The RSA is an on-line project submission process. Investigators are strongly encouraged to contact the PCGT prior to initiating or completing an RSA. Please contact the PCGT Coordinator here for any questions or to set up a meeting with the PCGT.
Investigators must be conducting gene therapy research at an institution located in the United States to qualify to submit an RSA.
• The subject of the RSA must be consistent with the NHLBI mission or if the research addresses a disease area consistent with the mission of another NIH Institute, that Institute must agree to cover the costs of the services.
• The applicant must be working in gene therapy research in a disease area funded by the NIH and on a translational pathway.
• RSA approval and implementation will be contingent upon availability of funds.
• Services provided will be at no cost to the investigator (please note all vectors must be provided by the investigator and at the quality necessary through a proven core or resource with documentation provided). Preclinical vector requests can also be made through the NHLBI Gene Therapy Resource Program (GTRP).
2. Submission Process
• Investigators must first complete the first page of the form during the Registration process to access the secure website to submit an RSA.
• Investigators can enter information and save the RSA in stages.
• Each RSA will be assigned a unique identifier at the time the RSA is initiated. Refer to this number in all correspondence or submission of supplemental forms or materials.
• Investigators must include information on any potential conflicts of interest (COI). Review cannot be initiated if this information is not included and the investigator(s) have not confirmed any COI.
• Amendments are used when a change or addition of documents to the submitted RSA is required.
• A PCGT External Advisory Board reviews all applications and makes recommendations to the NHLBI.
• All submissions are confidential.
• Investigators will be notified of the status of their application and final recommendation by the PCGT.
Investigators must be registered prior to submitting an RSA and must be conducting research in the United States to qualify.