Forms

Request for Protocol Approval

• Purpose: This is the standard form to request protocol approval for non-exempt research.
• Review Type: Your protocol will be reviewed using expedited or full board procedures.
• Note: Do not use this form if you are an undergraduate student.
• Download the form here

Undergraduate Student Request for Protocol Approval

• Purpose: This form is designated for undergraduate students conducting their own research.
• Exceptions: Do not use this form if your research is limited to the analysis of identifiable data collected by someone else.
• Reminder: Please review the 'Undergraduates as Researchers' page on our website before completing this form.
• Download the form here

Analysis of Existing Data Request for Protocol Approval

• Purpose: Use this form if your research involves the analysis of existing data, including individual records (academic, medical, financial), data sets, interview notes, biospecimens, online profiles and posts (e.g., social media), and audio- or video-recordings.
• Review Type: If IRB staff determine that the research described in this form meets the Category 4 eligibility activity, the Campus IRB may review the protocol as exempt.
• Download the form here

Ethnography Request for Protocol Approval

• Purpose: This form is for research that involves ethnographic field methods, such as participant-observation and developing insider and outsider points of view.
• Usage: This form should be used for preliminary field research and can be amended as the research develops.
• Note: Do not use this form if you are an undergraduate student.
• Download the form here

Request for a Screening for Exemption

• Purpose: Use this form if you believe your research qualifies for an exempt review based on specific categories, or if this has been confirmed by IRB staff.
• Eligibility: Your project must fall within one of the categories of research eligible for exemption, as listed in the form and on our website.
• Note: Do not use this form if you are an undergraduate student.
• Download the form here

Note: These forms may or may not be required, based on the specifics of your research. Please carefully read the conditions for each form and include the necessary ones with your protocol submission.

Research Involving a Component of the US Department of Defense (DOD)

• When to Use: Complete this form if your research:
  • Is funded by a component of the DOD (e.g., the Army Research Office)
  • Involves cooperation, collaboration, or agreement with the DOD
  • Uses DOD properties or facilities
  • Intentionally includes DOD personnel as part of the subject population, including bio-specimens.
• Submission Instructions: Append this form to your protocol submission.
• Download the attachment here

Independent Scientific Review Checklist

• When to Use: Complete this form if your research:
  • Is funded by a component of the DOD (e.g., the Army Research Office)
  • Involves cooperation, collaboration, or agreement with the DOD
  • Uses DOD properties or facilities
  • Intentionally includes DOD personnel as part of the subject population, including bio-specimens.
• Submission Instructions: Append this form to your protocol submission.
• Download the attachment here

Summary of Education

• When to Use: Complete this form if your research:
  • Is funded by a component of the DOD (e.g., the Army Research Office)
  • Involves cooperation, collaboration, or agreement with the DOD
  • Uses DOD properties or facilities
  • Intentionally includes DOD personnel as part of the subject population, including bio-specimens.
• Submission Instructions: Append this form to your protocol submission.
• Download the attachment here

Research Involving Prisoners as Subjects

• When to Use: This form is mandatory for all researchers who:
  • Intend to include prisoners as a subject population in their research, or
  • Have a currently enrolled subject who becomes a prisoner during the course of the study.
• Submission Instructions: Complete this form and append it to your protocol.
• Download the attachment here

Please ensure that you complete and attach all relevant forms as outlined above to ensure a smooth review process.

Unsure about how to amend an approved protocol? Refer to our Amendment Policy for guidance.

Request to Amend an Approved Protocol

• Purpose: Use this form when you need to request changes to any approved protocol, whether it is exempt, expedited, or full.
• Instructions: Proposed revisions should be clearly marked using the Track Changes feature in Word to distinguish them from the sections of the protocol that have already been approved.
• Note: If you are adding new members to the Duke research team as part of your amendments, you must also complete the Additional Personnel Form.
• Download the form here

Additional Personnel Form

• Purpose: Use this form when you are adding new members to the Duke research team.
• Instructions: Complete this form and attach it to your amendment request if you are adding new team members as part of your amendments.
• Note: If there are other changes in addition to the new team members, you must also complete the Request to Amend an Approved Protocol form.
• Download the form here

Please contact an IRB staff member if you want to remove Duke members from the research team or add researchers from another institution.

Have questions about our continuing review process? Refer to our Continuing Review Policy for guidance.

Periodic Check-in Form

• Purpose: Use this form to check in with the IRB before the check-in date of your non-exempt protocol.
• Instructions: Complete this form to provide updates on your research progress and to confirm ongoing compliance with IRB requirements.
• Download the form here

Request to Re-open a Closed Protocol

• Purpose: Use this form if you need to re-open a protocol that has previously been closed.
• Instructions: Complete this form to provide details about why the protocol needs to be reopened and any changes that have occurred since it was closed.
• Download the form here