Research using biological agents has increased dramatically and more companies need to set up Institutional Biosafety Committees to ensure compliance in safe handling of such agents. Elizabeth Gilman Duane, Environmental Health & Engineering, outlines the key considerations when putting together an IBC
In the US, an Institutional Biosafety Committee (IBC) is required for institutions that receive federal funding from the US National Institutes of Health (NIH) and/or are subject to a local ordinance that applies to work with recombinant or synthetic nucleic acid molecules. The institution must adhere to the requirements of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
The IBC is the cornerstone of the Biosafety Management System. Each IBC is unique yet there are best practices that will help every IBC function optimally to meet better its goal of protecting workers and the community. Whether the work covered under the NIH Guidelines pertains to research, clinical or manufacturing efforts, the IBC is an important part of the overall Biosafety Programme. The following points cover some major areas that should be considered.
1. Expand the scope to address additional biohazardous materials
Expand the purview of the IBC to include additional biohazardous materials, such as human and non-human primate materials, micro-organisms and biological toxins. Many IBCs limit their scope to the review of projects involving recombinant DNA as stipulated by the NIH Guidelines.
Often work with recombinant DNA involves the use of these other biohazardous materials, so it makes sense to look at the entire range of materials involved in a protocol when performing the risk assessment and determining the containment level. This has the added benefit of facilitating compliance with additional regulations, such as the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen Standard.
2. Automate data collection, record keeping and processing
Automate data collection, record keeping and processing tasks, such as the review process and management of protocols. Institutions that utilise software see improved documentation and efficiency, more complete and accurate data, and a reduction in the number of days from the receipt of protocol requests to approval. The protocol review process can be complex, involving the collaboration of multiple personnel, and it can be error prone. Automation streamlines the review process and prevents it from stalling, improving the turnaround time. An automated process makes it easier to manage and maintain the necessary documentation for compliance.
3. Establish new member and refresher training programmes
Establish a training programme for new IBC members that covers, at a minimum, the roles and responsibilities of the IBC and an overview of the NIH Guidelines and any other applicable regulations. Periodically provide retraining for all IBC members. Include professional development opportunities for IBC members both during and outside of IBC meetings. IBC meetings can include a brief training topic (e.g. regulatory update) or a technical topic (e.g. proper disinfection methods).
Training should be documented in the meeting minutes. There are a number of professional development courses, conferences and distance learning programmes related to IBCs and biosafety. The institution should provide a budget to the IBC so that members can participate in opportunities for continuous learning.
4. Designate a scientific or administrative staff member as chair
Appoint an IBC chairperson who is not the Environmental Health and Safety (EHS) Manager or the Biosafety Officer for the institution. It is recommended that the chairperson be a scientific or administrative member. This allows for the chairperson to change periodically, based on the term limits prescribed in the charter and procedures. Additionally, it demonstrates that safety committees are not solely an EHS function.
Effective safety committees involve multiple stakeholders. In many institutions the EHS Manager or Biosafety Officer has a role in facilitating the IBC meetings, which is different from assuming the role of the chairperson. The charter should detail term limits, and the chairperson should have a finite period of time to serve, to allow other stakeholders to participate in a leadership role.
For larger IBCs, the workload for the chairperson can be significant; as such, a stipend, honorarium or other form of compensation may be warranted.
5. Develop a written charter and procedures and review annually
Develop a written charter and procedures and review it at least annually. These documents should include:
The charter and procedures should be communicated to all stakeholders in the institution.
6. Incorporate senior leadership in IBC meetings
Ensure a member of the institution’s senior leadership team attends the meetings and periodically provides an update on the scientific programmes and other relevant information that has the potential to affect operations. This illustrates senior leadership’s commitment to promoting a ‘safety culture’. IBC meeting agendas and minutes should be forwarded to senior leadership so they can fully appreciate the IBC’s effort.
7. Start IBC meetings with the Conflict of Interest policy
At the beginning of each meeting remind members of the COI policy and ask if any of the members have any conflicts to disclose. It is not uncommon for a proposed registration from an IBC member to be on the meeting agenda. This should be declared at the beginning of the meeting, and that IBC member must leave the meeting room while the final discussion and voting takes place.
