75 
[From the New Sork Times, Dee 10, 1977] 
Health Institutes’ Action Prompted by Procedural Violation of Rules 
on Recombinant DNA Research 
(By Harold M. Schmeck Jr.) 
Bethesda, Md., Dec. 15 — The National Institutes of Health have for the first 
time ordered a laboratory to halt gene-splicing research supported by a Federal 
grant because, of a procedural violation of the rules governing such studies. 
A spokesman for the agency said today that the violation did not involve any 
known '.safety rules or laboratory procedures. .TM. action involved a laboratory 
at Harvard Medical School where recombinant DNA research, popularly known 
as gene-splicing research, has been in progress for several years; The investigation 
by the agency is continuing. 
The agency supports with funds more than 250 projects in recombinant DNA 
work at 110 institutions. Such research embraces experimental techniques that 
have been a subject pf much controversy because of the view of some critics that 
they are potentially dangerous and might lead to deliberate manipulation of 
heredity in. ways the critics consider improper. 
Many scientists consider the techniques extremely useful as a tool for learning 
more about the chemistry of genetics and possibly for developing important medici- 
nal drugs and Coping with some presently Un treatable genetic diseases. 
For about a year Congress has been considering legislation to set ruled for 
all recombinant DNA research, but has not acted/ 
memorandum of agreement 
The specific procedural violation made known today was Harvard’s failure to 
get an approved memorandum of understanding and agreement concerning the 
laboratory’s experiments before the Work actually began. The reason for this 
failure is unknown. 
The violation came to light because of a Freedom of Information request from 
Leslie Dach of the Environmental Defense Fund, who said today that he made the 
inquiry because of reports that persons in the laboratory had been using poor 
laboratory procedures in some of the experimental work. 
After his request for information on tne laboratory’s work, the N.I.H. investi- 
gated and found that the required agreement was lacking. Three officers of the 
institutes went to Boston for further investigation. 
Neither he nor spokesmen for the Institutes could confirm today the reports of 
poor laboratory procedures. Mr. Dach disclosed the agency’s action here after the 
opening session of a special meeting of the advisory committee to the director 
of the agency. The meeting was called to advise on proposed changes in the 
guidelines drafted by the Institutes to cover gene-splicing research by scientists 
working on Federal grants or contracts. 
GUIDELINES OF THE AGENCY 
The National Institutes of Health is the Federal Government’s main agency for 
conduct and support of biomedical research. The agency’s guidelines on gene- 
splicing research are considered binding on virtually all such research supported 
by any Federal agency. The guidelines, are not yet binding on industry. 
DNA, or deoxyribonucleic acid, is the active substance of genes. It is therefore 
the key chemical in the heredity of all life. The recombinant DNA techniques 
makes it possible to splice genes of widely divergent species, human and bacterial 
for example. 
One recent set of experiments succeeded in altering the genetic imbalance of 
bacteria so that they produced a hormone normally produced only in animals and 
man. 
In a letter to Harvard Medical School made public today, an officer of the Insti- 
tutes said that experiments under the grant in question “must not be carried out 
in the absence of an approved M.U.A.,” or memorandum of understanding and 
agreement. 
The laboratory is that of Dr. Charles A. Thomas Jr., and an official of the Insti- 
tutes said today that the grant was in the third of five planned years. The grant 
totals roughly $100,000 a year, according to agency figures, but only part of this 
involves recombinant DNA work. 
The agency is also investigating possible violations of the recombinant DNA 
rules by a group at the University of California at San Francisco. 
[Appendix B — 124] 
