HOME :: CHAPTER 0  :: 0.  :: SHOULD WE ALLOW GENETIC ENGINEERING? A PUBLIC POLICY ANALYSIS OF GERMLINE ENHANCEMENT

Should We Allow Genetic Engineering? A Public Policy Analysis of Germline Enhancement

A paper written as a backgound for discussion

N. Schichor, J. Simonet, C. Canano

Edited by S. F. Gilbert and E. Zackin
(Warning: Involves public policy, opinions )

Life would enter a new phase, one in which we seize control of our own evolution.
Gregory Stock of UCLA

There is a great divide in the bioethics community over whether we should open up this Pandora's box.
Sheldon Krimsky of Tufts University.

Germline enhancement may someday have the ability to alter the trajectory of human evolution. Furthermore, this technology could be available in the near future. For one proponent of genetic engineering, UCLA professor Gregory Stock (1), the question is not if, but when we will be able to engineer the human germline. However, the discourse surrounding germline engineering is full of controversy. There are strong advocates of furthering the fledgling technology, but many also believe that germline engineering research should be strictly regulated or banned.

Resistance to Genetic Engineering

Why is there a case against genetic engineering? Given that it might cure inherited diseases and enable us to expand our genetic repertoire, why should anyone be against it? The following are arguments that have been used against genetic engineering:

1. "We are playing God." This argument is used whenever a new technology is invented or proposed. It was used against Benjamin Franklin's lightning rod (which took away God's prerogative to strike down those the Deity thought evil) and it was used against smallpox vaccination. This is kin to the emotional argument that says we should not interfere with nature (2). Medical technologies do not see nature as benign, and they are by their very existence interfering with nature.

2. It is unsafe. In recent years, there have been several deaths due to genetic engineering. The viral vectors that are used to bring the DNA into the cell may cause lethal immune responses or even tumors. While this argument may be valid today, it is probably a technical problem that will eventually be circumvented. Another safety argument is that when transgenes become inserted into the genome, they may disrupt functional genes and cause mutations. This has certainly been seen in mice. (3)

3. We do not know what such genetic technology will be used for. Curing lethal diseases is a good idea, and certainly there are very few people who would be against curing lethal genetic diseases such as Lesch-Nyhan Syndrome or Huntington's chorea. However, these are diseases that can be screened for by pre-implantation genetics. Germline genetic engineering is seen as a very high-tech solution for a problem that can have a relatively low-tech cure. So what might the technology be used for? One possibility is that it could be used for phenotype enhancement. Is baldness or short-stature a disease? Probably not by most standards, although insurance companies differ on that question. So perhaps genetic manipulation will be used to increase height or muscle mass or make people thin. If genes involving intelligence were found, those who could afford this procedure might acquire them, while others would not. Jeremy Rifkin (4) voices his concern that "those families who can afford to program 'superior' genetic traits into their fetuses at conception could assure their offspring an even greater biological advantage, and thus, a social and economic advantage as well." Lee Silver (5) envisions a world where the genetic haves and the genetic have-nots are far apart in their abilities. Genetic engineering would thus convert economic differences into inherited biological differences.

4. Do we know which traits to enhance or get rid of? Genetic engineering assumes that we know which traits are good and which are bad. However, what is good in one environment might be deleterious in another. The genes for sickle cell anemia may be deleterious when homozygous, but advantageous when heterozygous. A gene for a lymphocyte adhesion molecule may usually be a good thing; but a mutation of this gene might protect one against HIV. If we know which genes or suites of genes produce aggressive or docile phenotypes should we change them? Are certain alleles or combinations of alleles deleterious in some situations but in others predispose towards acts of genius? We just don't know.

5. Do we even know the functions of the genes that might be changed? It is one thing to look at genes that are the end-products of developmentohemoglobin or insulin. They probably have a single function. But those proteins acting during development often have many functions. This is called pleiotropy. BMP4 can induce bone growth in one set of tissues and apoptosis in the same tissues at a later period. In another set of tissues, BMP4 can induce epidermal differentiation. We are constantly finding that genes are not "for" a particular function; rather they are "used in" a particular function. If we alter a gene thinking it will only affect one function, we may find that it also disrupts another function.

