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NOTICES 
the Recombinant Advisory Committee 
in April 1976 and made several modifica- 
tions. The suggested revisions were ac- 
ceptable to the full committee, and we 
have included them in the guidelines. 
The modifications are responsive to 
the stated concerns of the commentators. 
A description of greenhouse facilities is 
given, and physical containment condi- 
tions have been modified to take into 
account operations with whole plants. On 
the whole, the respective portions of the 
guidelines relating to plants are more 
fully explained and the intent is clarified. 
I have also accepted the recommenda- 
tion of the subcommittee to lower the 
biological containment level from EK2 to 
EK1 for experiments in which the DNA 
from plants is used in conjunction with 
the E. coli K-12 host-vector system, 
thereby setting containment in this in- 
stance at the same level required for ex- 
periments with lower-eukaryote DNA. 
VII. ROLES AND RESPONSIBILITIES 
1. Most commentators had suggestions 
for the section on the roles and responsi- 
bilities of investigators, their local insti- 
tutions, and NTH. Commentators gen- 
erally urged openness, candor, and 
public participation in the process, em- 
phasizing shared responsibility and ac- 
countability from the local to the na- 
tional level. We reviewed that section of 
the guidelines in light of these comments 
and have asked; the Recombinant Ad- 
visory Committee to review certain 
issues. 
It is clear that much of the success of 
the guidelines will lie in the wisdom with 
which they are implemented. Because of 
the importance of this section, especially 
in terms of safety programs and plans, 
we have carefully weighed the comments 
and suggestions made in this regard. NIH 
has a special responsibility to take a 
leading role in ensuring that safety pro- 
grams are part of all recombinant DNA 
research. Dr. Barkley and a specially 
convened committee were asked to pro- 
vide greater detail for safety, accident, 
and training plans for this section of the 
guidelines. Based on their recommenda- 
tions, the section has been extensively 
rewritten to clarify the respective re- 
sponsibilities of the principal investiga- 
tor, the institution (including the insti- 
tutional biohazards committee) , the NIH 
inital review group (study section), the 
NIH Recombinant DNA Molecule Pro- 
gram Advisory Committee, and NIH staff. 
This section has a definitive adminis- 
trative framework for assuring that 
safety is an essential and integrated com- 
ponent of research involving recombinant 
DNA molecules. The guidelines require 
investigators to institute, monitor, and 
evaluate containment and safety prac- 
tices and procedures. Before research is 
done, the investigator must have safety 
and accident plans in place and training 
exercises for the staff well under way. 
Some commentators suggested that 
the investigator be required to obtain in- 
formed consent of laboratory personnel 
prior to their participation. Rather than 
rely explicitly on an informed consent 
document, the guidelines now make the 
investigator responsible for advising his 
program and support staff as to the na- 
ture and assessment of the real and po- 
tential biohazards. He must explain and 
provide for any advised or requested pre- 
cautionary medical policies, vaccinations, 
or serum collections. Further, an appen- 
dix to the guidelines includes detailed 
explanations for*dealing with accidents, 
as well as instructions for the training of 
staff in safety and accident procedures. 
In response to suggestions for epi- 
demiological monitoring, the guidelines 
now require the principal investigator to 
report certain categories of accidents, in 
writing, to appropriate officials. NIH is 
investigating procedures for long-term 
surveillance of workers engaged in re- 
combinant DNA research. 
2. A number of comments on the role 
and responsibilities of the institutional 
biohazards committee were received. 
Comments were directed to the structure 
of the committee, the scope of its respon- 
sibility, and the methods for operation. 
Comments on structure included sugges- 
tions that the committee have a broadly 
based representation, especially in terms 
of health and safety expertise. Some 
others suggested NIH require certain 
classes of representation. In response to 
these suggestions, the guidelines now 
recommend membership from a diversity 
of disciplines relevant to recombinant 
DNA molecule technology, biological 
safety, and engineering. 
