Forms

If you have any questions about which forms to complete, please contact Campus IRB staff. We are available via email and by phone during normal business hours (Monday-Friday, 8:00AM-5:00PM).

Please review our COVID-19 Updates page before submitting a new protocol or amendment.

All research involving in-person interactions with participants should take place remotely where possible. While in-person restrictions continue to be eased or lifted, Duke currently expects all research activities that can be carried out remotely to remain remote. For more information, visit our COVID-19 Updates page.

Please note: Please complete the forms using Word. The IRB uses Track Changes to provide comments and feedback on submissions. We advise against the use of cloud-based tools (such as Google docs) to complete the protocol form. We have noted some formatting incompatibilities that may make it difficult to review the protocol.

 

The Campus IRB is currently experiencing a high volume of submissions. We thank you for your patience!

 

Request for Protocol Approval

This is the standard request for protocol approval for non-exempt research. The protocol will be reviewed using expedited or full board procedures. Do not use this form if you are an undergraduate student.

Undergraduate Student Request for Protocol Approval

Undergraduate students should use this form for all their research, unless their research is limited to the analysis of identifiable data collected by someone else. Please review the Undergraduates as Researchers page before completing this form.

Analysis of Existing Data Request for Protocol Approval

Use this form if your research is limited to the analysis of existing data. Existing data may be in the form of individual records (e.g., academic, medical, financial), data sets, interview notes, biospecimens, online profiles and posts (e.g., social media), and audio- or video-recordings. These data could be available for purposes other than research, and are sometimes, but not always, identifiable. If IRB staff determine that the research described on this form meets the Category 4 eligibility activity, the Campus IRB may review the protocol as exempt.

Ethnography Request for Protocol Approval

Use this form if your research involves ethnographic field methods such as participant-observation and developing insider and outsider points of views. The form should be used for preliminary field research and can be amended as the research develops. Do not use this form if you are an undergraduate student.

Request for a Screening for Exemption

Use this form if IRB staff have confirmed or you are confident that your research qualifies for exempt review. The Exemption form is still only allowed if your project falls in one of the categories of research eligible for exemption. The categories are listed in the form and on our website. If you are unsure whether your research is eligible, contact the IRB staff.

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

Complete this form if your research is funded by a component of the Department of Defense (DOD), such as the Army Research Office and/or if your research involves cooperation, collaboration, or agreement with DOD, uses DOD properties or facilities, or the subject population intentionally includes DOD personnel, including bio-specimens. Append this form to your protocol.

Independent Scientific Review Checklist for Studies funded by the DOD

Complete this form if your research is funded by a component of the Department of Defense (DOD), such as the Army Research Office and/or if your research involves cooperation, collaboration, or agreement with DOD, uses DOD properties or facilities, or the subject population intentionally includes DOD personnel, including bio-specimens. Append this form to your protocol.

Research Involving Prisoners as Subjects

All researchers who intend to include prisoners as a subject population must complete this form and append it to their protocol. This form must also be completed if a currently enrolled subject becomes a prisoner.

Request to Use Deception in Undergraduate Research

This form should be appended to your Undergraduate Student Request for Protocol Approval, if your research involves deception.

Effective October 2020, all consent processes should include the Protocol ID. Including the Protocol ID in each consent process will help participants identify the study in case they need to contact the research team or IRB. Adding the Protocol ID# to your consents does not require an amendment.

Request to Amend an Approved Protocol

Use this form to request changes to any approved protocol (exempt, expedited, or full). These changes should be done using Track Changes to distinguish them from the parts that have already been approved. You may need to include the Additional Personnel Form if you are adding new researchers to the protocol. (Removing staff can be done via email.)

Additional Personnel Form

Use this form if you are adding new personnel to an approved protocol. If there are additional changes, you will also need to complete the Request to Amend an Approved Protocol. (Removing staff can be done via email.)

Effective October 2020, all consent processes should include the Protocol ID. Including the Protocol ID in each consent process will help participants identify the study in case they need to contact the research team or IRB. Adding the Protocol ID# to your consents does not require an amendment.

Our Check-in forms have been updated to reflect our new Continuing Review and Post-approval Monitoring procedures, implemented April 2020.

Periodic Check-in Form

Use this form to check-in with the IRB before your nonexempt protocol's check-in date.

Request to Re-open a Closed Protocol

Use this form to re-open a closed protocol.