6. Do we have the right to make decisions about our children's genotypes? Kant (6) was adamant that parents not rule over the destiny of their children. What if the genes of the children were paid for by the parents? First, the parents would directly be controlling the qualities of their offspring. Currently, there is a great deal of chance involved in which traits will be inherited. If inheritance of certain traits were a certainty, the individuality of the child could be affected. What if the curly red hair that played such a role in your identity were the product of your parents wanting a child with such a trait and an ability to pay the money to have those genes placed into your embryo? If your parents gave you genes for height and body musculature, would they be disappointed if you were not a varsity athlete? The entire notion of individual personhood is called into question.

7. The ability to modify the genome could make children into a commodity. A range of critics believe that germline genetic engineering could convert a child from being a precious miracle to being a commercial product with expected parameters of normalcy and function. People who fall short of some technically achievable ideal would be seen as "damaged goods," while the standards for what is genetically desirable will be those of the society's economically and politically dominant groups. This would only increase prejudices and discrimination in a society where too many such prejudices already exist. One might also get "fads" in childrenoone generation preferring a certain hair color, height, or organ endowment in its children. Disability rights advocates are critical of germline engineering technology because they fear that a social objective of establishing the "perfect" human might lessen society's value on care and respect. In addition, an appreciation of diversity, the loss of care and respect for the less fortunate would leave disabled people as pitied mistakes. In a similar vein, many environmental groups fear that genetic engineering will be another technology in a string of technologies that prioritizes technical innovation over the preservation of nature resources. As the center for Genetics and Society states, "it is difficult to see how a world that accepts the production of children by cloning or with redesigned genes will long be able to maintain, much less deepen, any sense of respect for the rest of the natural world."

More on "normality"

8. Genetic engineering may lead to eugenics. Indeed, eugenic means "well born" and the eugenic program to breed better humans (like breeding better crops and livestock) was a major part of genetic science until the World War II. Eugenics attempted to make the human race more uniform and healthy. While it was based on unsound biological principles at the turn of the last century, it might now be accomplished scientifically through biotechnology. But such engineering of the genome might have consequences in reducing biological diversity. (7) Thus, some civil rights advocates have found reasons to organize against genetic engineering. Communities of color have historically suffered from the racist social applications of genetic theories, and they are concerned that germline engineering offers another opportunity for racism to manifest, veiled as science. While most scientists involved in germline engineering have no explicit racist agenda, the civil rights advocates have found it disconcerting that David Duke, former National Director of the Klu Klux Klan, heartily supports inheritable genetic modification development. The case for genetic engineering hasn't been helped by scientists claiming that it will cure homosexuality, criminality, and homelessness.

9. Some women's health advocates worry that germline engineering could create new pressures for the child-bearer. Genetic enhancement could be subtly or coercively suggested by a partner, but also by third party groups with financial incentives such as insurance companies, a doctor, a social circle, current fashions, biotech marketers or mass media advertisers. It is not implausible that women could lose the ability to make genetic decisions about their own progeny if the medical establishment or national government decided to regulate genetic engineering in some way.

If you seek more information on these issues, please see the following websites:

The Public Policy Debate

The public policy debate about germline engineering highlights an interesting question about regulating scientific technology. It is somewhat illogical to create restrictive legislation about an unknown technology, especially one with the ability to cause a great deal of good. On the other hand, once a new technology is invented, it often seems too late to create effective and comprehensive policy. Consequently, public policy becomes difficult to construct and different nations have approached it differently.

Policy makers in the United States have the opportunity to make laws about germline enhancement now because the technology is just being developed and is not embedded into our society already. In the United States, there are many voices of caution and many advocates of unrestricted research, both of whom are trying to influence U.S. policy in our time of policy flux.

Why is creating policy about germline engineering important? Germline engineering (GE) is a particularly sensitive subject to policy-makers not only because it allows science to tinker with life and death, but also because GE can affect future generations and the entire trajectory of human evolution. Currently, scientists perform somatic gene alterations—changing the genes in a specific person's body. Germline engineering changes the genes in a sperm or egg, which impacts all future DNA of every cell in the embryo. As Professor Weinberg of MIT (9) explains:

An altered [somatic] gene in your liver or brain may give you cancer, but it has no chance of being passed on to your descendants. Change a [germline] gene in the sperm or egg, and the possibility looms that your kids will inherit it. Geneticists can now manipulate mouse germline genes in several ways. Genes can be added or deleted from a mouse germline. Or the geneline can be subtly altered from its normal form into a novel version never seen in nature.

