What is the process when working with biological materials/organisms?

  1. Who do I contact?
  2. What approvals do I need prior to working with biological materials/organisms?
  3. How do I get started if my research does require approval? What are the recommended steps?
  4. What are training obligations? Are educational resources available?
  5. Will I be monitored after my approval?
  6. Relevant policies, procedures, link, etc.

1. Who do I contact?
The Research Safety Program in the Environmental Health & Safety Office (EHSO) is responsible for administration of programs in the research and non-research community regarding management of biological or infectious agents and biohazardous materials.  Program areas include biological toxins, recombinant DNA, infectious agents or human cells, tissues, etc. 

 
EHSO Main Phone: 404-727-5922
Biosafety Officers
Kalpana Rengarajan
Associate Director of EHSO
 Research Safety
 404-727-8863
 krengar@emory.edu 
 
Esmeralda Meyer
Assistant Director of EHSO
 Research Safety
 404-727-8083
 evargas@emory.edu

2. What approvals do I need prior to working with biological materials/organisms?
a.     Recombinant DNA, Stem Cell, Select Agent and Toxin Research, Additional Approvals

Recombinant DNA (rDNA) Research 
Authorization:  As required by the NIH Guidelines, all rDNA research covered under the Guidelines must be approved by the Institutional Biosafety Committee (IBC).  To start the review/approval process, submit an rDNA Registration Document, available through the Biosafety Protocol Submission and Approval (BIORAFT) process.
Expiration: Registration Documents are valid for three years from the date of IBC approval; a full application must be submitted prior to the expiration date in order to continue the research.
Modification:  Any modification you wish to make to your research must be approved by the IBC Chair as an amendment to your Registration Document prior to implementation.  Contact Biological Safety staff for guidance.  
 
Stem Cell Research 
·        Authorization:  If your research protocol involves the derivation and use of human embryonic stem cells, you must complete a Protocol Application for review and approval by the Embryonic Stem Cell Research Oversight (ESCRO) Committee.  To apply for review, complete the ESCRO Application Form and submit via email to phaugaa@emory.edu. 
·        Expiration: Approval is granted for the length of the award period; a full application must be submitted prior to the expiration date in order to continue the research.
·        Modification:  Any modification you wish to make to your research must be approved by the ESCRO Committee.   
 
Select Agent and Toxin Research
Authorization:  You must have prior Center for Disease Control (CDC) approval to access select agents and toxins (non-exempt quantities), and the Biosafety Officer can provide guidance in obtaining this approval.  If you will be using the Biological Safety Level III Laboratories (BSL3), your protocol will need to be reviewed and approved using the  Biosafety Protocol Submission and Approval (BIORAFT) process.
·        Expiration: For work that is performed inBSL3 facilities, standard operating procedures are reviewed annually and amended procedures must be submitted to the Biosafety Officer prior to the expiration date in order to continue the research. Refer to the BSL3 Manual for further information.
·        Modification:  Any modification you wish to make to your research must be approved by the CDC and the as an amendment to your research proposal prior to implementation.  Contact the Biosafety Officer for guidance.
Additional approvals:
 Additional approvals will depend upon your use of biological materials/organisms with animals, radioisotopes, and/or human subjects.  Use of the BSL3 facilities will also require additional approvals. Please view the BSL3 webpage for related documents.