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The purpose of the biological registration module in BioRAFT is to catalogue and summarize the types of work conducted across the varying disciplines of biological research at the University of Miami. The directive for rolling out the new biological registration program was initiated by University leadership and is a joint effort between the Biosafety Office and the Institutional Biosafety Committee (IBC).
The biological registration process is backed by the IBC and supported by University leadership. While unlikely, all biological registration submissions are subject to IBC review as needed.
While the upfront time investment for submitting a registration is not insignificant, it will save time in future IBC submissions as all work in BioRAFT will remain saved for future modifying and resubmissions. Further, it will help the Biosafety Office in a variety of efforts, including: tracking regulated materials, observing institutional obligations to OSHA compliance, adhering to federal guidelines, ensuring researchers are trained and enrolled in the occupational health program, providing more comprehensive safety consultations, and so much more.
Work involving biological organisms in the field should be included and summarized in an umbrella project for the lab.
Clinical work may or may not require abiological registration, depending on the nature of the work. Strict clinical work subject to IRB review, and hence the completion of the BARA form, does not require a biological registration. However, any sample processing or lab work associated with the project does require a biological registration. Example: Testing that can be conducted inside the clinical space, generally does not need a registration. For more guidance or questions, please reach out to biosafety@miami.edu.
At this point in time, human gene therapy research will continue using existing PDF application submissions as directed by the IBC.
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