Office of the Vice Provost for

       Research and Sponsored Programs

The ETSU Biosafety Committee is a University-wide committee responsible for developing institutional biosafety policies and for reviewing and approving research that uses biohazards and recombinant DNA. Biohazards are biological agents and materials which are potentially hazardous to humans, animals and/or plants including infectious agents, select agents and toxins. Examples include but are not limited to: certain bacteria, fungi, viruses, parasites, recombinant products, allergens, cultured human or animal cells and the potentially infectious agents these cells may contain, viroids, prions and other infectious agents as outlined in laws, regulations, or guidelines. 

Any research or testing activity that involves the use of biohazards or recombinant DNA requires review by the ETSU Biosafety Committee before a biohazardous material is acquired and before the study begins.

In order to obtain approval for your study:

1. Download and complete the relevant application form for use of recombinant DNA or pathogen, select agents, human cells/tissues. The form must be typed, and it is available below for you to download and complete electronically. 
    

   Registration Form for Pathogen, Select Agents and Human Cells/Tissues Form
   Registration for Recombinant DNA Experiments Form

    

2. Carefully read all instructions in the application materials. Important and helpful information for completing the form is contained in the application.

3. The Vice Provost for Research and Sponsored Programs is responsible for administering the Biosafety Committee and overseeing biosafety compliance at ETSU.  The principal investigator is directly responsible for adherence to biosafety regulations in his/her laboratory or classroom. 

4. Once you have completed the application you may mail the paper application to the Office of Research and Sponsored Programs Administration (ORSPA) or submit it via email to research@etsu.edu as an attachment (Word document file). Print out and submit the signature page with the original signature of the PI.

5. If you are using human source material (human blood, blood products, body fluids, organs, tissues, or cell lines of human origin) you need to consult the Blood borne Pathogen Control Plan and schedule training through the Health and Safety office. 

6. If your protocol involves the use of human subjects, you are required to submit a "Request for Review of Project Involving Human Subjects or Human Specimens" form to the Institutional Review Board and to complete a mandatory on-line training course and exam.

7. If your protocol involves the use of animals, you are required to submit an "Animal Study Protocol" form to the University Committee on Animal Care and to complete a mandatory on-line training course and exam and tour of the animal facilities.

8. Investigators should consult the ETSU Chemical Hygiene Plan for handling procedures when using potentially hazardous chemicals.

9. The review process takes on average 1-3 weeks. The application is forwarded from the ORSPA to the relevant Biosafety Subcomittee for their review and approval. If there are questions or concerns with the application form, the PI will receive feedback from the Committee directly.

10. For additional information or to track the status of your request, please contact Chris Skalko at 439-6000.

ETSU Office of Research and Sponsored Programs

Ada Earnest House · P.O. Box 70565 · Johnson City, TN 37614

(423)439-6000 phone · (423)439-6050 fax

research@etsu.edu

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