In effect, germline engineering gives humans the ability to efficiently manipulate evolution without the consent of future generations, a far-reaching and potentially harmful technology with many implications.

Ideally, policy makers would weigh the various considerations of the public interest and decide upon a thoughtful and comprehensive public policy regarding germline engineering. Due to the conflicting ethical, scientific and policy advice, the government has failed to create any binding policy. This paper highlights the major discussions and debates surrounding the legislation of the research and practice of inherited germline modification (IGM).

There are a few kinds of public policy strategies. The default state is the libertarian position (a) of leaving such decisions to the market place. That is to sayono regulations. The other extreme (b) would be to create laws that directly ban germline engineering research or application. Between these two extremes are the positions involving regulation. That is to say, such research and applications might be found warranted in some cases but not in others. The government (c) could regulate scientific studies relating to germline engineering and impose restrictions on the use and application of such studies, thereby prohibiting research on germline engineering. The government (d) could decide to restrict or not allocate public monies to fund any research on germline enhancement. The government (e) could disallow IGM technology or information to be patented, a decision that would decrease incentives in the private sector to pursue new technologies related to the human germline. Lastly, (f) the public could decide not to use IGM technologies, thus lessening the demand for such services.

Government officials do not shape policy alone; instead, that process is informed by scientists, non-government organizations like bioethical councils, the business community, religious groups and public opinion. The process is neither simple nor straightforward, and at times the style of public policy about germline engineering seems more ad-hoc than intentional.

The next obvious questions are: what is U.S. and International Policy about Germline Engineering now, and how has it changed over time? The rest of this paper will answer these questions, beginning with the history of public policy on germline engineering, a summary of current policy, an analysis of the key players creating public policy, and some hypotheses about future policy decisions regarding germline enhancement.

A Brief Political History of Germline Engineering.

As of 2003, the field of germline engineering is relatively small, and is dominated by a few key individuals and institutions. Scientific proposals asking for funding to try and manipulate the human gene were first penned in the early 1980's. They were very controversial; only a minority of scientists favored pursuing the research, and public sentiment was generally absent or negative. In 1983, a letter organized by activist Jeremy Rifkin (4, 9) and signed by 53 religious leaders declared that genetic engineering of the human germline "represents a fundamental threat to the preservation of the human species as we know it, and should be opposed with the same courage and conviction as we now oppose the threat of nuclear extinction." In 1994, the European Scientific Commission Chairperson, Noelle Lenoir said germline therapy was far too risky. "We have said such experiments should not be conducted on humans." (9) Germline enhancement was new, scary, and seemingly unpopular. Professor Gearhart of Johns Hopkins probably summed up popular opinion in 1997 when he articulated that "no one from the conventional scientific world would try germline therapy, for fear of ostracisation and out of ethical sensibility." (10)

Even amidst this negative public sentiment, the National Institutes of Health (NIH), received proposals to fund somatic and germline engineering experiments of humans. The government needed to systemically decide if these types of proposals should be funded, and the appropriate decision-making body was the Recombinant DNA Advisory Council (RAC). The RAC is a small branch of the NIH that is responsible for publicly reviewing gene therapy experiments that include recombinant DNA. The RAC seeks to ensure that experiments are ethical and safely conducted. Any recombinant DNA research conducted at institutions receiving federal funds, be they private or public, are regulated by the RAC. (11) In 1985, the RAC decided that it "[would not them] entertain proposals for germ line alterations but will consider proposals involving somatic cell gene transfer as long as the proposals meet the established criteria." (12)

Advocates of germline engineering saw this decision as the first step towards human laboratory experimentation, while opponents hoped that the NIH had drawn their final ethical line. Meanwhile, research has continued on somatic gene therapy, the genetic manipulations that are not inheritable. The results of somatic gene experiments have been well publicized and represent an area of experimental medicine. While there have been some successes with treating hereditary anemias and lymphocyte defects, there have also been numerous failures and deaths due to somatic gene therapy. Furthermore, in researching somatic engineering, scientists have quietly paved the way to engage in germline engineering clinic trials. (13) By 1998, Dr. John Campbell of UCLA said types of germline engineering, far from technically impossible, could be "a project for graduate students. (14)

