60092 
NOTICES 
served, as one commentator suggested, 
by "at least two members.” In addi- 
tion. at least 20 percent of the commit- 
tee shall not be affiliated with the in- 
stitution and shall represent the inter- 
est of the surrounding community 
with respect to protection of the 
public health and the environment. 
Moreover. nomination procedures 
need not be specified, but should be 
left to the discretion of the institution 
for the selection of these members. 
With respect to conflict of interest, 
some commentators recommended 
that IBC members be prohibited from 
any direct involvement in recombinant 
ONA or closely related research unless 
the member is a laboratory worker. 
The conflict-of-interest provisions in 
the Guidelines respond to these con- 
cerns while reflecting the paramount 
need for relevant scientific compe- 
tence on the IBCs. 
A commentator stated that "peer 
review does not adequately protect the 
public.” citing instances of noncompli- 
ance with the Guidelines at two NIH 
grantee institutions. It should be 
noted that the two cases in point in- 
volved administrative violations and 
presented no risk to the public health 
or the environment. 
Some of the commentators from the 
private sector expressed concern that 
the financial conflict-of-interest state- 
ment required in the Guidelines might 
be interpreted as denying IBC mem- 
bership to any member of a company. 
Others felt that a requirement for 
public members woud present prob- 
lems of protecting confidential infor- 
mation. However, at a meeting of the 
DHEW Committee and representa- 
tives from the Pharmaceutical Manu- 
facturers Association. It was agreed 
that public members could and do 
serve on the committees. Some are 
asked to sign agreements to honor 
confidentiality of proprietary and 
patent information. 
Health Surveillance. This area was 
one of deep concern to some witnesses 
and correspondents. Witnesses at the 
September IS hearing made several 
suggestions concerning medical sur- 
veillance. and correspondents suggest- 
ed that the term "medical surveil- 
lance" be changed to "health-risk sur- 
veillance” or “health surveillance.” 
That suggestion has been adopted in 
the Guidelines. 
Several commentators and witnesses 
urged that health surveillance pro- 
grams be required in the Guidelines. 
Concern was expressed that without 
such a requirement different stand- 
ards and different programs would 
result. In addition, there were many 
suggestions from commentators, in- 
cluding the Occupational Safety and 
Health Administration (OSHA). about 
what should constitute a health sur- 
veillance program— for example, com- 
plete medical histories, periodic medi- 
cal checkups, and serial serum sam- 
ples. It was recommended that labora- 
tories be required to keep official 
OSHA health and safety log forms, 
and that records be kept of all agents 
use. all modified organisms created, 
and all laboratory-acquired Illnesses. 
Several commentators also called for 
a clearinghouse, to be established at 
the Federal level, at which copies of 
all health surveillance plans and rec- 
ords would be filed. It was urged that 
NIH maintain such data, including 
records of workers in laboratories 
using recombinant DNA techniques, 
with particular regard to instances of 
possible work-related Illness. There 
were also several suggestions for a na- 
tional epidemiologic monitoring and 
surveillance program to be supported 
by DHEW. Such programs might, as 
one commentator suggested, promote 
national standards for health surveil- 
lance specific for each class of organ- 
isms and group of experiments. And fi- 
nally. there were suggestions for on- 
going epidemiologic and biostatlstical 
analysis of data as they are accumulat- 
ed to permit early detection of trends. 
I reviewed these issues in the Deci- 
sion document accompanying the pro- 
posed revised Guidelines as published 
in the Federal Racism July 28. 1978. 
As I noted in that document, the Issue 
of medical monitoring is one of consid- 
erable Interest to NIH and is not 
unique to recombinant DNA research. 
The “state-of-the-art." however. Is 
primitive in terms of effective moni- 
toring of workers' health generally, 
and particularly In recombinant DNA 
research, where there is no known 
hazard. 
One commentator noted that the 
Cambridge. Massachusetts, city ordi- 
nance for recombinant DNA research 
requires the institution, as part of its 
health surveillance responsibility, to 
monitor survival and escape of recom- 
binant DNA organisms in each labora- 
tory worker engaged in this type of re- 
search. as by the testing of Intestinal 
flora. Intestinal flora sampling is 
being undertaken at MIT. NIH will 
follow the MIT program closely. This 
in not the time, however, to propose 
extension of that experiment to gener- 
al practice. 
We recognize the need to aid the in- 
stitutions as much as possible in this 
Important area. The laboratory Safety 
Monograph provides extensive detail 
and guidance. It suggests monitoring 
Illnesses, collecting serum samples, 
and keeping a register of agents han- 
dled. Moreover, the Guidelines now re- 
quire the institution (rather than the 
principal investigator) to determine, in 
connection with each project, the ne- 
cessity for health surveillance of rele- 
vant personnel and to conduct a 
health surveillance program appropri- 
ate to the project. And the Memoran- 
dum of Understanding and Agreement 
will include reference to health-sur- 
veillance programs associated with the 
project. 
In response to the calls for a nation- 
al clearinghouse, it should be pointed 
out that the NIH Office of Recombin- 
ant DNA Activities (ORDA) has been 
designated in the Guidelines to re- 
ceive, review, and maintain certain 
medical and accident information. 
Through ORDA. NIH will have a col- 
lection of essential data which should 
provide the ability to discern if certain 
experiments result in unique health 
problems. It is emphasized, however, 
that for any health surveillance to be 
truly effective, it must be conducted at 
the local level. 
RESPONSIBILITIES OF THE INSTITUTION 
(SPECIAL) 
The special responsibilities of the in- 
stitution include establishing general 
policies, appointing the Institutional 
Biosafety Committee (IBC), appoint- 
ing a Biological Safety Officer (BSO) 
where required, and reviewing and im- 
plementing procedures applicable to 
the submission of the Memorandum of 
Understanding and Agreement (MUA). 
A number of commentators and wit- 
nesses addressed these requirements. 
One commentator recommended 
that the signature of an institutional 
off leal not be required on the MUA (in 
Appendix C of the July 28 revision), 
but that the IBC chairperson should 
represent the Institution. The signa- 
ture of an institutional official on the 
MUA Is requisite, for that individual is 
authorized to act for the Institution 
and assume on its behalf the obliga- 
tions Imposed by the Guidelines. If 
the institution so wishes, however, it 
may designate the IBC chairperson as 
the responsible official for MUAs that 
do not require prior NIH approval. 
This is newly noted in the Guidelines 
and the Administrative Practices Sup- 
plement (APS), which now incorpo- 
rates Appendix C. 
The correspondent also recommend- 
ed that MUAs for fellowships, as 
found in Appendix C, be deleted as an 
unnecessary duplication of effort. This 
recommendation Is sound, for It is du- 
plicative to require an MUA when the 
projects are registered. Thus, MUAs 
will not be required with fellowship 
applications. 
Another correspondent called for 
clarification of the difference, if any, 
between the IBC's procedures for 
review of NIH-funded and non-NIH- 
funded projects. The information re- 
quired for NIH- and non-NIH-funded 
projects in an institution receiving 
NIH support for recombinant DNA re- 
search is similar. Further information 
on the requirements has been included 
in the APS. For purposes of IBC 
Fl OCX At K FOSTER. VOL 43. NO. 247— FRIDAY, DECEMSER 72 , 197* 
[ 15 ] 
