77398 
Federal Register / Vol. 45, No. 227 / Friday, November 21, 1980 / Notices 
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. General Applicability. The 
Guidelines are applicable to all 
recombinant DNA research within the 
United States or its territories which is 
conducted at or sponsored by an 
Institution that receives any support for 
recombinant DNA research from NIH. 
This includes research performed by 
NIH directly. 
An individual receiving support for 
research involving recombinant DNA 
must be associated with or sponsored 
by an Institution that can and does 
assume the responsibilities assigned in 
these Guidelines. 
The Guidelines are also applicable to 
projects done abroad if they are 
supported by NIH funds. If the host 
country, however, has established rules 
for the conduct of recombinant DNA 
projects, then a certificate of compliance 
with those rules may be submitted to 
NIH in lieu of compliance with the NIH 
Guidelines. NIH reserves the right to 
withhold funding if the safety practices 
to be employed abroad are not 
reasonably consistent with the NIH 
Guidelines. 
IV-C. General Definitions. The 
following terms, which are used 
throughout the Guidelines, are defined 
as follows: 
IV-C-1. “DNA” means 
deoxyribonucleic acid. 
IV-C-2. “Recombinant DNA” or 
“recombinant DNA molecules” means 
either (i) molecules which are 
constructed outside living cells by 
joining natural or synthetic DNA 
segments to DNA molecules that can 
replicate in a living cell, or (ii) DNA 
molecules which result from the 
replication of a molecule described in (i) 
above. 
IV-C-3. (Deleted) 
IV-C-4. “Institution” means any 
public or private entity (including 
Federal, State, and local government 
agencies). 
IV-C-5. “Institutional Biosafety 
Committee” or “IBC" means a 
committee that (i) meets the 
requirements for membership specified 
in Section IV-D-2, and (ii) reviews, 
approves, and oversees projects in 
accordance with the responsibilities 
defined in Sections IV-D-2 and -3. 
IV-C-6. "NIH Office of Recombinant 
DNA Activities” or “ORDA” means the 
office within NIH with responsibility for 
(i) reviewing and coordinating all 
activities of NIH related to the 
Guidelines, and (ii) performing other 
duties as defined in Section IV-E-3. 
IV-C-7. "Recombinant DNA Advisory 
Committee” or "RAC” means the public 
advisory committee that advises the 
Secretary, the Assistant Secretary for 
Health, and the Director of the National 
Institutes of Health concerning 
recombinant DNA research. The RAC 
shall be constituted as specific in 
Section IV-E-2. 
IV-C-8. “Director, NIH” or “Director” 
means the Director of the National 
Institutes of Health and any other officer 
or employee of NIH to whom authority 
has been delegated. 
IV-C-9. "Federal Interagency 
Advisory Committee on Recombinant 
DNA Research” means the committee 
established in October 1976 to advise 
the Secretary, HEW, the Assistant 
Secretary for Health, and the Director, 
NIH, on the coordination of those 
aspects of all Federal programs and 
activities which relate to recombinant 
DNA research. 
IV-C-10. “Administrative Practices 
Supplement” or "APS” means a 
publication to accompany the NIH 
Guidelines specifying administrative 
procedures for use at NIH and at 
Institutions. 
IV-C-11. “Laboratory Safety 
Monograph" or “LSM” means a 
publication to accompany the NIH 
Guidelines describing practices, 
equipment, and facilities in detail. 
I V-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. (Deleted) 
IV-D-l-d. (Deleted) 
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-l-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. 
IV-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 
hazardous organisms during their 
treatment or illness.) 
IV-D-l-i. Report within 30days 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-D-2. Membership and Procedures 
of the IBC. The Institution shall 
establish an Institutional Biosafety 
Committee (IBC) meeting the following 
requirements: 
[17] 
