1 Laboratory Safety Monograph a supplement to the nih guidelines for
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- National Institutes of Health B. Establishing an Institutional Recombinant DNA Research Program
- DUTIES RESPONSIBILITIES Institution
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Laboratory Safety Monograph 1/2/79 184 (TO BE REVISED)
Laboratory Safety Monograph 1/2/79 185 (TO BE REVISED)
Laboratory Safety Monograph 1/2/79 186 (TO BE REVISED)
Laboratory Safety Monograph 1/2/79 187 (TO BE REVISED)
In addition to possessing the professional competence necessary to assess and review specific activities and facilities, the committee should possess, or have available to it, the competence to determine the acceptability of its findings in terms of applicable laws, regulations, standards of practices, community attitudes, and health and environmental considerations. Individually, the members should be recognized by their colleagues as capable scientists and persons of good judgment. The members should each have a personal commitment to laboratory safety in general and biosafety in particular. Any institution that has need for an IBC must recognize that there may be legitimate concern in the adjacent community about whether adequate safeguards are being taken at the institution to protect the general environment and community from potentially hazardous materials. How this concern might best be dealt with will vary from one community to another, but the institution should not ignore this concern. One suggestion is that community individuals with either statutory or political responsibility for the health and well-being of the residents of the community be invited to attend the meetings of the IBC and to participate in the deliberations of the committee when matters of concern to the public are under consideration. The minutes of the committee meetings could be shared with these individuals upon request. Another suggestion would be to appoint such an individual to serve as a member of the committee. 3. General Recommendations An independent assessment of the physical and biological containment levels for each recombinant DNA project and the analysis of requests for single step reductions in containment levels for experiments with purified DNA and characterized clones require considerable scientific Laboratory Safety Monograph 1/2/79 188 (TO BE REVISED) expertise, as well as scientific judgment. Not all IBCs will have among its members sufficient background and experience to deal thoroughly with the technical aspects of all project proposals that come to its attention. Advice and consultation from institutional scientists who are not members of the IBC may be desirable and necessary. It is suggested, therefore, that the IBC identify institutional scientists who could serve as consultants to the committee. The use of such consultants in supporting the work of the committee is to be encouraged. Many institutions have established environmental health and safety programs that deal with the broad area of laboratory safety. These programs are likely to have resources and capabilities that could be used to support the work of the IBC. For example, such programs may be well equipped to perform surveillance and monitoring of safety practices; review the integrity of safety equipment and facilities; investigate problems pertaining to operations and implementation of physical containment safeguards; investigate accidents causing serious exposure to personnel or danger of environmental contamination; assist principal investigators in the selection of appropriate safety practices and equipment and in the preparation of MUAs; and develop emergency procedures. These programs could also provide staff support to the IBC. It is suggested, therefore, that the IBC utilize the resources and capabilities of environmental health and safety programs, where appropriate, in the support of the work of the committee. This arrangement could be most beneficial in areas dealing with operational responsibilities of the committee such as those listed above. The work of the committee should be conducted in a deliberate but timely manner. The process by which the committee functions should be well defined and known by all institutional scientists who may wish to use recombinant DNA techniques in their research. This suggests that the procedures to be used by the committee and the logistics for maintaining communication with the principal investigator and other interested persons
189 (TO BE REVISED) should be documented. This will facilitate cooperation and will minimize difficulties in conducting the work of the committee. The following steps and procedures are offered for an IBC for reviewing and approving MUAs: The principal investigator should submit the proposed MUA to the executive secretary or the chairman of the IBC. It would be preferable to submit the document to the executive secretary, who would assign an identification number for administrative control during the review process and for future reference. The executive secretary would then initiate the review process. The MUA should then be transmitted to committee members. The members who receive the MUA may vary, depending on the workload, the pro- posed level of physical containment, and the committee review process. All committee members, however, should receive copies of any MUA for which the principal investigator has determined that a P3 or P4 level of physical containment would be required. It may be advisable to establish a scientific subcommittee that would be responsible for conducting an independent assessment of the physical and biological containment levels appropriate for a submitted MUA. This subcommittee should have sufficient flexibility to seek advice from other scientists, as required. After it has completed its assessment, the subcommittee should also be encouraged to discuss with the principal investigator any differences it has with respect to the initial assessment performed by the principal investigator. This may facilitate an early modification to the MUA, if required, prior to formal committee action. The subcommittee should submit its recommendations to the IBC within one month after receipt of the MUA, or sooner, if possible. Following IBC approval of the assessment conducted by the subcommittee, the IBC should determine that the required safeguards and expertise of the project staff for the assessed level of physical containment are available. Such a determination may require a visit to the laboratory in which the project is to be conducted. Visits for projects requiring P3 or P4 levels of physical containment should be coordinated by the biological safety officer. The professional staff of the institution's environmental health and safety program may be helpful in performing this task for the committee. Once this review has been completed, the committee would be in a position to make a final decision on the MUA. The final decision on the MUA should be transmitted, in writing, to the principal investigator. An approved copy of the MUA would serve this purpose. The committee should also initiate the submittal process for notifying NIH of the IBC approval action. Laboratory Safety Monograph 1/2/79 190 (TO BE REVISED) The IBC should develop a mechanism for reviewing periodically all projects having approved MUAs. This should be done to determine if new data or revised guidelines for assessing potential hazards warrant the revision of the MUA. Also, the IBC should be advised as to whether the project has been completed, temporarily stopped, or terminated for any reason.
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B. The Biological Safety Officer The "NIH Guidelines for Recombinant DNA Research" require that institutions engaged in recombinant DNA research at the P3 or P4 physical containment levels appoint a person who will serve as a biological safety officer. The following duties will be among those to be performed by the biological safety officer: Provide technical advice to the principal investigator and IBC on research safety procedures. Provide advice on laboratory security. Develop emergency plans for dealing with accidental spills and personnel contamination; and investigate recombinant DNA research laboratory accidents. Ensure through periodic inspections that laboratory standards are rigorously followed. Serve as a member of the IBC. The principal function of the biological safety officer should be to advise the principal investigator, the IBC and the laboratory worker concerning the most appropriate safety practice that will assure the safe conduct of recombinant DNA research. Depending on the nature and extent of the institution's recombinant DNA programs, the biological safety officer may be a full-time position, or the duties may be assigned to an individual who has other responsibilities. 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. Where this expertise does not exist, the appointed individual should interact closely with the basic safety group of the institution. If the position is to be full-time, consideration should be given to assigning this position to the basic health and safety program, rather than creating a separate program for biosafety in a different administrative setting. Laboratory Safety Monograph 1/2/79 192
Additional duties and responsibilities may be assigned to the biological safety officer. These will depend on the magnitude and complexity of the institution's recombinant DNA program, whether the position is full- or part- time, the relationship of the position to the institution's environmental health and safety program, and the qualifications of the individual. The following are examples of additional duties and responsibilities:
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