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.
Applications
Consent Paper for Clincal Research
Exempt Review - Attachment M - Revised Common Rule
Full Committee or Expedited Review - Attachment K
Protocol Template: Intervention Study - Attachment UUU
Protocol Template: Retrospective Study of Existing Data and or Specimens - Attachment TTT
Request for IRB Reliance Form
IRB Committee
Policies
Prompt Reporting
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
Mailing Address
701 Park Avenue
Shapiro 9.115
Minneapolis, MN 55415
Physical Location
914 South 8th Street
Shapiro 9.115
Minneapolis, MN 55404
Phone Number and Mail Code
Phone Number: 612-873-6881
Fax Number: 612-873-1646
Inter-Departmental Mail Code: S9.115
IRB Personnel
Craig Peine, MD
Chair
612-873-7461
peine002@umn.edu
Karen Heim-Duthoy, PharmD
Vice Chair
612-873-6880
heimd001@umn.edu
Cindy Hanson
IRB Coordinator
612-873-6881
chanson@hhrinstitute.org
Tracy Schmidt
Senior Research Secretary
612-873-6882
tschmidt@hhrinstitute.org
Helpful Links
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.