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Home > Departments > Environment, Health & Safety > EH&S Programs > Biological Safety > Biosafety Committee General Policies

Biosafety Committee General Policies

RESPONSIBILITIES OF PRINCIPAL INVESTIGATORS ENGAGED IN RESEARCH WITH RECOMBINANT DNA MOLECULES, INFECTIOUS AGENTS, OR ONCOGENIC MATERIALS OR AGENTS.

A University Biosafety Committee (UBC) has been instituted in accordance with requirements set forth in the National Institutes of Health "Guidelines for Research Involving Recombinant DNA Molecules". All research investigations involving Recombinant DNA, infectious agents or oncogenic materials or agents must be registered with the UBC. All work involving recombinant DNA that is subject to the current NIH Guidelines must be reviewed and approved by the University Biosafety Committee before such work can begin.

In order to expedite the processing of applications and to provide appropriate, deliberate review of proposals, the committee has developed additional guidelines which are specific to its needs. Each investigator contemplating initiation of such work must adhere to the following:

  1. A. As early as possible in the planning stage of the research, the Principal Investigator (PI) should contact Environment, Health & Safety (EH&S) to discuss plans for physical facilities and possible renovations that may be needed. Final certification of the Physical Level (BL) of containment will be made by the University Biosafety Officer.
  2. B. Two months prior to the proposed starting date of research involving recombinant DNA, infectious agents or potentially oncogenc materials, or preferably at the time a grant application is submitted, the following must be received by the UBC, each document beginning on a new page:
    1. The Informational Sheet supplied by the UBC.
    2. A Registration Document that has been prepared according to the current NIH Guidelines. These forms are available from EH&S. (This Registration Document must be dated and signed by the Investigator.)
    3. A lay summary of the proposed work. This summary should be between one and two pages, single-spaced type, and should be written so as to be understandable by lay persons. It should emphasize the potential pathogenicity of the microorganisms and recombinants to be used, safety precautions to be taken, and the importance of the research project to the furtherance of biological or medical sciences. The lay summary will be placed in the library of Environment, Health & Safety and will be available for public viewing.
    4. For local committee approval and evaluation, supply the following additional information:
      1. Names, addresses and phone numbers of persons employed in laboratories engaged in proposed studies; if persons have not yet been hired, list the number of persons proposed in the grant application who could be assigned to this work and state their positions (i.e., technician, graduate student, postdoctoral fellow, etc.);
      2. Description of personnel training relative to biohazard control; include background of principal investigator in microbiology, infectious diseases, and recombinant DNA techniques;
      3. Description of steps to be taken to prevent personnel contamination, and actions to be taken in the event of accidental spill, or personnel contamination, or release of agent.

All required documents listed above are to be submitted to:

University Biosafety Committee
Leonard Borzynski, Secretary
Environment, Health & Safety
220 Winspear Ave.
South Campus

After UBC has received all documents requested, it may be expected that the following steps will take place for proposed recombinant DNA work subject to the NIH Guidelines:

  • For those experiments involving work at a higher level than BL 1, a site visit may be made to the laboratory by a subcommittee of the UBC. The Principal Investigator shall determine the level of containment required by his protocol.
  • A meeting of the UBC will be held to review the documents submitted and to receive a report on the site visit and a certification of the BL level of containment. The PI may be asked to appear before the committee to provide additional information.

When research is first initiated, rules for observing the proper BL level of containment must be posted in the laboratory. Any changes in the names, addresses and phone numbers of persons employed in laboratories engaged in these studies must be reported to the Secretary of the UBC.

Training of Laboratory Personnel: It is the prime responsibility of the PI to provide instruction regarding specific techniques for recombinant DNA research and dangers of materials to be handled and to document this training. It is the responsibility of the PI to be certain that all technical personnel are familiar with these sections of the NIH Laboratory Safety Monograph that pertain to techniques being employed. The PI can obtain assistance in these matters from EH&S. It is recommended that all technical personnel and students attend courses on general laboratory safety organized by EH&S.

Reinspection of Facilities: The Biosafety Officer will make periodic inspections of major equipment items such as biological safety hoods, autoclaves, etc., in order to insure proper containment of agents being used.

Health Surveillance: Beyond the minimum requirements stated in the NIH Guidelines for the reporting of extended illnesses and accidents, the PI may initiate other measures such as those discussed in the NIH Laboratory Safety Monograph. Examples of such additional measures could include periodic physical and medical examinations or collection and maintenance of serum samples. The health status of a laboratory worker may place that person at increased risk in any endeavor where infectious agents are handled. Examples given in the Laboratory Safety Monograph include gastrointestinal disorders and treatment with steroids, immunosuppressive drugs or antibiotics. Workers with such disorders or treatment should be evaluated to determine whether they should be engaged in research with potentially hazardous organisms during their treatment or illness. The UBC will determine the necessity, in connection with each project, for health surveillance of recombinant DNA research personnel, and conduct, if found appropriate, a health surveillance program for the project.

The following procedures must be observed for making changes in an on-going research program:

  • Minor changes in the Registration Document can be approved by the Secretary of the UBC. A statement in writing by the PI must be sent to the Secretary as a matter of record.
  • Major changes in the proposal will require a revised Registration Document submitted with an Informational Sheet to the Secretary of the UBC. Examples of such major changes are (a) a significant change in hosts or vectors; (b) a significant change in the donor species or the nature of the DNA segment selected; (c) a major change in the physical location of the experiments; or (d) a change of the responsible investigator. An annual update must be submitted by the principal investigator. A renewal notice will be sent to all registered investigators by the University Biosafety Committee.

Meetings of the UBC will be open to the public, provided sufficient notice is given to the chairman so that adequate meeting space can be obtained. Only those parts of meetings dealing with privileged information (i.e., technical details of grant applications that have not been approved and funded) will remain closed. EH&S will maintain, for public viewing, minutes of committee meetings, information about future meetings, a lay summary of each recombinant DNA proposal submitted by principal investigators, and a list of reference material helpful to an understanding of the procedures involved in studies of recombinant DNA molecules.

Adopted by the University Biosafety Committee, February 4, 1981

Revised April 1989
Revised September 1991
Revised April 1996
Revised March 2000
Revised February 2001

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