Safety in Science: Biological Registration

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.

This guide provides an overview and clarification of the biological registration submission process through BioRAFT. If there are any additional questions you may have, please reach out to us at

See below for in-depth, step-by-step submission guidance and to login to BioRAFT.

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BioRAFT Biological Registration Guide

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  • Work to be Included

    • The biological registration process is required for any University lab that conducts any biological research. If your work involves a laboratory space where research is conducted, specimens are processed, or samples are packed up for shipping, you must submit a registration.
    • All work with biological materials should be included in your registration.
    • If the primary focus of the lab is non-biological, only the parts of that lab that involve biological materials need to be reflected in the registration.

  • Benefits

    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.

  • Field Research

    Work involving biological organisms in the field should be included and summarized in an umbrella project for the lab.

  • Clinical Work

    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.

    For example:

    • A clinician taking human specimens that are then sent to a core lab on site for processing or shipping would not require a registration.
    • A clinician taking samples that his/her team will be manipulating in a dedicated lab facility does require a registration.


    Testing that can be conducted inside the clinical space, generally does not need a registration. For more guidance or questions, please reach out to

  • Human Gene Therapy Research

    At this point in time, human gene therapy research will continue using existing PDF application submissions as directed by the IBC.

Supplemental / Required Documentation

Biological Hygiene Plan

The biological hygiene plan must be submitted as an additional document for the lab for approval. The document should outline the potential risks of for the biological research in the lab and what steps are in place to mitigate risks.
Biological Hygiene Plan Form Download

Prerequisites for Approval

For approval on submissions, the lab must:
  • Submit their registration.
  • Included the Biological Hygiene Plan with the submission.
    • Additional documentation may be uploaded as needed.
  • Researchers must complete associated safety trainings.
    • Applicable trainings are outlined in the hygiene plan depending on the nature of the work.
  • Researchers must enroll in the Occupational Health Program.
  • Successful lab inspection within the past year.
Modifications/amendments are needed when:
  • New projects involving new types of work are introduced.
  • New biological materials are introduced.
  • New research members are added to the lab.
  • Work on a project is ending.