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Amending an Approved Protocol

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Proposed changes to approved protocols need prior written approval from the IRB. Requests to amend protocols will be given high priority.

Form: Request to Amend an Approved Protocol

Timing the Request to Amend

Submit prior to implementing changes.

Process

IRB staff will pre-review the request, provide feedback if needed, and make a determination about what type of review, expedited or full, is required.

Expedited or Full Review?

If a proposed change is minor, the review may be expedited. If the change is major, the type of review required will depend upon whether the proposed change increases the level of risk.

Anticipated approval time

Requests to amend protocols are given the highest priority.

International Research

Researchers conducting research abroad may be permitted to submit requests to amend protocols via email or fax.

If research will be conducted in a remote area and it will be difficult to communicate with the IRB, please consult with the IRB staff prior to your departure, to discuss strategies for handling amendments.

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