Federal Register / Vol. 45, No. 20 / Tuesday, January 29, 1980 / Notices 
6741 
required by these Guidelines for the 
proposed research, and 
IV-D-3-a-(2). An assessment of the 
facilities, procedures, and practices, and 
of the training and expertise of 
recombinant DNA personnel. 
Note. — See Laboratory Safety Monograph 
(pages 187-190) for suggested guidance in 
conducting this review. 
IV-D-3-b. Authorizing the Principal 
Investigator (PI) to proceed with the 
project upon receipt of proper agency 
approval; or authorizing the PI to 
proceed without agfency approval to 
initiate or change a project for which 
none of the exceptions under IV-D-l-c 
apply. 
Note. — Some examples of work that might 
ordinarily proceed without prior funding- 
agency approval are the initiation of a project 
at the PI or P2 level (other than the first 
project at the institution). Other examples are 
significant changes in hosts or vectors, in the 
donor species or the nature of the DNA 
segment selected, or in the physical location 
of the experiments. It should be clear, 
however, that the funding agency must be 
notified of IBC approvals even when prior 
agency approval is not required. See the 
Administrative Practices Supplement for 
further discussion. 
IV-D-3-c. Reviewing periodically 
recombinant DNA research being 
conducted at the Institution, to ensure 
that the requirements of the Guidelines 
are being fulfilled. 
IV-D-3-d. 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 Laboratory 
Safety Monograph. Included are information 
and references on decontamination and 
emergency plans. NIH and the Center 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-D-3-e. Reporting within 30 days to 
the appropriate institutional official and 
to the NIH Office of Recombinant DNA 
Activities (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-D-3-f. Performing such other 
functions as may be delegated to the 
IBC under Section IV-D-1. 
1V-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): 
IV-D-4-a. Ensuring through periodic 
inspections that laboratory standards 
are rigorously followed; 
IV-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 illnesses of which the 
BSO becomes aware, unless the BSO 
determines that the Principal 
Investigator (PI) has done so. 
IV-D-4-c. Developing emergency 
plans for dealing with accidental spills 
and personnel contamination, and 
investigating recombinant DNA research 
laboratory accidents; 
IV-D-4-d. Providing advice on 
laboratory security; 
IV-D-4-e. Providing technical advice 
to the PI and the IBC on research safety 
procedures. 
Note. — See Laboratory Safety Monograph 
for additional information on the duties of the 
BSO. 
IV-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: 
IV-D-5-a-(l). Initiate or modify no 
recombinant DNA research subject to 
the Guidelines until that research, or the 
proposed modification thereof, has been 
approved by the Institutional Biosafety 
Committee (IBC) and has met all other 
requirements of the Guidelines and the 
Administrative Practices Supplement 
(APS), and make changes to conform if 
the NIH Office of Recombinant DNA 
Activities' (ORDA's) review so requires. 
Note. — No prior approval by the IBC is 
required for most experiments described in 
Section III— 0. 
IV-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; 
IV-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 accidental spills and personnel 
contamination; and 
IV-D-5-a-(6). Comply with shipping 
requirements for recombinant DNA 
molecules. (See Section II— C for shipping 
requirements, Laboratory Safety 
Monograph for technical 
recommendations, and the APS for 
administrative instructions and 
procedures. The requesting laboratory 
must be in compliance with the NIH 
Guidelines and under appropriate 
review by its IBC, and the sending 
investigator must maintain a record of 
all shipments of recombinant DNA 
materials.) 
IV-D-5-b. Submissions by the PI to 
NIH. The PI shall: 
IV-D-5-b-(l). Submit information to 
NIH (ORDA) in order to have new host- 
vector systems certified; 
IV-D-5-b-(2). Petition NIH, with 
notice to the IBC, for exemptions to 
these Guidelines (see Sections I-E-4 and 
I-E-5 and, for additional information on 
procedures, the APS); and 
IV-D-5-b-(3). Petition NIH, with 
concurrence of the IBC, for exceptions to 
the prohibitions under these Guidelines 
(see Section I-D and, for additional 
information on procedures, the APS). 
IV-D-5-c. Submissions by the PI to 
the IBC. The PI shall: 
IV-D-5-c-(l). Make the initial 
determination of the required levels of 
physical and biological containment in 
accordance with the Guidelines; 
IV-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 (and also subsequent 
changes — e.g., changes in the source of 
DNA or host-vector system, which 
require a new or revised Memorandum 
of Understanding and Agreement) to the 
IBC for review and approval or 
disapproval; and 
IV-D-5-c-(4). Remain in 
communication with the IBC throughout 
the conduct of the project. 
IV-D-5-d. Pi Responsibilities After 
Approval But Prior to Initiating the 
Research. The Pi is responsible for: 
IV-D-5-d-(l). Making available to the 
laboratory staff copies of the approved 
protocols that describe the potential 
biohazards and the precautions to be 
taken; 
IV-D-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-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 Conduct of the Approved Research. 
The PI is responsible for: 
IV-D-S-e-(l). Supervising the safety 
performance of the staff to ensure that 
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