Initial Review Guidance


Submission Process

  1. Review the eligibility page to ensure that the study can be reviewed an independent IRB.
  2. Create a new IRB application in ARROW by clicking the "Start ARROW Application" button in the upper left-hand corner, choosing "IRB Application," and then picking "Request to Cede IRB Review."
    • Complete the first section of the application as you would for any other study.
    • See the Training section below for requirements for study personnel.
    • The funding pages are the same as other application. Please see the fee policy for more information about fees.

  3. If the study involves enrolling participants at UW, obtain the sponsor’s template consent that can be used to enter UW-required language. Enter changes into the sponsor template using track changes in Microsoft Word.
    • Use the Local Context Checklist to review what items apply to the protocol and what UW required language may be needed.
    • Use the consent language template for independent IRBs to enter specific UW-required language into the sponsor’s consent template.
    • Combined consent/authorization templates from sponsors are acceptable because independent IRBs can serve as the privacy board for UW.

  4. Submit the application to the HS-IRBs office. Any questions will be returned to the study team via ARROW.
  5. Once all items have been resolved, the HS-IRBs Reliance Team will accept the ceded review. This will generate a letter that can be used as the UW institutional sign-off when submitting to the independent IRB.
  6. Submit directly to the independent IRB using the documents accepted under the ceded review.
  7. For links to independent IRB submission systems and guidance, please see the contact information page.
  8. General requirements for CVs and Licenses are outlined below.

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Training

Anyone listed as a study team member on the WIRB application who is engaged in human subjects research must complete human subjects protection and HIPAA Privacy Rule training for researchers. Prior to submitting a ceded review application in aRROW, study teams must verify all study team members have completed required training:

  • CITI Human Subjects Training - The UW-Madison requires CITI training for UW personnel engaged in human subjects research.
    • Search the Research Certification Course Completion Database to review and print training certificates. NOTE: This requires a UW-Madison NetID.
    • Did you complete UW-Madison CITI training without a NetID? Here's how to request a merger of your new NetID account with your completed training account.
    • Did you previously take CITI human subjects training at another institution? Here's to get credit against the UW-Madison CITI human subjects training for training you previously took at another institution.

  • Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Training - The UW-Madison requires HIPAA Privacy Rule training for those who are within the Health Care Component of the university or part of the Affiliated Covered Entity (UW-Madison and UW Health).
    • If a study team member's HIPAA Privacy Rule training cannot be verified in Research Certification Course Completion Database, please contact the Reliance Team.

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CVs and Licenses

Independent IRB CV and License Requirement
Chesapeake
  • PI’s CV and medical license
  • Any regulatory audits (such as FDA/OHRP) of the PI which occurred in the past five years
  • If the PI is new to research, CV(s) from a sub-Investigator and/or other study staff with the appropriate research experience who will be assisting in the conduct of the study
  • Log in to CIRBI for more information.

Schulman
  • PI/Qualified Investigator (PI/QI)'s CV, if not already on file.
    • CVs must reflect experience, be signed and dated within the past 2 years.

  • CVs for each Sub-Investigator (Sub-I), if not already on file.
    • Sub-I CVs are not generally required for site submissions on studies that have been qualified by the Board as minimal risk and/or non-interventional.
    • CVs must reflect experience, be signed and dated within the past 2 years.

  • Please see “Submit a Site” instructions.

Quorum
  • PI's CV - this needs to be submitted to Quorum Review once unless information has been changed. Quorum will store the CV for subsequent submissions.
  • See resources on the “Start a Study” page.

WIRB
  • PI’s CV and medical license, if not already on file.
    • If already on file with WIRB, only an updated version is required.

  • CVs for each Sub-Investigator (Sub-I), if not already on file.

    • If already on file with WIRB, only an updated version is required.

  • License and/or CV submission of additional personnel as necessary for sponsor requirements

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Keywords:initial review, cede application, training, CVs and Licenses   Doc ID:18816
Owner:Mike B.Group:Central IRB Gateway
Created:2011-06-13 19:00 CDTUpdated:2018-03-30 13:30 CDT
Sites:Central IRB Gateway
Feedback:  24   24