Institution Roles and Responsibilities for Recombinant DNA Research

Section IV-B. Responsibilities of the Institution

Section IV-B-1. General Information
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:

Section IV-B-1-a. Establish and implement policies that provide for the safe conduct of recombinant DNA research and that ensure compliance with the NIH Guidelines. As part of its general responsibilities for implementing the NIH Guidelines, the institution may establish additional procedures, as deemed necessary, to govern the institution and its components in the discharge of its responsibilities under the NIH Guidelines. Such procedures may include: (i) statements formulated by the institution for the general implementation of the NIH Guidelines, and (ii) any additional precautionary steps the institution deems appropriate.

Section IV-B-1-b. Establish an Institutional Biosafety Committee that meets the requirements set forth in Section IV-B-2-a and carries out the functions detailed in Section IV-B-2-b.

Section IV-B-1-c. Appoint a Biological Safety Officer (who is a member of the Institutional Biosafety Committee) if the institution: (i) conducts recombinant DNA research at Biosafety Level (BL) 3 or BL4, or (ii) engages in large scale (greater than 10 liters) research. The Biological Safety Officer carries out the duties specified in Section IV-B-3.

Section IV-B-1-d. Appoint at least one individual with expertise in plant, plant pathogen, or plant pest containment principles (who is a member of the Institutional Biosafety Committee) if the institution conducts recombinant DNA research that requires Institutional Biosafety Committee approval in accordance with Appendix P, Physical and Biological Containment for Recombinant DNA Research Involving Animals.

Section IV-B-1-e. Appoint at least one individual with expertise in animal containment principles (who is a member of the Institutional Biosafety Committee) if the institution conducts recombinant DNA research that requires Institutional Biosafety Committee approval in accordance with Appendix Q, Physical and Biological Containment for Recombinant DNA Research Involving Animals.

Section IV-B-1-f. Ensure that when the institution participates in or sponsors recombinant DNA research involving human subjects: (i) the Institutional Biosafety Committee has adequate expertise and training (using ad hoc consultants as deemed necessary), and (ii) all aspects of Appendix M, Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA Molecules into One or More Human Subjects (Points to Consider), have been appropriately addressed by the Principal Investigator 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 (as opposed to each institution involved in the production of vectors for human application and each institution at which there is ex vivo transduction of recombinant DNA material into target cells for human application).

Section IV-B-1-g. Assist and ensure compliance with the NIH Guidelines by Principal Investigators conducting research at the institution as specified in Section IV-B-4.

Section IV-B-1-h. Ensure appropriate training for the Institutional Biosafety Committee Chair and members, Biological Safety Officer and other containment experts (when applicable), Principal Investigators, and laboratory staff regarding laboratory safety and implementation of the NIH Guidelines. The Institutional Biosafety Committee Chair is responsible for ensuring that Institutional Biosafety Committee members are appropriately trained. The Principal Investigator is responsible for ensuring that laboratory staff are appropriately trained. The institution is responsible for ensuring that the Principal Investigator has sufficient training; however, this responsibility may be delegated to the Institutional Biosafety Committee.

Section IV-B-1-i. Determine the necessity for health surveillance of personnel involved in connection with individual recombinant DNA projects; and if appropriate, conduct a health surveillance program for such projects. The institution shall establish and maintain a health surveillance program for personnel engaged in large scale research or production activities involving viable organisms containing recombinant DNA molecules which require BL3 containment at the laboratory scale. The institution shall establish and maintain a health surveillance program for personnel engaged in animal research involving viable recombinant DNA - containing microorganisms that require BL3 or greater containment in the laboratory. The Laboratory Safety Monograph discusses various components of such a program (e.g., records of agents handled, active investigation of employees' work experience). Certain medical conditions may place a laboratory worker at increased risk in any endeavor where infectious agents are handled. Examples cited 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. Copies of the Laboratory Safety Monograph are available from the Office of Recombinant DNA Activities. National Institutes of Health/MSC 7010, 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010, (301) 496-9838.

Section IV-B-1-j. Report any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to NIH/ORDA within thirty days, unless the institution determines that a report has already been filed by the Principal Investigator or Institutional Biosafety Committee. Reports shall be sent to the Office of Recombinant DNA Activities, National Institutes of Health/MSC 7010, 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010, (301) 496-9838.