The story for the year 1997 was the cloning controversy, the public debate over cloning human beings. Ian Wilmut, the laboratory midwife to the world famous sheep, Dolly, never intended to clone a human being. He still opposes the idea. Almost everyone opposes the idea.Yet, the cultural explosion ignited by this new scientific achievement continues to spread fallout. The prospect of gaining too much control–too much choice–over our own evolutionary future elicits anxiety, fear, suspicion. Genetic science seems to be igniting fires previously smoldering in our primordial sensibilities. Science is secular. And when secular science enters our DNA we fear it is entering a realm of the sacred. We fear a Promethean blunder. We fear that our own human hubris will violate something sacred in our nature; and we fear that nature will retaliate with disaster. To protect ourselves from a possible Promethean blunder by science, we are tempted to stop further research with the commandment: “thou shalt not play God!”

Then, during 1999, we opened the first few pages on chapter two of the cloning controversy story. I will refer to this chapter as “the stem cell debate.” The debate has only begun. What is not yet clear is just what needs to be debated. Perhaps nothing. Perhaps everything. What is clear is that the fallout from the cloning explosion is still lighting fires here and there. Whether or not the public will add stem cells to the fuel to make those fires burn hotter remains to be seen.

Stem cells have become front page news in Australia, as well as in the United States and other countries. On February 4, 1999, the Australian National Academy of Science issued a position statement. Note the structure of Recommendation 1.

Council considers that reproductive cloning to produce human fetuses is unethical and unsafe and should be prohibited….However, human cells derived from cloning techniques, from ES cell lines, or from primordial germ cells should not be precluded from use in approved research activities in cellular and developmental biology

Here two things are put together. First, disapproval of reproductive cloning for the purposes of making children. Second, approval of research on human embryonic stem cells, approval even in the face of ethical squeamishness regarding embryo research. If this Australian statement is a barometer, we need to ask: what is the cultural weather forecast? What might be coming?

In what follows it will be my task to report on the fast-moving frontier of stem cell research within the field of genetics. I will try to identify the ethical questions that are relevant to what could turn out to be one of the most dramatic new chapters in medical history, a chapter just beginning and expected to continue over the next decade or longer. Then I will try to formulate questions regarding theological anthropology, agenda questions raised by science that need to be addressed by systematic theologians and public policy makers. I will ask more questions than I am ready to answer. Yet, I believe that such work invested in trying to formulate the relevant question (die Fragestellung) takes us more than just halfway toward a helpful answer.

Stem Cells

Stem cells are essentially undifferentiated cells. There are many kinds of stem cells, some more differentiated than others. When they divide, their progeny mature and specialize into a specific type of cell (i.e. heart, blood, liver). These differentiated cells form an embryo. Stem cells also exist in adults (Adult Stem (AS) cells) and are used to repair and regenerate damaged organs and tissues throughout life. However, in adults the repair and regeneration by stem cells is limited to only certain cell types. In contrast, embryonic stem (ES) cells are not limited in there potential to differentiate into every cell type. Embryonic germ (EG) cells have the same potential as ES cells. It is the versatility and nonspecifically of these cells that gives them the potential to have therapeutic applications.

What are the New Discoveries?

Human embryonic stem cells (hES cells) are cells that are self-renewing–virtually immortal–and have the capacity to develop into any or all tissue types in the human body. If medical scientists could gain the ability to turn on selected genes to grow selected tissues and organs for transplantation, hES cell-based therapies would revolutionize treatment of degenerative age-related diseases such as Parkinson’s disease, diabetes, and congestive heart failure.

Two recent claims of laboratory triumph are relevant. First is the isolation of human embryonic stem cells (hES cells) by James Thomson, an associate veterinarian in the University of Wisconsin’s Regional Primate Research Center. Thomson began with fertilized ova–spare embryos from in vitro fertilization (IVF) not placed in a uterus–and cultured them to the blastocyst stage, about four to six days. At this point he removed the outer shell of the blastocyst, separated out the individual cells, and placed them on a feeder tray. The cells divided. They reproduced themselves. Because these cells are as yet undifferentiated–that is, they are pluripotent and able to make any part of a human body–they are the cells from which other cells stem. Because they replicate themselves indefinitely, Thomson in effect created an immortal line of embryonic stem cells.I will provide more detail on the Gearhart discovery in the description that follows.

