IRB Submission

IRB submission

All study team members should review Duke IRB submissions.

Below is a guide to assist with IRB submissions for retrospective and prospective studies. This guide is not exhaustive; please contact your PI, CRC, or RPM for guidance on special study situations that may not align with standard submission guidelines.

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IRB Submission Website

  • Submissions are completed through iris.duke.edu. You can begin the IRB submission process once you have completed your CITI training.
  • You can review both current and prior IRBs on this website.
  • To start a new submission, click “Create a New Protocol”, then select “DUHS IRB Application”.
iris chart

General Guidelines

  • All study personnel must be added to the IRB as key personnel at the time of submission.

    • If a divisional coordinator helps oversee the research progress, they should also be included.

  • All study personnel should review the IRB submission prior to finalization.

    • This ensures that unintentional IRB violations are avoided. For retrospective studies, pay close attention to enrollment numbers, study start dates, and end dates. Do not exceed the enrollment number or the date range specified in your retrospective study.

  • Prospective studies will be reviewed through the CRU feasibility process. This review helps ensure that the study is properly supported and that the statistical plan and study protocol are evaluated before submission, reducing the potential for future issues.

  • Prospective studies must have a clear funding plan, either through grants or internal division funds.

    • Subject screening, patient enrollment, consenting, data management, study startup, and study close-out all require the involvement of the Clinical Research Coordinator (CRC) team, which incurs costs for the study.

Case Reports

  • For three or fewer cases, an IRB is not technically required. However, most journals will request IRB approval, and obtaining an exempt IRB typically takes minimal time. We recommend obtaining IRB approval as a precaution.

  • When presenting case reports, you must adhere to the ‘Authorization to Use and/or Disclose Protected Health Information (HIPAA Form)’ policies, which can be found [here].

Retrospective Study Submissions

  • To begin, click “Create a New Protocol”, followed by “DUHS IRB Application”.

  • Retrospective studies can generally be submitted as Exempt.

  • For assistance with filling out Exempt Retrospective Review IRBs, complete the RedCap form via this link.

  • Carefully consider your enrollment numbers and study dates before submission:

    • If your study team plans to review 100 patient charts and this number is submitted to the IRB, enrolling 102 patients would violate the IRB. Enrolling fewer patients is acceptable if the IRB includes up to 500 patients.
    • If the study start date is listed as January 1, 2015, including patients enrolled before this date (e.g., December 1, 2014) would violate the IRB.
    • If necessary, the IRB can be amended later, which may delay the study's progress.

Adding Key Personnel to an Existing IRB

  • If additional study personnel are needed after IRB approval, log into IRIS and select the study protocol of interest.

  • On the left side, under ‘DUHS IRB,’ click on ‘DUHS IRB KSP Change Form.’

IRB submit form

  • Click ‘Add a New Form,’ in most cases, you will select ‘All other KSP types.’

  • Click ‘Setup Key Study Personnel Request’ at the top right to enter the name of the person being added. If the individual has not completed their onboarding or CITI training, their name will not appear as an option.

  • Select the correct person, assign their role, and click ‘Save’.

  • At the top right, click ‘Save and Continue to Next Section’. The PI will then be prompted to sign off on the personnel change request.

Prospective Research

  • Prospective studies are not exempt; submission must be done through the iris.duke.edu website.

  • Prospective protocols require a feasibility review before IRB submission. This review helps prevent issues and future amendments to the protocol and ensures that budget considerations are addressed. Enrollment, CRC effort, and data management for prospective studies all incur costs.

  • If your study is intended to be funded, follow the myRESEARCHpath portal and the intent-to-submit process.

  • The Primary Investigator (PI) and Clinical Research Coordinators (CRCs) should be closely involved in prospective protocols. In general, trainees should not submit these studies independently without substantial oversight.