SCIENTIFIC REVIEW BOARD
The GTRP Scientific Review Board (SRB) is a “virtual” board comprised of approximately 40 members with expertise in various disciplines relevant to NHLBI research. The SRB functions in a capacity similar to that of other NIH peer review groups.
Members of the SRB review and assess the scientific merit of the clinical protocol and related materials submitted as part of the Request for Service Application (RSA) for clinical trial funding assistance. Review of RSAs for pharmacology/toxicology testing will be on a case-by-case basis determined by the NHLBI Gene Therapy Group. The NHLBI Gene Therapy Group assigns 3-5 SRB members to review each RSA submission. Assignment of reviewers is known only to the NHLBI Gene Therapy Group and, after completion of an RSA review, to the GTRP Steering Committee.
SRB members sign the GTRP Confidentiality and Non-Disclosure Agreement annually and a Conflict of Interest Form prior to review of each RSA. Written reviews and recommendations from the SRB are securely maintained and are considered by the GTRP Steering Committee and, subsequently, the NHLBI Gene Therapy Group prior to dispositions of the RSA. SRB reviewers may additionally provide comments and recommendations addressed to the Applicant Investigator.
TRENDING NEWS
REGULATORY UPDATES
- INTERACT Meetings (formerly pre-pre-IND meetings)
- FDA INTERACT Announcement 2018
- CBER INTERACT Meeting Process Overview (PowerPoint | Word)
- Revised NIH Guidelines (April 2019)
RESOURCE CENTER
- GTRP Request for Service Application (RSA)
- NHLBI Home
- Future Directions and Resource Needs for NHLBI Gene Therapy Research
- Funding Resources – NIH and Other Programs
- GTRP FAQs
- Regulatory Resources
- Training Resources - NIH and FDA
- Publications and Presentations by GTRP Investigators
- American Society of Gene and Cell Therapy (ASGCT) Homepage
- Archived GTRP Newsletters