For broader representation beyond the 
immediate scientific expertise, the guide- 
lines now recommend that local commit- 
tees should possess, or have available, the 
competence necessary to determine -the 
acceptability of their findings in terms 
of applicable laws, regulations, standards 
of practice, community attitudes, and 
health and environmental considerations. 
The names of and relevant background 
information on the committee members 
will be reported to NIH. 
In response to suggestions that deci- 
sions of the committee be made publicly 
available, the guidelines now recommend 
that minutes of the meetings should be 
kept and made available for public in- 
spection. 
Commentators generally approved of 
the responsibility given to the institu- 
tional biohazards committee to serve as 
a source of advice and reference to the 
investigator on scientific and .safety ques- 
tions, It was further suggested that the 
committee’s responsibility be broadened 
in the development, monitoring, and 
evaluation of safety standards and pro- 
cedures. In response to these suggestions, 
the guidelines now indicate that the in- 
stitutional biohazards committee has the 
responsibility to certify, and recertify 
annually, to NIH that the facilities, pro- 
cedures, practices, training, and exper- 
tise of involved personnel have been re- 
viewed and approved. The Recombinant 
Advisory Committee suggested that ex- 
amination might be unnecessary for PI 
facilities, but w r e believe that all facilities 
should be reviewed to emphasize the im- 
portance of safety programs. 
Some commentators suggested that the 
guidelines should stipulate that the local 
committees be required to determine the 
containment conditions to be imposed for 
a given project (which the draft guide- 
lines specifically noted was not their re- 
sponsibility) . The Recombinant Advisory 
Committee took exception to this sugges- 
tion. They urged NIH not to include these 
conditions as local requirements, argu- 
ing among other things that review by 
the NIH study sections would provide the 
necessary scrutiny at the national level 
and assure uniformity of standards in 
application of the guidelines. I do not 
believe that NIH should require the local 
institution to have its biohazards com- 
mittee assess what containment condi- 
tions are required for a given project. On 
the other hand, the guidelines should not 
prohibit the local institution from hav- 
ing its biohazards committee perform 
this function. Accordingly, I have deleted 
the prohibition that appeared in the pro- 
posed guidelines. 
Another suggestion was that the local 
committee ensure that research is carried 
out in accordance , with standards and 
procedures under the Occupational Safe- 
ty and Health Act (OSHA). This is an 
area of importance to the local institu- 
tions under Federal and State law, but 
need not be included as a requirement in 
the guidelines. NIH will maintain liaison 
with the Occupational Safety and Health 
Administration (Department of Labor) 
to ensure maximum Federal cooperation 
in this venture. 
I would also encourage all institutions, 
as suggested by several commentators, to 
review their insurance compensation pro- 
grams to determine whether their lab- 
oratory personnel, in the research area, 
are covered for injuries. 
3. The commentators approved of hav- 
ing the NIH study sections responsible 
for making an independent evaluation of 
the classification of the proposed re- 
search under the guidelines, along with 
the customary judgment of the scientific 
merit of each grant application. This ad- 
ditional element of review will ensure 
careful attention to potential hazards in 
the research activity. The study sections 
will also scrutinize the proposed safe- 
guards. Biological safety expertise shall 
be available to the study section for con- 
sultation and guidance in this regard. 
4. Several commentators made sugges- 
tions concerning the structure, function, 
and scope of responsibility of the NIH 
Recombinant DNA Molecule Program 
Advisory Committee. 
Comments on possible structural 
mechanisms for decision, making in- 
cluded suggestions that there be a sci- 
entific and technical committee and a 
general advisory public policy committee. 
It was also suggested that the scientific 
committee include scientists who are not 
actively engaged in recombinant re- 
search, and that the public policy com- 
mittee have a broad scientific and pub- 
lic representation. 
I have carefully reviewed these com- 
ments and suggestions. In response, the 
following structure has been devised. The 
Recombinant Advisory Committee shall 
serve as the scientific and technical com- 
mittee. Its membership shall continue to 
FEDERAL REGiSTER, VOL 41, NO. 131 — WEDNESDAY, JULY 7, 1976 
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