A PI may not implement any changes to the protocol without first receiving CPHS approval unless it was necessary in order to avert or minimize apparent immediate hazard to subject(s). In the event of any immediate necessary changes, the PI has five business days to contact CPHS via iRIS to inform them of such change.
Making your change in iRIS
- Revise the protocol or document with the exact text changes and resubmit in iRIS
- Submit the Change Request Form and describe the necessary changes and their rationale.
- Changes to the protocol may need to be reflected in revisions to the the informed consent form which should accompany the change request form.
How changes to your research are processed
- Modifications to research are reviewed by the same CPHS panel that reviewed the original protocol.
- If the research was previously deemed as exempt, the changed protocol must be approved by CPHS prior to the initiation of the research. CPHS will then decide the appropriate review (exempt, expedited, or full)
- If the research was previously sent for expedited review, the modifications will be sent to the expedited reviewer assigned to the research. The reviewer will either approve the changes or approve pending modifications. However, the reviewer may determine that the research is not eligible for expedited review, and forward for Full Board Review.
- If the Informed Consent form must be changed, the CPHS may request that the research subjects be re-consented.
As always, the investigator will be notified of the outcome of the review via iRIS.
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