Brian Ranger, biosafety officer at the University of Tennessee, Knoxville, spent nearly a decade as a researcher. As such, he understands the difficulties that researchers often face as they manage administrative and academic concerns.
“I am very aware of the many pressures that researchers experience. Experimentation, grant deadlines, paper submissions, graduate student mentoring, teaching appointments and departmental service leave very little time to address administrative obligations.”
Considering these competing priorities, the Biosafety Office strives to reduce administrative burden, streamline compliance operations, and support faculty, staff and students as they conduct their research.
Regulatory standards, federal funding mandates and contractual agreements are often accompanied by compulsory paperwork. For example, because UT is an NIH-funded institution, researchers working with certain types of recombinant or synthetic nucleic acids must obtain institutional and sometimes federal approvals. This requires submission of a registration document to the Institutional Biosafety Committee (IBC) and ongoing review of approved protocols. Institutional policy includes other biological hazards in this process as well. However, the Biosafety Program can reduce, or even eliminate, administrative burden by:
- Developing a comprehensive registration form inclusive of all categories of biological hazards. This interactive form only requires information specific to the biological hazards used by the researcher/laboratory, and only one form is required per principal investigator or research scope. The forms are submitted and routed electronically. (Forms page)
- Note: the registration process will soon be moved to the iMedRIS data management system. The Biosafety Program has worked with system developers to ensure that the submission form and interactive format are conserved to the extent possible.
- Granting approvals for three-year terms. Interim updates are conducted annually using an abbreviated form, but most annual updates do not require full IBC review and are approved administratively.
- Excluding low-risk materials such as Risk Group 1 microbial agents and/or recombinant or synthetic nucleic acids specifically exempted by the NIH Guidelines from IBC review.
- Administratively approving some categories of biological hazards (e.g. human-derived materials) and/or amendments that do not alter the risk assessment.
In some cases, there is little recourse in paring down bureaucracy (e.g. applying for federal transit and use permits). Even so, in these cases, the Biosafety Program facilitates the process(es) by interpreting the requirements and providing investigators with the appropriate forms, completion instructions and other pertinent information.
The Biosafety Program also aims to streamline operations by reducing or eliminating redundancies, unnecessary document routing, and other inefficiencies. Some examples include:
- Incorporating a laboratory safety/compliance self-assessment into the IBC annual update, reducing the in-person laboratory site visits (inspections) to one per year.
- Conducting safety/hazard assessments for the Institutional Animal Care & Use Committee (IACUC) on behalf of UT safety programs. This allows for hazard-specific safety reviews and approvals to be conducted only as applicable and parallel to the IACUC process, thus minimizing approval time.
- Screening material transfer agreements (MTAs) for hazardous agents on behalf of UT safety programs so that routing to each safety office for approval is unnecessary.
- Reviewing proposals and confirming IBC/biosafety approvals in Evisions. If additional approvals are necessary, starting the process at the proposal stage reduces post-award lag time.
- Communicating Biosafety Program requirements to incoming researchers prior to their arrival so that they can begin their research endeavors as quickly as possible.
- Providing easy-to-access electronic training, including initial biosafety and bloodborne pathogens training, biological hazards shipping training, regulated medical waste packaging and annual refresher courses.
Finally, the Biosafety Program provides ongoing support to research faculty and staff by:
- Maintaining electronic records of IBC approvals, federal permits, training dates or other relevant information. Currently, records are made available to researchers through the SharePoint platform
- Note: Many of these records will be migrated to iMedRIS once the implementation process is complete.
- Communicating regulatory updates, programmatic announcements and other pertinent safety and compliance information through a Biosafety Program listserv. To join the Biosafety listserv, please contact us at email@example.com.
- Consulting with research faculty and staff on new or upcoming projects to determine relative risk and appropriate mitigation strategies.
- Conducting accident or exposure investigations and recommending corrective actions.
- Assisting with the packaging and shipment of biological hazards upon request.
The Biosafety Program welcomes suggestions for improving operations or service. Please send your recommendations to firstname.lastname@example.org or call 865-974-5547 and speak to a member of our staff.