Institutional Biosafety Committee
Terms of Reference
(extract from Guidelines for Small Scale Genetic Manipulation Work;
Genetic Manipulation Advisory Committee. April 1995)

3.3 Institutional Biosafety Committees

The IBCs are vital components of the overall monitoring and surveillance of genetic manipulation work, and of the administration of these Guidelines. The calibre and experience of members on the IBC shall be such that it can competently carry out its duties. The Chair of the Committee shall be of sufficient standing in the institution for decisions and advice by the 'BC to be effectively implemented. Appropriate deputising arrangements shall be made when the Chair is on leave.

3.3.1 Composition

The IBC shall include:

• people with the requisite knowledge and expertise to assess, evaluate and oversee work being carried out in the institution;
• the Biological Safety Officer, where applicable;
• an engineer with expertise in testing biological safety facilities and equipment;
• at least one lay person, not associated with the institution, who is in a position to consider the wider community interests.

A microbiologist, and a molecular biologist and/or a geneticist, shall be included among persons with requisite expertise. The IBC membership shall include an ecologist with expertise relevant to the organism, if release of a live modified organism is envisaged. In general, the scientific disciplines need only be represented where work falling into that area is performed in the institution. For example, an institution working only on plants need not have an animal geneticist.

Roles and responsibilities may be combined in the same person where appropriate.

3.3.2 Biological Safety Officer

It is recommended that institutions either appoint a Biological Safety Officer, or assign such duties to the 'BC. If institutions have more than one officer, for the purposes of these Guidelines, only one name from each institution is to be submitted to GMAC in the annual reporting requirements. The officer, ideally, should have experience of working with containment conditions. The officer shall be adequately trained and be able to offer advice on, or participate in, training of new staff or laboratory personnel. Appropriate deputising arrangements shall be made when the officer is on leave.

The Biological Safety Officer or the 'BC Chair shall act as adviser to the head of the institution or firm in all matters relating to containment, biological hazards, and the safety of staff Regular safety audits and the supervision of a regular testing program for appropriate pieces of equipment shall be undertaken by the Biological Safety Officer or the IBC.

3.3.3 Conflicts of Interest

The composition of IBCs is such that it often includes members with specialist expertise who themselves originate proposals. It is undesirable for members to assess their own proposals and these Guidelines recommend that the 'BC have sufficient scientific members so that it is not dependent on the advice of the person submitting the proposal. However, to ensure that no conflicts of interest arise, it is recommended that proposals be assessed in the absence of the originator

It is also becoming more usual for investigators to have, in addition to their usual responsibilities, other commercial affiliations or interests. It is recommended that, in such cases, members should declare their interests and leave the meeting when a related item of the agenda is being considered.

3.3.4 Monitoring of work

The IBC shall ensure that GMAC's and its own advice on specific proposals is conveyed to the principal investigator(s) and, where necessary, is acted upon. The IBC shall visit laboratories and facilities from time to time to monitor safety aspects of ongoing projects.

The IBC may draft whatever rules it considers appropriate to supplement these Guidelines or to give effect to their intent. It shall have appropriate powers to ensure that the Guidelines and rules are observed. These rules may relate to laboratory practice, or to handling, transport and storage of genetically manipulated organisms.

3.3.5 Duties

The main functions of the IBC are to:

