Guidance on Making Editorial Changes to Recruitment Materials

Version: October 2019

The purpose of this guidance is to assist study teams in determining whether or not a change of protocol is necessary in order to update recruitment materials. Note that this guidance only refers to already approved recruitment materials, not recruitment or other study methods. As part of its review process, the IRB is responsible for evaluating whether recruitment materials will affect the equitable selection of participants, and ensuring that the proposed methods adequately protect the rights and welfare of participants, as outlined in the Recruitment of Research Participants Guidance. This includes review and approval of all subject-facing letters, flyers, posted advertisements (including social media posts), and brochures.

Approved materials are routinely revised and updated for a number of reasons. To reduce the administrative burden for both study teams and the IRB office, some limited editorial changes can be made without prior IRB approval. If a study team is not clear as to whether the change falls into one of these categories, the IRB office should be consulted.

Editorial updates to approved recruitment materials do not require submission of a change of protocol if the change is limited to the following:

Changes to approved recruitment materials that do require submission of a change of protocol prior to use. The following list provides examples, but is not inclusive: