Principal Investigators conducting rsNAM research responsibilities

Principal Investigators conducting rsNAM research are responsible for full compliance of the NIH Guidelines.

These responsibilities are outlined in Section IV-B-7 of the NIH Guidelines.

    General requirements state that the investigator shall:

    1. Initiate or modify rsNAM research subject to the NIH Guidelines only after that research or the proposed modification thereof, has been approved by the IBC and has met all other requirements of the NIH Guidelines.
    2. Determine the classification of the experiment and follow appropriate procedures.
    3. Report within 30 days to the Biosafety Officer (BSO), IBC and NIH/OBA all significant problems with and violations of the NIH Guidelines and all significant research-related accidents and illnesses. Spills or accidents in BSL2 labs resulting in an overt exposure and any spills or accidents occurring in BSL3 labs must be immediately reported to the BSO, IBC and NIH OBA.
    4. Report new information bearing on the NIH Guidelines to the IBC and NIH/OBA.
    5. Be adequately trained in good microbiological techniques.
    6. Adhere to IBC approved emergency plans for dealing with accidental spills and personnel contamination.
    7. Comply with shipping requirements for rsNAM molecules (Appendix H of the NIH Guidelines).

    In submissions to the NIH/OBA, the PI shall:

    1. Submit information to NIH/OBA for certification of new host-vector systems.
    2. Petition NIH/OBA, with notice to the IBC, for proposed exemptions to the NIH Guidelines.
    3. Petition NIH/OBA, with concurrence to the IBC, for approval to conduct experiments specified in Sections III-A-1 and III-B.
    4. Petition NIH/OBA for determination of containment for experiments requiring case-by-case review.
    5. Petition NIH/OBA for determination of containment for experiments not covered by the NIH Guidelines.
    6. Ensure that all aspects of Appendix M have been appropriately addressed prior to submission of a human gene transfer experiment to NIH/OBA, and provide a letter signed by the PI(s) on institutional letterhead acknowledging that the documentation being submitted to NIH/OBA complies with the requirements set forth in Appendix M. No research participant shall be enrolled in a human gene transfer experiment until the RAC review process has been completed; IBC approval has been obtained; Institutional Review Board (IRB) approval has been obtained; and all applicable regulatory authorization(s) have been obtained.
      For a clinical trial site that is added after the RAC review process, no research participant shall be enrolled at that site until the following documentation has been submitted to NIH/OBA:
    • IBC approval (from the clinical trial site);
    • IRB approval;
    • IRB-approved informed consent document;
    • Curriculum vitae of the principal investigator(s) (no more than two pages in biographical sketch format); and
    • NIH grant number(s), if applicable.

    In submissions to the IBC, the PI shall:

    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 to the IBC for review and approval or disapproval.
    4. Remain in communication with the IBC throughout the conduct of the project.

    Prior to initiating the research, the PI shall:

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

    During the conduct of the research, the PI shall:

    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 Biological Safety Officer (BSO), IBC, NIH/OBA, and other appropriate authorities, if applicable. Reports to NIH/OBA shall be sent to the Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, Maryland 20892-7985, (301) 496-9838.
    3. Correct work errors and conditions that may result in the release of rsNAM materials.
    4. Ensure the integrity of the physical containment (biological safety cabinets) and the biological containment (purity, genotypic and phenotypic characteristics).
    5. Comply with reporting requirements for human gene transfer experiments (see Appendix M-I-C).​