Human Research Protection Office (HRPO)

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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:

Request access to Cayuse Human Ethics (HE)

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.

Configuring your browser

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:

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
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.

Logging into Cayuse HE

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:

Creating a new submission

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.

Transitioning legacy studies to Cayuse HE

Legacy studies

The majority of paper-based IRB submissions (legacy studies) have been imported into Cayuse Human Ethics (HE). Studies that were approved as Exempt were not imported; to modify an exempt legacy study, you must create an Initial submission (based on the previously approved submission).

For legacy studies, their established IRB approval will be valid through their renewal date until a Renewal submission is approved in Cayuse HE.

Initial Modification submission to transition a legacy study

An initial Modification submission must be completed by the study team to fully transition the study into Cayuse HE. This must be submitted and approved before any actual study modification is requested and at least 60 days before a study is due for renewal. For studies relying on an external IRB, a limited amount of information is needed for the modification submission, e.g., entering all the current study personnel.

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: since this is a required field, you may state for the rationale: Legacy study update - no change to previously approved study.
- In the Submission intro section: You may add/remove PC personnel; however, anyone removed will immediately have no access to the submission. 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. Do NOT list the PI in this section. 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 the list of potential attachments and upload previously IRB-approved study documents, as applicable

If a legacy study requires a modification, first complete the initial Modification submission to transition the study and then complete a submission for the requested change. A Renewal submission for a legacy study cannot be reviewed until the initial Modification submission has been approved. You may submit an Incident submission at any time (after the Legacy submission has been completed); however, an Incident submission cannot be reviewed until the initial Modification submission has been approved. All submission types (Modification, Incident, as well as Closure) are immediately available after completion of the Legacy submission.

How to complete a Legacy submission as a PI/PC

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

Follow the Logging into Cayuse HE section above to navigate to Cayuse HE.
Click on the study from your Cayuse Human Ethics (HE) home screen
On the Study Details tab, click +New Submission and choose Legacy:
Click the Complete Submission link or the Edit button
Complete the Getting started section (one response)
Complete the Submission intro section -
Is this a Legacy submission? Choose YES
Click COMPLETE SUBMISSION in the left-side navigation
The PI will receive a notification to certify the submission

How to change/add another PC to a legacy study after a Legacy submission

A simple Modification submission can be completed if another PC needs to be added to a legacy study to complete future submissions (such as the initial Modification submission to complete the Cayuse HE study record):

Follow the Logging into Cayuse HE section above to navigate to Cayuse HE.
Click on the study from your Cayuse Human Ethics (HE) home screen
On the Study Details tab, click +New Submission and choose Modification
Complete the Getting started section (one response)
Complete the Submission intro section -
Use the FIND PEOPLE button under the Primary Contact section to add another PC (you may also delete a PC; however, anyone removed will immediately have no access to the submission)
Is this a Legacy submission? Keep the response YES
Click COMPLETE SUBMISSION in the left-side navigation
The PI will receive a notification to certify the submission

Completing follow-on submissions for legacy studies

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 required elements, as applicable
5. In the List of attachments section, attach all currently IRB-approved materials

IMPORTANT: Attachments must have a file name that includes a version number and date for the IRB to reference in the approval letter. For editable documents, the file name version and date should also be present in the body of the attachment (e.g., title page, header, or footer). File names may not exceed 96 characters (including spaces) and file size may not exceed 20 MB.

Education & training for research involving human subjects

All personnel engaged in research overseen by the Hennepin Healthcare IRB must complete education/training - For specific requirements, refer to the HHRI Human research training and education policy You may also refer to the 401 CHECKLIST Required education for research involving human subjects

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 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 process for medical students, residents, fellows, and shadows

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

OHRP guidance on whether research may qualify as exempt

OHRP decision charts

FDA guidance on research involving human specimens

Guidance on informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable

21 CFR 812.3(p) (FDA Investigational device exemptions - definition of subject)

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)

109 GUIDANCE Informed consent (23 JUN 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)

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 (JUN 2021)

630 TEMPLATE Intervention Study (JUN 2021)

Informed consent templates

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)

FAQs

900 FAQ Verbal and electronic informed consent (MAY 2020)

901 FAQ IRB reliance (MAY 2020)

902 FAQ Single IRB review (MAY 2020)

903 FAQ Using Cayuse HE (28 JUN 2021)

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.

Human Research Protection Office (HRPO)