By Susan J. Friedman

Recombinant DNA technology, genetics and in vitro fertilization (IVF) have opened whole new areas to scientific exploration, medical treatment, commercial exploitation and controversy. The merger of these technologies has enabled numerous controversial techniques including:

• preimplantation genetic diagnosis for gender selection and the creation of bone marrow and stem cell donors;
• genetic modification of higher life forms and the potential for manipulating genetic material of humans;
• donation of eggs and sperm and the use of invitro fertilized embryos for human embryo research; and
• cryopreservation of gametes that can be used for posthumously conceived children.

The advent of these and other genetic and reproductive technologies poses new challenges and opportunities in bioethics and law.

Bioethics is a branch of ethics that deals with issues raised by biological research and medical practice--issues such as allocation of health care, medical privacy, euthanasia and assisted suicide, and informed consent of human research subjects, for example. Bioethics impacts, and is informed by, medicine, law, politics, philosophy, religion, and public policy.

Although the term “bioethics” was coined at the end of the 1960’s, earlier examples of bioethical principles can be found in the Hippocratic Oath, in professional codes of medical practice, and in guidelines for research on human subjects and animals.

The U.S. Government has appointed Advisory Commissions to gather information about developing genetic technologies and to look into ethical concerns about genetic engineering, organ transplantation, human experimentation, allocation of health care resources, and other areas. 1

Bioethics has taken on new life and vigor as the result of advances in genetic technologies. The mass media and the Internet have increased public awareness of, and concern about, issues such as genetically modified organisms (GMOs), gene patents, stem cells, cloning, and human embryo research, which suggests that the relatively low level of scientific literacy in this country has not deterred debate of the underlying bioethical issues.

The bioethics movement is not without its skeptics, however. There are some who feel that bioethics is simply another tool for advocacy groups and expert commissions to use in lobbying for particular public policies and legislation. Others view it as a positive step towards encouraging public debate and discussion about science as a social institution.

The “new bioethics kid on the block” in Seattle is the Women’s Bioethics Project (WBP)(www.womensbio ethics.org), a non-profit, non-partisan, independent public-policy think tank, founded earlier this year by philanthropist Kathryn Hinsch. WBP’s mission is to bring women’s perspectives and experiences to the public policy debate about bioethical issues in health care and biotechnology.

Women’s stake in the outcome of the debate on certain issues is different from men’s. Issues such as commercial surrogate motherhood, the short-term and long-term health effects of egg donation, whether forced consent to caesarean delivery is appropriate in certain circumstances, assisted reproductive technologies (ART) and genetic enhancement of pre-implantation embryos, and the exclusion of women from disease studies and clinical trials of new drugs, has a direct effect upon women’s lives.2

Through scholarship, reports, legislative testimony, articles, public conferences and debates, media coverage, and its own website, the WBP hopes to promote objective public discourse among scholars, scientists, legal practitioners, corporate leaders, decision-makers, and the public about bioethical issues that impact society generally, and women’s lives specifically. The long-term goal of the WBP is to develop an ethical framework that will optimize the use of technology through rational, rather than ad hoc, decision-making.

The legal challenges inherent in regulating the new biotechnologies in the U.S. are substantial. There are recommendations and guidelines in place at the national level for the safe conduct of research and clinical trials that involve human subjects, and reports on the ethical, social, and legal issues, but little thought and effort has gone into how best to regulate the new biotechnologies without suppressing them.3

None of the existing Federal health agencies (FDA, CDC, NIH) has jurisdiction or expertise to monitor and regulate the uses of genetic and reproductive technologies,4 and there is little or no Federal oversight or regulation of ART, genetic modification of embryos or gametes, or privately-financed human embryo research.

The most recent Report of the President’s Council on Bioethics5 identifies the following as areas that are currently unregulated, or poorly regulated and monitored: the safety and well-being of children born using ART and the safety of the women involved; access to IVF and ART; genetic screening and selection of embryos for non-disease-related traits; new reproductive possibilities that alter the biological relationships between parents and children; commercialization of gametes and embryos; biomedical research involving early-stage human embryos and blastocysts; and implantation of human embryos into human or non-human uteri for biomedical research. The Report also discusses various national policy options for oversight and regulation of these activities.

Congress has made many attempts to pass human cloning legislation,6 but there is still no Federal law that prohibits human cloning or inheritable genetic modification. The government has relied instead on the use of federal funding as a policy tool to prevent human embryo research and cloning. These activities are not prohibited, however, if privately funded.

