Submission Process

   

   

Submission and Approval

  1. The Principal Investigator should submit a completed IBC Registration Form for Recombinant DNA (rDNA) Experiments or Registration Form for Pathogen, Select Agents and Human Cells/Tissues (PSAHT) electronically to the Office of Research and Sponsored Programs via email to research@etsu.edu as an attachment (Word document file). And submit the signature page with the original signature of the PI.
     
  2. The Chair of the IBC will review the for Recombinant DNA Registration Form and request changes or additional information as necessary.  The Chair will refer all registrations the rDNA subcommittee for review and comment and refer all requests to use Pathogens, Select Agents, or Human Cells/Tissues to PSAHT subcommittee for review and comment.
     
  3. Requests to use BSL-1 organisms will be considered exempt.   All requests will be reviewed to determine if the organism meets the BSL-1 definition and whether appropriate safety measures are documented.  If the Chair determines organism meets the Exempt requirements, an approval will be granted within two (2) weeks.  All requests will be considered at the next scheduled meeting of the committee.
     
  4. The full committee will review all registrations and requests at the next regularly scheduled meeting.
     
  5. A letter will be sent to the PI outlining the outcome of the review soon after the meeting.
     
  6. If the Approval Letter includes stipulations, the PI must ensure that these requirements are addressed prior to initiating work.
     
  7. Approvals will be granted for a (3) year period for BSL-1 and BSL-2 registrations and for one year for BSL-2+ and BSL-3 and Human Gene Transfer Registrations. 

Renewal Process

  1. New Registrations must be submitted every three years for BSL-1 and BSL-2 registrations and annually for BSL-2+ and BSL-3 and Human Gene Transfer Registrations
     
  2. Three months (120 days) prior to registration expiration, an e-mail will be sent to the PI of the registration.  This will be followed by a two month (60 day) notice.
     
  3. It is the responsibility of the PI to submit a renewal registration or provide notice that the PI will discontinue registered research after the anniversary date of the approval.
     
  4. The IBC will review the Registration Renewal at the next meeting date and a letter will be sent to the PI soon after the meeting.
Annual Review Process
  1. PI's must submit an Annual Review Form, describing progress, and any proposed changes to the approved registration or request.
     
  2. Three months (120 days) prior to registration expiration, an e-mail will be sent to the PI of the registration.  This will be followed by a two month (60 day) notice.
     
  3. Failure to submit an Annual Review Form will lead to the termination of an approval
     
  4. The IBC will review the Annual Renewal at the next meeting date and a letter will be sent to the PI soon after the meeting.