The NIH will still not entertain proposals on human germline engineering, but social and political changes have occurred that make a future shift in NIH policy possible and even likely. (15) First of all, the opinion of the scientific community is more amenable to germline engineering now than it was 15 years ago. Princeton Professor Lee Silver's opinion, dramatically different from popular opinions 20 years ago, is currently shared by many scientists: "All of the reasons people have given for saying [germline gene therapy] is wrong are either irrational or religious-based. Some people say we should not go against nature, but that's illogical because every time we cure a disease we go against nature." (16) His statement shows a softening in scientific perception of germline engineering.

The 1998 UCLA symposium entitled "Engineering the Human Germline" may have been a watershed moment for pro-germline engineering forces because it gathered many pro-germline engineering academics together and endowed their individual voices with the strength of academia and the scientific institution. In other words, the UCLA symposium allowed its coordinators, two academics from UCLA highly interested in pursuing germline engineering research, to frame the dialogue about germline enhancement as they wished, and then present their findings as scientific consensus and the findings of academia. According to the New York Times, the purpose of the conference was: "to discuss how, why and when germline engineering should proceed. The scientists, leaders in the fields, were meeting on their own, with no government or other mandate to issue guidelines or regulations and, in fact, no wish to restrict their work." (18) In other words, the UCLA symposium lent a sense of inevitability to the progress of germline engineering research.

Gregory Stock, a vocal leader in the pro-germline engineering camp, was the coordinator of the conference. Stock believes in germline engineering and he is significantly unconcerned with the long-term religious, ethical and environmental implications of germline engineering. He believes:

We best serve ourselves, as well as future generations, by focusing on the short-term consequences of our actions rather than our vague notions about the needs of the distant futureoeven if half the world's species were lost, enormous diversity would still remain. When those in the distant future look back on this period of history, they will likely see it not as the era when the natural environment was impoverished, but as the age when a plethora of new formsosome biological, some technological, some a combination of the twooburst onto the scene (Gregory Stock, quoted in 17).

The conference was well attended, well respected, and well documented; over 1,000 people came and it received front-page coverage in The New York Times and The Washington Post as well as thirty major news sources. Although not all responses were positive, the majority of published opinions were more positive than negative. Professor John Wheeler of SUNY Stony Brook represents an important exception; he wrote that the symposium was arrogant and reminiscent of eugenics: "The freedom and selection of evolution is a wonderful yet messy process. If directed by human manipulation, it will become a moral indignity." (19)

In addition to creating a large and positive public sentiment surrounding germline engineering, the UCLA symposium produced a new test case, a case that would allow the NIH to agree to the possibility of germline engineering without explicitly approving the technique. W. French Anderson, an experimental scientist interested in germline engineering, proposed a clinical trial to begin somatic gene transfer experiments on human fetuses. The proposal acknowledged that this procedure would have a "relatively high" potential for "inadvertent gene transfer to the germline." Anderson hopes to get approval to begin clinical trials next year, and if he does, the door to federally funded testing on the human germline would be knocked ajar for the first time.

Anderson's proposal caused the NIH to receive over seventy pages of public comments, the overwhelming majority of which oppose germline gene therapy. (20) The myriad comments show that public opinion is not as universally positive as the UCLA symposium sponsors wish; germline engineering is still a hot and undecided issue. Anderson's proposal has not yet been approved by the NIH. (21)

Legally, there is no ban in the United States on germline engineering research, so a rejection from the NIH only means that Anderson and others would have to find private sources to fund his idea, a plausible goal considering the large quantities of money currently funding human genetics projects. In fact, private sources have recently funded related experiments. Starting in 1996, doctors at an infertility clinic in New Jersey started using a crude form of germline manipulation called "cytoplasmic transfer" to help fertilize their clients. The doctors, employees of the Institute for Reproductive Medicine and Science in Livingston, NJ, helped their clients conceive by slightly altering the cytoplasm of a mother's egg. Essentially, the doctors took a fertilized egg and added 5% of the cytoplasm (including the mitichondraowhich have their own genes) from a donor egg to replace any malfunctioning units in the client's egg. It has been reported that sixteen babies with the genetic makeup of three parents have been born using this method between 1996 and 2001. (22)

