Federal Register / Vol. 45, No. 227 / Friday, November 21, 1980 / Notices 
77399 
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 poitential risk to 
public health or the environment. At 
least 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 
m,eet 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 
institution 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 Practice 
Supplement for further guidance.) 
IV-D-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-D-2-e. The Institution 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-D-3-a.) 
IV-D-2-f. Central to implementation 
of the Guidelines is the review of 
experiments by the IBC. In carrying out 
this responsibility, the Institution shall 
comply with instructions and procedures 
specified in the Administrative Practices 
Supplement. 
IV-D-2-g. Institutions are encouraged 
to open IBC meetings to the public 
whenever possible, consistent with 
protection of privacy and proprietary 
interests. 
IV-D-2-h. 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 (e.g., reports of Guideline 
violations and significant research- 
related accidents, and agency directives 
to modify projects). 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. 
IV-D-3. Functions of the IBC. On 
behalf of the Institution, the IBC is 
responsible for: 
IV-D-3-a. Reviewing for compliance 
with the NIH Guidelines all recombinant 
DNA research 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-D-3-a-(l). An independent 
assessment of the containment levels 
required by these Guideline? for the 
proposed research, and 
IV-D-3-a-(2). An assessment of the 
facilities, procedures, and practices, and 
of the training and expertise of 
recombinant DNA personnel. 
Note. — See Laboratory Safety Monograph 
(pages 187-190) for suggested guidance in 
conducting this review. 
IV-D-3-b. Notifying the Principal 
Investigator (PI) of the results of their 
review. 
IV— D — 3 — c. Reviewing periodically 
recombinant DNA research being 
conducted at the Institution, to ensure 
that the requirements of the Guidelines 
are being fulfilled. 
IV-D-3-d. Adopting emergency plans 
covering accidental spills 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 Laboratory 
Safety Monograph. 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 reseach-related illness or 
accident that appears to be a hazard to the 
public health. 
IV-D-3-e. Reporting within 30 days to 
the appropriate institutional official and 
to the NIH Office of Recombinant DNA 
Activities (ORDA) any significant 
problems with or violations of the 
Gidelines, and any significant research- 
related accidents or illnesses, unless the 
IBC determines that the PI has done so. 
IV-D-3-f. The IBC may not authorize 
initiation of experiments not explicitly 
covered by the Guidelines until NIH, 
(with the advice of the RAC when 
required) establishes the containment 
requirement. 
IV-D-3-g. Performing such other 
functions as may be delegated to the 
IBC under Season IV-D-1. 
IV-D-4. Biological Safety Officer. The 
Institution shall appoint a BSO if it 
engages in recombinant DNA research 
at the P3 or P4 containment level. The 
officer shall be a member of the 
Institutional Biosafety Committee (IBC), 
and his or her duties shall include (but 
need not be limited to): 
IV-D-4-a. Ensuring through periodic 
inspections that laboratory standards 
are rigorously followed; 
IV-D-4-b. Reporting to the IBC and 
the Institution all significant problems 
with and violations of the Guidelines 
and all significant research-related 
accidents and illnesses of which the 
BSO becomes aware, unless the BSO 
determines that the Principal 
Investigator (PI) has done so; 
IV-D-4-c. Developing emergency 
plans for dealing with accidental spills 
and personnel contamination, and 
investigating recombinant DNA research 
laboratory accidents; 
IV-D-4-d. Providing advice on 
laboratory security; 
IV-D-4-e. Providing technical advice 
to the PI and the IBC on research safety 
procedures. 
Note. — See Laboratory Safety Monograph 
for additional information on the duties of the 
BSO. 
IV-D-5. Principal Investigator. On 
behalf of the Institution, the PI is * 
responsible for complying fully with the 
Guidelines in conducting any 
recombinant DNA research. 
IV-D-5-a. PI — General. As part of this 
general responsibility, the PI shall: 
IV-D-5-a-(l). Initiate or modify no 
recombinant DNA research subject to 
the Guidelines until that research, or the 
proposed modification thereof, has been 
approved by the Institutional Biosafety 
Committee (IBC) and has met all other 
requirements of the Guidelines and the 
Administrative Practices Supplement 
(APS). 
[ 18 ] 
