Journal Assignment Week 9

Request for Change in Procedures Form

Please email this change request form to [email protected].

1. Clearly describe the requested change and indicate what prompted the request (i.e. sponsor-requested changes, researcher’s assessment of need, etc.) as well as whether the change necessitates revision of the consent documents.

2. Please send [email protected] a copy of all documents revised or added as a result of the proposed change (i.e. consent/assent forms, recruitment letters or ads, revised protocols, questionnaires, etc.) with changes clearly highlighted. If the change involves a request for additional subjects, indicate the number of additional subjects for which approval is requested.

3. If your request involves a change in research staff, please provide contact information for all new personnel, as well as any relevant degrees and qualifications.

Your request to change study procedures/staff will be reviewed by the same method in which the study was first reviewed, either by the full-committee or through the expedited review process, unless the change is minor and can be managed through expedited review. The IRB staff will route changes for review through the most rapid means possible and will provide an update as to the status of this request when confirming receipt of the form.