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Federal Register / Vol. 45, No. 20 / Tuesday, January 29, 1980 / Notices 
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-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 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-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 
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 
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.) 
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 
proposed experiments by the IBC. The 
Institutions shall submit, within 30 days 
of IBC approval, an MUA to NIH 
(ORDA), or shall otherwise register 
proposed experiments as specified 
under Section IV-D-l-c, IV-D-l-d, and 
IV-F. 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. 
lV-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., NUAs, 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 DBC is 
responsible for: 
IV-D-3-a. Reviewing for compliance 
with the NIH Guidelines all recombinant 
DNA research to be conducted at or 
sponsored by the Institution, and 
approving those research projects that it 
finds are in conformity with the 
Guidelines. (See Administrative 
Practices Supplement, II-D, for prior 
NIH approval requirements.) This 
review shall include: 
IV-D-3-a-(l). An independent 
assessment of the containment levels 
[32] 