The Enormous Potential Value of Stem Cell Research

Stem cell research is a step to be taken toward the improvement of transplantation therapy and toward lengthening a person’s lifeWe will postpone discussion of life-extension, noting here the relevance to transplantation medicine. Specifically, rejuvenation through transplantation of tissue grown in a laboratory from stem cells would be of enormous value for cardiomyocytes to renew heart muscle to prevent congestive heart failure; replacement of hematopoietic stem cells for producing healthy blood in bone marrow to resist infection by the human immunodeficitent virus and to treat AIDS and possibly sickle cell anemia; cultivating endothelial cells to reline blood vessels as treatment for atherosclerosis, angina, and stroke due to arterial insufficiency; rejuvenating islet cells in the pancreas to produce natural insulin to fight diabetes; renewal of neurons in the brain to treat Parkinson’s disease and victims of stroke; fibroblast and keratinocyte cells to heal skin in the treatment of burns; and chondrocytes or cartilage cells to treat osteoarthritis or rheumatoid arthritis.

The trick will be to discover just what turns which genes on and off. Once scientists have learned how to trigger gene expression, they can apply it to pluripotent stem cells and direct the growth of selected bodily tissue. Particular organs could be grown in culture. Heart tissue or entire organs such as the pancreas or liver could be grown in the laboratory. These would be healthy rejuvenating organs ready for transplantation.

In order to transplant the laboratory grown organs, however, we need to override our immune system in order to avoid organ rejection. Two scenarios lie before us. One would be to create a ‘universal donor’ cell that would be compatible with any organ recipient. The task here would be to disrupt or alter the genes within the cell responsible for the proteins on the cell’s outer surface that label them as foreign to the recipient’s immune system. This approach would be difficult. It would involve disrupting genes within the same DNA in which we are trying to express certain other genes. Exposing such cells to harsh conditions with rounds of different drugs may damage more than just the targeted surface proteins.

A preferable second scenario would be to make cells that are genetically compatible (histocompatible) with the organ recipient–that is, to make cells with an identical genotype. If the organ genotype matches that of the recipient, no immune system rejection will take place.

Enter cloning–that is, somatic cell nuclear transfer. We can imagine the fo llowing scenario for customizing organ growth and transplantation. We could begin with an enucleated human oocyte–that is, we could begin with an egg with the DNA nucleus removed. Via somatic nuclear transplantation–cloning–we could insert the DNA nucleus of the future transplant recipient. We could then turn on selected genes–that is, we could cause the stem cell to differentiate into cardiomyocytes to produce heart tissue. The heart tissue could be grown>ex vivo, outside the body, and then through surgery placed within the recipient. Because the implanted heart tissue has the same genetic code as the recipient, no rejection would occur. This is in part the Dolly scenario. It differs in part because it grows only organ tissue and not an entire fetus.

Another variant on the second scenario that distinguishes it from Dolly would be one that eliminates the use of the oocyte. Instead of an oocyte, the recipient’s DNA nucleus might be placed within a non-egg cell. The goal would be to accomplish laboratory organ growth in a stem cell that is not an egg. To accomplish this, we need further research on cytoplasm’s role in gene expression.

What is there in the cytoplasm that programs the DNA? Could we discover this? If so, we could begin not with an oocyte but rather with an hES cell. We could enucleate a non-egg stem cell and insert the specific DNA nucleus, then reprogram the cytoplasm to cause the desired differentiation.

Ethics Influencing Science?

At this point we should see that ethical factors are beginning to influence the science. This variant on the second scenario appears to have a slight ethical advantage. The removal of the DNA nucleus from the donated oocyte might be considered the destruction of a potential human life; and the insertion of a DNA nucleus appears to be an asexual creation of a human embryo. We suddenly find ourselves in the middle of the abortion debate. By beginning with hES cells, scientists think this debate could be avoided. However, the use of hES cells does not avoid the embryo problem completely. The Thomson method relies on destroyed blastocysts as the source for hES cells; and the Gearhart method relies on aborted fetuses. Much needs to be cleared up here.

The primary task, as I see it, will be for scientists and ethicists to agree on the relevant vocabulary. In particular, the distinction between totipotent and pluripotent stem cells must be stipulated with sufficient clarityto permit ethical analysis. Right now it appears that only one attribute distinguishes them, namely, a totipotent stem cell has the potential for becoming an embryo and hence a human being, whereas a pluripotent stem cell does not. Yet, we must ask, why is this the case? Is it because totipotent cells have a genetic potential lacking in pluripotent cells? No. What distinguishes them is that totipotent cells have access to a placenta making them available for implantation; whereas pluripotent stem cells lack placenta access. Will this distinction hold? We will see.

