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Human Research Protection Office (HRPO)

Human Research Protection Office (HRPO)

The Human Research Protections Office (HRPO) serves to support Institutional Review Board (IRB) activities for HHRI and the Hennepin Healthcare System (HHS).  The IRB is charged by the federal government to protect the rights and welfare of human subjects in research.  No research involving human subjects conducted under the auspices of HHRI/HHS may proceed without IRB approval.

IRB members include hospital and community representatives, scientists and non-scientists.  The IRB 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 IRB monitors progress and any problems that research subjects may encounter.

Education & training for research involving human subjects

IMPORTANT: Investigators wishing to engage students on Hennepin Healthcare research involving human subjects must follow HHS requirements: HHRI Research Trainees with HHS – Key Components and Processes

All personnel engaged in research overseen by the Hennepin Healthcare IRB must complete education/training - For specific requirements, refer to the 401 CHECKLIST below

CITI training courses overview:
http://www.hhrinstitute.org/updates-and-new-requirements-for-citi-training/

CITI online training access:
http://www.hhrinstitute.org/citi-enrollmentaffiliation-instructions/

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

Investigators wishing to engage students on Hennepin Healthcare research involving human subjects must follow HHS requirements: HHRI Research Trainees with HHS – Key Components and Processes

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.

For non-ceded studies, submit all forms and other communications to:

HRPO@hhrinstitute.org

For ceded studies, submit all forms and other communications to:

IRBreliance@hhrinstitute.org

Prompt reporting

5 Day Follow-up Report by INVESTIGATOR of Emergency Use of a Test Article - Attachment RRR

In accordance with FDA guidance, DO NOT submit unrelated SAEs to the IRB; only report unanticipated problems that meet reporting criteria, (e.g., unexpected in nature, related to participation in the research, and resulted in new circumstances that increased the risk of harm to subjects).

Use the 313 FORM for reportable SAEs, UPIRTSOs, noncompliance, use of an informed consent short form, and external new information

IMPORTANT: The Principal Investigator/study team is responsible for recording, tracking, and reporting adverse events, protocol deviations, and other unanticipated problems in accordance with sponsor and regulatory requirements, which may include information that is not reported to the IRB.

Other links

For drug and/or device studies, visit the links below to understand FDA requirements.

For federally funded research, the OHRP link provides information on regulatory requirements.

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