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Guidance: When to Submit Amendments for Approved Research

Regulations and institutional policy require that non-exempt human research be conducted in accordance with the IRB-approved plan or protocol.

NOTE: The only exception to this requirement is when a change needs to be implemented to eliminate an apparent immediate hazard to a subject, in other words, to prevent injury to the subject. Such a change must be promptly reported to the IRB after it has been done, within 5 business days.

However, OIA is aware that in the course of performing human research, modifications may be needed that do not have an effect on the regulatory criteria for approval and do not affect the subjects or data integrity in any way. Such modifications are considered administrative modifications and do not need to be submitted for IRB review and approval prior to implementation.

 The below list is of examples is not exhaustive, but reflects the most common changes we see that fall into the category of “administrative changes.” 

  • Correction of typographical, formatting, or grammar errors in approved documents when such correction does not alter the meaning of the documents.
  • Changes to revise the phone number, mailing address, or email address which subjects should use if they have questions during a study.
    • NOTE: Current subjects receiving study related interactions or interventions must be provided the updated information as soon as is feasible but in no case later than their next study related interaction or intervention.
  • Changes in the name or contact information of a study monitor in a multi-site industry sponsored study.
  • Changes in shipping couriers to be used in the course of a study (e.g. FedEx vs. UPS).
  • Changes to allow remote monitoring of studies by the Sponsor (or designee) so long as the methods have been previously approved and vetted by ITS.

 When in doubt, please reach out to us at irb@ucsd.edu. We would be happy to assist you in assessing your changes so that you can be confident that you are compliant with regulatory and institutional requirements.

 NOTE: Often, sponsors of multi-site research will require that sites provide to them documentation of IRB approval of all modifications regardless of type/impact, including updated approval stamps on consent/assent documents and recruitment materials. If your sponsor requires this, it is acceptable to submit via the amendment pathway so that OIA can review and provide you with the needed documentation. Alternatively, you may direct the sponsor to this webpage so that they might consider modifying their requirements so as to reduce your administrative burden.