Question: What’s in the Petri Dish, Property or Person?

One inescapable ethical question to be confronted has been formulated by Glenn McGee and Arthur Caplan, “What’s in the dish?”

The Roman Pontiff and the Congregation for the Doctrine of the Faith attribute full human personhood and dignity and moral status to us from the moment of fertilization on. In order to avoid any slight of ethical hand that might compromise this firm position, the Vatican uses interchangeably terms such as ‘zygote’, ‘pre-embryo’, ’embryo’, and ‘foetus’.

What is of indispensable value here for our ethical deliberation is the Vatican’s unflinching resolve to protect the dignity of human personhood. Yet, the questions raised by stem cell research are more than this line of ethical deliberation is presently ready to handle. The Vatican’s approach is like an ethical spray gun; whereas what we need in this instance is to paint with a fine pencil brush. We need to color within the lines, so that we avoid accidentally blotting out advances in the quality of human health and flourishing.

Question: Will Stem Cell Research Encourage an Increase in Embryo Destruction and Abortions?

Although this is a quantitative question applied to a qualitative ethical concern, we intuitively sense that the public impact of such science is morally relevant. We rightly fear that if such science and its resulting technology proceed this might encourage couples to fertilize ova for the purposes of sale or donation and that it might encourage abortions for harvesting hEG cells. At this point, however, it appears that this would be an unfounded fear.

More fertilized ova are already being generated by reproductive technology clinics than will ever be implanted. It is known well in advance that many will be destroyed as a matter of course. Therefore, diverting some for scientific research purposes constitutes a potential beneficial use for tissue that would otherwise be discarded. Scientific research is not in effect preventing human births.

Let us press the question: would stem cell research lead to increased demand for fetal tissue or for IVF embryos? Probably not. Over the last four or five years of research, relatively few fetuses, less than 100, have actually been harvested for experimentation. Experiments at University of San Francisco and University of Wisconsin use less than two dozen IVF embryos per year. The hope downstream is that laboratories could generate enough stem cells in culture to preclude constant demand for more and more tissue. In sum, stem cell research as presently understood should have a negligible impact on IVF or abortion practices.

The Ethics Advisory Board of the Geron Corporation, for a case in point, has taken a position against deliberately fertilizing ova for the purpose of selling or even donating them to make hES cells. Stem cell research of this type should proceed on the assumption that it would have a sufficient supply of discarded fertilized ova that would never have had the opportunity for implantation. The Ethics Advisory Board strongly recommends that the donating women or couples provide fully informed consent, but not that they share in the financial profit.

Reading between the lines, perhaps we can see Roman Catholic or right-to-life logic at work here. The use of fetal tissue for research is licit when the fetuses result from spontaneous abortions; but it is not licit when elective abortions are involved. Roman Catholics want to avoid any direct or indirect support for elective abortion. Yet, a hint of moral wiggle room seems to exist when deriving stem cells from fetal sources. No wiggle room seems to exist presently in right-to-life thinking regarding the deliberate destruction of embryos. One might surmise that, without saying it, these proposed government guidelines are responding to such concerns regarding the moral inviolability of what is perceived to be the integrity of the embryo, an integrity that goes as far back as the fertilized zygote. Governmental response to this is most appropriate, and welcomed. My only plea is that, if this is the operative thinking, it should be stated clearly as an ethical concern and not hid it under an alleged scientific distinction between totipotency and pluripotency.

Question: is There a Potential Baby in Every Body Cell?

Now, though still quite hypothetically, we might engage in further ethical speculation regarding the possible totipotency inherent in any pre-differentiated pluripotent cell. Recall the yet to be discovered role that cytoplasm and other nonnuclear factors play in gene expression. One significant research task lying before molecular biologists is to determine just how the cytoplasm interacts with the DNA nucleus, and to gain the ability to reprogram cytoplasm to make specific tissue. Once this ability to reprogram is achieved, then in principle it could be used with any cell. We would not necessarily at that point have to rely on oocytes or fertilized ova or, perhaps, even blastocysts as the source. Somatic cells might become the source for pluripotent cells.

Then we would experience a shift in ethical ground tantamount to an earthquake. Initially and naively, we could breathe a sigh of relief. If laboratory scientists are no longer tempted to harvest stem cells from IVF products or aborted fetuses, then it appears that our fears are over. Human dignity is no longer threatened, because potential babies will no longer lose their potential lives in laboratory procedures. After all, nature (or God) has given us one source for making babies–fertilized ova–and this source will be protected. We could brush off our hands and thank the alliance of scientists and ethicists for solving this sticky problem.

