Involving Human Subject / Tissue / Information
- Investigational Drug Service (IDS)
Health care professionals must comply with federal and state regulations and University of Michigan policies and procedures when conducting research with investigational drugs.
- Tissue Procurement Service (TPS)
Procurement of any tissue that is linked to the patient from whom it was procured requires IRB approval. You will first need a letter of approval from the TPS before IRB approval is granted.
back to top
Research Involving Animal Subject
back to top
Other Research Regulations and Policies
- UMHS Compliance
Introduction to policies and procedures and links to the information to ensure investigators are performing daily duties within the many rules, regulations and policies that regulate the health care industry.
- Institutional Biosafety Committee (IBC) (for recombinant DNA and select agents research)
All work with recombinant DNA must be registered with the IBC prior to its initiation, even if it is deemed "exempt" by the NIH Guidelines. Work with "select agents" must be approved by the IBC.
- OSEH Radiation Safety Service (RSS)
RSS/OSEH must approve each purchase or transfer of radioactive materials, including transfers from other institutions or other UM researchers. Only Authorized Users can take possession of radioactive materials and only for use in accordance with prior approval.
back to top
Documentation of UM Compliance with FDA 21 CFR Part 11
back to top
Compliance with the NIH Public Access Policy
back to top
Required Training
- Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS)
PEERRS is a web-based instruction and certification program for members of the University community engaged in or associated with research. All PIs or Co-Is on sponsored projects (including competing renewals) at the UM must be certified in the PEERRS system before spending on newly established sponsored research projects will be authorized.
back to top
Medical School Policies
back to top
OVPR Policies
back to top
Other Regulatory Resources
back to top
