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Human Research Protection Office (HRPO)

Human Research Protection Office (HRPO)

As part of the Human Research Protection Program (HRPP) at Hennepin Healthcare, HRPO provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted under the auspices of Hennepin Healthcare. HRPO support Hennepin Healthcare review boards responsible for oversight of human research, supports researchers to meet review requirements, and manages ongoing oversight activities.

HRPO staff

Cayuse Human Ethics (HE) submission system

Virtual office support for Cayuse HE

HRPO will be hosting weekly online sessions on Wednesdays @noon to provide demonstrations and answer questions for HE submissions. Please contact HRPO@hhrinstitute.org for a Zoom invitation to the open Wednesday sessions or to request an individual appointment.

HRPO strives to provide high-quality and timely services for review and approval of human research. The conversion from our paper-based record system to Cayuse HE is a major undertaking and we appreciate your patience through the transition.

Cayuse Help Center

Visit the Cayuse Help Center for online guidance and tutorials on the Human Ethics module.

To access Cayuse Human Ethics HE: hhrin.app.cayuse.com

 

User instructions:

To request access to Cayuse HE, email HRPO@hhrinstitute.org. Only individuals affiliated with Hennepin Healthcare will be set up with a user account. If you are not listed in either the HHRI or HHS company directory, please provide other documentation of your affiliation. You may request access for both the Investigator(s) and Primary Contact(s) for an initial submission.

HRPO will initiate the Cayuse activation request. If you do not receive a Cayuse mail within one business day regarding your user account, please contact HRPO@hhrinstitute.org

NOTES:

  • When your user account is activated, you'll receive an email from Cayuse: New Cayuse Account Created.
  • The temporary password to log in will expire after 30 days.
  • If you're experiencing technical difficulties logging in, please review the Configuring your browser section or contact HRPO@hhrinstitute.org
  • There is currently an intermittent issue with the Cayuse Forgot your password? reset. Please securely store your password for future reference.

Cayuse HE is a web-based submission system. You will need internet access to login to the system.   

Cayuse recommends using Chrome and opening a New incognito window. The URL to access Cayuse is hhrin.app.cayuse.com. If saving as a bookmark, make sure that the URL is hhrin.app.cayuse.com (e.g., vs a signin page).

If you're able to log into Cayuse but are having issues accessing the Cayuse HE module, you my need to clear your browser cache. See the Cayuse Support Center for guidance on clearing your your browser cache.

If using Firefox, you may need to configure your Firefox browser as follows:

  1. Cookies Enabled

    Under Options, Privacy & Security, Cookies and Site Data, click Manage Exceptions and enter Address of website: hhrin.app.cayuse.com - click Allow - Save Changes to accept cookies for only Cayuse while blocking cookies on other websites

  2. Pop-ups Allowed

    Under Options, Privacy & Security, Permissions, when Block pop-up windows is checked, click Exceptions... and enter Address of website: hhrin.app.cayuse.com - click Allow - Save Changes to allow pop-up windows only for Cayuse while blocking pop-ups on other websites.

For additional information on updating Firefox, see: https://support.mozilla.org/en-US/kb/update-firefox-latest-release or for additional information about your current Firefox version, see: https://support.mozilla.org/en-US/kb/find-what-version-firefox-you-are-using.

Once you've activated your Cayuse HE account, you can create a submission.

Note that when you initially login, you'll see the Cayuse platform Home page. This screen will show ad-hoc tasks only. To see your tasks in Cayuse HE, you must choose Human Ethics from the Products switcher:

Choosing Human Ethics will bring you to your HE dashboard:

 

Follow the Logging into Cayuse HE section above to navigate to Cayuse HE.

From your HE dashboard, click +New Study to create a new submission:

On the next screen, enter the study title and click the checkmark:

On the Study Details tab, click +New Submission and choose Initial:

Complete the required elements of the submission, as applicable

Once all sections of the submission are complete, click COMPLETE SUBMISSION to route it to the PI for certification.

IMPORTANT: All first-time submissions of any type (Initial, Renewal, Modification, Incident, and Closure) require PI certification. The PI will receive an email notification to log into Cayuse HE to certify the submission. If a submission is sent back for changes, the PC may re-certify, as designated by the PI.

Legacy studies

Cayuse has imported the majority of paper-based IRB submissions (legacy studies). Legacy studies that have expired approval dates and Exempt studies have not yet been imported.

For legacy studies, their established IRB approval will be valid through their renewal date if no submissions (other than the Legacy submission) are completed in Cayuse HE.
 
If a legacy study requires an IRB approval prior to renewal, e.g., there's a change or incident to report, you'll need to complete the applicable submission type in Cayuse HE (e.g., Modification, Incident). These submission types (as well as Closure) are immediately available after completion of the Legacy submission.

For legacy studies administratively activated by HRPO

For studies with renewal dates through March 2021, HRPO has administratively activated them to allow the immediate ability for the PI and PC to complete a Renewal submission.

Renewals: Prior to the IRB approving a Renewal submission for a study that was administratively activated by HRPO, the PI or PC must complete a Modification submission to complete the study record in Cayuse. The Cayuse HE Smartforms don't necessarily match the former paper-based forms and Cayuse only allows basic information to be imported from paper-based records. Therefore, there is some information and attachments that researchers will need to provide (again)  to complete the study record in Cayuse HE. The Modification submission allows the IRB to provide renewal approvals based on information in Cayuse HE.
 
