Urgent Amendment Procedures
Urgency is based solely on urgent health needs of one or more subjects.
Sometimes situations arise which, while they do not meet the magnitude to constitute "an apparent immediate hazard," they do require changing the research in some way on an urgent basis. The most common example occurs when a patient does not meet all the eligiblity criteria for entry into a study and the patient would need to be enrolled on the study prior to the usual time amendment approvals take to receive IRB review and approval (on average, 3-4 weeks). Follow the steps below to request an urgent amendment review.
If the change is a one-time-only exception:
- Submit the request for IRB approval using the ORIO Protocol Deviation form.
- State in the submission that this is a request for "Approval prior to changing the research."
- Note any urgency involved in the request in correspondence and free text fields (e.g. the subject/patient is scheduled for a clinic exam next week) and call the IRB regulatory staff.
*OR*
- If there is insufficient time for the ORIO report, click here for an Urgent Request Expedited Review form that must be sent by fax or email to the IRB chair on call (IRBMED only) and approved prior to making the change or enrolling a subject who does not meet the eligibility criteria.
- This amendment can only be expedited if the change constitutes a minor change to the previously approved research.
- This amendment form cannot be used to make changes not directly related to the subject (e.g. it cannot be used to change members of the study team).
- This amendment must be followed up with an ORIO report. Include a copy of the completed Urgent Amendment form into the ORIO submission.
If the change is a permanent change to the protocol:
- Submit an amendment.
- Note any urgency involved in the request in correspondence and free text fields (e.g. the subject/patient is scheduled for a clinic exam next week) and call the IRB regulatory staff.
*OR*
- If there is insufficient time to complete the amendment application or another amendment is already in process, click here for an Urgent Request Expedited Review form that must be sent by fax or email to the IRB chair on call (IRBMED only) and approved prior to making the change or enrolling a subject who does not meet the eligibility criteria.
- This amendment must be followed up with a full amendment application. Upload a copy of the completed Urgent Amendment form into section 44 of the eResearch amendment application or submit a copy with the Legacy amendment application..
Examples:
-
Request to enroll a subject that does not meet currently approved eligibility criteria such as:
- Lab values are other than stated in the protocol
- Age of subject
- Disease stage
- Subjects previous treatment is other than described in the protocol
- Change dosage
- Extend administration of an agent (drug, device, or biologic)
- Delete or add a procedure or test
- The protocol indicates that a nurse will conduct in-take interviews and review the consent document with subjects. The nurse retires so the study coordinator does the procedure instead.
6/1/09, Updated 4/16/12
