When does work with recombinant DNA or other biological materials require approval?
All research involving recombinant DNA (including transgenic animals and gene transfer) must be reviewed by the Institutional Biosafety Committee (IBC) prior to its initiation. Forms to be filed for reporting such research to the Committee can be obtained from the Grants & Contracts Division of Research and Sponsored Programs. In addition, certain specific categories of research, designated by the National Institutes of Health (NIH), Office of Biotechnology Activities (OBA), require prior notification and/or prior approval by the NIH before initiation. Reporting such research to other Federal agencies (e.g., FDA, CDC) may be required in special circumstances. Faculty initiating research involving development of transgenic animals or gene transfer should consult with the Biological Safety Officer (BSO), who can be reached through Environmental Health and Safety, for advice on reporting/approval requirements in specific cases.
Related Questions
- What assurance to the investigator and their subjects is there that NIDA will handle the clinical data and biological materials (DNA) as indicated in the data-sharing plan?
- What types of training do I need for biological, chemical and recombinant DNA protocols?
- When does work with recombinant DNA or other biological materials require approval?
