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Federal Register / Vol. 51, No. 88 / Wednesday, May 7, 198G / Notices 
responsibility properly establishes 
accountability for safe conduct of the 
research at the local level. 
The following roles and 
responsibilities constitute an 
administrative framework in which 
safety is an essential and integral part of 
research involving recombinant DNA 
molecules. Further clarifications and 
interpretations of roles and 
responsibilities will be issued by NIH as 
necessary. 
IV-B — Responsibility of the Institution 
IV-B-1. General Information. Each 
institution conducting or sponsoring 
recombinant DNA research covered by 
these Guidelines is responsible for 
ensuring that the research is carried out 
in full conformity with the provisions of 
the Guidelines. In order to fulfill this 
responsibility, the institution shall: 
TV-B-l-a. Establish and implement 
policies that provide for the safe 
conduct of recombinant DNA research 
and that ensure compliance with the 
Guidelines. The institution as part of its 
general responsibilities for implementing 
the Guidelines may establish additional 
procedures as deemed necessary to 
govern the institution and its 
components in the discharge of its 
responsibilities under the Guidelines. 
This may include: (i) Statements 
formulated by the institution for general 
implementation of the Guidelines, and 
(ii) whatever additional precautionary 
steps the institution may deem 
appropriate. 
IV-B-l-b. Establish an IBC that meets 
the requirements set forth in Section IV- 
B-2 and carries out the functions 
detailed in Section IV-B-3. 
TV-B-l-c. If the institution is engaged 
in recombinant DNA research at the BL3 
or BL4 containment level, appoint a 
BSO, who shall be a member of the IBC 
and carry out the duties specified in 
Section IV-B— 1. 
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. 
rV-B-l-e. Ensure appropriate training 
for the IBC chairperson and members, 
the BSO, PI 3 , 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 
responsibility to the IBC. 
IV-B-l-f Determine the necessity in 
connectior 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 medical 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 Guildelines and 
significant research-related accidents 
and illnesses, unless the institution 
determines that the PI or IBC has done 
so. 
IV-3-2. Membership and Procedures 
of the IBC. The institution shall 
establish an IBC whose responsibilities 
need not be restricted to recombinant 
DNA. The committee shall meet the 
following requirements: 
IV-B-2-a. The IEC 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 activities, 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 knowledgeable 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. 
1V-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 public 
whenever possible, consistent with 
protection of privacy and proprietary 
interests. 
IV-B-2-g. Upon request, the 
institution 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. If comments are made by 
members of the public on IBC actions, 
the institution shall forward to NIH both 
the comments and the ICB's response. 
IV-B-3. Functions of the IBC. On 
behalf of the institution, the IBC is 
responsible for: 
IV-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 tfiat it finds are in 
conformity with the Guidelines. This 
review shall include: 
I\'-B-3-a-(l). An independent 
assessment of the containment levels 
required by these Guidelines for the 
proposed research, and 
TV-B-3-a-(2). An assessment of the 
facilities, procedures, and practices, anu 
of the training and expertise of 
recombinant DNA personnel. 
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Recombinant DNA Research, Volume 1 1 
