Chapter 8 - Compliance Issues: Regulatory Bodies, Policies and Assurances


Federal guidelines require institutional approval and oversight of activities involving human subjects, animals, human body parts and fluids, and hazardous materials. Researchers whose projects, whether externally funded or not, will involve one or more of these activities should seek the appropriate institutional clearances as early in the proposal development stage as possible, and must obtain approval before research proceeds.

Funding organizations and federal and state agencies require numerous certifications and assurances as a part of the proposal submission and award acceptance process. Many of these are standard and simply require the signature of the university’s authorizing official to certify compliance. Other clearances must be initiated by the Principal Investigator/Project Director, depending on the type of project planned. Federal regulations stipulate that institutions applying for federal funds assure the appropriate federal agency that certain conditions and policies are in place and implemented at the applicant institution.

Federal funding is at risk institution-wide if individuals do not comply with these requirements. The Office of Research and Sponsored Programs coordinates the assurance process and provides the signature of the authorizing official, the Vice Chancellor for Research and Sponsored Programs, on institutional certifications for a number of compliance issues. Note that these compliance issues pertain to all research activities conducted on the UM campus, regardless of the funding source or the type of sponsored or unsponsored program.