However, the relief will be only momentary. At this point we will begin to feel the ground under our feet starting to shift. The needles on our ethical seismograph will begin to dance furiously. Would we begin to think of each cell in our body as an embryo? Would this mean that, in principle, we could make a baby from any cell in our body? Here is what we need:

1. The full genetic code to make every tissue available in every somatic cell;

2. The ability to return our DNA nucleus to quiescence and then to its pre-differentiated state, as in the case of Dolly; and

3. The ability to reprogram the cytoplasm to cause selected genetic expression and, along with this, to initiate embryonic development. This is all it takes. The first two are already in the well. Nature has given us a full complement of genes in every somatic cell. The cloning experiments at the Roslin Institute have given us the technology of quiescence for returning an already differentiated somatic nucleus to its pre-differentiated state and, hence, pluripotency. Only the third scientific task remains to be accomplished; and this would demonstrate the principle that babies can come from anywhere.

Now, we find ourselves in a most fascinating ethical situation. Let us ask: does every cell in our existing body have the same moral status as that of a pluripotent hES cell? Or, the same status as a totipotent fertilized ovum or blastocyst? What have we done? Have we sent the moral status of common somatic cells up the ethical staircase? Or, have we brought pluripotent hES cells down a few steps? Or, have we done both?

We have little remorse at going to the barber for a haircut or clipping our finger nails. Nor do we feel immoral at donating blood or even a kidney to save the life of someone who might die without our bodily gifts. We tend not to think of our cells or limbs or body parts as themselves potentially whole persons with full dignity. Our body parts have a level of dignity, to be sure, but it is a dignity borrowed from ourselves as whole persons.

Nor do we feel compelled morally to exhaust our potential for reproduction. Despite the millions of ova in a woman and sperm in a man, we do not feel a compulsion to see every one individually contribute to the making of a new human person. Despite the Onan incident (Genesis 38:8-10), we recognize that God’s creation begins with an excess of ova and sperm in the reservoir of potentiality within which some individual persons become an actuality. In natural sexual processes, only a fraction of ova become fertilized by only a fraction of sperm. And, of the resulting zygotes, the majority are flushed naturally out of the mother’s body before implantation. If this natural parsimony is already operative with germ cells, might it relieve us of moral pressure to treat every pluripotent stem cell as an embryo, as a potential individual person?

What’s in the petri dish? A person? No, I don’t think so. Even if we can say in principle that what’s in the petri dish is genetically a potential person, this does not in itself warrant putting an end to stem cell research. The genetic potential for making persons is virtually ubiquitous. In principle, it lies in every cell of every human body. Yet, we have no ethical warrant to actualize all this potential. No warrant exists to make babies out of every available germ cell let alone every already differentiated somatic cell; nor do I think it is required of every pluripotent stem cell.

This is a safety-in-numbers argument. In itself, it may not be persuasive in ethical deliberation. This I grant. Yet, it gains persuasive strength when combined with the argument from beneficence.

What I find decisive is the related argument from beneficence: stem cell research carries with it promise of significant advances in medicine. The potential for reducing human suffering and improving human health and well-being is enormous. If it cannot be shown conclusively that individual human dignity is violated at the source of stem cells, then it seems to me that the argument from beneficence should be decisive in providing ethical encouragement to proceed with such research.

Findings and Recommendations Human stem cell research holds enormous potential for contributing to our understanding of fundamental human biology. Although it is not possible to predict the outcomes from basic research, such studies will offer the real possibility for treatments and ultimately for cures for many diseases for which adequate therapies do not exist.

The benefits to individuals and to society gained by the introduction of new drugs or medical technologies are difficult to estimate. The introductions of antibiotics and vaccines, for example, have dramatically increased life spans and improved the health of people all over the world. Despite these and other advances in the prevention and treatment of human diseases, devastating illnesses such as heart disease, diabetes, cancer, and diseases of the nervous system such as Alzheimer’s disease present continuing challenges to the health and well-being of people everywhere. The science leading to the development of techniques for culturing human stem cells could lead to unprecedented treatments and even cures for these and other diseases.

As with all research, our ability even to contemplate the possibilities offered by stem cell-derived therapies is a result of many years of research. The science of stem cells dates to the mid-1960s, and many papers have been published on the isolation and laboratory manipulation of stem cells from animal models. While these models are imperfect, they are accepted in the scientific community as good initial predictors of what occurs in human beings.

