The Role of the Institutional Biosafety Committee (IBC)
The ClinicalTrials.gov website lists over 3,000 active and recruiting clinical research studies involving COVID-19 or SARS-CoV-2. The National Institutes of Health (NIH) have updated their guidelines for handling and processing specimens associated with coronavirus disease. The Centers for Disease Control and Prevention also updated their guidance. Likewise, research sites and laboratories have updated their policies and procedures.
Most researchers understand the requirement of having a research protocol reviewed by an institutional review board (IRB) to protect the interests of study subjects. Some may be less familiar with an institutional biosafety committee (IBC) and its role in ensuring a safe work environment.
Areas of IBC Oversight
As a condition for NIH funding of recombinant or synthetic nucleic acid molecule research, institutions shall ensure that such research conducted at or sponsored by the institution, irrespective of the source of funding, shall comply with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) including Institutional Biosafety Committee (IBC) review and approval. Organizations and individuals not covered by the NIH Guidelines are encouraged to voluntarily comply with the NIH Guidelines.
An IBC reviews, approves, and oversees research involving the use of recombinant nucleic acid molecules, synthetic nucleic acid molecules including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, and cells, organisms, and viruses containing such molecules. The committee approves procedures for procurement, use, storage, transportation, and disposal of biohazardous material. IBCs may stipulate additional biosafety precautions based on their risk assessment of the specific modifications to and manipulations of the material.
Institutions may, at their discretion, assign additional overview responsibilities to the IBC, including areas of research that include:
- Blood borne pathogens
- Xenotransplantation
- Stem cell research
- Nanotechnology
Composition and Expertise of IBCs
Like IRBs, there are some requirements for the composition of an IBC. There should be at least five members, with collective expertise in recombinant and synthetic nucleic acid. They should also be versed in biohazard risk assessment, including risk to the environment and public health. Finally, they should understand the institution’s own policies, as well as laws governing the use and disposal of biohazard materials.
Depending on the type of research and the agents being used, members may also require expertise in plant and animal biohazards. At least two members of the IBC should not be affiliated with the institution.
Some institutions also appoint or employ a biosafety officer (BSO), depending on the scale of research and the risk level of the laboratory. This person provides expert technical consultation and is responsible for developing, implementing, coordinating, and maintaining a comprehensive biosafety, biocontainment, and biosecurity management program at an institution.
A BSO’s duties include:
- Periodic inspection of labs
- Reporting to the IBC and institution of any problems, violations, research-related accidents or illnesses
- Developing emergency plans for handling accidental spills and personnel contamination
- Advice on lab security
- Technical advice to principal investigators (PI) and the IBC on research safety procedures
IBC Activities
Members of an IBC review research protocols and ensure conformity with NIH guidelines. They also evaluate potential risk to personnel, the environment and public health.
A full risk assessment includes the evaluation of:
- Adequacy of facilities
- Standard operating procedures (SOPs) and containment policies
- PI and lab personnel training
IRB’s will often make their approval conditional on the researcher obtaining IBC approval. IBC’s have the authority to lower the containment levels for certain experiments, as well as set the containment levels in compliance with regulations. The IBC can also require organization/researchers to adopt emergency plans covering accidents or personnel exposure or contamination.
Finally, it is the duty of the IBC to report any significant problems with or violations of the NIH Guidelines and any significant research-related accidents, or illnesses to the appropriate institutional official and NIH and/or Office of Science Policy within 30 days, unless the IBC determines that a report has already been filed by the PI.
Remote IBC Meetings
The NIH indicates that convening the IBC by teleconference or videoconference is permissible as these modes enable a live meeting to be conducted, thereby fulfilling the expectations of the NIH Guidelines. IBC requirements, such as a quorum present for the conduct of official IBC business and documentation of the meeting (e.g., meeting minutes), still apply regardless of the mode of convening.
Compliance Requirements
An institution must register its IBC with the NIH, which provides an online registration system. Registration includes listing the names of the members and their relevant expertise and qualifications for serving on an IBC.
The role of the IBC is essential in research that involves human gene transfer or use of recombinant or synthetic nucleic acid molecules. It not only ensures compliance with federal, state, and local guidelines, but it is tasked with protecting the safety and well-being of research personnel, patients, and the community.
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