Amendments

It is the responsibility of the principal investigator to ensure that the study is conducted as approved by the IRB. Any modifications to the study, including changes or additions to the Protocol, Informed Consent, Study Personnel, Advertising Materials, Investigator's Brochure, an increase in number of subjects enrolled, change in age range, change in risks from study drug or procedure, any new recruitment tool and any information provided to the research subjects must be approved by the IRB prior to implementation. Modifications are submitted as amendments.

Amendment requests and related back-up documentation must be submitted electronically using the Amendment form in IRB+.

The IRB Chair, Vice Chair or designated Board Member will review each amendment to determine whether or not Full Board approval is required. If Full Board review is required, the amendments will be included on the next meeting agenda for discussion and vote. The IRB Chair or designee may approve an Expedited Review. (Federal regulations determine which studies may be approved via an expedited process.) Expedited amendments are reported at the next IRB meeting in a summary format.