Regulatory Resources

This page provides links to other offices and departments.

 

Research Involving Human Subject / Tissue / Information

Institutional Review Boards of the University of Michigan Medical School (IRBMED)
Provide oversight of human subjects research conducted by medical school faculty, students, and staff at any University of Michigan Health System (UMHS) facility or site.

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.

Office of Human Research Compliance Review

Privacy Board / Privacy Office
If your research involves protected health information.

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.

 

Research Involving Animal Subjects

University Committee on Use and Care of Animals (UCUCA)
The Office reviews animal use applications and protocol modifications, conducts inspections, and provides training for people working with animals.

Other Research Resources

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.

Occupational Safety & Environmental Health (OSEH)
Your resource for management of research risks involving chemical and biological hazards and training.

  • 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.
  • OSEH Training

Documentation of UM Compliance with FDA 21 CFR Part 11

eResearch Part 11 Certification Letter

CareWeb Part 11 Certification Letter

 

Compliance with the NIH Public Access Policy

Compliance with the NIH Public Access Policy

 

Required Training

Health Insurance and Portability Accounting Act (HIPAA)
The Health System is required to train all of our entire workforce, including faculty, staff, students, volunteers, contract employees and others on the new privacy regulations, and we must document that training.

MLearning / Mandatories

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