There already exists evidence from animal studies that stem cells can be made to differentiate into cells of choice, and that these cells will act properly in their transplanted environment. In human beings, transplants of hematopoietic stem cells (the cells which eventually produce blood)

following treatments for cancer, for example, have been done for years now. Further, somewhat cruder experiments (e.g., the transplantation of fetal tissue into the brains of Parkinson’s patients) indicate that the expectation that stem cell therapies could provide robust treatments for many human diseases is a reasonable one. It is only through controlled scientific research that the true promise will be understood.

This research raises ethical and policy concerns, but these are not unique to stem cell research.

Innovative research and new technologies derived from such research almost always raise ethical and policy concerns. In biomedical research, these issues include the ethical conduct of basic and clinical research as well as the equitable distribution of new therapies. These issues are relevant to discussions about stem cell research and its eventual applications; however, they are part of a constellation of ethical and policy concerns associated with all advances in biomedical research. Guidelines or policies for the use of human biological materials have been issued at many levels, from internal review boards to the National Bioethics Advisory Commission, which recently released a detailed report on the use of such materials. Existing policies cover all aspects of research, from the use of cell lines in laboratories, to human subjects protections, that will surface in the consideration of stem cell research.

It is essential that there be a public that is educated and informed about the ethical and policy issues raised by stem cell research and its applications. Informed public discussion of these issues should be based on an understanding of the science associated with stem cell research, and it should involve a broad cross-section of society.

It is essential for citizens to participate in a full and informed manner in public policy deliberations about the development and application of new technologies that are likely to have significant social impact. The understanding of the science is particularly important for discussing ethical and policy issues. Ideally, scientists should communicate the results of their research in ways that will be readily understandable to a diverse audience, and participate in public discussions related to stem cell research.

The ethical and policy issues raised by stem cell research are not unique, but this research has received a significant amount of public attention and there is much to gain by open reflection on the implications of this sensitive area of research. Congressional hearings, public meetings by government agencies, and media coverage have pushed stem cell research issues into a spotlight. There should be continued support for the open manner that has allowed all those interested to observe or participate in these processes and for a sustained dialogue among scientists, policy makers, ethicists, theologians, and the public to consider issues that emerge with the advancement of stem cell research.

Existing federal regulatory and professional control mechanisms, combined with informed public dialogue, provide a sufficient framework for oversight of human stem cell research.

The appearance of new technology can evoke apprehension and engender uncertainty among segments of the population about its uses. Where these concerns are related to issues having important ethical and social implications, certain levels of oversight are appropriate. But it is important to create new oversight mechanisms or regulatory burdens only when there are compelling reasons for doing so.

Federal funding would automatically trigger a set of oversight mechanisms now in place to ensure that the conduct of biomedical research is consistent with broad social values and legal requirements. While basic laboratory research with personally non-identifiable stem cells does not pose special ethical or oversight challenges, an elaborate system of review is in place for research involving human subjects, ranging from procurement issues to the conduct of clinical trials. The Federal Common Rule governing human subjects research provides for local and federal agency review of research proposals in such circumstances, weighing risks against benefits and requiring involved and voluntary consent. The Food and Drug Administration (FDA) has the authority to regulate the development and use of human stem cells that will be used as biological products, drugs, or medical devices to diagnose, treat or cure a disease or underlying condition. Further, states should adopt the Federal Government’s Model Program for the Certification of Embryo Laboratories.

Complementing these regulatory mechanisms are the National Bioethics Advisory Commission (NBAC), which has demonstrated its legitimate claim to respect for its efforts as a national body to promote public input into social policy related to advances in biomedical research, and the Recombinant DNA Advisory Committee (RAC), which currently has a mandate to review the ethical and policy issues associated with gene therapy and could be authorized to change its mission to broaden its purview. These federal bodies should work with interested stakeholders in the conduct of stem cell research – professional organizations, patient disease groups, religious communities, the Congress, funding agencies and private foundations, industry, and others – so that the public can be assured that appropriate safeguards are in place as this research evolves.

Thus, at the present time, no new regulatory mechanisms are needed to ensure responsible social and professional control of stem cell research in the United States.

Federal funding for stem cell research is necessary in order to promote investment in this promising line of research, to encourage sound public policy, and to foster public confidence in the conduct of such research.

Realizing the potential health benefits of stem cell technology will require a large and sustained investment in research. The federal government is the only realistic source for such an infusion of funds. For those who are challenged daily by serious diseases that could in the future be relieved by therapies gained through stem cell research, public funding holds the greatest promise for sooner rather than later research results that can be transferred from the bench to the bedside. Without the stimulus of public funding, new treatments could be substantially delayed.