• undertake the assessment and review of all the research proposals it receives, including changes to Category C 'Special Exemption' projects, in order to identify all potential hazards to the researchers, the community and the environment, and to provide advice to the investigator on these hazards and their management;
• determine containment and procedures for all experimental work falling into GMAC Categories A and B (see Section 2), and for the housing, storage and transportation of genetically manipulated organisms falling under these Guidelines;
• send a legible original typewritten proposal form and an 'BC assessment form to GMAC for review and assessment of experiments falling into Category A and C, and ensure that GMAC advice is complied with; send an original typed proposal form and assessment form to GMAC for notification of experiments falling into Category B. See Appendix 5.3 for instructions on completing proposal and IBC assessment forms;
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• inspect and certify PC2 laboratories, plant houses, animal houses, bird houses, insectaries and aquaria before they are used for genetic manipulation work. GMAC certifies laboratories and facilities of higher containment levels than PC2 but the IBC shall conduct inspections and monitor procedures in all the institution's containment facilities. At least annual inspections of these facilities shall be undertaken to ensure that they continue to meet the relevant containment standards and requirements. Detailed requirements for these facilities are given in Appendices 5.8 et seq. Signs are available from the GMAC Secretariat;
• monitor ongoing work within the institution and make recommendations to investigators from time to time;
• review the qualifications and experience of personnel involved in- research proposals, to ensure that they are adequate for good microbiological practice and for the supervision of junior personnel;
• maintain a register of approved projects on genetic engineering and their assessment, and projects exempted under Sections 1.2.1 to 1.2.6 of these Guidelines;
• maintain a list of people working in containment facilities, and ensure that new personnel are familiar with procedures at the relevant containment level, and the correct use of laboratory equipment. A kit of slides on safety in laboratories is available from the Safety Unit of the University of NSW. Please contact the Bio Safety Officer (Telephone: (02) 697 2914) for access to these slides;
• take responsibility for drafting rules and take decisions on specific procedural safety matters. GMAC need not be consulted on these, provided that they are consistent with these Guidelines.

3.3.6 Reporting requirements

At the time of establishment, the IBC shall provide GMAC with a completed 'Institutional Biosafety Committee Information' form. This form is available from the GMAC Secretariat.

Once a year IBCs are required to report to GMAC details of the following:

• Chair and Secretary;
• Biological Safety Officer, where applicable;
• membership of the Committee;
• list of current Category A, Category B and Category C 'Special Exemption' proposals;
• list of certified PC2, PC3, PC4,PC2-LS and PC4-LS laboratories, plant houses, animal houses, bird houses, insectaries and aquaria.
  For each facility of containment level higher than PC2,and for each large scale facility, the following information is required:
  • Facility name
  • Special features of facility
  • Date of last inspection
  • Date of previous inspection
  • Period of room use and projects for which it has been used
  • Staff training:
    • cleaning staff (date)
    • emergency staff (date)
    • engineering staff (date)
  • List of current manuals and inspection date
  • Inspection dates for:
    • air handling system
    • alarms
    • biosafety cabinet
    • building finishes
    • centrifliges
    • cleanliness
    • decontamination equipment
    • effluent disposal
    • HEPA filters
    • refrigeration
    • sterilisers
• any significant accident or incident relating to health of workers which may reasonably be attributed directly to genetic manipulation work;
• any other matter to which the IBC deems it necessary to draw GMAC's attention.

To fulfil these reporting requirements, GMAC shall send the IBC its computer printout for amendment.

3.3.7 Medical history of workers

For workers using PC2 physical containment facilities, GMAC believes that no special arrangements are necessary beyond the normal institutional practices for laboratory workers.

Many institutions carrying out microbiological research, as a matter of routine, take serum samples from workers at regular intervals. The samples are stored and are available for later diagnostic tests on workers exposed to accidents or who develop unexplained illness.

For work requiring a physical containment level of PC3 or higher, the Australian Standard 2243.3 (Safety in Laboratories, Part 3, 1995 - Microbiology) requires that each person working in the laboratory undergo an initial medical examination. Baseline serum samples should be obtained from personnel working in the laboratory and stored for future reference.

3.3.8 Accidents and incidents

The IBC or the Biological Safety Officer shall record accidents and the action taken in dealing with accidents. If the IBC Chair is satisfied that an accident or incident occurred which was directly attributable to work with genetic manipulation, and was of sufficient significance, he/she shall make a report to GMAC and the head of the institution. An example of such an incident might be the deliberate failure to comply with these Guidelines, or any incident which may have resulted in a risk to human health or to the environment.