For research involving administration (directly or indirectly) of recombinant and synthetic nucleic acid molecules, microorganisms and biological toxins into human research participants, no such experiment shall be initiated until IBC approval has been obtained and all applicable regulatory authorization(s) and approvals have been obtained.
Besides the items requested to be submitted as described in the eProtocol forms, the following additional items need to be uploaded in eProtocol for review:
- The Clinical Trial Protocol
- The Investigators' Brochure
- Informed Consent document submitted to the MUSC IRB (optional)
In addition, please note that some uploads, in particular the safety protocol, will most likely undergo multiple revisions so that during the course of processing uploads will need to be replaced with the most current versions. Each version should be dated and numbered. It is most useful if changes in versions are indicated e.g. by highlighting them.
When preparing materials, applicable Medical Center, Pharmacy, and Infection Control Policies should be referred to. HRPP 4.11, Human Gene Transfer Studies Policy and Procedures, in the MUSC's IRB HRPP Program Guide should be consulted also.
Furthermore, the Biosafety Officer should be contacted at email@example.com or 843-792-3125 as soon as possible for assistance with preparation of the safety protocol and the facilities inspection. The inspection which must be conducted of all areas in which the agents being registered are received, stored, processed, and administered and those in which the study participants will be until the time of discharge. Initial instructions on preparation of a safety protocol and the facilities inspection may be found on the Horseshoe (login required).