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Institutional Biosafety Committee

A University Institutional Biosafety Committee (IBC) has been created 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 IBC before such work can begin.

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

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. 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 PI must complete an IBC Registration Document to be submitted to the IBC Secretary.
  2. As early as possible in the planning stage of the research, the Principal Investigator (PI) should contact 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.

After IBC has received all documents requested, it may be expected that the following steps will take place for proposed work:

  • 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 IBC. The Principal Investigator shall determine the level of containment required by his protocol.
  • A meeting of the IBC 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 IBC.

Training of Laboratory Personnel: It is the prime responsibility of the PI to provide instruction regarding specific techniques for 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 and the Biosafety in Microbiological and Biomedical Laboratories (5th Edition) 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 IBC 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 IBC. 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 to the Secretary of the IBC. 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. A renewal notice will be sent to all registered investigators by the IBC.

Meetings of the IBC 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.