FAQ - Changing an Exisiting Protocol/Study
How to submit a change in protocol to the IRB.
Provide a written request for IRB review. Clearly describe the requested change in a cover letter (with the original signature of the PI) and indicate what prompted the request (i.e. sponsor-requested changes, PI assessment of need, etc.). Describe how the change affects the overall risk to subjects and whether the change necessitates revision of the consent documents. Instead of a cover letter, researchers also have the option of using the Change in Protocol Form signed by the PI.
Provide 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 highlighted. If the change involves a request for additional subjects, indicate the number of additional subjects for which approval is requested.
How to change the principal investigator or co-investigator of a study.
Provide a written request using the Add/Change/Remove Study Personnel Form (with the original signature of the existing PI AND the new PI/Co-Investigator). Include contact address and telephone/fax numbers when requesting to have personnel added.
How will changes in protocol be reviewed.
A change in protocol 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.
How to change/add titles of research protocols already approved by the IRB.
Provide a written request (with the PI’s original signature) for IRB review. Indicate whether the existing title is to be changed or whether another title is to be added to the existing title and provide the rationale for doing so (i.e. new funding source, PI assessment, etc.).
Be aware that the addition or change of a title does NOT reflect IRB approval for any changes to the protocol or additional subjects—such changes to the protocol must be submitted for review.
If the request is due to an additional funding source, provide a copy of the grant application (in its entirety) that reflects that funding AND assure the IRB in the cover letter that the research described in the attached grant application is THE SAME RESEARCH as that already approved by the IRB.
How to reactiviate a study which has been filed "Inactive".
Provide a written request for reactivation of approval (with the original signature of the PI) and indicate the reason for requesting reactivation. Be aware that upon review, the IRB may also request an updated IRB application (with all updated original signatures) along with consent/assent forms.
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