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Title: Section 61-1.33 - Principal investigator; responsibilities

61-1.33 Principal investigator; responsibilities. On behalf of the institution, the PI is responsible for complying fully with this Subpart in conducting any recombinant DNA activity.

(a) PI: general. As part of this general responsibility, the PI shall:

(1) initiate or modify no recombinant DNA activity requiring approval by the IBC prior to initiation (section 61-1.20 of this Subpart: class III-A or III-B) until that activity, or the proposed modification thereof, has been approved by the institutional biosafety committee (IBC) and has met all other requirements of this Subpart;

(2) determine whether recombinant DNA activity is covered by section 61-1.20 of this Subpart: class III-C;

(3) report within 30 days to the IBC and the commissioner all significant problems with and violations of this Subpart and all significant recombinant DNA activity-related accidents and illnesses;

(4) report to the IBC and to the commissioner new information bearing on provisions of this Subpart;

(5) be adequately trained in good microbiological techniques;

(6) adhere to IBC-approved emergency plans for dealing with accidental spills and personnel contamination; and

(7) comply with shipping requirements for recombinant DNA molecules.

(b) Submissions by the PI to NIH. The PI shall:

(1) submit information to NIH (ORDA) in order to have new host-vector systems certified;

(2) petition NIH, with notice to the IBC, for exemptions to the NIH guidelines (see section 61-1.20 of this Subpart: class III-D);

(3) petition NIH, with concurrence of the IBC, for approval to conduct experiments specified in section 61-1.20 of this Subpart: class III-A;

(4) petition NIH for determination of containment for experiments requiring case-by-case review; and

(5) petition NIH for determination of containment for experiments not covered by this Subpart or the NIH guidelines.

(c) Submissions by the PI to the IBC. The PI shall:

(1) make the initial determination of the required levels of physical and biological containment in accordance with this Subpart or the NIH guidelines;

(2) select appropriate microbiological practices and laboratory techniques to be used in the recombinant DNA activity;

(3) submit the initial recombinant DNA activity protocol if covered under section 61-1.20 of this Subpart: class III-A, III-B or III-C (and also subsequent changes--e.g., changes in the source of DNA or host-vector system) to the IBC for review and approval or disapproval; and

(4) remain in communication with the IBC throughout the conduct of the recombinant DNA activity.

(d) PI responsibilities prior to initiating the activity. The PI is responsible for:

(1) making available to the laboratory staff copies of the protocols that describe the potential biohazards and the precautions to be taken;

(2) instructing and training staff in the practices and techniques required to ensure safety and in the procedures for dealing with accidents; and

(3) informing the staff of the reasons and provisions for any precautionary medical practices advised or requested, such as vaccinations or serum collection.

(e) PI responsibilities during the conduct of the activity. The PI is responsible for:

(1) supervising the safety performance of the staff to ensure that the required safety practices and techniques are employed;

(2) investigating and reporting in writing to the commissioner, the biological safety officer (where applicable) and the IBC any significant problems pertaining to the operation and implementation of containment practices and procedures;

(3) correcting work errors and conditions that may result in the release of recombinant DNA materials; and

(4) ensuring the integrity of the physical containment (e.g., biological safety cabinets) and the biological containment (e.g., purity, and genotypic and phenotypic characteristics).


VOLUME A-1a (Title 10)