Guidance on Making Editorial Changes to Subject-Facing Study Materials

Version: 1/31/20

The purpose of this guidance is to assist study teams in determining whether or not a change of protocol is necessary in order to make editorial updates to subject-facing study materials. 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, please consult the IRB office. Changes to consent forms and protocols, however minor, must still be submitted to the IRB.

Note that this guidance only refers to changes to approved study materials, it does not refer to the creation of new materials or changes study methods. As part of its review process, the IRB is responsible for evaluating whether subject-facing study materials accurately convey the details of study participation, and in terms of recruitment materials, whether they affect the equitable selection of participants, and ensure the adequate protection of the rights and welfare of participants, as outlined in the Recruitment of Research Participants Guidance. This requires IRB review and approval of all subject-facing letters, flyers, posted advertisements (including social media posts), brochures, surveys, interviews, and questionnaires. See Guidance Regarding Types of Supporting Materials that Require IRB Review and Approval for guidance on the types of study materials that require IRB review and approval.

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

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