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.
