Federal Register / Vol. 53, No, 251 / Friday, December 30, 1988 / Notices 
53267 
V. Review of Public Information 
Brochure — “Gene Therapy For Human 
Patients" 
The Human Gene Therapy 
Subcommittee of the Recombinant DNA 
Advisory Committee has developed a 
document to be used in educating the 
nonscientific public about human genp 
therapy. The information brochure 
includes background material about the 
purposes and potential of research in 
gene therapy, about its supervision, and 
about why and how the public is 
involved. The RAC will review the 
document. 
VI. Proposal To Amend Section IV-C — 
Responsibilities of NIH 
The Foundation on Economic Trends 
and Jeremy Rifkin have submitted a 
petition to the NIH Office of 
Recombinant DNA Activities to amend 
the NIH Guidelines to establish a 
Human Eugenics Advisory Committee. 
The proposed amendment is as follows: 
Proposed Amendment to the National 
Institutes of Health Guidelines for 
Research Involving Recombinant DNA 
Molecules To Establish a Human 
Eugenics Advisory Committee by the 
Foundation on Economic Trends 
November 4. 1988. 
Amend Section IV-C-2 as follows: Ai 
the end of Section IV-C-2, add the 
following: 
IV-C-2-a. Human Eugenics Advisory 
Committee. The Human Eugenics 
Advisory Committee (HEACJ is 
responsible for carrying out specified 
functions described below as well as 
others assigned under its charter or by 
the Secretary, HHS, trie Assistant 
Secretary for Health, and the Director. 
NIH. 
The committee shall consist of 
eighteen members, including the chair, 
appointed by the Secretary or his or her 
designee, as follows: 
(1) Three members who are 
experienced and knowledgeable in 
protecting the health, safety, and 
welfare of workers. 
(2) Three members who are 
experienced and knowledgeable in the 
protection of privacy and civil liberties. 
(3) Three members who are 
experienced and knowledgeable in 
protecting the rights of the handicapped, 
(4) Three members who are 
experienced and knowledgeable in the 
abuses and ethical problems in the field 
of ante-natal and neo-natal testing. 
(5) Three members who are 
experienced in the protection of the 
Interests of consumers, especially in the 
medical and insurance fields. 
(6) Three members who are 
experienced and knowledgeable in 
molecular biology and one or more of 
the following fields: Discrimination in 
education, bio-ethics, and public affairs. 
Groups which have been the 
traditional victims of past 
discrimination, including minorities, 
women, and the disabled shall be well 
represented on the committee. 
All meetings of the 11EAC shall be 
announced in the Federal Register, 
including tentative agenda items, 30 
days in advance of the meeting with 
final agendas [if modified) available at 
least 72 hours before the meeting. 
The HEAC shall be responsible for 
advising the Director, NIH, on each and 
every proposal that involves any human 
gene therapy, including both somatic 
cell and germ line therapy. The term 
"major actions" in Section IV-C-l-b of 
these Guidelines includes all such 
proposals. The HEAC chairperson shall 
be notified of all final decisions by the 
Director, NIH, on all such proposals in 
the same manner as the RAC and IBC 
chairpersons are notified of certain final 
decisions under Section IV-C-l-b-(l), 
Amend Section IV-C-1 to road as 
follows: Amend the second sentence to 
read as follows: 
The Director has responsibilities 
under the Guidelines that involve 
ORDA, the RAC and the HEAC. 
After the third sentence of section IV- 
C — 1, add: 
Advice from the HEAC is primarily on 
the ethical, philosophical, social, 
economic, and eugenic implications and 
impacts of human genetic therapy'. 
Amend Section IV-C-l-b by striking 
all of the language after "Guidelines" 
and inserting language thereafter so that 
the text of the provision reads as 
follows: 
In carrying out the responsibilities set 
forth in this section, the director or a 
designee shall weigh each proposed 
action through appropriate analysis and 
consultation to determine that it 
complies with the Guidelines, presents 
no significant risk to health or the 
environment, and presents no significant 
risk of (i) adverse impacts on the civil 
liberties or on the social or economic 
status of those persons who may be the' 
subject of proposed actions involving 
gene therapy, (ii) creating undue ethical 
or philosophical dilemmas or problems 
for such persons, and [iiij encouraging 
unsound, undesirable or frivolous 
human eugenics practices by either 
public or private institutions or 
individual practitioners. The term 
"significant risk" herein includes 
adverse implications for the interest to 
be protected. 
Amend Section IV-C-l-b-(l) by 
adding "and the IfEAC” after "the RAC" 
wherever it appea-s in that provision. 
Amend Section lV-C-3-b-(l) by 
adding “and HEAC” after "RAC" where 
it appears in the text. In the note that 
follows the text, add "or a HEAC” 
before "meeting". 
Amend Section IV-C-3-b-(2) by 
adding “and HEAC" after "RAC" and 
change '‘meeting" to “meetings”. 
Amend Sections lV-C-3-b-[3j ami 
lV-C-3-d hy adding “the HEAC’ after 
"RAC". 
The reasons for these proposed 
revisions arc set forth in thE Petition to 
the Director accompanying these 
proposals. 
Reft nonet's 
Anderson WFc 1984, "Prospects for huiit.ui 
gene therapy", Science 226. 401-409. 
Anderson W.F.: 1985, "Human gene therapy: 
Scientific and ethical considerations", 
/ournal of Medicine and Philosophy 10, 
275-291. 
Anderson VV and Fletcher J.Cc 1980. "Gene 
therapy in human beings: When is it ethical 
to begin" 7. New England Journal Medicine 
303, 1293-1297. 
Ashley B.M.: 1985, "What does Science say 
we are" ? Theologies of the Body: 
Humanist and Christian, Chapter 2, The 
Pope John Center, pp. 19-50. 
Bloch N.: 1978, "Reductionism", W.T. Reich 
(ed.) Encyclopedia of Bioethics. Free Press. 
Macmillan, New York, pp. 1419-1423. 
Capion A.Mz 1983. "Don't ban genetic 
engineering". Washington Post. June 1(i. p. 
A 25. 
Davis RDc 1983, The two faces of genetic 
engineering in man". Science 219. 1301. 
Department of Health and Human Services: 
1955. "National institutes of Health points 
to consider in the design and submission nT 
hitman somaticcell gene therapy 
protocols". Recombinant DNA Technical 
Bulletin 9[4). 221-242. 
Fischhoff B.. Ur.htenstein S„ Slovic P., Derby 
S.l... Keeney R.l..: 1981, Acceptable risk. 
Cambridge University Press. 
Fletcher J.C.: 1983. "Moral problems and 
ethical issues in prospective human gene 
therapy”. Virginia Law Review 69, 515-540. 
Fletcher J.C.: 1985. "Ethical issues in and 
beyond prospective clinical trials of human 
gene therapy ", Journal of Medicine and 
Philosophy 10. 293-309. 
Fletcher. Joseph: 1979, "Humanness", in 
Humanhood: Essays in Bioethics. 
Prometheus Press. Npw York, pp. 7-19. 
Friedmann T. and Roblin R.: 1972. "Gene 
therapy for human genetic disease" ?. 
Scienc e 175. 949-955. 
( Hover J.: 1084, 11 hut Sort of People Should 
There Be?, Penguin Books, Middlesex. 
England, pp. 13-56. 178-187. 
GorovitzS.: 1984, "Will we still be 'human' if 
we have engineered genes and animal 
organs'' ?. Washington Post. December 9. 
pp. Cl. Cl. 
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Recombinant DNA Research, Volume 13 
