PI Responsibilities

The PI, as a representative of the university, has specific responsibilities outlined by the NIH Guidelines and is responsible for full compliance

There are 5 areas of responsibility:

  1. General
  2. Information to be submitted to the IBC
  3. Things to be done before initiation of the research
  4. Things to be done during conduct of the research
  5. Information that has to be submitted to NIH OSP (Office of Science Policy)

General Responsibilities

7 responsibilities:

  1. Get approval from the IBC for any research covered by the Guidelines or modification of that research before starting.
  2. Determine under what section your research falls (III-A through III-E) and follow the appropriate procedures.
  3. Report any significant problems, violations, research-related accidents and illnesses to the appropriate institutional official or entity (BSO, IBC, NIH, etc).
  4. Report any new information involving the NIH Guidelines to the IBC and NIH OSP.
  5. Be adequately trained in good microbiological techniques.
  6. Adhere to IBC approved emergency plans for handling accidental spills and personnel contamination.
  7. Comply with shipping requirements for recombinant or synthetic nucleic acid molecules.

Submissions to the IBC

4 responsibilities:

  1. Make an initial determination of the required levels of physical and biological containment in accordance with the NIH Guidelines.
  2. Select appropriate microbiological practices and laboratory techniques to be used for the research.
  3. Submit the initial research protocol and any subsequent changes (e.g., changes in the source of DNA or host-vector system) to the IBC for review and approval or disapproval.
  4.  Remain in communication with the IBC throughout the conduct of the project.

Responsibilities Before Initiation of Research

3 responsibilities

  1.  Make available to all laboratory staff the protocols that describe the potential biohazards and the precautions to be taken.
  2. Instruct and train laboratory staff in:  (i) the practices and techniques required to ensure safety, and (ii) the procedures for dealing with accidents.
  3. Inform the laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations or serum collection).

Responsibilities During the Conduct of the Research

5 responsibilities 

  1. Supervise the safety performance of the laboratory staff to ensure that the required safety practices and techniques are employed.
  2. Investigate and report any significant problems pertaining to the operation and implementation of containment practices and procedures in writing to the BSO, IBC, NIH OSP, and other appropriate authorities.
  3. Correct work errors and conditions that may result in the release of recombinant or synthetic nucleic acid molecule materials.
  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).
  5. Comply with reporting requirements for human gene transfer experiments conducted in compliance with the NIH Guidelines.

Information to Be Submitted by the Principal Investigator to NIH OSP

Sometimes, the PI is doing research that may require additional reporting to the NIH: 

  1. Submit information to NIH OSP for certification of new host-vector systems.
  2. Petition NIH OSP, with notice to the IBC, for proposed exemptions to the NIH Guidelines.
  3. Petition NIH OSP, with concurrence of the IBC, for approval to conduct experiments specified in Sections III-A-1, Major Actions Under the NIH Guidelines, and III-B, Experiments that Require NIH OSP and Institutional Biosafety Committee Approval Before Initiation.
  4. Petition NIH OSP for determination of containment for experiments requiring case-by-case review.
  5. Petition NIH OSP for determination of containment for experiments not covered by the NIH Guidelines.
  6. If you are doing human subjects research, ensure that all aspects of Appendix M have been appropriately addressed prior to submission.  No research participant shall be enrolled in a human gene transfer experiment until the NIH protocol registration process has been completed; IBC approval (from the clinical trial site) has been obtained; Institutional Review Board (IRB) approval has been obtained; and all applicable regulatory authorization(s) have been obtained.