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BIOSAFETY ROLES AND RESPONSIBILITIES

Policy:

The safe conduct of experiments involving recombinant DNA depends on the individual conducting such activities. It is the responsibility of the institution and those associated with it to adhere to the intent of the NIH Guidelines as well as to their specifics. Each institution (and the Institutional Biosafety Committee acting on its behalf) is responsible for ensuring that all recombinant DNA research conducted at or sponsored by that institution is conducted in compliance with the NIH guidelines. The following roles and responsibilities constitute an administrative framework in which safety is an essential and integral part of research involving recombinant DNA molecules.

Responsibilities of the Institution

Each institution conducting or sponsoring recombinant DNA research, which is covered by the NIH Guidelines, is responsible for ensuring that the research is conducted in full conformity with the provisions of the NIH Guidelines. In order to fulfill this responsibility, the institution shall:

• Establish and implement policies that provide for the safe conduct of recombinant DNA research and that ensure compliance with the NIH Guidelines.
• Establish an Institutional Biosafety Committee that meets the requirements and carries out the functions listed below.
• Appoint a Biological Safety Officer (who is also a member of the Institutional Biosafety Committee) if the institution: (a) conducts recombinant DNA research at Biosafety Level (BL) 3 or BL4, or engages in large scale (<10 L) research.
• Appoint at least one individual with expertise in plant, plant pathogen or plant pest containment principles to IBC if needed. ***
• Appoint at least one individual with expertise in animal containment principles to IBC if needed ***
• Ensure that when the institution participates in or sponsors recombinant DNA research involving human subjects: the Institutional Biosafety Committee has adequate expertise and training (using ad hoc consultants as deemed necessary) and the PI addresses all requirements prior to submission to NIH/ORDA. Institutional Biosafety Committee approval must be obtained from each institution at which recombinant DNA material will be administered to human subjects.
• Assist and ensure compliance with the NIH Guidelines by Principal Investigators conducting research at the institution.
• Ensure appropriate training for the Institutional Biosafety Committee Chair and members, Biological Safety Officer, and other containment experts, Principal Investigators, and laboratory staff regarding laboratory safety and implementation of the NIH Guidelines.
• Determine the necessity for health surveillance of personnel involved in individual recombinant DNA projects; and if appropriate, conduct a health surveillance program for such projects.
• Report any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to NIH/ORDA.

Institutional Biosafety Committee (IBC)

The institution shall establish an Institutional Biosafety Committee whose responsibilities need not be restricted to recombinant DNA.

• The IBC membership shall be selected so they collectively have experience and expertise in recombinant DNA technology and the capability to assess the safety of recombinant DNA research and to identify any potential risk to public health or the environment.
• The institution shall file an annual report with the NIH/ORDA including a roster of the IBC.
• The institution, that is ultimately responsible for the effectiveness of the IBC, may establish procedures that the IBC shall follow in its initial and continuing review and approval of applications, proposals, and activities.
• The institution is encouraged to open the IBC meetings to the public. The IBC shall make documentation regarding public funding available to the public upon request.

Functions of the IBC

On behalf of the institution, the IBC is responsible for:

• Reviewing recombinant DNA research conducted at or sponsored by the institution for compliance with the NIH Guidelines, and approving those research projects that are found to conform to the NIH Guidelines. This review shall include: (a) independent assessment of the containment levels required; (b) assessment of the facilities, procedures, practices, and training and expertise of the personnel involved in recombinant DNA research; and (c) ensuring compliance with all surveillance, data reporting, and adverse event reporting requirements.
• Notifying the Principal Investigator of the results of the IBC's review and approval
• Lowering containment levels under certain defined circumstances
• Setting containment levels for experiments conducted with whole animals and whole plants.
• Periodically reviewing recombinant DNA research conducted at the institution to ensure compliance with NIH Guidelines.
• Adopting emergency plans covering accidental spills and personnel contamination resulting from recombinant DNA research.
• Reporting 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/ORDA within 30 days, unless the IBC determines that a report has already been filed by the Principal Investigator.
• The IBC may not authorize initiation of experiments, which are not explicitly covered by the NIH Guidelines until NIH (with the advice of RAC when required) establishes the containment requirement.
• Performing such other functions as may be delegated to the IBC.

Biological Safety Officer (BSO)

The Biological Safety Officer's duties include, but are not limited to:

• Periodic inspections to ensure that laboratory standards are rigorously followed;
• Reporting to the Institutional Biosafety Committee and the institution any significant problems, violations of the NIH Guidelines, and any significant research related accidents or injuries of which the BSO becomes aware unless the Biological Safety Officer determines that a report has already been filed by the Principal Investigator.
• Developing emergency plans for handling accidental spills and personnel decontamination and investigating laboratory accidents involving recombinant DNA research;
• Providing advice on laboratory security;
• Providing technical advice to Principal Investigators and to the IBC on research safety procedures.
• Serve as a member of the IBC
• Where the institution has a comprehensive environmental health and safety program that includes expertise in biological safety, it would be useful to select the individual from the program's professional staff. This would ensure effective collaboration with other safety professionals and would allow all elements of a laboratory safety program to be carried out in a unified manner. (From Laboratory Safety Monograph)

Principal Investigator (PI)

On behalf of the institution, the Principal Investigator is responsible for compliance with the NIH Guidelines in conduct of the recombinant DNA research.

As part of this responsibility the Principal Investigator shall:

• Initiate or modify no recombinant DNA research, which requires IBC approval prior to initiation until that research or the proposed modification thereof has been approved by the IBC and has met all other requirements of the NIH Guidelines.
• Determine whether experiments are covered by Section III-E, Experiments that Require IBC Notice Simultaneous with Initiation, and ensure that the appropriate procedures are followed.
• Submit Registration Documentation to the IBC for all recombinant DNA protocols, even if exempt under NIH Guidelines. IBC approval is NOT required to initiate work. (Internal UBC requirement)
• Report any significant problems, violations of the NIH Guidelines, or any significant research related accidents and illnesses to the BSO, Greenhouse/Animal Facility Director (Where applicable), IBC, NIH/ORDA, and other appropriate authorities (if applicable) within 30 days.
• Report any new information bearing on the NIH Guidelines to the IBC and to NIH/ORDA.
• Be adequately trained in good microbiological techniques;
• Adhere to Institutional Biosafety Committee approved emergency plans for handling accidental spills and personnel contamination; and
• Comply with shipping requirements for recombinant DNA molecules.