State lawmakers have acted more decisively than the Congress to enact legislation governing human cloning and research on human embryos. Nine states have enacted laws that prohibit the cloning of human embryos for therapeutic and/or reproductive purposes.7

Spurred by the biotechnology industry, researchers and patient’s rights organizations who predict that stem cell research will be instrumental in developing medical treatments for a variety of currently intractable diseases (such as cancer, diabetes, neurodegenerative disorders, Parkinson’s disease), bills designed to allow stem-cell research and the research use of human embryo-derived cells are pending in Illinois, Maryland, New York, Pennsylvania, Texas, Vermont and Washington [SB 5466, HB 2336].8

There’s a strong international consensus that reproductive cloning of human embryos and inheritable modification of the human genome are unsafe and unpredictable activities that violate human dignity and human rights, and have the potential to introduce undesirable changes in the human species. It is not surprising that these activities have been banned in many countries,9 and there is considerable support for a global treaty banning human reproductive cloning.10

Summary and Perspectives
Profound changes have taken place in biology and medicine during the past four decades. The emergence of new genetic and reproductive technologies in particular has raised provocative social, ethical, and legal questions that must be addressed sooner or later by non-scientists and policy-makers. Our concerns should be directed towards answering such questions as:

• What is the best way to regulate the practice of new biotechnologies without suppressing them?
• Which activities are likely to require government regulation?
• When will the need for regulation arise?
• In the context of particular technologies, which of the regulatory options will likely be useful?
• Can we find ways to monitor and enforce the laws and regulations that are put into place?
• Who will be accountable for the uses of genetic and reproductive technologies?
• Who will have liability for “mistakes” and “unanticipated consequences” of using these technologies for medical diagnosis and treatment?
• How will the expected benefits of these new technologies, diagnostic methods and treatments be apportioned among members of our society, and who will provide funding?
• How can we raise the scientific literacy of society as a whole, and lawmakers in particular, to allow for more rational decision-making?
• Is rational decision-making even possible, given the political and ideological divisions in our society?
• How can we balance commercial interests with societal goals and individual rights?
• How can the law keep pace with the rapidly changing landscape of biomedical science and biotechnology?

Right now, there are many problems and few solutions. We still have time to find solutions to these problems. We should take the time to educate ourselves about these issues, to develop a basic level of scientific literacy, and to engage in public discourse that will provide an effective ethical framework for public policy decisions.

1 Advisory Commission on Health Science and Society (1973); National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974); National Bioethics Advisory Commission (1995); The President’s Council on Bioethics (2001); The Recombinant DNA Advisory Committee (2001); and The Human Research Subjects Advisory Committee (2003).

2 The National Association of Women Judges has recognized this need and is developing pilot programs on “Genome Justice.” The first pilot program , “Disparate Impacts of Genetic Testing on Women and Vulnerable Populations” was hosted by the University of Washington Law School , July 8--10, 2004.

3 The National Academy of Sciences and the President’s Council on Bioethics have issued reports with recommendations, but these have not been implemented at the Federal level. The National Human Genome Institute recently announced the funding of Centers for Excellence in Ethical, Legal and Social Implications Research at Case Western Reserve University, Duke University, Stanford University, and the University of Washington. The intent is to bring together experts in bioethics, law, behavioral and social sciences, clinical research, theology, public policy, and genetic and genomic research to provide information about the implications of genomic research that can be used to formulate health and social policies.

4 By comparison, agencies have been set up in the UK (Human Fertilization and Embryology Authority) and in Canada (Assisted Human Reproduction Agency) to carry out certain activities, such as regulation and inspection of IVF clinics and laboratories; donation and storage of eggs, sperm, or embryos; licensing and monitoring of in research on in vitro human embryos (e.g., therapeutic cloning); information-gathering and analysis; and government advisory functions.

5 “Reproduction and Responsibility: Regulating the New Biotechnologies,” March 2004, available at www.bioethics.gov.

6 See www.genetics-and-society.org for list of bills that have been introduced from 1998-2003.

7 For additional details, see www.nscl.org/programs/health/genetics/rt-shcl.htm.

8 A summary of state laws on embryonic and fetal research is provided at www.ncsl.org/programs, health/genetics/embfet.htm.

9 See summary at www.glphr.org/genetic/ europe.htm.

10 See, e.g., Annas, Andrews and Isasi, “Protecting the Endangered Human: Toward an International Treaty Prohibiting Cloning and Inheritable Alterations”, American Journal of Law & Medicine 28 (2002): 151-178.

GLOSSARY

Assisted Reproductive Technologies (ART): a treatment or procedure that involves the handling of human eggs, sperm or embryos to assist reproduction. Examples include IVF; blastocyst culture and transfer; intracytoplasmic sperm injection (ICSI); ooplasmic transfer; oocyte nuclear transplantation; and embryo assessment for implantation.

Cell Cloning: The process of creating cells that are genetically identical to the progenitor cell from which they are derived.

Genome: the total genetic information in a cell or an organism.

Inheritable Genetic Modification: The process of stably incorporating genetic material into the genome of an organism such that the genetic material is transmitted to successive generations of progeny.

In Vitro Fertilization (IVF): The process of fertilizing eggs with sperm in vitro to produce embryos that can be transferred to a uterus to continue their development in vivo.

Recombinant DNA technology: the technology of preparing recombinant DNA in vitro by cutting up DNA molecules and splicing together fragments from more than one organism.

Reproductive Cloning: The deliberate production of genetically identical individuals by implanting cloned embryos in the uterus.

Stem Cells: Self-renewing progenitor cells that can give rise to one or more specialized cell types. Stem cells from early embryos are able to generate all of the differentiated cell types in the body. Adult stem cells are usually restricted in their developmental capacities.