Office of Human Subjects Research
The Human Subjects Research Committee is the Institutional Review Board (IRB) for HHRI and the Hennepin Healthcare System (HHS). Institutional Review Boards are charged by the federal government with protecting the rights and welfare of research subjects. No human subjects research at this campus or by its faculty may proceed without the HSRC approval.
The Human Subjects Research Committee (HSRC) membership includes hospital and community representatives, scientists and non-scientists. The HSRC reviews research proposals, considering the risk and benefits to subjects. It ensures that research subjects provide voluntary and informed consent. Once a research study is approved, the HSRC monitors its progress and any problems that research subjects may encounter.
5 Day Follow-up Report by INVESTIGATOR of Emergency Use of a Test Article - Attachment RRR
External New Information - Attachment HHH
Non-Compliance - Attachment III
Prompt Reporting Guidelines - Attachment EEE
Serious Adverse Event - Attachment FFF
Unanticipated Problem Involving Risks to Subjects or Others - Attachment GGG
Submit an Application
701 Park Avenue
Minneapolis, MN 55415
914 South 8th Street
Minneapolis, MN 55404
Phone Number and Mail Code
Phone Number: 612-873-6881
Fax Number: 612-873-1646
Inter-Departmental Mail Code: S9.115
Craig Peine, MD
Karen Heim-Duthoy, PharmD
Senior Research Secretary
Below are links to the Food and Drug Administration's New Drug Application and Investigational Device Exemption Application, and the Office of Human Research Protections (OHRP) page on the information on the rights, welfare, and wellbeing of subjects involved in research.