Federal Register / Vol. 47, No. 102 / Wednesday, May 26, 1982 / Notices 
23119 
or final, since all conceivable 
experiments involvnng recombinant 
DNA cannot be foreseen. Therefore, it is 
the responsibility of the Institution and 
those associated with it ta adhere to the 
purpose of the Guidelines as well as to 
their specifics. 
Each Institution (and the IBC acting 
on its behalf) is responsible for ensuring 
that recombinant DNA activities comply 
with the Guidelines. General recognition 
of institutional authority and 
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. Responsibilities 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: 
IV-B-l-a. Establish and implement 
policies that provide for the safe 
conduct of recombinant DHA 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 
fii) whatever additional precautionary 
steps the Institution may deem 
appropriate. 
IV-B-l-b. Establish an Institutional 
Biosafety Committee (IBC) that meets 
the requirements set forth in Section IV- 
B-2 and carries out the functions 
detailed in Section IV-B-3. 
IV-B-l-c. If the Institution is engaged 
in recombinant DNA research at the P3 
or P4 containment level, appoint a 
Biological Safety Officer (BSO), who 
shall be a member of the IBC 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 IBC chairperson and members, 
the BSO, Principal Investigators (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 responsibility 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 die 
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 steriods, 
immimosuppressive 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. The Institution shall 
establish an Institutional Biosafety 
Committee (IBC) whose responsibilities 
need not be restricted to recombinant 
DNA. The committee shall meet the 
following requirements: 
IV-B-2-a. Tlie 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 widi 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 Biological Safety 
Officer (BSO), mandatory when 
research is being conducted at the P3 
and P4 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, K 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. 
IV-B-2-C. The Institution shall 
identify the committee members by 
name in a report to the NIH Ofrice of 
Recombinant DNA Activities (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 whidi 
he or she has been, or expects to be, 
engaged or has a direct ^ancial 
interest. 
rV-B-2-e. The Institution, which 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. 
(ffiC 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 widi 
protection of privacy and proprietary 
interests. 
IV-B-2-g. Upon request, the 
Institution shall make available to the 
public aU 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 IBC’s response. 
[ 442 ] 
