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Office of Human Subjects Research

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

3/16/2020: Effective immediately: submit via email vs office drop-off

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.

01/20/2020: Revised Common Rule Single IRB Mandate Now in Effect

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.

02/12/2019: Non-English Speaking Short Form Consent

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:

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

 

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.

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