Institutional Biosafety Committees (IBCs)

This section answers frequently asked questions on guidelines that provide a framework for institutions, both public and private, within national biosafety systems and which are engaged, or have the intent to engage in the purchase, construction, propagation or field release of GMOs or their products. These answers are derived from existing guidelines in a number of developing and industrial countries and are intended to serve as reference materials for consideration in developing country specific guidelines that comply with national laws and regulations.

Institutional Biosafety Committees (IBCs) are committees mandated through biosafety legislation to review and have oversight responsibilities for any work involving use of recombinant DNA for all purposes including the development of GM crops, production of vaccines, and processes that involve artificial gene transfer in academic and research institutions. An IBC may have a broader purview than this but the nature and scope of its mandate is subject to institutional discretion within the ambit of the biosafety law.

Typically, IBCs are established to perform biosafety functions within institutions involved in rDNA work by:

• ensuring the safe conduct of biological research;
• providing a mechanism for public scrutiny of, and access to biological research;
• ensuring adequate containment of potentially hazardous biological agents;
• providing a means of communication among stakeholders including the public about the experimental plans and kind of biological research.

By this arrangement, the interests of the public, scientists and technicians as well as the environment are safeguarded.

Characteristically, IBC members are appointed and number five (5) or more persons. Membership is drawn from within the institution, representatives of cognate institutions, and from the local community. It is common practice for an institution to appoint or recruit a biosafety officer to work with the IBC.

In many jurisdictions, an IBC may be composed of the following:

• the biosafety officer;
• persons with experience and expertise in the evaluation of biosafety issues and environmental effects associated with biotechnology research;
• persons who are not affiliated with the institution but are knowledgeable in biotechnology. These may be persons in government institutions, public health or environmental agencies;
• persons active in human, plant or animal health concerns;
• persons knowledgeable/active in environmental concerns or community issues and who have had no previous affiliation with the institution;
• persons knowledgeable in policies and laws, economics, and social work.

There are two possibilities. First, small research institutions which may not have the human resource base needed to constitute an independent IBC may request another IBC to help monitor and supervise the biosafety aspects of their work and may enter into an agreement to that effect. A representative of the institution requesting such assistance then works closely with, or serves as a member on, the supporting IBC. Second, separate institutions can come together to form an IBC that oversees their work. Yet again, this requires an agreement on the modalities of operation. Both options require the NBC being notified of such an arrangement.

With the passage of national biosafety laws, the requirement is for every public or private institution that intends to conduct work in rDNA to establish an IBC. For institutions that have already existing IBCs that predate the biosafety law, these IBCs must necessarily seek endorsement from the NBC before engaging in any work involving rDNA. The norm is for the NBC to formally endorse each IBC. The endorsement process involves the parent institution submitting completed notification forms of the IBC to the NBC. The form shall provide information on the credentials of each member appointed to the IBC and where applicable that for the biosafety officer. In addition, a list of the current projects (indicating the risk assessment category), laboratories approved for nucleic acid work (indicating the category of containment) and the institution’s green and animal houses, certified and intended for work with transgenic species (indicating category of containment) must be submitted.

The functions of an IBC are very extensive and critical to the effectiveness and efficiency of the NBC.

The major functions of the IBC include:

• enforcing all the Guidelines issued by the NBC at the institutional level;
• serving as the channel of communication between the institution/research team and the NBC. The IBC serves as the conduit for information or any data that needs to be submitted to the NBC;
• facilitating the preparation of dossiers for submission to the NBC;
• evaluating and approving, on behalf of the NBC, all low and medium risk containment laboratory work;
• receiving applications, proposing measures for improvement and for laboratory set-up as well as planned release and effectively monitoring any of these matters.
• reporting infractions to the institutional head or to the NBC and recommending appropriate action to be taken by the relevant authority including discontinuation of GM work if the existing circumstances pose a threat to the public, the environment or to laboratory personnel;
• monitoring the regulated work under progress within the institution and counselling the proponents on issues of biosafety;
• determining additional bio-safeguards and draft supplementary operating instructions for work at the institution, in line with and addressing the specific risks and concerns uncovered;
• assisting research in undertaking risk assessment and organizing training programmes;
• maintaining records of approved project proposals for laboratory genetic manipulation work, including notification for project exemption and the committee’s assessment;
• in conjunction with the research teams, specify contingency plans after undertaking risk assessments and reviewing project proposals;
• inspect and certify, before use in genetic manipulation work, the appropriate level laboratories, conventional animal houses, plant glass houses, and quarantine and medical facilities for infected animals, for which the Committee with the advice of the technical advisory sub-committee will be responsible for certification of higher-level laboratories only.

