NOTICES 
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Ration of relevant Illnesses acquired by 
recombinant DNA research personnel, 
and the maintenance of serial serum 
samples (see ^“Laboratory Safety 
Monograph— A supplement to the 
{JTH Guidelines for Recombinant DNA 
Research’’ for additional information 
6n medical surveillance); 
XV-A-l-f. Establish rules as neces- 
sary to implement the Guidelines. 
IV-A-2. Institutional Biosafety Com- 
mittee. The principal functions of the 
IBC are to review and oversee all re- 
combinant DNA projects and to advise 
the institution and ORDA whether 
the proposals and the research comply 
with the NIH Guidelines. 
The IBC shall be a committee of not 
less than five members so selected 
that the committee has the experience 
and expertise to assess the safety of 
proposed recombinant DNA research 
projects and any potential risks to 
public health or the environment. Its 
membership should include individ- 
uals from disciplines relevant to re- 
combinant DNA technology, biological 
safety, and engineering. It is recom- 
mended that the EBC also include 
members knowledgeable about such 
matters as applicable law, standards of 
professional conduct and practice, 
community attitudes, and the environ- 
ment, It is recommended that at least 
one member be a nondoctoral person 
from a laboratory technical staff. No 
member of an IBC may be involved 
(except to provide information re- 
quested by the IBC) in the review or 
approval of a project in which he or 
she has been, or excepts to be en- 
gaged, or has a direct flnanical inter- 
est. At least one member shall not be 
affiliated with the institution, i.e., no 
IBC may consist entirely of persons 
who are officers, employees, or agents 
of the institution, or are otherwise as- 
sociated with it apart from their mem- 
bership on the IBC. 
On behalf of the Institution, the EBC 
shall: 
IV-A-2-a. Review and, if in compli- 
ance with the NIH Guidelines, ap- 
proved the initiation of all proposed 
recombinant DNA research conducted 
at or sponsored by the institution re- 
ceiving NIH funds for any recombin- 
ant DNA research. (All P4 research 
must recieve prior approval by NIH 
before its initiation.) This review shall 
include (i) an independent assessment 
of the containment levels required by 
these guidelines for the proposed re- 
search, and (li) review and approval of 
facilities, procedures, practices, and 
the training and expertise of recom- 
binant DNA personnel; 
IV-A-2-b. Consider requests for ap- 
proval of single-step reductions in con- 
tainment levels for experiments with 
purified DNA and characterized clones 
and report to ORDA those actions in 
which approval is given (see section 
m-A-3); 
IV-A-2-c. Review periodically recom- 
binant DNA research being conducted 
at the institutions; 
IV-A-2-d. Review and approve emer- 
gency plans covering accidental spills 
and personnel cpntamlnation resulting 
from this research; 
IV-A-2-e. Report promptly to 
ORDA any problems with the Guide- 
lines of violations; 
IV-A-2-f. Keep minutes of meetings 
and, upon request, make them availa- 
ble to the public; 
IV-A-2-g. Otherwise advise the insti- 
tution and ORDA on policy matters 
relating to recombinant DNA re- 
search. 
Appendix C and “Laboratory Safety 
Monagraph— A Supplement to the 
NIH Guidelines for Recombinant DNA 
Research” contain additional informa- 
tion and suggestions regarding the 
function and operation of EBCs. 
IV-A-3. Biological Safety Officer. A 
biological safety officer shall be desig- 
nated by each institution engaged in 
recombinant DNA research at the P3 
or P4 containment level. The officer 
shall be a member of the EBC. His or 
her duties shall include, but need not 
be limited to: 
IV-A-3-a. Insuring through periodic 
inspections that laboratory safety 
standards are rigorously followed; 
IV-A-3-b. Developing emergency 
plans for dealing with accidental spills 
and personnel contamination, and in- 
vestigating recombinant DNA research 
laboratory accidents; 
IV-A-3-c. Providing advice on labo- 
ratory security; 
IV-A-3-d. Providing technical advice 
to the principal investigator and EBC 
on research safety procedures. 
See “Laboratory Safety Mono- 
graph— A Supplement to the NIH 
Guidelines for Recombinant DNA Re- 
search" for additional Information on 
the duties of the Biological Safety Of- 
ficer. 
IV-A-4. Principal Investigator. The 
principal investigator is responsible 
for conducting his or her recombinant 
DNA research in compliance with the 
NIH Guidelines. On behalf of the in- 
stitution, the principal investigators 
responsible for; 
IV-A-4- a. Complying fully with the 
guidelines in carrying out the re- 
search; 
EV-A-4-b. Making the initial deter- 
mination of the required levels of 
physical and biological containment in 
accordance with the guidelines; 
IV-A-4-c. Selecting appropriate mi- 
crobiological practices and laboratory 
techniques to be used In the research; 
IV-A-4 -d. Being adequately trained 
in good microbiological techniques; 
IV-A-4-e. Submitting the proposed 
research (including subsequent 
changes in the protocol— e.g., changes 
in the source of DNA or host-vector 
system to be used) to the IBC for 
review and approval or disapproval, 
and remaining in communication with 
the IBC throughout the conduct of 
the project; 
IV-A-4-f. Initiating no recombinant 
DNA research subject to the guide- 
lines until it has been approved by the 
IBC and has met all other require- 
ments of the guidelines, and agreeing 
to make changes to conform if 
ORDA’s review so requires; 
IV-A-4-g. Petitioning NIH, after no- 
tifying the EBC, for exceptions or ex- 
emptions (4) to these guidelines — e.g., 
for an exception to a prohibition (see 
section I-D) or an exemption from the 
guidelines (see section I-E-4 and I-E- 
5). Each request for such an exception 
or exemption must be accompanied by 
adequate documentation (see appen- 
dix C for additional information on 
procedures); 
IV-A-4-h. Reporting promptly to 
the EBC and NIH (ORDA) any prob- 
lems with or violations of the guide- 
lines; 
IV-A-4-1. Submitting information on 
proposed new host-vector systems to 
ORDA in order to have them certified; 
EV-A-4-J. Reporting to the IBC and 
ORDA new information bearing on 
the guidelines; 
IV-A-4-k. Adhering to EBC-approved 
emergency plans for dealing with acci- 
dental spills and personnel contamina- 
tion; 
IV-A-4-1. Complying with shipping 
requirements for recombinant DNA 
molecules (see section H-C, appendix 
C, and “Laboratory Safety Mono- 
graph— A Supplement to the NIH 
Guidelines for Recombinant DNA Re- 
search” for instructions on shipping 
and distributing organisms and viruses 
containing recombinant DNA); 
IV-A-4-m. After receiving EBC ap- 
proval and before initiating the re- 
search, the principal investigator is re- 
sponsible for: 
IV-A-4-m-( 1 ). Making available to 
the laboratory staff copies of the ap- 
proved protocols that describe the po- 
tential biohazards and the precautions 
to be taken; 
IV-A-4-m-<2). Instructing and train- 
ing the staff in the practices and tech- 
niques required to insure safety and in 
the procedures for dealing with acci- 
dents; 
IV-A-4-m-(3). Informing the staff of 
the reasons and provisions for any ad- 
vised or requested precautionary medi- 
cal practices, such as vaccinations or 
serum collection. 
IV-A-4-n. During the conduct of the 
research, the principal investigator is 
responsible for 
IV-A-4-n-(I). Supervising the safety 
performance of the staff to insure 
FEDERAL tEOISTM, VOL 43, NO. 146— FRIDAY, JULY 23, 1973 
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