Biological Protocol Review

There are several committees at the University of Miami that review biological research depending on the nature of the project. 

Below you will find all such relevant entities pertaining strictly to biological research.  While specific prerequisites for protocol approval may vary committee to committee, generally at a minimum approvals will require (1) All individuals listed on the application (including the PI) must be up-to-date with all required trainings and (2) A successful biosafety lab inspection completed within the past year.

Approval in these respective fields is required before research may proceed. Depending on the nature of the research, multiple committee approvals may be necessary prior to the initiation of research. For more general information or inquiries into research compliance at the University, along with a listing of additional offices, please visit the UResearch website. In some situations, a Biological Ancillary Review Assessment (BARA) form may be required for protocol approval.  For further guidance on navigating this form, please scroll to the bottom of the page.

Institutional Biosafety Committee (IBC)

The Institutional Biosafety Committee (IBC) reviews all research dealing with recombinant/synthetic nucleic acid molecules. The IBC additionally reviews all work involving SARS-CoV-2, including clinical specimens and use of recombinant/synthetic nucleic acids.

Institute Animal Care and Use Committee (IACUC)

The Institutional Animal Care & Use Committee (IACUC) review and approval is needed for animal research at the University. The campus IACUC ensures all faculty and staff conducting research with animals comply with federal and state guidelines.

Institutional Review Board (IRB)

The Institutional Review Board (IRB) reviews all human research conducted at the University of Miami (UM), Jackson Health Systems (JHS), and research conducted elsewhere under the auspices of these institutions. The IRB ensures adherence to all federal, state, local, and institutional regulations concerning the protection of human subjects in research. All human research conducted by UM faculty, staff, and students or employees of JHS must receive IRB review and approval prior to commencement. The Human Subject Research Office (HSRO) serves as the administrative arm of the University IRB.

Contact: hsro@miami.edu 

Phone : 305-243-3195

Web: hsro.uresearch.miami.edu

Institutional Review Entity (IRE)

The Institutional Review Entity (IRE) is charged with providing institutional oversight for life sciences research that may fall under the definition of Dual Use Research of Concern (DURC) as established by the US Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.

The Institutional Biosafety Committee administers the IRE as a subcommittee of the IBC. During IBC review, any research that may be considered DURC is passed to the IRE for further assessment.

Contact: IBCsupport@miami.edu

Phone: 305-243-2311

Embryonic Stem Cell Research Oversight Committee (ESCRO)

The University of Miami Embryonic Stem Cell Research Oversight Committee (ESCRO) provides ongoing oversight of research activities to ensure that faculty and staff comply with federal and state guidelines concerning the use of human embryonic stem cells (hESCs) and human somatic cell nuclear transfer (hSCNT).

Biosafety Office (BSO) Ancillary Review

The Biosafety Office provides specialized protocol review for research as needed or requested using the Biological Ancillary Review Assessment (BARA) form. This includes reviews for the IRB, for projects dealing with biohazards or collection of human materials, but may also include research falling outside the scope of the committees listed above, and research dealing with significant human pathogens or toxins. If required, labs submit the BARA form for BSO review.

Contact: BSO_Review@miami.edu

Phone: 305-243-3269


Biological Ancillary Review Assessment (BARA) Form Guidance

The BARA form is required for some IRB applications, such as IRB projects involving work with biohazards or the collection of human materials, but the form may also be required for some research projects that fall outside the scope of the committees listed above or research dealing with significant human pathogens or toxins. The form is aimed at collecting essential project information on page 1, with the following pages detailing enhanced safety considerations and SOPs in place to keep researchers safe. The different sections will be outlined below for clarification. You can reach out to the Biosafety Office at biosafety@miami.edu for further guidance, or you can reach out to us at BSO_Review@miami.edu to submit your completed BARA form for review.

Section 1 – General Protocol Information:

Section 1 should provide the essential information about your lab, including the lab location, the protocol the BARA form is in reference to, and whether the lab has biosafety cabinets for conducting the research outlined below.

Section 2 – Lab Members:

All lab members involved in the portion of the project that involves materials as marked off in section 3 must be listed here. This would naturally include anyone collecting human specimens, researchers processing samples, and lab workers preparing samples for shipment.  The first line of this section should have the projects principal investigator (PI) listed. Regardless of the role of the PI within the project, the PI is expected to complete the same trainings required for everyone else in the lab.  Anyone not involved in this work, such as regulatory analyst or coordinators, does not need to be listed here nor are they expected to complete the training requirements.

Section 3 – Pre-Screening Questions:

This section should closely match the answers used in the eProst application during the IRB submission process. These questions give the reviewer a quick snapshot of the types of risks associated with this protocol.

Section 4 – Protocol/Pathogen Overview:

The last section on page 1 outlines briefly, in layman's terms, the project overview and the aims of the research, with regards to the biohazardous portion of this project. You should specify the key hazards associated with this project with as much specificity as is available. For instance, if you are collecting human specimens list that in the first box, if it is known that those specimens are positive for HIV, that should be listed in the following box.  If your lab is only collecting specimens then turning them over to another lab for further processing, detail that and to which lab they are going for reviewer assessment.  If samples are being sent to another lab for further processing, that lab should separately submit a BARA form regarding the work conducted in their facility and sent in separately. Note that your approval will not be held up for the review of lab BARA submissions external to yours.

Section 5 – Biohazard Risk Assessment:

If the project involves risk group 2 biohazards, such as infectious materials or human specimens collected from the study, you must proceed by completing all remaining sections. Section 5 contains additional questions aimed at guiding you in the risk assessment process, answering questions that are likely to arise as a result of working with such materials.  Being able to adequately answer these questions is essential for approval. Feel free to reach out to the Biosafety Office at biosafety@miami.edu if you have questions and need further assistance.

Section 6 – Hygiene Plan Adoption:

Section 6 lists numerous Standard Operating Procedures (SOPs) as they might relate to your lab and project. Please check the box of SOPs that apply to your lab that researchers will be expected to adhere to.

Section 7 – Acknowledgement and E-Signature:

The final section requires the e-signature of the PI for the lab. This must be completed by the PI who is submitting and responsible for this project.