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Federal Register / Vol. 47, No. 102 / Wednesday, May 26. 1982 / Notices 
rV-B-3. Functions of the IBC. On 
behalf of the Institution, the IBC is 
responsible for 
rV-B-3-a. Reviewing for compliance 
with the NIH Guidelines recombinant 
DNA research as specified in Part III 
conducted at or sponsored by the 
Institution, and approving those 
research projects that it finds are in 
conformity with the Guidelines. This 
review shall include: 
IV-B-3-a-{l). An independent 
assessment of the containment levels 
required by these Guidelines for the 
proposed research, and 
IV-B-3-a-{2). An assessment of the 
facilities, procedures, and practices, and 
of the training and expertise of 
recombinant DNA personnel. 
IV-B-3-b. Notifying the Principal 
Investigator (PI) of the results of their 
review. 
IV-B-^-c. Lowering containment 
levels for certain experiments as 
specified in Section lll-B-2. 
IV-B-3-d. Setting containment levels 
as specified in Section III-B-4-b and III- 
B-5. 
IV-B-3-e. Reviewing periodically 
recombinant DNA research being 
conducted at the Institution, to ensure 
that the requirements of the Guidelines 
are being fulfilled. 
IV-B-3-f. Adopting emergency plans 
covering accidental spills and personnel 
contamination resulting from such 
research. 
Not*. — Basic elements In developing 
spedfic procedures for dealing with major 
•pills of potentially hazardous materials in 
the laboratory are detailed In the Laboratory 
Safety Monograph (LSM). Included are 
Information and references on 
decontamination and emergency plans. NIH 
and the Centers for Disease Control are 
available to provide consultation, and direct 
assistance if necessary, as posted in the LSM. 
The Guidelines shall cooperate svith the State 
and local public health departments, 
reporting any significant research-related 
Illness or acddent that appears to be a 
hazard to the public health. 
rV-B-3-g. 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. 
rV-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. 
rV-B-3-1. Performing such other 
functions as may be delegated to the 
IBC under Section IV-B-1. 
IV-B-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-B 4 a . Ensuring through periodic 
inspections that laboratory standards 
are rigorously followed: 
IV-B-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-Ei-4-c. Developing emergency 
plans for dealing with accidental spills 
and personnel contamination, and 
investigating recombinant DNA research 
laboratory accidents; 
IV-B-4^. Providing advice on 
laboratory security: 
IV-B 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-B-5. Principal Investigator. On 
behalf of the Institution, the PI is 
responsible for complying fully with the 
Guidelines in conducting any 
recombinant DNA research. 
lV-B-5-a. PI — General. As part of this 
general responsibility, the PI shall: 
IV-B-5-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; 
IV-B-5-a-{3). 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-a-(4). Report to the IBC and to 
NIH (ORDA) new information bearing 
on the Guidelines; 
IV-B-5-a-(5). Be adequately trained 
in good microbiological techniques; 
lV-B-6-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 Laboratory Safety 
Monograph for technical 
recommendations.) 
IV-B-5-b. Submissions by the PI to 
NIH. The PI shall: 
IV-B-5-b-(l). Submit information to 
NIH (ORDA) in order to have new host- 
vector systems certified: 
lV-B-5-b-(2). Petition NIH. with 
notice to the IBC, for exemptions to 
these Guidelines; 
lV-B-5-b-{3). Petition NIH, with 
concurrence of the IBC, for approval to 
conduct experiments specified in 
Section Ill-A of the Guidelines; 
1V-B-5-M4). Petition NIH for 
determination of containment for 
experiments requiring case-by-case 
review; 
IV-&-5-b-(5). Petition NIH for 
determination of containment for 
experiments not covered by the 
Guidelines. 
I V-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. III-B, or III-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-B-5-c-{4). Remain in 
communication with the IBC throughout 
the conduct of the project. 
IV-B-5-d. P! 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; 
IV-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 
Biological Safety Officer (where 
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