17190 
Federal Register / Vol. 47, No. 77 / Wednesday, April 21. 1982 / Notices 
•ny tignificani r«March-related illnesa or 
accident that appears to be a hazard to the 
public health. 
rV-D-3-e. Reporting within 30 days to 
the appropriate institutional official and 
to the NIH Office of Recombinant DNA 
Activities (OROA) 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. 
rV-D-3-f. 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 
rV-D-'3-g. Performing such other 
functions as may be delegated to the 
IBC under Section IV-Q-l. 
rV-D-4. Biological Safety Officer. The 
Institution shall appoint a BSO if it 
engages in recombinant DNA research 
at the P3 or P4 containment level The 
officer shall be a member of the 
Institutional Biosafety Committee (IBC). 
and his or her duties shall include (but 
need not be limited to): 
rV-D-4-a. Ensuring through periodic 
inspections that laboratory standards 
are rigorously followed: 
rV-D-4-b. Reporting to the IBC and 
the Institution all significant problems 
with and violations of the Guidelines 
and all significant research-related 
accidents and iUinesses of which the 
BSO becomes aware, unless the BSO 
determines that the Principal 
Investigator (PI) has done so; 
rV-D-4-c Developing emergency 
plans for dealing with accidental spills 
and personnel contamination, and 
Investigating recombinant DNA research 
laboratory accidents; 
rV-D-4^ Providing advice on 
laboratory security, 
IV -D 4 e . Providiing technical advice 
to the PI and the IBC on research safety 
procedures. 
Note. — S«« Laboratory Safety Monograph 
for additional information on the duties of the 
BSO. 
rV-D-5. Principal Investigator. On 
behalf of the Institution, the PI is 
responsible for complying fully with the 
Guidelines in conducting any 
recombinant DNA research. 
IV-D-5-a. PI— General. As part of this 
general responsibility, the PI shall; 
rV-D-5-a-(l). Initiate or modify no 
recombinant DNA research requiring 
approval by the IBC prior to IniUation 
(see Sections Ill-A cmd IH-B) until that 
research, or the proposed modincation 
thereof, has been approved by the IBC 
and has met all other requirements of 
the Guidelines; 
rV-D-5-a-{2). 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-D-5-a-(3). Report to the IBC and 
to NIH (ORDA) new information bearing 
on the Guidelines; 
rV-D-5-a-(4). Be adequately trained 
in good microbiological techniques; 
IV-D-5-a-(5). Adhere to IBC- 
approved emergency plans for dealing 
with accidential spills and persoimel 
contamination; and 
rV-D-8-a-(6). Comply %vith shipping 
requirements for recombinant DNA 
molecules. (See Section II-C for shipping 
requirements and Laboratory Safety 
Monograph for technical 
recommendations.) 
IV-D-8-b. Submissions by the PI to 
NIH. The PI shaU: 
rV-D-5-b-(l). Submit Information to 
NIH (ORDA) in order to have new host- 
vector systems certified; 
IV-D4-b-{2). Petition NIH. with 
notice to the IBC. for exemptions to 
these Guidelines; 
rV-D-5-b-(3). Petition NIH with 
concurrence of the IBC for approval to 
conduct experiments specified in 
Section ni-A of the Guidelines; 
IV-D-8-b-{4). Petition NIH for 
determination of containment for 
experiments requiring case-by-case 
rovidw* 
IV-D-«-b-(5). Petition NIH for 
determination of containment for 
experiments not covered by the 
Guidelines. 
rV-D-S-c. Submissions by the PI to 
the IBC. The PI shaU; 
IV-D-5-c-(l). Make the initial 
determination of the required levels of 
physical and biological containment in 
accordance with the Guidelines; 
rV-D-5-c-(2). Select appropriate 
microbiological practices and laboratory 
techniques to be used in the research; 
IV-D-5-c-(3). Submit the initial 
research protocol if covered under 
Guidelines Sections IIl-A UI-B, or lU-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 
IV-D-5-o-{4). Remain in 
communication with the IBC throughout 
the conduct of the project. 
IV-D-5-d. PI Responsibilities Prior to 
Initiating Res^rch. The PI is 
responsible for. 
IV-D-5-d-(l). Making available to the 
laboratory staff copies of the protocols 
that describe the potential biohazards 
and the precautions to be taken; 
IV-D-^3-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-D-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. 
IV-D-5-e. PI Responsibilities During 
the Condust of the Research. The PI is 
responsible for 
IV-D-5-e-(l). Supervising the safety 
performance of the staff to ensure that 
the required safety practices and 
techniques are employed; 
IV-D-5-e-{2). Investigating and 
reporting in writing to ORDA. the 
Biological Safety Officer (where 
applicable), and the IBC any significant 
problems pertaining to the operation 
and Implementation of containment 
practices and procedures; 
IV-D-S-e-(3). Correcting work errors 
and conditions that may result in the 
release of recombinant DNA materials; 
IV-D-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); and 
IV-D-5-e-(5). Publications. Pis are 
urged to include, in all publications 
reporting on recombinant DNA research, 
a description of the physical and 
biological containment procedures 
employed. 
IV-E. Responsibilities of NIH. 
rV-E-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 a number of 
responsibilities under the Guidelines 
that involve the NIH Office of 
Recombinant DNA Activities (ORDA) 
and the Recombinant DNA Advisory 
Committee (RAC). ORDA’s 
responsibilities under the Guidelines are 
administrative. Advice from the RAC is 
primarily scientffic and technical. In 
certain circumstances, there is specific 
opportunity for public comment, with 
published response, before final action. 
rV-E-l-a. General Responsibilities of 
the Director, NIH. The responsibilities 
of the Director shall include the 
following; 
IV-E-l-a-(l). Promulgating 
requirements as necessary to implement 
the Guidelines; 
rV-E-l-a-(2). Establishing and 
maintaining the RAC to carry out the 
responsibilities set forth in Section IV- 
E-2. The RAC's membership is'specihed 
in its charter and in Section IV-^2; 
IV-E-l-a-(3). Establishing and 
maintaining ORDA to carry out the 
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