Initial Instructions for MUSC IBC Applications Involving Human Gene Transfer Studies
All human gene transfer clinical trials occurring at or sponsored by institutions receiving NIH funds for recombinant DNA research must be submitted to the NIH Office of Biotechnology Activities (OBA) for review by the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC). NExTRAC review occurs before final IBC approval in order to inform that committee of the NExTRAC's recommendations before the IBC makes its final determination.
If MUSC is initiating a gene transfer trial, information can be found about protocol submission deadlines for the quarterly NExTRAC meetings on the OBA website. Please familiarize yourself with Appendix M of the NIH Guidelines, which RAC uses to evaluate the appropriate biosafety practices and containment measures in a gene transfer study. Appendix M through Appendix M-I-B in particular is applicable at this stage of the process.
If MUSC is added as a site in a multi-center trial and MUSC is not the lead-site, then most likely the lead-site or the sponsor will submit a package to the RAC for review. The investigator at MUSC should request from the lead-site or sponsor copies of most of the documents listed below.
OBA has developed many tools to help you in your preparation of a submission to RAC, including a list of frequently asked questions on their website.
The investigator at MUSC should submit an IBC application through eProtocol. At minimum the uploads listed below need to be attached. It may not be possible to provide all uploads with the initial application, but if they are not available, they should be provided as soon as possible so as not to delay IBC processing.
- A document that contains responses to Appendices M-II through M-V of the NIH Guidelines as submitted to the NIH OBA Recombinant DNA Advisory Committee (RAC)
- Any correspondence sent by RAC to the submitting investigator regarding its review of the protocol
- Any correspondence sent by the submitting investigator to RAC in response to its review of the protocol
- The Clinical Trial Protocol
- The Investigators' Brochure for the clinical trial
- Informed Consent document submitted to the MUSC
- IRBSafety protocol covering the work described in the MUSC IBC application and specific to MUSC. (Template [Doc])
- Biosafety training materials to be used with personnel at MUSC who may be exposed to the IBC registered agents
- Documentation from the Investigational Drug Services (IDS) Pharmacy regarding its role in handling the IBC registered agents
- "Cards" to be given to study participants and/or their caregivers with information relative to aftercare such as disposal of bandages or information for health care workers that the study participant may see
- If MUSC is not the lead-site, a document detailing the delegation (if any) of reporting responsibilities as described in section M of the NIH Guidelines. (Template [DOC])
- Other information requested in the IBC application form.
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. See Resources for links.
Furthermore, the Biosafety Officer should be contacted (firstname.lastname@example.org, 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 accessed here.
Reporting Requirements for MUSC IBC Applications Involving Human Gene Transfer Studies
For details, please read Section 8.5 of the IBC Policies and Procedures.