The responsibilities of the Biosafety Officer include:

• periodic inspection of laboratory facilities;
• providing advice to the Principal Investigator (s) and the IBC on safety procedures concerning the research;
• reporting any problems, violations, research-related accidents or illnesses to the IBC and its parent institution;
• developing emergency plans for handling accidental spills and personnel contamination
• providing advice on laboratory security
• together with the IBC, reviewing biosafety operating procedures and facilities for GM work.

This is normally a trained scientist with thorough understanding of biosafety regulations and laws applicable to genetic engineering.

Duties include:

• being in charge of the specific project and leading the proposal writing and application submission process for the IBC permit;
• assessing the nature of the research and determining whether the work proposed falls within the scope of the Guidelines;
• where the work is regulated under the guidelines, submitting a completed project proposal form, including requests for exempt status to the supervising IBC for consideration and recommendations and inform the committee of any notable intents such as plans to import regulated material;
• enforcing the provisions, and adhering to the intent, of the Guidelines throughout the duration of a research work;
• establishing and maintaining working conditions appropriate to the level of biosafety as approved and advised by the IBC and in the case of risk work, in accordance with the recommendations of the NBC;
• co-operating closely with the IBC and the biosafety officer in carrying out various safety tests including inspection of containment facilities;
• relaying to the IBC, details of the contingencies and the emergency procedures instigated to deal with incidents.

At the institutional level, four key players are normally involved in supervising work in genetic engineering. These are the NBC, regulatory agencies, relevant IBC and the Principal Investigator.

The IBC is mandated to evaluate and grant permission for GMO work in the laboratory, greenhouse or confined field trials stages that is described as “no risk”, “minimal risk”, and “low risk” works. However, any laboratory, greenhouse or confined field trials categorized as risk work, is evaluated by the NBC and the same body grants permission. When the IBC approves any work categorised as “no risk”, “minimal risk”, or “low risk”, the NBC is notified and the approval lodged with the national depository.

The IBC also serves as a conduit for the flow of information between the researcher (PI) and the NBC, forwarding proposals, assessments and recommendations to the NBC.

Though the NBC is responsible for the overall monitoring, risk management and commercial release of regulated materials, monitoring and enforcement is normally implemented via a 2-tier arrangement. The IBC is the first tier of monitoring and enforcement while the second tier is performed by the NBC through the regulatory agencies and any designated individuals or companies assigned inspectorate functions. The principal investigator is responsible to the community in the monitoring and implementation of laboratory work. This responsibility is subject to the approval of the IBC. It must be noted that the burden of meeting the compliance criteria is on the applicant or PI.

A conflict of interest is a situation in which a person has a private or personal interest sufficient to appear to influence the objective exercise of his or her official duties as, say, a public official, an employee, or a professional (MacDonald et al 2002). In the specific instance of an IBC, situations of conflicting interest may include the IBC member:

• being the principal investigator for the research being evaluated by the IBC;
• having a financial or administrative interest in a sponsoring entity or product being evaluated in the research;
• having close family ties with an individual who is one of the investigators or who has a significant financial or administrative interest in a sponsoring entity or product being evaluated in the research; and/or
• perceiving him/herself to have a personal conflict with the project which suggests potential bias.

• Lack of a SWOT analysis of the institution regarding human and technical capabilities before constituting the IBC.
• Lack of financial support for the functioning of the IBC by the parent institution. It is important for the institution to support the needs and demands of the IBC to enable it perform its functions efficiently.
• Non-involvement of IBCs in institutional resource planning and allocation.
• Non-involvement of IBCs in the design of research facilities and acquisition.