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. A Principal Investigator engaged
in human gene transfer research may delegate to another party, such as
a corporate sponsor, the reporting functions set forth in Appendix M, with written notification to the NIH OBA
of the delegation and of the name(s), address, telephone, and fax numbers
of the contact. The Principal Investigator
is responsible for ensuring that the reporting requirements are fulfilled
and will be held accountable for any reporting lapses.
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;
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/OBA, and other appropriate authorities (if applicable) within 30 days. 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, MD 20892-7985
(20817 for non-USPS mail), 301-496-9838, 301-496-9839 (fax);
Section IV-B-7-a-(4). Report any new information bearing on the NIH Guidelines
to the Institutional Biosafety Committee and to NIH/OBA (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, MD 20892-7985 (20817 for non-USPS mail), 301-496-9838,
301-496-9839 (fax);
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).
The Principal Investigator shall:
Section IV-B-7-b-(1). Submit information to NIH/OBA for certification of
new host-vector systems;
Section IV-B-7-b-(2). Petition NIH/OBA, with notice to the Institutional
Biosafety Committee, for proposed exemptions to the NIH Guidelines;
Section IV-B-7-b-(3). Petition NIH/OBA, 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/OBA and Institutional Biosafety Committee
Approval Before Initiation;
Section IV-B-7-b-(4). Petition NIH/OBA for determination of containment
for experiments requiring case-by-case review; and
Section IV-B-7-b-(5). Petition NIH/OBA 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 have been appropriately addressed prior to
submission of a human gene transfer experiment to NIH OBA, and provide
a letter signed by the Principal Investigator(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 (see definition of enrollment in Section
I-E-7) in a human gene transfer experiment until the RAC review process
has been completed (see Appendix M-I-B, RAC Review Requirements);
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.
For a clinical trial site that is added
after the RAC review process, no research participant shall be enrolled
(see definition of enrollment in Section
I-E-7) at the clinical trial site until the following documentation
has been submitted to NIH OBA: (1) IBC approval
(from the clinical trial site); (2) IRB approval; (3) IRB-approved informed
consent document; (4) curriculum vitae of the principal investigator(s)
(no more than two pages in biographical sketch format); and (5) NIH grant
number(s) if applicable.
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 the 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/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,
MD 20892-7985 (20817 for non-USPS mail), 301-496-9838,
301-496-9839 (fax);
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-I-C, Reporting Requirements).
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