The commitment of federal funds also offers a basis for public review, approval, and monitoring through well established oversight mechanisms that will promote the public’s interest in ensuring that stem cell research is conducted in a way that is both scientifically rigorous and ethically proper. Additionally, public funding contributes to sound social policy by increasing the probability that the results of stem cell research will reflect broad social priorities that are unlikely to be considered if the research is carried out in the private sector alone.

There are segments of American society that disagree on moral grounds with using public monies to support certain types of stem cell research. However, public policy in a pluralistic society cannot resolve all the differences that arise in national debates on sensitive social issues. In the context of stem cell research, this leads to three practical conclusions. One is a willingness to permit individuals, whether they are researchers or embryo or fetal tissue donors, to act in conformity with their own moral views on these matters. A second is the commitment to public involvement in research support when this research is related to the promotion and protection of public health, includingthe acquisition of new molecular and cellular insights into basic human developmental biology. A third is respect for opposing views, especially those based on religious grounds, to the extent that this is consistent with the protection and promotion of public health and safety.

Public and private research on human stem cells derived from all sources (embryonic, fetal, and adult) should be conducted in order to contribute to the rapidly advancing and changing scientific understanding of the potential of human stem cells from these various sources.

There are three primary sources of stem cells, each with different characteristics as to how many different developmental paths they can follow and how much they can contribute to our understanding of a functioning organism. Embryonic stem cells (ES cells), derived from a very early embryo, and embryonic germ cells (EG cells), collected from fetal tissue at a somewhat later stage of development, have particular promise for a wide range of therapeutic applications because, according to our present knowledge, they are capable of giving rise to virtually any cell type. Research on these primordial cells will also provide a unique opportunity to study human cell biology.

Adult stem cells, obtained from mature tissues, differentiate into a narrower range of cell types. As a result, many cells of medical interest cannot currently be obtained from adult-derived stem cells. It is also less feasible to develop large-scale cultures from adult stem cells. However, it is important to note that, at this time, it is only adult human stem cells that are well-enough understood that they can be reliably differentiated into specific tissue types, and that have proceeded to clinical trials.

Because the study of human stem cells is at an early stage of development, it is difficult to predict outcomes and findings at this point in time. As more research takes place, the full developmental potential of different kinds of stem cells will become better understood.

In view of the moral concerns surrounding the uses of embryonic and fetal tissue voiced by a segment of the American population, strengthening federally and privately funded research into alternative sources and/or methods for the derivation of stem cells, including further initiatives on adult stem cells, should be encouraged.Human stem cell research can be conducted in a fully ethical manner, but it is true that the extraction of embryonic stem cells from the inner mass of blastocysts raises ethical questions for those who consider the intentional loss of embryonic life by intentional means to be morally wrong. Likewise, the derivation of embryonic germ cells from the gonadal tissue of aborted fetuses is problematic for those who oppose abortion. In contrast, adult stem cell research is more broadly acceptable to the American population.

Public funding should be provided for embryonic stem cell and embryonic germ cell research, but not at this time for activities involved in the isolation of embryonic stem cells, about which there remains continuing debate. This approach will allow publicly-funded researchers to move more quickly toward discoveries that will lead to alleviating the suffering caused by human disease.

Although the derivation of human stem cells can be done in an ethical manner, there is enough objection to the process of deriving stem cells to consider recommending against its public funding. Further, for the foreseeable future there will be sufficient material isolated by researchers not using public funding that this exclusion will not have a negative impact on research.

There are many individuals who believe that any use of human embryos other than for achieving a pregnancy is unethical, believing that the embryo is a full human being from the earliest moments in the conception process. Howev er, many religious traditions take a “developmental” view of personhood, believing that the early embryo or fetus only gradually becomes a full human being and thus may not be entitled to the same moral protections as it will later; others hold that while the embryo represents human life, that life may be taken for the sake of saving and preserving other lives in the future. The dialogue about these issues is ongoing in the United States, but these concerns need not exclude publicly-funded research activities on cell lines that have already been established.

Embryonic stem cells should be obtained from embryos remaining from infertility procedures after the embryo’s progenitors have made a decision that they do not wish to preserve them. This decision should be explicitly renewed prior to securing the progenitors’ consent to use the embryos in ES cell research.

