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 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
Effectively immediately, send all paper-based materials as electronic documents to: tschmidt@hhrinstitute.org or chanson@hhrinstitute.org
Approval letters and other communications from the IRB will be returned via email.
Revised Common Rule Single IRB Mandate Now in Effect
Effective January 20, 2020, the revised Common Rule requires that research involving human subjects that is conducted by more than one U.S. institution must use a single IRB (sIRB) unless the research meets exemption criteria.
What does this mean?
Federally-funded research involving more than one U.S.-based institution engaged in non-exempt human research will require the use of a single IRB unless the research meets exception criteria described in §46.114(b)(2).
What are the exceptions to the Common Rule “cooperative research” provision?
The following research is not subject to this provision:
- Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or
- Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context
- Cooperative research conducted or supported by DHHS agencies other than NIH, if an IRB approved the research before January 20, 2020
- Cooperative research conducted or supported by NIH if either:
- The NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or
- NIH excepted the research from its single IRB policy before January 20, 2020
What are my options for obtaining sIRB review?
sIRB review may be conducted by a participating site when their IRB agrees to serve as the IRB of record or an independent IRB. The institution submitting the grant application or the federal awarding agency is responsible for selecting an sIRB.
Hennepin Health Research Institute (HHRI) IRB is not currently agreeing to serve as the sIRB for cooperative research. Efforts are currently underway to evaluate and prepare for the HHRI IRB to serve in this capacity; more information will be provided as this process evolves.
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
FAQs
919 FAQ Human subjects' research and COVID-19
Submission Forms
Full Committee or Expedited Review - Attachment K
Elements of Informed Consent Checklist
300 FORM Request for HIPAA waiver or alteration of authorization for research
302 FORM - Request for Reliance
311 FORM Request for exempt determination (formerly Attachment M)
319 FORM Temporary study modification in response to COVID-19
398 FORM Not human subject research determination
399 FORM Project determination
400 CHECKLIST Hennepin Healthcare Resource Utilization & Coverages Analysis (Appendix A)
401 CHECKLIST Required education for research involving human subjects
Personnel Approval Forms (for new submissions and changes to active studies)
303 FORM - Study personnel approval request form
Study personnel approval request form (single individual)
Study personnel removal request form
Protocol Templates
Protocol Template: Intervention Study - Attachment UUU
Protocol Template: Retrospective Study of Existing Data and or Specimen - Attachment TTT
Informed Consent Guidelines/Templates
600 TEMPLATE Informed Consent (formerly Attachment O)
NOTE: HCMC-format Consent Paper is no longer being used
117 GUIDELINE - External IRB reliance: localized language for consent forms
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
IRB Chair
612-873-7461
peine002@umn.edu
Karen Heim-Duthoy, PharmD
IRB Vice Chair
612-873-6880
KHeim-Duthoy@hhrinstitute.org
Cindy Hanson
IRB Analyst
612-873-6881
chanson@hhrinstitute.org
Jennifer Hart
IRB Deputy Vice Chair
612-873-6883
jhart@hhrinstitute.org
Tracy Schmidt
IRB Coordinator
612-873-6882
tschmidt@hhrinstitute.org
Erin Venegoni
IRB Reliance Manager
612-873-6651
evenegoni@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.