Guidance on Making Editorial Changes to Subject-Facing Study Materials
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 contact point person, as long as all listed contacts are current study team members.
- Changes to contact phone number, as long as the new/updated phone number is an internal UW number.
- Changes to contact email address as long as the use of email was previously approved AND the new email is a university-approved email account [NOTE: Only secure, university-issued or approved email accounts should be used, such as @wisc.edu, @medicine.wisc.edu or @uwhealth.org accounts. Personal email accounts, such as @gmail.com, may not be used. Use encrypted email if possible. Use of Email for Research Purposes Guidance].
- Correction of typographical or spacing errors (e.g. correction of misspelled words, removal of blank spaces, reorienting the layout).
- Changes in graphics, unrelated to subject remuneration
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:
- Changes to study materials’ text or images about subject remuneration
- Changes to the description or presentation of study activities.
- Changes to the estimated length of visits or study participation.
- Changes to content, such as adding or removing questions from a survey.
- Any change to consent documents or to the protocol.