The most ethical source of human primordial stem cells isembryos produced for the process of in vitro fertilization whose progenitors have decided not to implant them and have given full and informed consent for the use of these embryos for research purposes. Two appropriate potential sources of donation are embryos with poor quality that makes them inappropriate for transfer and embryos remaining when couples have definitely completed their family and do not wish to donate the excess embryos to others.

Informed consent requires that the woman or couple, with substantial understanding and without controlling influences, authorize the use of their spare embryos for research purposes. Because assisted reproduction can be a stressful process, informed consent should be secured in two stages. The two-stage process would also maintain a separation between personnel working with the woman or couple who hope to get pregnant and personnel requesting embryos for stem cell research.

At the beginning of the process, personnel working with the woman or couple who hope to become pregnant should ascertain their preferences as to the future of embryos remaining after the assisted reproduction process. These options should include consent for embryo donation to another couple, consent for donation for research, and consent for destruction of the spare embryos. Once a couple has definitely decided that it has completed its family, then the couple should be approached a second time to secure an explicit consent to use the embryos in ES cell research.

Persons considering donating their excess embryos for research purposes should be afforded the highest standards of protection for the informed consent and voluntariness of their decision.

Securing embryos for the purpose of harvesting stem cells must proceed in a careful fashion for several reasons. These are to protect the interests of the gamete donors, to reassure the public that important boundaries are not being overstepped, to enable those who are ethically uncomfortable with elements of this research to participate to the greatest extent possible, and to ensure the highest quality of research and outcomes possible.

Consonant with good research practice, policies on the procurement of embryos should include at least the following points: (1) Women should not undergo extra cycles of ovulation and retrieval in order to produce more “spare” embryos in the hope that some of them might eventually be donated for research;

(2) Analogous with our current practice for organ donation, there should be a solid “wall” between personnel working with the woman or couple who hope to get pregnant, and personnel requesting embryos for stem cell purposes; (3) Women and men, as individuals or as couples, should not be paid to produce embryos, nor should they receive reduced fees for their infertility procedures for doing so; and (4) Consent of both gamete donors should be obtained.

Where appropriate, guidelines that can attract professional and public support for conducting stem cell research should be developed.

At present, stem cell research raises no unique ethical or policy issues. As research advances issues may emerge that challenge acceptable ethical practices and public policy. Hence, there should be opportunities for public reconsideration of the need for guidelines specifically targeted to human stem cell research. Such efforts should be informed by the most current scientific evidence and should occur through a process that encourages broad involvement by all sectors of society.

Almost two decades of experience with the Recombinant DNA Advisory Committee ‘s (RAC) oversight of recombinant DNA research suggest that the RAC could be an effective institutional focal point within the federal government to facilitate the type of public dialogue on stem cell research proposed here, and to coordinate efforts to develop new guidelines, where needed. The RAC has a proven track record of providing an open forum for sorting out complex ethical issues and of defusing conflict. Furthermore, it has acquired a degree of legitimacy among scientists in both the public and private sectors, with its widely accepted Points to Consider in the design and conduct of gene therapy.

In order to allow persons who hold diverse moral positions on the status of the early embryo to participate in stem cell research to the greatest degree possible without compromising their principles, and also to foster sound science, stem cells (and stem cell lines) should be identified with respect to their original source.

Patients and researchers should be able to avoid participating in stem cell use if the cells were derived in a way that they would consider to be unethical. As a matter of good scientific practice, records are routinely maintained on the sources of biological materials. It is of utmost importance that documentation of the original source of the stem cells can be made readily available to researchers and to potential recipients of stem cell therapies.

Special efforts should be made to promote equitable access to the benefits of stem cell research.

The therapeutic potential for treating and possibly curing many serious diseases constitutes a major rationale for large-scale investments of public and private resources in human stem cell research. To justify funding stem cell research on the basis of its potential benefits, particularly the use of public resources, however, requires some assurance that people in need will have access to the therapies as they become available.

Several factors make it unlikely that there will be equitable access to the benefits of this research. Unlike other western democracies, the United States does not have a commitment to universal health care. More than 44 million people lack health insurance and therefore do not have reliable access even to basic health care. Others are underinsured. Moreover, if stem cell research were to result in highly technological and expensive therapies, health insurers might be reluctant to fund such treatments.

Overcoming these hurdles and assuring equitable access to the benefits of stem cell research in this country will be a politically and financially challenging task. It is therefore appropriate to begin considering how to do so now in advance of the development of applications. The federal government should consider ways to achieve equitable access to the benefits derived from stem cell research.

