33066 
NOTICES 
the local and national levels have been 
delineated In Appendix C to the guide- 
lines which contains documentation of 
NIH administrative procedures for re- 
combinant DNA research projects. 
Considerable attention has been 
given to the Issue of training. Several 
commentators urged that training 
standards be set by the NIH. prefer- 
ably In the guidelines. Other commen- 
tators wanted the guidelines to direct 
the Institution or IBC to set standards 
for training; however, some opposed 
this view. Still others wanted Investi- 
gator competency evaluated or certi- 
fied after training had been undertak- 
en. It should be noted that the PRO- 
RAC represented a strengthening of 
training requirements, compared to 
those In the 1976 guidelines. Commen- 
tators remain concerned regarding the 
quality and uniformity of such train- 
ing. The NIH Is responding to this by 
placing as a high priority the develop- 
ment of training standards and 
courses. Currently. NIH Is supporting 
a Working Panel of the American So- 
ciety for Microbiology (ASM) which is 
considering standards of training In 
microbiological techniques for recom- 
binant DNA research. When a report 
Is submitted to NIH. It will be shared 
with Institutions. IBC's, and principal 
Investigators for their use. At this 
time, however, national certification 
should not be attempted until the 
ASM/NIH criteria for training have 
been formulated and subsequently 
evaluated. It should be noted that, 
aside from Nuclear Regulatory Com- 
mission standards for training for ra- 
dioisotope work, there are apparently 
no other formal training criteria pres- 
ently required for biomedical research. 
Thus, the work of the ASM Panel will 
be establishing a precedent. It Is for 
these reasons that I feel NIH should 
proceed carefully and In stages, at the 
same time promoting safety training 
for researchers. Accordingly. NIH will 
develop courses based on these stand- 
ards of training and make them widely 
available. 
Responsibilities of the NIH ( General) 
Due Process Considerations. A focus 
of public comment at the December 
hearing was on "procedural due proc- 
ess." to Insure public participation In 
the development of NIH recombinant 
DNA policies. Much of the public testi- 
mony and comment In letters thereaf- 
ter focused on public representation 
on committees. Also stressed was the 
need for public notice of all meetings, 
and for procedures to Insure public 
participation In the exercise of respon- 
sibilities by the RAC. the Office of the 
Director. NIH, and the Advisory Com- 
mittee to the Director. NHL 
Several commentators specifically 
urged that the guidelines spell out the 
procedures to be used for the follow- 
ing: 
• To develop and amend the list of 
"non-novel experiments"; 
•To permit the Director, on the 
advice of the RAC, to grant exceptions 
from prohibited experiments, such as 
for risk- assessment experiments; 
•To certify host-vector systems; 
•To modify guidelines In the future. 
There were also suggestions that 
guidance be given on how to deal with 
Infractions of the guidelines. Specifi- 
cally, one commentator suggested that 
procedures outline In detail: 
•How charges of non-compliance 
could be brought; 
•How charges of non-compliance 
would be evaluated; 
•What opportunities would be pro- 
vided for the principal Investigator 
and his Institution to defend them- 
selves against charges; and 
•What appeals procedures would be 
available before the termination of 
funding or the Invoking of other pen- 
alties. 
Because of the key role of the RAC 
In the development and monitoring on 
NIH recombinant DNA policies, a 
number of comments were directed to 
Its composition and functions. Many 
commentators focused on the RAC's 
membership, urging that the guide- 
lines define procedures for nomination 
and selection of members. Suggestions 
for potential membership on the RAC 
Included more representation for cer- 
tain scientific disciplines, such as viro- 
logy and microbiology; greater repre- 
sentation of Individuals skilled In occu- 
pational and environmental health 
and safety; and more public represen- 
tation. Including perhaps a "dissenter" 
from current NIH policies. 
A number of comments concerned 
Committee operations. The RAC was 
urged to formalize schedules so that 
all would know when It would meet 
over the next 2 to 3 years. Further. It 
was urged that notices and complete 
agendas be placed In the Federal Reg- 
ister for each meeting; that all docu- 
ments for Committee consideration be 
made available to the public; and that 
the NIH pay for public witnesses to 
attend meetings of the RAC. 
In response to these comments. Part 
IV of the guidelines has been reorga- 
nized extensively. The responsibilities 
from the local to national level have 
been stated and defined more clearly. 
Further, for NIH responsibilities, pro- 
cedures suggested by commentators 
have been specified to afford opportu- 
nity for public comment. A special ap- 
pendix to the guidelines Includes rele- 
vant Implementation documents from 
ORDA that explain the administra- 
tion of the NIH guidelines at the local 
and national levels. 
From the beginning, the NIH has 
gone to great lengths to Insure proce- 
dural due process for the public and 
scientific communities. The RAC con- 
ducts all meetings In the open, and 
files notice of each meeting In the Fed- 
eral Register. All the documents 
listed on the agenda of the RAC meet- 
ings have been available to the public. 
Additionally, the Advisory Committee 
to the Director, NIH. has provided a 
public forum on the 1976 guidelines 
and now on the proposed revisions. 
The public hearing In February 1970 
on the originally proposed guidelines 
resulted In extensive revision of that 
proposal. The PRG-RAC was pub- 
lished In the Federal Register on Sep- 
tember 27, 1977. for public comment, 
and the meeting of the Director’s Ad- 
visory Committee held In December 
1977 was announced In the Federal 
Register. In addition to a general Invi- 
tation for public testimony, the NIH 
provided funds for witnesses from the 
public, private, and scientific sectors 
to attend and present their views. 
The proposed reorganization of Part 
IV has more clearly defined a struc- 
ture for responsibilities at the local 
and national level, with opportunity 
for public and scientific participation. 
It makes more formal a process that 
has been occurring Informally. Flexi- 
bility. however, remains essential to 
avoid unnecessary and protracted 
delays In decisionmaking. Clearly a 
full panoply of review. Including a 
public hearing. Is not essential for 
most of the functions under the guide- 
lines. For many functions, the need 
for public review can be met through 
publication In the Federal Register. 
For certain responsibilities comment 
may be solicited. Because procedures 
by which policies will be developed at 
the national and local levels are of key 
Importance, notice for major policy 
Initiatives is required. I believe the re- 
organization of Part rv achieves that 
goal. 
Application to the Private Sector. 
Several commentators spoke on the 
application of the NIH guidelines to 
the private sector. Specifically, the 
NIH was urged to provide, voluntarily, 
to the private sector, the following: 
•Advice on interpretation of the 
guidelines; 
•Registration of projects; 
•Certification of host-vector sys- 
tems; 
•Advice on the operation of Institu- 
tional biosafety committees; and 
•Protection for patent and propri- 
etary Information. 
Prior to the release of the guidelines 
In June 1976, representatives of pri- 
vate Industry were Invited to NIH to 
be briefed on the guidelines. Since the 
release of the guidelines, several other 
meetings with representatives from 
the private sector have been held. 
Commerce Department representa- 
tives on the Interagency Committee 
FKCftAl IKHSTH, VOL 4k MO. 144— fllOAY, JULY H, 1Y7* 
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