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Federal Register / Vol. 49, No. 227 / Friday, November 23, 1984 / Notices 
and carry out the duties specified in 
Section IV-B-4. 
IV-B-l-d. Require that investigators 
responsible for research covered by 
these Guidelines comply with the 
provisions of Section IV-B-5 and assist 
investigators to do so. 
IV-B-l-e. Ensure appropriate training 
for the 1BC chairperson and members, 
the BSO, Pis, and laboratory staff 
regarding the Guidelines, their 
implementation, and laboratory safety. 
Responsibility for training IBC members 
may be carried out through the IBC 
chairperson. Responsibility for training 
laboratory staff may be carried out 
through the PI. The Institution is 
responsible for seeing that the PI has 
sufficient training but may delegate this 
responsbility to the IBC. 
IV-B-l-f. Determine the necessity in 
connection with each project for health 
surveillance of recombinant DNA 
research personnel, and conduct, if 
found appropriate, a health surveillance 
program for the project. [The 
"Laboratory Safety Monograph” (LSM) 
discusses various possible components 
of such a program — for example, records 
of agents handled, active investigation 
of relevant illnesses, and the 
maintenance of serial serum samples for 
monitoring serologic changes that may 
result from the employees’ work 
experience. Certain rpedical conditions 
may place a laboratory worker at 
increased risk in any endeavor where 
infectious agents are handled. Examples 
given in the LSM include 
gastrointestinal disorders and treatment 
with steroids, immunosuppressive drugs, 
or antibiotics. Workers with such 
disorders or treatment should be 
evaluated to determine whether they 
should be engaged in research with 
potentially hazardous organisms during 
their treatment or illness. Copies of the 
LSM are available from ORDA.j 
IV-B-l-g. Report within 30 days to 
ORDA any significant problems with 
and violations of the Guidelines and 
significant research-related accidents 
and illnesses, unless the institution 
determines that the PI or IBC has done 
so. 
IV-B-2. Membership and Procedures 
of the IBC. Institution shall establish an 
IBC whose responsibilities need not be 
restricted to recombinant DNA. The 
committee shall meet the following 
requirements: 
lV-B-2-a. The IBC shall comprise no 
fewer than five members so selected" 
that they collectively have experience 
and expertise in recombinant DNA 
technology and the capability to assess 
the safety of recombinant DNA research 
experiments and any potential risk to 
public health or the environment. At 
least two members 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 environment. Members 
meet this requirement if, for example, 
they are officials of State or local public 
health or environmental protection 
agencies, members of other local 
governmental bodies, or persons active 
in medical, occupational health, or 
environmental concerns in the 
community. The BSO, mandatory when 
research is being conducted at the BL3 
and BL4 levels, shall be a member (see 
Section IV-B-4). 
IV-B-2-b. In order to ensure the 
competence necessary to review 
recombinant DNA activites, it is 
recommended that: (i) The IBC include 
persons with expertise in recombinant 
DNA technology, biological safety, and 
physical containment: (ii) the IBC 
include, or have available as 
consultants, persons konwledgeable in 
institutional commitments and policies, 
applicable law, standards of 
professional conduct and practice, 
community attitudes, and the 
environment: and (iii) at least one 
member be from the laboratory 
technical staff. 
IV-B-2-c. The Institution shall 
identify the committee members by 
name in a report to ORDA and shall 
include relevant background 
information on each member in such 
form and at such times as ORDA may 
require. 
IV-B-2-d. No member of an IBC may 
be involved (except to provide 
information 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 has a direct Financial 
interest. 
IV-B-2-e. The Institution, who is 
ultimately responsible for the 
effectiveness of the IBC, may establish 
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-B-3-a.) 
IV-B-2-f Institutions are encouraged 
to open IBC meetings to the public 
whenever possible, consistent with 
protection of privacy and proprietary 
interests. 
IV-B-2-g. Upon request, the 
Instituiton 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 1 to make available to the 
public. If comments are made by 
members of the public on IBC actions. 
the Instituiton shall forward to NIH both 
the comments and the IBC's response. 
IV-B-3. Functions of the IBC. On 
behalf of the Institution, the !BC is 
responsible for: 
IV-B-3-a. Reviewing for compliance 
with the NIII 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 PI of the 
results of their review. 
IV-B-3-c. Lowering containment 
levels for certain experiments as 
specified in Section III— 13— 2. 
IV-B-3-d. Setting containment levels 
as specified in Section III— B — 4 — d 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-2-f. Adopting emergency plans 
covering accidental spille 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 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 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-B-3-g. Reporting within 30 days to 
the appropriate institutional official and 
to 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-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) established the containment 
requirement. 
IV-B-3-i. Performing such other 
functions as may be delegated to the 
IBC under Section IV-B-1. 
[267] 