The Institute for Reproductive Medicine and Science was not covered by the ban on federally funded embryo and germline research. Therefore, although many consider their actions un-ethical, they were not unlawful. Furthermore, their goal was not to create a "designer" baby, but just to help women conceive. Nevertheless, this new germline manipulation made many people uncomfortable and the government took three distinct actions. The Food and Drug Administration (FDA), declared the clinic's fertilization technique as a procedure under their jurisdiction and ordered the clinic to stop using the procedure. (23) Also, the genetics-focused ethics panel of the National Institutes of Health and the White House's Bioethics Commission decided to look at developing guidelines for broader oversight of human genetic experiments. (24)

These steps have resolved the New Jersey example, but the larger policy issue has been left ambiguously undecided. In the New Jersey reproductive clinic case, the FDA's authority was tenuous at best. The federal Food and Drug Administration (FDA) is branch of the executive government that tries to protect the public health. According to their website: (25)

Stated most simply, FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use. Our work is a blending of law and science aimed at protecting consumers.

But FDA has other powers that enable it to regulate the New Jersey germline engineering case, specifically, the authority to regulate the research into products that have an intended human use and move in interstate commerce. Therefore, if the products being researched possess an intended human use, and most biotechnology probably would, the FDA could regulate the research. (26)

Recent court precedents support an extension of the FDA into germline engineering research regulation. Court decisions granted the FDA the power to regulate products that substantially affect interstate commerce, even if the products do not move in interstate commerce. It would seem any and all research on germline enhancement would affect interstate commerce because no research is likely to remain in a single state. Thus, the FDA could become an influential regulator of all public and privately funded germline enhancement research. Additionally, since the FDA requires that any procedures submitted to it involving recombinant DNA also pass RAC review, involving the FDA in private sector research effectively enables the RAC to supervise and regulate private research (27).

Perhaps the FDA and RAC will continue to serve as a watch-dog on the private sector in the absence of actual legislation, or perhaps legislation will supplant them. If the government wanted to create new laws, they would look to the White House's Bioethics Commission for advice; the Bioethics Commission is an executive-branch committee with the jurisdiction to consider such ethical issues. It functions as an advisory agency to the president, and the president gets to decide who sits on it. It has no legislative ability, but can make policy recommendations, and since President Bush appointed all the members of the council, he is likely to listen to their analysis. (28) The council has been instructed to learn and "advise the President on bioethical issues that may emerge as a consequence of advances in biomedical science and technology." (29) Issues specifically within their purview are the moral significance of developments in biomedical technology and the ethical and policy questions related to these developments.

The council has proven to be a conservative force and prioritize religion over medical research. The chair of the council is Dr. Leon Kass, a philosophy and ethics professor at the University of Chicago, and the author of Life, Liberty, and the Defense of Dignity: The Challenge for Bioethics (San Francisco: Encounter Books, 2002). He believes that science can and does threaten the human condition, "both by undermining human self-esteem and by generating tools that might be misused, particularly by genetically reshaping the human mind or body." (30) Dr. Kass publicly endorsed the ban on human cloning and the cloning of embryos for research when the bill was in the House of Representatives in July, 2001. Furthermore, he was quoted as calling the ban a way to "seize the initiative and to gain some control of the bio-technical project." (31)

American policy makers might also look for advice from the largest and most influential professional scientific organization: the American Academy for the Advancement of Sciences. (32) The AAAS appointed a panel of 20 experts to consider germline engineering in 1998 and recently published a study on inheritable genetic modification called "Exploring the Ethical, Religious, and Policy Implications of Human Germ-Line Interventions."(33) The goals of the study were to develop proposals for national oversight of germ-line genetic interventions, and the proposal prioritized ethical and humanitarian concerns over unregulated scientific research.

The AAAS study noted that two working groups were formed to create more detailed legislative guidelines. These two working groups had paper topics with the potential for very useful policy analysis. Cooks-Deegan and Palmer are working on a paper called "Options for National Policies to Oversee Inheritable Genetic Modifications," and John C. Fletcher is working on papers called "The New Debate About Human Germ-Line Gene Therapy" and "American Society for Bioethics and the Humanities." (http://www.asbh.org/exchange/1998/F98fletch.htm) These papers will not be published until early next year. The National Academy of Sciences is another organization that could oversee research into the ethical issues of human germline engineering.

