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Forms

Current forms related to the Duke Health IRB and Human Research Protection Program (HRPP) are located here. Click on the drop-down menu below, and you can search for forms in the following categories:

  • Advertisement and Flyer Templates
  • Continuing Review Forms
  • Consent Form Templates
  • IDE Billing Notice
  • Outside Duke Key Personnel Form
  • Research Summary Instructions and Templates
  • Review Preparatory to Research (RPR) Form
  • Telephone Scripts
  • Waivers
  • Specialty Committee Review Forms
  • CRU/Departmental Checklists
  • IRB Primary Reviewer Checklists
  • IRB Reviewer Checklists
  • Principal Investigator Checklists

Outside Duke Key Personnel Form

Outside Duke Key Personnel Form

Please note in iRIS this form is no longer uploaded but part of the application.

If your study includes outside key personnel, you would fill out the outside key personnel section in iRIS by creating a regular amendment. In this same amendment, you will need to also revise the research summary to include what type of data they will have access to (PHI, de-identified data, anonymous) or state they will not have access to any data.  If outside key personnel will have access to Duke PHI, an agreement/IRB site approval will also be needed. If the site intends to rely on the Duke IRB as the IRB of record, please contact Minna Pak for the appropriate agreement.  For Material Transfer Agreements (MTA) or Data Use Agreements (DUA), please contact the Office of Corporate Research Collaborations (OCRC).

You will also need to attach the documentation of Human Subjects Certification for each individual (it can be from their own institution) in the submission packet (this is required in most circumstances but not all--for example when Duke is serving as the Central IRB--it is not required for sites to provide their key personnel CITI reports)

Please list adjunct faculty members and affiliates  who are serving on a study on the Outside Key Personnel smartform in iRIS.  Unpaid interns and volunteers must also be listed on the Outside Key Personnel smartform in iRIS--click here for policy.

Please note: if you are the coordinating center for a multi-site study or if Duke is serving as the Central IRB, you can upload the following form (staff listing) below into the submission packet and do not need to fill out the outside key personnel smartform embedded in iRIS.  You also in these cases do not need to upload CITI completion reports.

 

Pathology Review Form (for Study Team)

Specialty Committee Review Forms

This form is a request for Department of Pathology approval for research involving human tissues (biopsies, resection, or excess/waste tissues). This form is now a smart form (embedded) in iRIS.

For questions about Pathology review, please call the Pathology Department:  919-684-4530.

Payment Form For Participant (Personal Data Disclosure Form for Research Participants)

Consent Form Templates

This form is referred to as the Personal Data Disclosure Form for Research Participants. It is the payment form that the participant signs in order to get paid. For more information on processing payments to research participants, click here.

Pediatric Risk Assessment Form (for Reviewer)

Specialty Committee Review Forms

The pediatric risk assessment form that is filled out by Robert Drucker.

Pregnant Partner Information Form

Consent Form Templates

This form should be used in conjunction with the DUHS HIPAA Authorization form (or the authorization form used by the pregnant partner’s care provider) whenever a sponsor is requesting permission to collect information regarding pregnant partners of male study participants.  No information regarding the partner’s pregnancy (accompanied with identifiers) should be recorded by the study team or the sponsor until the partner has given permission and signed this form.

QI Summary Template and Instructions

Research Summary Instructions and Templates

This template/instructions should only be used for Quality Improvement (QI) Projects.  The template is designed for projects involving the translation of existing knowledge into clinical practice.

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