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Submitting a Biosafety Protocol

Investigators who conduct research involving potential biological risks to University faculty, staff, or students are required to submit biosafety protocols to the UBSC. Once a protocol has been submitted to the committee, it is pre-reviewed by select members of the committee. Reviewer comments and requests for revision are returned to the investigator with sufficient time to complete the revisions and submit a revised protocol for review at the next UBSC meeting. Once a project has been approved, an approval letter is prepared and sent to the investigator. The approval letter will include the approval date, the protocol expiration date, the project title, and the UBSC protocol number.

Use the following guide to choose the proper forms for completing and submitting your biosafety protocol:

  • Complete the General Biohazard Form (Form A) for all biosafety protocols to be submitted to the UBSC. If your research includes the use of pathogenic organisms or human/primate samples but does not involve recombinant DNA (rDNA), hazardous chemicals, or animals, then this is the only form required to submit your protocol for approval.
  • If your research involves the use or generation of rDNA, you also need to complete the Recombinant DNA Registration Addendum (Form B).
  • If your research involves the use of chemical carcinogens or cytotoxic agents, you also need to complete the Hazardous Substance Addendum (Form C).
  • If your research involves the use of biohazardous agents in animals, you also need to complete the Animal Use Addendum (Form D).

Biosafety protocols are reviewed at the monthly UBSC meeting. Completed protocols must be submitted in advance of the monthly meeting with sufficient time for pre-review and revision prior to the meeting. For specific deadline and meeting dates, go to the Meeting Deadlines and Calendar page.

If you need to make changes to an approved and active biosafety protocol, fill out a Protocol Amendment Form (Form E) for UBSC review. This form can be used to (i) provide information on new personnel to be added to the protocol, (ii) indicate personnel who are no longer involved in the project, (iii) indicate a

change to the project that deviates from the approved protocol, or (iv) record a change in the location of laboratory facilities. This form can be filed with the UBSC at any time.

The UBSC approves biosafety protocols for a period of three years. At the end of years 1 and 2 of an active protocol, you will be asked to submit a Periodic Review form, which will be reviewed and approved by the UBSC. Annual reviews are required to maintain an active protocol.

If you are performing low-risk research that involves the collection of human cells, tissues, or fluids, you will be asked by the Drexel University Institutional Review Board (IRB) to submit a Human Specimens Registration Form (Form F). This form and more information about human tissue and specimen procurement (policy document) are available on the Drexel IRB website.