Complete the sections in the Modification submission as they populate.
    • In the Modification request section: If there are no changes from your previous IRB approval, you can state for the rationale: Legacy study update - no change to previously approved study.
    • In the Submission intro section: You may add or change PC personnel. For the question: Is this a Legacy submission?Choose NO.
    • In the Study personnel section: Add all the personnel you wish to have approved on the study going forward. If a PC (who is not a PI) is also serving as study personnel, be sure to add him/her to this section.
    • In the List of attachments section: Review attachments and upload previously IRB-approved study documents, as applicable

How to complete a Legacy submission as a PI/PC

The PI/PC (as named in the paper-based records) can complete a Legacy submission for a legacy study that hasn't been activated by HRPO.

On the Submission intro page of the Legacy submission, choose NO instead of YES for the question: Is this a Legacy submission? Choosing NO allows you to complete the study record in Cayuse HE for future submissions.
IMPORTANT: Do not make changes in this submission to the previously approved version of the study. Legacy submissions cannot be reviewed by the IRB, i.e., there's no IRB approval attached to a Legacy submission. 
 
  1. Follow the Logging into Cayuse HE section above to navigate to Cayuse HE.
  2. Click on the study from your Cayuse Human Ethics (HE) home screen
  3. On the Study Details tab, click +New Submission and choose Legacy:
  4. Click the Complete Submission link or the Edit button
  5. Complete the Getting started section (one response)
  6. Complete the Submission intro section -
    Is this a Legacy submission? Choose NO to complete the study record in Cayuse HE for future submissions. If you choose YES, no additional sections will populate
  7. Complete the applicable sections that populate
  8. When all sections in the left-side navigation panel are complete, click COMPLETE SUBMISSION
  9. The PI will receive a notification to certify the submission

After the Legacy submission is complete, the PI and PC will be able to submit follow-on submissions (e.g., Modification, Incident, Renewal, and Closure).

IMPORTANT: Prior to the first Renewal submission in Cayuse HE, you must complete a Modification submission to complete the legacy study record. The renewal to follow will be approved based on study information contained in the modification.

To request a change to the Primary Contact (PC) only:

    1. Click +New Submission and choose Modification
    2. Complete the Getting started section
    3. In the Submission intro section, edit the Primary Contact (PC) accordingly
    4. Is this a Legacy submission? Choose YES to submit the PC change request

For a Renewal or Modification submission:

    1. Click +New Submission and choose the applicable type
    2. Complete the Getting started section
    3. In the Submission intro section:
      - Is this a Legacy submission? Choose NO
    4. Respond to all required elements, as applicable

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

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/

Guidance: How to update your email in CITI

Hennepin Healthcare Human Subjects Protection online training:
http://www.hhrinstitute.org/hhri-learning-center-guide/

For Office of Education & Quality in Clinical Research in-person training, contact EQ@hhrinstitute.org

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

IMPORTANT: 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

Virtual Data Warehouse

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.

IMPORTANT: 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).

Guidance documents

101 GUIDANCE Investigator responsibilities

106 GUIDANCE Human research determinations (06 JAN 2021)

107 GUIDANCE Engagement determinations (2008 OHRP)

108 GUIDANCE Regulatory and external guidance references (JAN 2021)

110 GUIDANCE Criteria for external IRB reliance (SEP 2020)

111 GUIDANCE Transitioning studies to 2018 Common Rule (JUN 2020)

112 GUIDANCE Relying on an external IRB (09 FEB 2021)

113 GUIDANCE Notifications to HRPO for ceded studies (09 FEB 2021)

117 GUIDANCE External IRB reliance: localized language for consent forms (MAR 2020)

118 GUIDANCE Informed consent for investigational COVID-19 convalescent plasma - eINDs (MAR 2020)

133 GUIDANCE New information/Incident reporting (DEC 2020)

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 (JAN 2021)

161 GUIDANCE Criteria for expedited IRB review (08 MAR 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)

 

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 (updated SEP 2020)

FAQs

900 FAQ Verbal and electronic informed consent (MAY 2020)

901 FAQ IRB reliance (MAY 2020)

902 FAQ Single IRB review (MAY 2020)

Protocol Builder

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

GUIDE: Protocol Builder Getting Started and Quick Tips

Protocol templates

620 TEMPLATE Retrospective study of existing data and/or specimens

630 TEMPLATE Intervention Study

Informed consent templates

NOTE: HCMC-format consent paper is no longer being used

600 TEMPLATE Informed consent (OCT 2020)

601 TEMPLATE HIPAA authorization for research (OCT 2020)

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)

Information Sheet Template

Interpreter services

Informed consent short form

Checklists

ACT CHECKLIST (ClinicalTrials.gov)

400 CHECKLIST HHS Resource Utilization Checklist (JUN 2019)

401 CHECKLIST Required education for research involving human subjects (01 MAR 2021)

410 CHECKLIST Elements of informed consent (MAY 2019)

Forms

300 FORM Conflict of interest disclosure (MAY 2020)

305 FORM HHRI Epic access request (06 JAN 2021)

312 FORM Notification to HRPO for ceded studies (AUG 2020)

319 FORM Administrative check-in (MAY 2021)

322 FORM Physician Chief acknowledgement (APR 2020)

323 FORM Independent physician certification (JUL 2020)

324 FORM Community consultation and public disclosure for EFIC (MAY 2020)

Other information

ServiceNow instructions

Virtual Data Warehouse (VDW)

REDCap

HHRI COI Policy

Researcher Resources

Hennepin Healthcare review boards for human research compliance

The Institutional Review Board (IRB) and Continuing Review Committee (CRC) are 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/CRC oversight unless determined by HRPO review to be exempt.

IRB members include hospital and community representatives, scientists and non-scientists. The CRC is comprised of a subset of IRB members. The IRB and CRC review 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 2021 meeting schedule

Board members

Board member resources

 IORG0000123
FWA00006047
IRB00000203 (IRB) & 00007957 (CRC)

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).

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.

FDA - Investigational Device
FDA - New Drug
OHRP Information
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