The President's Council on Bioethics, the Center for Genetic and Society, Genewatch, The Council for Responsible Genetics and the American Academy for the Advancement of Science are cautionary voices. Other countries have passed legislation banning germline engineering. Australia, Austria, Costa Rica, Denmark, France, Germany, Hungary, India, Israel, Japan, Norway, Peru, Spain, Sweden, Trinidad y Tobago, and the United Kingdom have all passed laws or regulations that somehow proscribe and/or limit human germline engineering. (34) International groups have also discussed genetic modifications and hope to impede the speed of science by interjecting ethical, environmental and religious considerations into the decision-making process.

Currently, the Council of Europe's 1997 Convention on Human Rights and Biomedicine is the most comprehensive and authoritative international agreement. The Convention bans inheritable genetic modification and bans or regulates many other human genetic technologies. (35) On a global scale, the United Nations recently formed an Ad Hoc Committee to look at reproductive cloning. The Committee held an International Convention Banning Human Reproductive Cloning in February of 2002 to create the foundations of a binding treaty; they will meet again in September. However, this treaty, like most UN documents, would not have the force of the law (35).

Another non-enforceable document was created in 1997 by UNESCO, the United Nations Educational, Social, and Cultural Organization. UNESCO adopted a non-binding Universal Declaration on the Human Genome and Human Rights, part of which told UNESCO's International Bioethics Committee to study "practices that could be contrary to human dignity, such as germ-line interventions." (36) The Universal Declaration was signed by 186 nations. (37) Although it would be ideal to have an international body capable of regulating scientific research and the advances in biotechnology, UNESCO does not have that power or authority. Ultimately, the United States could create its own legislation and ignore UN regulations, just as it has countless times in the past.

The World Health Organization is a somewhat more powerful international governing body; the mandates passed down by the WHO are operational. Furthermore, there was a major study done in 1999 about genetics, cloning and biotechnology that included a public health component which explicitly called for a global ban on inheritable genetic modification. However, these guidelines were never published in final form. More recently, the WHO established a different advisory committee to enable policy decisions to be made about genetic technologies, but its final advice is yet undetermined.

In sum, the landscape of international operational policy and United States' domestic policy are currently in a state of flux. The United States has used stopgap measures to prevent one situation from progressing, but it does not have a proactive mechanism in place to stop the private sector from engaging in other research or practices like the New Jersey reproductive healthcare clinic example. That would require an act of Congress, a slow and drawn out legislative process loaded with ethical decisions. Our experiences with eugenics have shown that government should be wary of becoming too involved. On the other hand, leaving germline engineering free to develop in an unregulated market doesn't allow morality or the public interest to affect the trajectory of germline engineering. Ultimately, the United States will have to make a legislative decision in the near future, or risk the private sector dictating the next steps.

FOOTNOTES

1. http://research.mednet.ucla.edu/pmts/Stock.htm. Now published as Redesigning Humans: Our Inevitable Genetic Future. Houghton Mifflin, Boston.

2. White, A. D. (1960/1896). A History of the Warfare of Science with Theology in Christendom. Dover, New York.

3. Gilbert, S. F. 2003. Developmental Biology. Sinauer Associates, Sunderland, MA.

4. Rifkin, J. 1998. The Biotech Century. Putnam Press, NY.

5. Silver, L. 1998. Remaking Eden: How Genetic Engineering and Cloning Will Transform the American Family. Avon, New York.

6. Kant, I. (1959). Foundations of metaphysics. (L. W.Beck, translator). Bobbs-Merrill, Indianapolis. P. 39.

7. Allen G.E. 2001. Essays on science and society. Is a new eugenics afoot? Science 294:59-61. See also:

8. Weinberg, Robert A. "The Genetic Pipeline: Should We Tamper." Newsday. 31 March 1996: A46.

9. Hayes, Richard. "The Quiet Campaign for Genetically Engineered Humans" Earth Island Journal—News From Around the World. Spring 2001: v16, #1.

