Who is Responsible for the RAC Submission?
See the RAC Submission Flowchart for an overview of the submission process. • For UCI investigator initiated studies (i.e., the production of vectors for human application is performed by the UCI investigator), the UCI investigator is responsible for the submission of the relevant information on the proposed human gene transfer experiments to NIH Office of Biotechnology Activities (OBA) in accordance with Appendix M of the NIH Guidelines. • For Sponsor initiated studies (i.e., the production of vectors for human application is not performed by the UCI investigator) the Sponsor must complete the RAC submission process and provide the UCI investigator with the required Appendix M information for the IBC review.
