All changes to previously approved protocols must be submitted to the IRB for review and approval before they are implemented (this includes changes initiated by a study sponsor). If you are unsure if the changes requires review, send us an email.
If your study has been created in PRISM, the modification must also be submitted in PRISM. If you have not created your study in PRISM this is a good time to do so.
To initiate review of a modification:
- In PRISM, submit the amendment with or without a cover memo to detail the change and rationale for the change. Provide your assessment of the effect of the study's risks and benefits and if consent form revisions are required.
- Include a revised copy of all relevant material. For example, if you are adding personnel to the study, you will need to submit a summary form.
- If you are proposing a change to the compensation structure of the study, you will need to submit a revised copy of the protocol summary form and the consent forms.
- Revised Consent Forms must comply with the revised Common Rule. Please review our guidance document and the CF Template for details regarding these regulatory requirements.
- To facilitate review, please highlight all changes. Provide an un-highlighed copy of the consent for stamping.
To request a protocol exception ( a one time change to inclusion/exclusion criteria, procedures, or any other element of the study), write to IRBMail