Principal Investigator Roles and Responsibilities for Recombinant DNA Research

Section IV-B-7. Principal Investigator (PI) On behalf of the institution, the Principal Investigator is responsible for full compliance with the NIH Guidelines in the conduct of recombinant DNA research.

Section IV-B-7-a. General Responsibilities As part of this general responsibility, the Principal Investigator shall:

Section IV-B-7-a-(1). Initiate or modify no recombinant DNA research which requires Institutional Biosafety Committee approval prior to initiation (see Sections III-A, III-B, III-C, III-D, and III-E, Experiments Covered by the NIH Guidelines) until that research or the proposed modification thereof has been approved by the Institutional Biosafety Committee and has met all other requirements of the NIH Guidelines;

Section IV-B-7-a-(2). Determine whether experiments are covered by Section III-E, Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation, and ensure that the appropriate procedures are followed;** Note: Texas A&M requires IBC approval before initiation for all biosafety research.

Section IV-B-7-a-(3). Report any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to the Biological Safety Officer (where applicable), Greenhouse/Animal Facility Director (where applicable), Institutional Biosafety Committee, NIH/ORDA, and other appropriate authorities (if applicable) within 30 days. Reports to NIH/ORDA 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;

Section IV-B-7-a-(4). Report any new information bearing on the NIH Guidelines to the Institutional Biosafety Committee and to NIH/ORDA (reports to NIH/ORDA 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);

Section IV-B-7-a-(5). Be adequately trained in good microbiological techniques;

Section IV-B-7-a-(6). Adhere to Institutional Biosafety Committee approved emergency plans for handling accidental spills and personnel contamination; and

Section IV-B-7-a-(7). Comply with shipping requirements for recombinant DNA molecules (see Appendix H, Shipment, for shipping requirements and the Laboratory Safety Monograph for technical recommendations).

Section IV-B-7-b. Submissions by the Principal Investigator to NIH/ORDA
The Principal Investigator shall:

Section IV-B-7-b-(1). Submit information to NIH/ORDA for certification of new host-vector systems;

Section IV-B-7-b-(2). Petition NIH/ORDA, with notice to the Institutional Biosafety Committee, for proposed exemptions to the NIH Guidelines;

Section IV-B-7-b-(3). Petition NIH/ORDA, with concurrence of the Institutional Biosafety Committee, for approval to conduct experiments specified in Sections III-A-1, Major Actions Under the NIH Guidelines, and III-B, Experiments that Require NIH/ORDA and Institutional Biosafety Committee Approval Before Initiation;

Section IV-B-7-b-(4). Petition NIH/ORDA for determination of containment for experiments requiring case-by-case review; and

Section IV-B-7-b-(5). Petition NIH/ORDA for determination of containment for experiments not covered by the NIH Guidelines.

Section IV-B-7-b-(6). Ensure that 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 prior to submission of human gene therapy experiments to NIH/ORDA.

Section IV-B-7-c. Submissions by the Principal Investigator to the Institutional Biosafety Committee
The Principal Investigator shall:

Section IV-B-7-c-(1). Make an initial determination of the required levels of physical and biological containment in accordance with the NIH Guidelines;

Section IV-B-7-c-(2). Select appropriate microbiological practices and laboratory techniques to be used for the research;

Section IV-B-7-c-(3). Submit the initial research protocol and any subsequent changes (e.g., changes in the source of DNA or host-vector system), if covered under Sections III-A, III-B, III-C, III-D, or III-E (Experiments Covered by the NIH Guidelines), to the Institutional Biosafety Committee for review and approval or disapproval; and

Section IV-B-7-c-(4). Remain in communication with the Institutional Biosafety Committee throughout the conduct of the project.

Section IV-B-7-d. Responsibilities of the Principal Investigator Prior to Initiating Research
The Principal Investigator shall:

Section IV-B-7-d-(1). Make available to all laboratory staff the protocols that describe the potential biohazards and the precautions to be taken;

Section IV-B-7-d-(2). Instruct and train laboratory staff in: (i) the practices and techniques required to ensure safety, and (ii) the procedures for dealing with accidents; and

Section IV-B-7-d-(3). Inform the laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations or serum collection).

Section IV-B-7-e. Responsibilities of the Principal Investigator During the Conduct of Research
The Principal Investigator shall:

Section IV-B-7-e-(1). Supervise the safety performance of the laboratory staff to ensure that the required safety practices and techniques are employed;

Section IV-B-7-e-(2). Investigate and report any significant problems pertaining to the operation and implementation of containment practices and procedures in writing to the Biological Safety Officer (where applicable), Greenhouse/Animal Facility Director (where applicable), Institutional Biosafety Committee, NIH/ORDA, and other appropriate authorities (if applicable) (reports to NIH/ORDA 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);

Section IV-B-7-e-(3). Correct work errors and conditions that may result in the release of recombinant DNA materials; and

Section IV-B-7-e-(4). Ensure the integrity of the physical containment (e.g., biological safety cabinets) and the biological containment (e.g., purity and genotypic and phenotypic characteristics).

Section IV-B-7-e-(5). Comply with reporting requirements for human gene transfer experiments conducted in compliance with the NIH Guidelines (see Appendix M-VII, Reporting Requirements--Human Gene Transfer Protocols).