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.
Education & training for research involving human subjects
Required education for research involving human subjects CHECKLIST:
Required CITI training courses:
http://www.hhrinstitute.org/updates-and-new-requirements-for-citi-training/
CITI online training access:
http://www.hhrinstitute.org/citi-enrollmentaffiliation-instructions/
Required Hennepin Healthcare Human Subjects Protection online training:
http://www.hhrinstitute.org/hhri-learning-center-guide/
For OEQCR in-person training, contact the HHRI Office for Education & Quality in Clinical Research (OEQCR):
Bonnie Crissman - (612) 873-5316 bcrissman@hhrinstitute.org
Deb Grillo - (612) 873-6997 dgrillo@hhrinstitute.org
Form & Policy Updates
HHRI has added the short form as an option to the consent process. The short form consent is an alternative to using a translated consent form. The short form consent is a brief, standard document, translated into the subject's preferred language. The short form contains a description of the required elements of informed consent. The short form notes that these elements, as they pertain to the specific study and are contained in the full English-language informed consent form, will be presented orally to the subject or legally authorized representative.
For more details on the required process for using the short form, please see the following links:
- OEQCR Study Management SOP: 2.10 Obtaining Informed Consent
- Human Subjects Research (IRB) Page
- HSRC Informed Consent Form - English, Hmong, Somali, and Spanish short form - Attachment WWW
- Short Form Certificates - Hmong, Somali, and Spanish
- Prompt Reporting Guidelines - Attachment EEE - V. Non-English Speaking Consent - Short Form
For any questions, please contact the EQ office:
Bonnie Crissman: bcrissman@hhrinstitute.org | 612-873-5316
Deb Grillo: dgrillo@hhrinstitute.org | 612-873-6997
Mary Berchem: mberchem@hhrinstitute.org | 612-873-5467
Submission Forms
Full Committee or Expedited Review - Attachment K
Hennepin Healthcare Resource Utilization & Coverages Analysis Checklist - Appendix A
Exempt Review - Attachment M - Revised Common Rule
Elements of Informed Consent Checklist
Personnel Approval Forms (for new submissions and changes to active studies)
Study personnel approval request form
Study personnel approval request form (single individual)
Study personnel approval request form (volunteers only)
Protocol Templates
Protocol Template: Intervention Study - Attachment UUU
Protocol Template: Retrospective Study of Existing Data and or Specimen - Attachment TTT
Informed Consent Guidelines/Templates
Informed Consent Guidelines - Attachment O - Revised Common Rule
NOTE: HCMC-format Consent Paper is no longer being used
Information Sheet Template
Informed Consent Short Form
Informed Consent Short Form Certificate of Translation
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
Short Form - Attachment YYY
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
KHeim-Duthoy@hhrinstitute.org
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.