8. Invite Principal Investigators to present
Invite the Principal Investigator (PI) to present an overview of the proposed project to the IBC. This is especially valuable when the proposed project involves a new scientific technique or biological materials that have not been previously used at the institution. The PI’s attendance improves communication by allowing IBC members to ask questions and receive answers directly from the PI.
Training programmes for new members and refresher training for existing members should be planned and budgeted for
9. Reach a consensus during committee votes
While the actual vote tally should be recorded, it is important to have consensus among all members. Obtaining agreement among all members is the best method to achieving IBC goals. If consensus cannot be obtained, consider the reasons that are preventing consensus and consider deferring the vote to a future meeting until more information can be obtained or issues can be resolved. If even one member has legitimate concerns about a registration involving work with biohazardous materials, that member should be given the opportunity to have their concerns addressed.
This is especially important given that NIH requires that IBCs have community representatives who are the eyes and ears of the community where the institution is based. If community representatives anticipate or have evidence of issues involving compliance, they are empowered to report to NIH or their respective public health authority if based in a location where there is local oversight.
10. Conduct facility tours as part of the Project Registration Review
Include a facility tour prior to or after an IBC meeting to facilitate review of project registrations. This provides the opportunity to see where the work will be conducted and ask questions about the biosafety programme. The Principal Investigator or supervisor for the area to be toured should be available for questions during the tour.
11. Appoint a Biosafety Officer with proper qualifications
Appoint a Biosafety Officer with biosafety competency. Per the NIH Guidelines, in cases where the institution performs BSL-3 or higher work, or conducts large scale work, a Biosafety Officer must be appointed. In cases where the work being performed is at BSL-1 or BSL-2, the institution may voluntarily appoint a Biosafety Officer.
Ideally a Biosafety Officer should have credentials such as the Registered Biosafety Professional (RBP) or Certified Biological Safety Professional (CBSP) designations through the American Biological Safety Association.
If the institution is small and does not have an EHS Department and/or Biosafety Officer, having a scientist serve as the Biosafety Officer may be the only option. In that case, a qualified consultant with proper biosafety credentials should assist the IBC and the Biosafety Officer to provide expert knowledge and direction in areas where there is a knowledge gap.
Misinterpreting a regulatory requirement, not being aware of an applicable regulation, or being unfamiliar with the appropriate biosafety procedures could be a liability to the organisation.
12. Keep regulators and Public Transparency in mind when preparing meeting minutes
Summarise IBC meeting discussions in the meeting minutes. While it is not necessary to record by name each person who participates, the major points of the discussion should be captured, along with relevant regulatory citations. A non-member, such as a regulator, should be able to review the meeting minutes and understand what was discussed and how containment levels were established.
If redaction of some aspects of the meeting minutes is required to protect proprietary information, the institution’s legal representative should participate in the development of the redacted meeting minutes; and the minutes should not be so limited as to make it difficult to ascertain the details of the review of a project.
13. Involve IBC members in review of biosafety procedures
Involve IBC members in the review of relevant biosafety procedures such as procedures for inactivation of biological materials that may allow for removal to a laboratory of a lower containment level. There may be local or state requirements such as that the IBC approve the biological waste management plan for the disposal of liquid biological waste.
Committee members may be able to provide valuable input to the development of a new protocol.
14. Obtain information on the final disposition of Registered Materials
Upon termination of IBC registrations, request that the Principal Investigator identify to the IBC the final disposition of the materials that were registered. The final disposition may include destruction via autoclaving or transfer to a collaborator.
In the case of transferring the material to an internal collaborator, the collaborator will need to register the materials with the IBC. If the material is transferred to an external collaborator, the recipient institution should provide documentation that they are equipped to safely store and work with the material.
15. Conduct regular audits of IBC functions
Periodically audit the IBC function as part of the Biosafety Management System to facilitate continuous improvement. Review aspects such as membership, meetings and minutes, how risk assessments and registration reviews are conducted, charter and procedures, and training and education of IBC members and personnel. An independent, expert review of the IBC will highlight any programme gaps as well as recommendations for best practices.
Each IBC is unique but all IBCs should strive for continuous improvement, not just when NIH or another regulator may request additional efforts. Sharing best practices and being open to adopting new practices will allow the IBC and the institution to ensure the safe and compliant use of biohazardous materials.