10. Irwin, Aisling. "Science: Changing the Species. A genetic breakthrough in Baltimore raises profound ethical problems as well as medical hopes." The Daily Telegraph. 30 July 1997: pg. 14

11. http://www4.od.nih.gov/oba/rdna.htm (and Princeton)

12. Recombinant DNA Advisory Committee, "Guidelines for Research Involving Recombinant DNA Molecules," (Available from The Department of Health and Human Services, National Institutes of Health, http://www.nih.gov, Appendix M: NIH document entitled "Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA into the Genome of Human Subjects", "Regulatory Issues: The Revised 'Points to Consider' Document," Human Gene Therapy 1 (1990), 93-103).

13. Professor John Gearhart of John Hopkins made an especially useful contribution when he was able to keep the germ cells from an aborted six-week old fetus alive, just as they were on the brink of specializing. (for citation, see Irwin Aisling's article)

14. Kolata, Gina. "Scientists Brace for Changes in Path of Human Evolution" New York Times. 21 March 1998.

15. From John Fletcher, Bioethicist at University of Virginia.

16. Weiss, Rick. "Science on the Ethical Frontier: Engineering the Unborn: The Code of Cross-Generation Cures." The Washington Post. 22 March 1998.

17. Hayes, Richard. "The Quiet Campaign for Genetically Engineered Humans" Earth Island Journal—News From Around the World. Spring 2001: v16, #1.

18. Kolata, Gina. "Scientists Brace."

19. Wheeler, John C. "Crafting Genes is About Ego, not Science." New York Times. 23 March 1998.

20. Begley, Sharon. "Designer Babies, Altering Unborn Babies through Gene Therapy." Newsweek. 9 November 1998.

21. http://www.genetics-and-society.org/resources/cgs/2001_earthisland_hayes.html

22. Mangles, John. "Geneticists jump across Ethical Frontier" National. 21 May 2001; Meek, James. "IVF breakthrough modified genes" Guardian Homes Pages. 5 May 2001: pg 4. "Genetically Modified Children." Alberta Report. 28 May 2001.

23. Brave, Ralph. "Governing the Genome: Which genetic modifications should be encouraged?" The Nation. 10 December 2001.

24. Mangles, John. "Geneticists jump."

25. http://www.fda.gov/opacom/hpview.html

26. The National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research. Rockville, Maryland. September 1999: pg 93.

27. Food and Drug Administration, "Tissue Action Plan: Tissue Reference Group Annual Report FY98," http://www.fda.gov, accessed January 2000. http://www.fda.gov/cber/tissue/tapfy98.htm

28. President's Council on Bioethics is composed of members appointed by the president. They serve two-year terms and are eligible for re-appointment. The council aims to include non-government workers who are members of a variety of fields and disciplines: science and medicine, law and government, philosophy and theology, and other areas of the humanities and social sciences. The members of the council are not paid a salary, but they are compensated and all of their expenses are paid. The funding and administrative support for this committee comes from the Department of Health and Human Services. (Mission statement, Council of Bioethics, GEORGE W. BUSH, THE WHITE HOUSE, November 28, 2001, Federal Register date: November 30, 2001, Federal Register page: 66 FR 59851.)

29. Section 2, Mission Statement of Bioethical Council

30. Wade, Nicolas, "Moralist of Science Ponders Its Power." New York Times. 19 March 2002.

31. http://www.nytimes.com/2002/03/19/science/19KASS.html

32. Weiss, Rick. "Science on the Ethical Frontier."

33. http://www.aaas.org/spp/dspp/sfrl/projects/germline/report.pdf

34. http://www.glphr.org/genetic/genetic.htm

35. http://www.genetics-and-society.org/policies/other/igm.html

36. http://www.unesco.org/ibc/

37. The Declaration and its signatories are at http://portal.unesco.org/shs/en/ev.php-URL_ID=1881&URL_DO=DO_TOPIC&URL_SECTION=201.html.

© All the material on this website is protected by copyright. It may not be reproduced in any form without permission from the copyright holder.

HOME :: CHAPTER 0  :: 0.  :: SHOULD WE ALLOW GENETIC ENGINEERING? A PUBLIC POLICY ANALYSIS OF GERMLINE ENHANCEMENT
Home Link