Human Research Protection Office (HRPO)
As part of the Human Research Protection Program (HRPP) at Hennepin Healthcare, HRPO supports researchers, Institutional Review Board (IRB) members, and HRPP stakeholders to ensure appropriate protections of the rights, welfare, and wellbeing of human subjects involved in research conducted under the auspices of Hennepin Healthcare.
HRPO staff
501 MANUAL Conducting Human Research (04 NOV 2022) (PDF)
Cayuse Human Ethics (HE) submission system
To access Cayuse Human Ethics HE: hhrin.app.cayuse.com/rs/irb
Virtual office support for Cayuse HE
Please contact HRPO@hhrinstitute.org to request an overview of Cayuse navigation and features via a Zoom session with an IRB analyst.
Cayuse Help Center
Visit the Cayuse Help Center for online guidance and tutorials on the Human Ethics module.
Education & training for IRB approval
All personnel engaged in research overseen by the Hennepin Healthcare IRB must complete education/training - For specific requirements, refer to the 501 MANUAL Conducting Human Research - section 1.6 What training and education is required to conduct human research?
CITI Program:
http://www.hhrinstitute.org/citi-enrollmentaffiliation-instructions/
2022 - updated CITI Program requirements
- How to update your email in CITI
- How to add the Biomedical PI course to your CITI profile
- How to add the Annual HIPAA and Safety Training for Researchers course to your CITI profile
Hennepin Healthcare Human Subjects Protection online training for investigators conducting non-exempt research:
http://www.hhrinstitute.org/hhri-learning-center-guide/
For Office of Education & Quality in Clinical Research in-person training, contact EQ@hhrinstitute.org
HHS onboarding of medical students, residents, fellows, and shadows
Investigators wishing to engage non-employees on Hennepin Healthcare research involving human subjects must follow institutional requirements. Please contact Karin Fisher Hills: khills@hhrinstitute.org
Researchers not affiliated with Hennepin Healthcare
Do not add researchers that are external to Hennepin Healthcare to the personnel section of a Hennepin Healthcare IRB submission - human subject activities for external researchers must be approved in accordance with their own institutional requirements.
For data subject to HIPAA that is released to external researchers, a data agreement should be established (contact HHRI Grants and Contracts)
Secondary research with Epic data
For secondary research involving Epic data, the IRB requests that researchers engage the Analytics Center of Excellence (ACE) or Virtual Data Warehouse (VDW) to extract data for the study unless it is not obtainable via their services (e.g., information contained in notes fields). The IRB will accept hybrid extraction, e.g., if research needs information from notes, ACE/VDW should be engaged to provide required data with a link to access notes data.
ServiceNow instructions for ACE requests
If secondary research involves ONLY de-identified data obtained via ACE/VDW or other honest broker, the research is NOT human subject research, i.e., not subject to IRB oversight.
Non-employees (e.g., NRCs) will NOT be granted access to Epic or PHI for secondary research.
Care Everywhere
The Epic Care Everywhere user agreement states that Care Everywhere may not be used for research recruitment or to access records for research purposes. This is because Epic designed Care Everywhere to be used for treatment and care coordination purposes, and all Epic organizations that participate in Care Everywhere consent patients to its use as a patient care tool, not a research tool. Patient Information from Care Everywhere that is already in the Hennepin Healthcare Epic system because it was previously requested for treatment or care coordination may be used for research or other lawful purpose; however, accessing Care Everywhere to retrieve/use patient information for research is not permitted.
