In general you must have approval before initiating activities with recombinant DNA.
See "Investigator Responsibilities" on our Policies page.
Submit a Biosafety Form to firstname.lastname@example.org.
If you have questions about how to fill out the Biosafety Form, please contact either the IBC Coordinator or the Biosafety Officer (BSO) for assistance. After you have submitted the Biosafety Form, the BSO will assist you with developing/reviewing your Biosafety manual and completing a facility review.
While many of the commercially available vectors are exempt, you must file a Biosafety Form for determination of covered or exempt status by the IBC. All covered work must be approved by the IBC.
Three years, unless indicated otherwise.
It is the Principal Investigator's responsibility to renew a protocol. This is done by sending a current Biosafety Form to email@example.com. The Office of Research Assurances (ORA) has developed a system whereby in the future every attempt will be made to send a reminder in advance of the three years expiration to investigators to assist them in managing this compliance piece.
Biological toxins are poisonous substances that can be produced by animals, plants, insects, fungi, and microorganisms. Biological toxins are not considered infectious because they do not replicate, yet they may be extremely toxic in small quantities.
Biological toxins are typically handled with biosafety level 2 practices and facilities. Safe lab practices and controls must be implemented before working with biological toxins. Standard operating procedures (SOP) must be implemented in the lab before use. Toxins must be inactivated prior to disposal.
Some biological toxins are considered Select Toxins under the Center for Disease Control and Prevention (CDC) Select Agent Program. Please contact the Biosafety Office if you plan to perform research with CDC Select Agents and Toxins as there may be additional requirements when working with these materials.
These are agents and toxins that have been determined to have dual use potential by the federal government and require registration and approval from the federal government to work with.
View a 7-minute video developed by NIH-HHS with more information about what is meant by “dual use.”
All work with Select Agents and Toxins must be submitted via a Biosafety Form to firstname.lastname@example.org.
Work that requires Federal oversight must be registered with CDC. It may take 6 months or longer to obtain this approval. Contact the Biosafety Officer for assistance with this process.
Some work with Select Agents and Toxins is excluded from federal oversight.