bership of the committee) shall not be 
affiliated with the Institution (apart 
from their membership on the IBC) 
and shall represent the interest of the 
surrounding community with respect 
to health and protection of the envi- 
ronment. Members meet this require- 
ment if. for example, they are officials 
of State or local public health or envi- 
ronmental protection agencies, mem- 
bers of other local governmental 
bodies, or persons active in medical, 
occupational health, or environmental 
concerns in the community. "The Bio- 
logical Safety Officer (BSO), manda- 
tory when research Is being conducted 
at the P3 and P4 levels, shall be a 
member (see Section IV-D-4). 
IV-D-2-b. In order to ensure the 
professional competence necessary to 
review recombinant DNA activities, it 
is reco mended that (1) the IBC Include 
persons from disciplines relevant to re- 
combinant DNA technology, biological 
safety, and engineering; (ID the IBC 
Include, or have available as consul- 
tants. persons knowledgeable in insti- 
tutional commitments and policies, ap- 
plicable law. standards of professional 
conduct and practice, community atti- 
tudes, and the environment; and flii) 
at least one member be a non doctoral 
person from a laboratory technical 
staff. 
IV-D-2-C. The Institution shall iden- 
tify the committee members by name 
in s report to the NIH Office of Re- 
combinant DNA Activities (ORDA) 
and shall include relevant background 
information on each member in such 
form and at such times as ORDA may 
require. (See the Administrative Prac- 
tices Supplement for further guid- 
ance.) 
IV-D-2-d. No member of an IBC 
may be Involved (except to provide in- 
formation requested by the IBC) In 
the review or approval of a project in 
which he or she has been, or expects 
to be. engaged or bas a direct financial 
interest. 
rV-D-2-e. The Institution may es- 
tablish procedures that the IBC will 
follow in its initial and continuing 
review of applications, proposals, and 
activities. (IBC review procedures are 
specified in section IV-D-3-a.) 
IV-D-2-f. Central to implementation 
of the Guidelines is the review of pro- 
posed experiments by the IBC. The 
Institution shall submit, within 30 
days of IBC approval, an MU A to NIH 
(ORDA), or shall otherwise register 
proposed experiments as specified 
under Sections IV-D-l-c, IV-D-l-d. 
and IV-P. In carrying out this respon- 
sibility. the Institution shall comply 
with Instructions and procedures spec- 
ified In the Administrative Practices 
Supplement. 
IV-D-2-g. Institutions are encour- 
aged to open IBC meetings to the 
public whenever possible, consistent 
FEDBtAL 
NOTICES 
with protection of privacy and propri- 
etary interests. 
IV-D-2-h. Upon request, the Institu- 
tion shall make available to the public 
all minutes of IBC meetings and any 
documents submitted to or received 
from funding agencies which the 
latter are required to make available • 
to the public (e.g.. MUAs. reports of 
Guideline violations and significant re- 
search-related accidents, and agency 
directives to modify projects). If com- 
ments are made by members of the 
public on IBC actions, the Institution 
shall forward to NIH both the com- 
ments and the IBC's response. 
IV-D-3. Functions of the IBC. On 
behalf of the Institution, the IBC is 
responsible for 
IV-D-3-a. Reviewing for compliance 
with the NIH Guidelines all recombin- 
ant DNA research to be conducted at 
or sponsored by the Institution, and 
approving those research projects that 
it finds are in conformity with the 
Guidelines. (See Administrative Prac- 
tices Supplement, II-D. for prior NIH 
approval requirements.) This review 
shall include: 
IV-D-3-a-(I). An Independent as- 
sessment of the containment levels re- 
quired 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. 
Not*; 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 pro- 
ceed without agency approval to initi- 
ate or change a project for which none 
of the exceptions under IV-D-I-c 
apply. 
Note Some examples of wo k that might 
ordinarily proceed without prior funding- 
agency approval are the ln dation of a proj- 
ect at the PL or P2 levei (other than the 
first project at the Institution). Other exam- 
ples are significant changes In hosts or vec- 
tors. in the donor species or the nature of 
the DN A segment selected, or in the physi- 
cal location of the experiments. SUli others 
are single-step reductions In containment 
level for (1) experiments with DNA recom- 
binants from cellular DNAs that have been 
purified and are Judged to be free of harm- 
ful sequences (see Section ITI-A-3-a) and 
for Cli > clones that have been characterized 
and judged to be free of harmful sequences 
(see Section ni-A-3-b). It should be dear, 
however, that the funding agency must be 
notified of IBC approvals even when prior 
agency approval is not required. See the Ad- 
ministrative Practices Supplement for fur- 
ther discussion. 
IV-D-3-c. Reviewing periodically re- 
combinant DNA research being con- 
ducted at the Institution, to insure 
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60125 
that the requirements of the Guide- 
lines are being fulfilled. 
IV-D-3-d. Adopting emergency plans 
covering accidental spills and person- 
nel contamination resulting from such 
research. 
Note: Basic elements in developing specif- 
ic procedures for dealing with major spills 
of potentially hazardous materials in the 
laboratory are detailed in the Laboratory 
Safety Monograph. Included are informa- 
tion and references on decontamination and 
emergency plans. NIH and the Center for 
Disease Control are available to provide con- 
sultation. and direct assistance if necessary, 
as posted in the LSM. The Institution shall 
cooperate with the State and local public 
health departments, reporting any signifi- 
cant 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 offi- 
cials and to the NIH Office of Recom- 
binant DNA Activities (ORDA) any 
signficant 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. 
IV-D-4. Biological Safety Officer. 
The Institution shall appoint a BSO if 
it engages in recombinant DNA re- 
search 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 in- 
clude (but need not be limited to): 
IV-D-4-a. Insuring 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 ac- 
cidents and illnesses of which the BSO 
becomes aware, unless the BSO deter- 
mines that the Principal Investigator 
(PI) has done so. 
TV-D-4-C. Developing emergency 
plans for dealing with accidental spills 
and personnel contamination, and in- 
vestigating recombinant DNA research 
laboratory accidents; 
IV-D-4-d. Providing advice on labo- 
ratory 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 re- 
sponsible for complying fully with the 
Guidelines in conducting any recom- 
binant DNA research. 
IV-D-5-a. PI— General. As part of 
this general responsibility, the PI 
shall: 
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