Federal Register / Vol. 51, No. 83 / Wednesday. May 7, 1986 / Notices 
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[V-B-3-b. Notifying the PI of the 
results of their review. 
IV-B-3-C. Lowering containment 
levels for certain experiments as 
specified in Sections IU-B-2. 
IV-B-3-d. Setting containment levels 
as specified in Section III— B — t-b and III— 
B-5. 
r\/-B-3-e. Reviewing periodically 
recombinant DNA research being 
conducted at the institution to ensure 
that the requirements of the Guidelines 
are being fulfilled. 
lV-B-3-f. Adopting emergency plans 
covering accidental spills and personnel 
contamination resulting from such 
research. 
Note. — Basic elements in developing 
specific procedures for dealing with major 
spills of potentially hazardous materials in 
the laboratory are detailed in the LSM. 
Included are information and references on 
decontamination and emergency plans. The 
N!H and the Centers for Disease Control are 
available to provide consultation and direct 
assistance, if necessary, as posted in the 
LSM. The institution shall cooperate with the 
State and local public health departments 
reporting any significant research-related 
illness or accident that appears to be a 
hazard to the public health. 
IV-B-3-g. Reporting within 30 days to 
the appropriate institutional official and 
to ORDA any significant problems with 
or violations of the Guidelines and any 
significant research-related accidents or 
illnesses unless the IBC determines that 
the PI has done so. 
IV-B-3-h. The IBC may not authorize 
initiation of experiments not explicitly 
covered by the Guidelines until NIH 
(with the advice of the RAC when 
required) establishes the containment 
requirement. 
tV-B-3-i. Performing such other 
functions as may be delegated to the 
IBC under Section IV-B-1. 
IV-B-i. Biological Safety Officer. The 
institution shall appoint a BSO if it 
engages in recombinant DNA research 
at the BL3 or BL4 containment level. The 
officer shall be a member of the IBC. 
and his or her duties shall include (but 
need not be limited to): 
TV-B—4-a. Ensuring through periodic 
inspections that laboratory standards 
are rigorously followed; 
IV-B—t-b. Reporting to the IBC and 
the institution all significant problems 
with and violations of the Guidelines 
and all significant research-related 
accidents and illnesses of which the 
BSO becomes aware unless the BSO 
determines that the PI has done so; 
fV-B-4-c. Developing emergency 
plans for dealing with accidental spills 
and personnel contamination and 
investigating recombinant DNA research 
laboratory accidents, 
rV-B-4-d. Providing advice on 
laboratory security: 
IV-B—t-e. Providing technical advice 
to the PI and the IBC on research safety 
procedures. 
Note. — See the LSM for additional 
information on the duties of the BSO. 
IV-B-o. Principal Investigator (PI). 
On behalf of the institution, the PI is 
responsible for complying fully with the 
Guidelines in conducting any 
recombinant DNA research. 
rV-B-5. PI — General. As part of this 
general responsibility, the PI shall: 
rV-BS-a-(l). Initiate or modify no 
recombinant DNA research requiring 
approval by the IBC prior to initiation 
(see Sections III-A and III— B) until that 
research or the proposed modification 
thereof has been approved by the IBC 
and has met all other requirements of 
the Guidelines; 
IV-B-5-a-(2). Determine whether 
experiments are covered by Section III— 
C and follow the appropriate 
procedures: 
[V-B-5-a-(3j. Report within 30 days 
to the IBC and NIH (ORDA) all 
significant problems with and violations 
of the Guidelines and all significant 
research-related accidents and illnesses: 
IV-B-5-o-(4). Report to the IBC and to 
NTH (ORDA) new information bearing 
on the Guidelines: 
lV-B-5-a-(5). Be adequately trained 
in good microbiological techniques: 
rV-BS~a-(6). Adhere to IBC- 
approved emergency plans for dealing 
with accidental spills and personnel 
contamination: and 
IV-B-5-a-(7). Comply with shipping 
requirements for recombinant DNA 
molecules. (See Appendix H for shipping 
requirements and the LSM for technical 
recommendations.) 
rV-BS-b. Submissions by the PI to 
NIH. The PI shall: 
rV-B-S-b-(l). Submit information to' 
NIH (ORDA) in order to have new host- 
vector systems certified; 
IV-B-5-b-(2). Petition NIH with 
notice to the IBC for exemptions to these 
Guidelines; 
IV-B~5-b-{3). Petition NIH with 
concurrence of the IBC for approval to 
conduct experiments specified in 
Section III-A of the Guidelines; 
IV-B-5-b-(4). Petition NIH for 
determination of containment for 
experiments requiring case-bv-case 
review; 
IV-B—5-b~{5). Petition NIH for 
determination of containment for 
experiments not covered by the 
Guidelines. 
IV-B-5-c. Submissions by the PI to 
the IBC. The PI shall: 
IV-B-5-c-(l). Make the initial 
determination of the required levels of 
physical and biological containment in 
accordance with the Guidelines; 
IV-B-5-c-{2). Select appropriate 
microbiological practices and laboratory 
techniques to be used in the research; 
IV-B-5-c-(3). Submit the initial 
research protocol if covered under 
Guidelines Section III-A. Ill— B. or III— C 
(and also subsequent changes — ex- 
changes in the source of DNA or host- 
vector system) to the IBC for review and 
approval or disapproval; and 
IV-B-5-c-(4). Remain in 
communication with the IBC throughout 
the conduct of the project. 
IV-B-5-d. PI Responsibilities Prior to 
Initiating Research. The PI is 
responsible for 
IV-B-5-d-{l). Making available to the 
laboratory staff copies of the protocols 
that describe the potential biohazards 
and the precautions to be taken: 
lV-B-5-d-(2). Instructing and training 
staff in the practices and techniques 
required to ensure safety and in the 
procedures for dealing with accidents; 
and 
IV-B-5~d-(3). Informing the staff of 
the reasons and provisions for any 
precautionary medical practices advised 
or requested, such as vaccinations or 
serum collection. 
lV-B-5-e. PI Responsibilities During 
the Conduct of the Research. The PI is 
responsible for: 
IV-B-5-e-(l). Supervising the safety 
performance of the staff to ensure that 
the required safety practices and 
techniques are employed: 
IV-B-5-e-(2 ). Investigating and 
reporting in writing to ORDA, the BSO 
(where applicable), and the IBC any 
significant problems pertaining to the 
operation and implementation of 
containment practices and procedures; 
IV-B-5—e-(3). Correcting work errors 
and conditions that may result in the 
release of recombinant DNA materials; 
rV-B-5~e-(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). 
IV -C — Responsibilities of NIH 
IV-C-1. Director. The Director, NIH, 
is responsible for (i) establishing the 
NIH Guidelines for Research Involving 
Recombinant DNA Molecules, (ii) 
overseeing their implementation, and 
(iii) their final interpretation. 
The Director has responsibilities 
under the Guidelines that involve ORDA 
and RAC. The ORDA’s responsibilities 
under the Guidelines are administrative. 
Advice from the RAC is primarily 
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