Amending an Approved Protocol

General Policy

Before changes are implemented to an approved protocol, a Request to Amend an Approved Protocol should be submitted and approved by the Campus IRB.

This policy is applicable to all approved protocols, including Screenings for Exemption.

Personnel Changes

To add new research team members to an approved protocol, submit an Additional Personnel Request form. New research team members should have completed the required IRB training, and cannot begin research activities until the Additional Personnel Request form has been approved.

New members of the research team who may interact with minors must be listed on the protocol. These new members must also complete the Youth in Duke Programs training. For more information, visit the Youth in Duke Programs website.

Additional Personnel Request forms can be submitted alongside a Request to Amend an Approved Protocol if there are other changes.

Removing members from a research team does not necessitate an amendment and can be done via email.

Annotating Changes

Amendment requests must include the revised protocol with the proposed changes annotated using Track Changes.

Submitting an amendment request without the revised protocol or the use of Track Changes will delay the pre-review of the amendment and may necessitate a resubmission of the amendment.

Adding or Revising

Amendments to a protocol could include making additions or revisions to the research design, instruments/measures, subject population, compensation, and confidentiality.

When informing the IRB of new federal funding, please append the grant proposal to the amendment request.

Deleting and Removing

Amendments proposing the deletion or removal of already-approved components to a protocol is not allowed. It is especially important to keep content under which data were collected, even if those materials may no longer be in use.

Instead of deleting or removing these components, the Campus IRB asks that researchers add simple annotations within the protocol to indicate which activities have been discontinued or are no longer in use. Sometimes it is helpful to include a date for reference. For any materials in the Appendices that will undergo substantive or meaningful updates, leave the currently approved materials “as is” and include new, track changed versions as separate appendix items. Appendix items that are no longer in use should be noted with an end date rather than deleted.

New Elements of Informed Consent

Consent forms that were approved prior to January 21, 2019 must be revised to include the new required elements of informed consent. Updated consent forms can be submitted at the time researchers request other changes.

Amendments vs. New Protocols

The amendment process can be used for adding studies in a highly related series. New studies must be described in full. Amendments can also be used if researchers are proposing to include new data sets not already listed in the approved protocol. Any documents and agreements associated with the new data set must be included in the amendment request.

Studies posing new research questions should be submitted as new protocols.

Amending Screenings for Exemption

While uncommon, it is possible that requested changes to a Screening for Exemption may not be meet one of the eligible categories for exemption. IRB staff will contact researchers to inform them if the proposed changes need to be submitted as a new protocol. In rare cases, IRB staff may recommend the research study be submitted on a Request for Protocol Approval.