This staff working paper was discussed at the Council's
July 2003 meeting.
It was prepared by staff solely to aid discussion, and does not represent
the official views of the Council or of the United States Government.
U.S. Public Policy and the Biotechnologies
That Touch the Beginnings of Human Life: Findings
This document is an effort to enumerate the key findings growing
out of the Council’s survey and analysis of the current regulation
of the biotechnologies that touch the beginnings of human life.
Each of these findings has been identified by a significant number
of Members as of concern or worthy of note. The listing of findings
here is not intended to imply that anything in particular, or indeed
anything at all, is required by way of public policy response.
I. DOMAIN OF INQUIRY
The fields of assisted reproduction, genetics, and human
embryo research are increasingly converging. The fusion
of genomic knowledge and assisted reproduction is no longer speculative.
Techniques and practices, such as PGD, greatly enhance our control
over human procreation and the character, fate, and future of our
II. GENERAL CONCLUSIONS
There is no uniform, comprehensive, enforceable system
of data collection, monitor-ing, or oversight for the biotechnologies
that touch the beginnings of human life. The present system
is a patchwork of federal, state, and professional self-regulation.
A. Assisted Reproduction
a. Institutional Governance
i. Governmental Oversight
There is minimal governmental regulation of the practice
of assisted reproduction. The primary animating values
of current federal regulation are consumer protection, and safety
and efficacy of products when employed for their intended use. In
the main, ART is regulated as the practice of medicine—with
licensure, certification, professional oversight, and malpractice
litigation as chief means of regulation. Under this system, the
child-to-be is not generally considered as a patient, and parents
are left solely responsible for safeguarding the interests of their
ii. Professional Oversight
There is extensive professional self-regulation of the
practice of assisted reproduction, but these standards are hortatory
and unenforceable. The animating values of current professional
self-regulation are safety, efficacy, and privacy for the individuals
seeking infertility services. The standards are merely advisory,
with no meaningful enforcement mechanisms.
b. Substantive Areas of Concern
i. Well Being of Children, Egg Donors, and Gestational
There is no comprehensive, uniform, or enforceable mechanism
for data collection, monitoring, or oversight of how the new biotechnologies
that touch the beginnings of human life affect the well being of
the children conceived with their aid, egg donors, or gestational
mothers. There is no definitive understanding of how ART
or its adjuncts affect the well-being of children born with their
aid. Some studies suggest that such children are normal and healthy;
others raise serious concerns. Multiple gestations are significantly
more common in pregnancies initiated with the help of ARTs as cur-rently
practiced; such pregnancies are associated with serious health problems
for both mothers and children. There is presently no system for
reporting adverse health effects from the use of ARTs or their adjuncts.
ii. Access to Services
There are no uniform laws or policies relating to access
to assisted reproduction. State law relating to insurance
coverage of ART services varies greatly; fourteen states have laws
speaking to the question, the rest do not. The Fertility Clinic
Success Rate and Certification Act does not require the reporting
of the average cost of a successful preg-nancy.
iii. Movement of Techniques and Practices from Experimental
to Clinical Use
Given the present framework of regulation, novel technologies
and practices move from the experimental context to clinical practice
with very little oversight or deliberation. Once in practice, these
techniques are used at clinician’s discretion with little
or no external oversight. Use becomes widespread rapidly.
Two exam-ples: (1) ICSI was discovered by accident in 1992. Two
years later it was in clinical practice. In 2000, ICSI was used
in 47 percent of IVF treatment cycles. (2) PGD was developed in
1989. Since then, there have been 6,000 cases of PGD use, with an
esti-mated 2,000 children born thereafter. There have been no longitudinal
studies of the effects of PGD on these children. Current professional
guidelines dictate only that there be two peer-reviewed papers showing
the risk-benefit ratio is acceptable before a given practice moves
from “experimental” to “clinically acceptable.”
There is no system for reporting the reasons for using ICSI, PGD
and similar technologies. Nor is there any system for reporting
possible adverse effects.
iv. Public Discussion and Deliberation regarding Ethical
Significance of New Technologies and Practices
There is no uniform system for public review and deliberation
regarding the larger human or social significance of new technologies
that touch the beginnings of human life. Practices fusing
assisted reproduction and genomic knowledge have come into clinical
usage with little or no deliberation about their human, social,
or ethical significance. Such practices include PGD for nontherapeutic
indications or for concep-tion of donor siblings, ooplasm transfer,
and the like. There is presently no system for data collection on
the uses and application of these or similar technologies.
B. Preimplantation Genetic Diagnosis
PGD is not regulated as such. There is no system
of data collection, monitoring, or oversight for preimplantation
genetic diagnosis per se, and no system for reporting of possible
adverse effects. Nor is there mechanism for the collection of data
regarding the frequency or specific applications of PGD (for example,
screening for disease, for traits, or for the creation of donor
C. Gene Transfer Research
Gene transfer research is regulated robustly.
The federal government regulates gene transfer research in terms
of safety, efficacy, and protection of human subjects. More-over,
there exists a long-standing system for public discussion regarding
novel protocols (through the Recombinant DNA Advisory Committee
D. Use and Disposition of Human Embryos in Research
There is no comprehensive, uniform, or enforceable mechanism
for data collection, monitoring, or oversight relating to the use
and disposition of human embryos in the context of clinical practice
or research. A credible industry estimate suggests there
are 400,000 embryos in cryopreservation in the United States. There
are no limits on what one can do to or with an embryo, so long as
one is privately funded. Meanwhile, no federal funds may be used
for the destruction of human embryos. Many in the research community
believe that the federal ban on funding of human embryo research
creates a chilling effect on embryo research generally. Anecdotally,
it seems that few researchers are currently engaged in research
involving human embryos, although an increasing number of researchers
are taking up research involving stem cell lines derived from human
There is no comprehensive mechanism for regulation of commerce
in gametes, embryos, and ART services. Professional guidelines
exist that attempt to place limits on commerce in human reproductive
tissue and human embryos, in order to safeguard the health of women
and the dignity of gamete donors, but these guidelines are unenforce-able.
Regarding the sale of ART services generally, there are general
federal guidelines relating to truth in advertising, and professional
societies have propounded guidelines on this matter as well.
Patenting of human organisms is presently ambiguous.
The only obstacle to patenting human embryos is a Patent and Trademark
Organization policy (memorialized in the Patent Examiners’
manual) that is ambiguously worded. PTO has approved at least one
patent on a process for cloning mammals that could be construed
to include humans. PTO has called for congressional guidance to
clarify the current ambiguity.