Any institution that receives federal funding from the National Institutes of Health (NIH) is required to have an Institutional Biosafety Committee (IBC) to review research that involves the use of recombinant DNA (rDNA). Even if your institution doesn’t receive federal funding, you might need an IBC to meet local ordinances, depending on your location.
In addition to meeting regulatory requirements, following certain best practices will improve the knowledge base of your committee members, provide more effective institutional oversight and strengthen the biosafety culture at your institution. With this in mind, here are six recommended best practices for an effective and compliant IBC:
Review the entire range of biohazardous materials involved in a protocol
While the NIH only requires your IBC to review projects that involve rDNA, including other biohazardous materials in your review will provide a more thorough risk assessment. Since the use of rDNA is often one part of a larger project involving human-derived materials, microorganisms, biological toxins or other biohazardous materials, this is a simple adjustment to make. Plus, by taking this extra step, your IBC can help ensure compliance with other regulations, like the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard.
Create new member training and refresher programs on biosafety topics
As new members join your IBC, establishing a formal training program helps ease transitions and keeps processes running smoothly. Make sure to cover the roles and responsibilities of the IBC, as well as an overview of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. You can also include refresher training, topical information and regulatory updates as part of your regular IBC meetings.
Prepare meeting minutes with regulators and public transparency in mind
Keeping regular meeting minutes is an important step in having a fully compliant IBC. Since these minutes may be subject to the Freedom of Information Act (FOIA) or other regulations, they may be reviewed by regulators or members of the general public. Therefore, minutes should follow a consistent format that includes a clear summary of any discussions and any relevant regulatory citations. If you need to redact certain proprietary information, just make sure an outside party can still understand the minutes.
Conduct routine audits of IBC functions
Regularly reviewing your IBC is an important part of ensuring the continued improvement of your biosafety program. Auditors should review documentation and solicit feedback from committee members and researchers in order to determine where improvements could be made to committee components, such as membership, the efficiency of meetings, the accuracy of minutes, the process for conducting risk assessment and protocol reviews, and training for IBC members and research personnel. For a non-biased perspective, these audits are best conducted by an independent expert.
Track the final disposition of registered materials
Your IBC should have procedures in place to inactivate a registered protocol when work on that protocol is completed or stopped. Part of that inactivation procedure should include letting the IBC know what will happen to any leftover biohazardous research materials. The transportation and disposal of biohazardous materials are subject to various state and federal regulations. Whether registered materials are destroyed, stored or sent to a collaborating researcher, it is important to ensure that they are managed correctly.
Coordinate with other oversight committees at your institution
Your institution probably has other committees that review research protocols, such as an Institutional Animal Care and Use Committee (IACUC) or an Institutional Review Board (IRB). These other committees focus on different aspects of a protocol than your IBC, but there is still some overlap. Sharing information, membership and best practices between committees helps everyone to stay on the same page and can provide valuable insight on internal and external processes.
Every IBC is unique, but their common goal is to ensure that biological research is conducted safely and compliantly. Adopting these best practices can make your IBC stronger and more efficient, and ensure that biosafety remains a key component of the safety culture at your institution.
About The Author
Jessica M. Healey
Senior Scientist, Environmental Health & Engineering, Inc.
A senior scientist at Environmental Health & Engineering, Inc., Jessica provides essential onsite support and technical guidance for life science companies, academic institutions and hospitals in the areas of biosafety, hazardous materials management, laboratory and chemical safety, training, and regulatory compliance. This includes conducting risk assessments, reviewing and assessing project registrations for Institutional Biosafety Committees (IBC) and Institutional Animal Care and Use Committees (IACUC), serving on IBCs, and investigating and reporting safety incidents. Jessica is a Registered Biosafety Professional (RBP) and Certified Biological Safety Professional (CBSP) through the American Biological Safety Association, and a Specialist Microbiologist in Biological Safety (NRCM) through the American Society for Microbiology. Learn more: https://www.eheinc.com/