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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

Consent Addendum Template

Consent Form Templates

The Consent Addendum Template can be used as a supplement to the main consent form.  The Consent Addendum Template is appropriate to use when informing participants of a minor change, or adding a new risk.

Consent Form Language for HIPAA Compliance

Consent Form Templates

With the implementation of the Health Insurance Portability and Accountability Act (HIPAA), consent forms for all studies that accrue subjects within Duke University Health System must be modified for HIPAA compliance.  This document provides sample HIPAA language for the consent form and suggestions for where it may be added. 

Continuing Review Progress Report

Continuing Review Forms

Please note in iRIS this form is no longer uploaded but part of the continuing review submission. 

Creating Advertisements and Flyers for Your Study

Advertisement & Flyer Templates

Click below to create new study advertisements and flyers, developed by the Duke Health Office of Marketing and Communications.  After you click on the link below, click on the Login for Employees (SSO Access), log in with your Duke netID and password.  Then at the Duke Health Brand Center website, choose Customized Materials, then Templates.  Then answer the security question and all the available templates will appear for you.

Click Here for Creating Advertisements and Flyers for Your Study

If you have any questions, call Duke Health Marketing and Communications:  919-419-3270.

DCRI Research Summary Templates

Research Summary Instructions and Templates

Please note in iRIS these forms are no longer uploaded but part of the application.

  1. Coordinating Center Regular Study Application Research Summary Template for iRIS submission of a multi-site clinical research protocol, regular study application in which Duke is “engaged in research” and serves as a Coordinating Center (e.g., central clinical coordinating center, statistical coordinating center) or provides a central resource (e.g., Data Coordinating Center, Health Economics and Quality of Life (EQOL) coordinating center, Clinical Events Committee, Central Imaging, etc.) for the study.
  2. Coordinating Center Request for Exemption Research Summary Template for iRIS submission of a multi-site Coordinating Center Study Application research protocol (e.g., central clinical coordinating center, statistical coordinating center, or a central resource such as Data Coordinating Center, Health Economics and Quality of Life (EQOL) coordinating center, Clinical Events Committee, Central Imaging, etc.) in which Duke may be considered “not engaged in human subjects research".
  3. Database and Specimens Repository Research Summary Template for iRIS submission of a data and/or specimens repository protocol from DCRI under which samples and/or private information are collected and stored for future research.  

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