Guidance documents
106 GUIDANCE Human research determinations (06 JAN 2021)
107 GUIDANCE Engagement determinations (2008 OHRP)
108 GUIDANCE Regulatory and external guidance references (JAN 2021)
109 GUIDANCE Informed consent (02 DEC 2021)
110 GUIDANCE Criteria for external IRB reliance (31 OCT 2022)
111 GUIDANCE Transitioning studies to 2018 Common Rule (JUN 2020)
112 GUIDANCE Relying on an external IRB (09 AUG 2021)
113 GUIDANCE Notifications to HRPO for ceded studies (31 OCT 2022)
117 GUIDANCE External IRB reliance: localized language for consent forms (01 AUG 2022)
118 GUIDANCE Informed consent for investigational COVID-19 convalescent plasma - eINDs (MAR 2020)
133 GUIDANCE New information/Incident reporting (31 OCT 2022)
145 GUIDANCE IRB review of research subject to 45CFR46 (2018 Common Rule) (DEC 2020)
150 GUIDANCE Data and safety monitoring in research (12 APR 2021)
160 GUIDANCE Criteria for exemption from IRB oversight 25 APR 2022)
161 GUIDANCE Criteria for expedited IRB review (04 FEB 2022)
190 GUIDANCE Case reports (JAN 2021)
197 GUIDANCE Criteria for IRB approval (24 JAN 2021)
198 GUIDANCE Secondary research with de-identified data (02 FEB 2020)
199 GUIDANCE QA/QI activities (29 JAN 2021)
OHRP guidance on whether research may qualify as exempt
FDA guidance on prompt reporting
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). 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.
- 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
FDA guidance on research involving human specimens
21 CFR 812.3(p) (FDA Investigational device exemptions - definition of subject)
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 (updated SEP 2020)
Forms
300 FORM Conflict of interest disclosure (MAY 2020)
305 FORM HHRI Epic access request (25 APR 2022)
306 FORM PI eligibility exception request (25 APR 2022)
315 FORM Protocol exception request (31 OCT 2022)
322 FORM Physician Chief acknowledgement (20 OCT 2021)
323 FORM Independent physician certification (JUL 2020)
324 FORM Community consultation and public disclosure for EFIC (MAY 2020)
FORM A Registration for inpatient investigational drug studies (25 OCT 2022)
FORM B Registration for investigational drug not stored in pharmacy (25 OCT 2022)
Checklists
ACT CHECKLIST (ClinicalTrials.gov)
400 CHECKLIST HHS Resource Utilization Checklist (JUN 2019)
Informed consent templates
NOTE: HCMC-format consent paper is no longer being used
600 TEMPLATE Informed consent with embedded HIPAA authorization (01 AUG 2022)
601 TEMPLATE HIPAA authorization for research (25 APR 2022)
602 TEMPLATE Informed consent for emergency use of a test article (OCT 2020)
604 TEMPLATE Information sheet for use of an FDA-regulated HUD (APR 2021)
605 TEMPLATE Signature blocks (01 AUG 2022)
606 TEMPLATE Information sheet for EXEMPT research (09 FEB 2022)
608 TEMPLATE Consent for using body fluid/tissue samples for genetic research (11 FEB 2022)
609 TEMPLATE Letter to withdraw permission to use sample(s) for genetic research (11 FEB 2022)
Information Sheet Template (to be used ONLY for prospective activities with full waiver of consent)
Interpreter services
Hennepin Healthcare Interpreter Services
(link requires access to InfoOnCall)
Additional information on translation and interpreter services
Informed consent short form
610 TEMPLATE Informed consent short form (English)
611 TEMPLATE Informed consent short form (Hmong)
- certificate of translation
612 TEMPLATE Informed consent short form (Somali)
- certificate of translation
613 TEMPLATE Informed consent short form (Spanish)
- certificate of translation
Protocol templates
620 TEMPLATE Retrospective study of existing data and/or specimens (JUN 2021)
630 TEMPLATE Intervention Study (JUN 2021)
FAQs
900 FAQ Verbal and electronic informed consent (MAY 2020)
901 FAQ IRB reliance (20 MAY 2020)
902 FAQ Single IRB review of federally-funded research (25 APR 2022)
903 FAQ Using Cayuse HE (28 JUN 2021)
Other information
Prompt reporting
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
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.
Hennepin Healthcare Institutional Review Board
The Institutional Review Board (IRB) is charged by the federal government to protect the rights and welfare of human subjects in research. All research involving human subjects that is conducted under the auspices of Hennepin Healthcare requires IRB approval and ongoing oversight unless determined by IRB review to be exempt.
IRB members include hospital and community representatives, scientists and non-scientists. The IRB reviews research submissions to consider the risk and benefits to subjects and to ensure that research subjects provide voluntary and informed consent. Studies subject to IRB oversight must maintain approval throughout the conduct of the study.
IMPORTANT
You must receive written IRB approval or an exempt determination prior to initiating any study activities that involve human subjects; retrospective approval for research is unallowable.
FY 2022 meeting schedule
Board members
Board member resources
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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.