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:
CITI online training access:
Hennepin Healthcare Human Subjects Protection online training:
For OEQCR in-person training, contact the HHRI Office for Education & Quality in Clinical Research (OEQCR):
Bonnie Crissman - (612) 873-5316 firstname.lastname@example.org
Deb Grillo - (612) 873-6997 email@example.com
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
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.
Protocol Builder is a cloud-based smart tool to help you write your protocol based on the type of study you plan to conduct
Anyone can request a user account to access this tool - contact Bonnie Crissman for setup
Informed consent templates
NOTE: HCMC-format consent paper is no longer being used
Use of interpreters
- Hennepin Healthcare Interpreter Services
(link requires access to InfoOnCall)
- Additional information on translation and interpreter services
Informed consent short form
- Hmong - certificate of translation
- Somali - certificate of translation
- Spanish - certificate of translation
303-1 FORM Study personnel approval request (MAY 2020) (single individual)
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).
- Examples of adverse events that do not represent unanticipated problems and do not need to be reported
- Examples of adverse events that represent unanticipated problems and need to be reported
- Examples of unanticipated problems that do not involve adverse events and need to be reported
The 313 FORM (above) replaces EEE, FFF, GGG, HHH, III, and YYY for reporting to the IRB all SAEs, UPIRTSOs, noncompliance, use of short form, and external new information
IMPORTANT: The Principal Investigator/study team is responsible for recording, tracking, and reporting adverse events and unanticipated problems in accordance with sponsor and regulatory requirements, which includes information that is not reported to the IRB.
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.