Federal Register / Vol. 44, No. 232 / Friday, November 30, 1979 / Notices 
69225 
IV-C-11. “Laboratory Safety 
Monograph” or "LSM” means a 
publication to accompany the NIH 
Guidelines describing practices, 
equipment, and facilities in detail. 
IV-D. Responsibilities of the 
Institution 
IV-D-1. 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-D-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-D-l-b. Establish an Institutional 
Biosafety Committee (IBC) that meets 
the requirements set forth in Section IV- 
D-2 and carries out the functions 
detailed in Section IV-D-3. 
IV-D-l-c. Submit, for each 
recombinant DNA project that meets 
with its approval, a Memorandum of 
Understanding and Agreement (MUA) to 
the funding agency for approval and 
registration. (NOTE: No MUA is 
required for experiments described in 
Section III— O.) All projects, however, 
can proceed upon IBC approval (before 
submission of the MUA to the funding 
agency) except for the following, which 
require prior approval by NIH (or other 
funcing agency designated by NIH for 
this purpose): 
IV-D-l-c-(l). Projects for which 
containment levels are not specified by 
the Guidelines or NIH, 
IV-D-l-c-{2). Projects requiring P4 
containment, 
IV-D-l-c-(3). Reductions of 
containment levels for characterized or 
purified DNA preparations or clones 
(see Section II-A-3), 
IV-D-l-c-{4). The first project 
conducted in a facility at P3 
containment, or 
IV-D-l-c-(5). The first project 
conducted by an Institution. 
Note. — The MUA shall be submitted to the 
funding agency within 30 days of the IBC 
approval. If the funding agency does not 
routinely register recombinant DNA projects 
with NIH. the MUA must be submitted to 
NIH as well as to the funding agency. 
Authority to submit MUAs (or addenda) for 
which prior approval is not required may be 
delegated to the IBC chairperson. All MUAs 
that require NIH approval before the work 
can proceed shall be submitted to the NIH by 
the institutional official to whom the IBC is 
responsible. 
IV-D-l-d. Take appropriate action to 
bring protocols into compliance when 
advised by NIH or other funding agency 
that IBC-approved projects do not 
conform to standards set forth in the 
Guidelines. This responsibility may be 
delegated to the IBC. (See 
Administrative Practices Supplement for 
further details). 
IV-D-l-e. 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-D- 
4. 
IV-D-1 -f. Require that investigators 
responsible for research covered by 
these Guidelines comply with the 
provisions of Section IV-D-5, and assist 
investigators to do so. 
rV-D-l-g. 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-D-l-h. 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 
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 
[ 211 ] 
hazardous organisms during their 
treatment or illness.) 
IV-D-l-L 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 EBC has done 
so. 
IV-D-2. Membership and Procedures 
of the IBC. The Institution shall 
establish an Institutional Biosafety 
Committee (IBC) meeting the following 
requirements: 
IV-D-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 leat 
two members (but not less than 20 
percent of the membership 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 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-D-4). 
IV-D-2-b. In order to ensure the 
professional competence necessary to 
review recombinant DNA activities, it is 
recommended that (i) the IBC include 
persons from disciplines relevant to 
recombinant DNA technology, biological 
safety, and engineering: (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 a nondoctoral person from a 
laboratory technical staff. 
IV-D-2-c. The Institution shall 
identify the committee members by 
name in a report to the NIH Office 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. (See the Administrative 
Practices Supplement for further 
guidance.) 