Intellectual property regimes for stem cell research should set conditions that do not restrict basic research or encumber future product development.

The U.S. Patent and Trademark Office (PTO) has already stated that purified and isolated stem cell products and research tools meet the criteria for patentable subject matter. When research is funded by the private sector, as is currently the case with stem cell research, and is patented, it is a private matter whether and under what terms new intellectual property is obtainable for research purposes or development. This is of particular concern because the private sector will not invest resources in potential applications that they consider to lack commercial value, but that may have considerable therapeutic promise.

Given the promise of stem cell research, it is important to encourage the development of broadly beneficial therapeutic products with widespread access. This objective could be achieved in a variety of ways. Government investment in promising areas of research would enable federal agencies and laboratories to hold patents and toexercise them in ways that enhance development and contribute to the dissemination of this stem cell technology. Congress or the PTO shoulddefine a strong research exemption that would give third parties access to stem cell products and research tools for research purposes without having to obtain permission from the patent holder. Another possibility is to require compulsory licensing under limited and clearly defined circumstances.

The formation of company-based, independent ethics advisory boards should be encouraged in the private sector.

Private sector research has played a crucial part in the advancement of research on stem cells. The leadership exhibited by the company that has sponsored all of the published human embryonic and germ cell research to date in establishing an external Ethics Advisory Board to develop guidelines for the ethical conduct of such research is laudable. While these private sector boards are not a substitute for public oversight and guidance, they can be a positive influence on the way that industry-funded stem cell research proceeds.

The credibility and impact of such ethics advisory boards will be enhanced if they review ethical issues at the start-up phase of the research, have multidisciplinary membership, including representatives from the local community, give minimum, if any, financial compensation for service, and share their own findings and recommendations with other companies. The latter provision could be especially helpful in developing a “case law” in the private sphere that would inform public efforts to develop national guidelines.

The Moral Status of Human Stem Cells

Human embryonic germ (EG) cells are derived from the gonadal ridge tissue of an aborted fetus within five to eight weeks after conception. The procedure is analogous to the harvesting of organs from a cadaver. Here the ethical issue is not so much the status of the aborted fetus, but whether those who consider abortion an illicit act, despite its legality, can participate in the research on tissues so derived.

The ethical status of human embryonic stem cells partly hinges on the question of whether they should be characterized as embryos or specialized bodily tissue. Although the answer to this question will be less important to those who believe that the early embryo has little or no moral status, it will shape the views of those who regard the embryo as significantly protectable.

One way of approaching this question is by looking first at ways in which the embryo has been understood. In the context of the abortion and human embryo research debates, a series of criteria has been proposed to determine the moral status of the pre-implanation human embryo. Among these are an entity’s possession of a full human genome; its potential for development into a human being; sentience; and the presence of well-developed cognitive abilities such as consciousness, reasoning ability, or the possession of self-concept. Those taking the position that the early embryo has full moral status (equal to that of any child or adult human being) usually stress the first two of these criteria: possession of a unique human genome and the potential for development into a human being are regarded as sufficient for ascribing full moral status to it.

Since most cells in the human body possess a unique diploid genome and are not regarded as morally protectable, the question of whether ES cells are morally equivalent to somatic cells or whether they are more like human embryos largely hinges on an understanding of stem cells’ potentiality. Here the matter calls for further refinement since, as developments in mammalian cloning technology suggest, any human cell (or tissue) may have the potential to become a person. To avoid this problem, potentiality arguments typically appeal to some consideration of normal or natural processes: embryos have a natural potentiality to become a person in that the natural development of an embryo, unlike tissue, is to become a human being. Of course, the interpretation and significance of the word “natural” is controversial.

Can we conclude that stem cells have equivalent moral status because of their potential to become a human being? Since potentiality is being understood here as “natural potentiality,” determining the moral status of a stem cell rests in part on whether its potential to become a person is natural, as it is with embryos, or contrived, as it would be with cells that are cloned. Being natural or contrived does not refer to the ease or facility of the process or the need for technological intervention. Regardless of how cloning technology may develop, for example, it will not be seen as a natural process by those who hold that embryos have a natural potential to become a full human being. To fail to distinguish between the natural and contrived development of the embryo would otherwise, among other things, unreasonably commit us to the full moral protection of every human cell.

The potential of a stem cell to become a human being seems to be much more like that of a somatic cell that could be cloned than like an embryo. The natural development of the individual cells of the embryonic disk (from which stem cells are derived) is to become parts of a human being. Isolated from the total structure of the embryo or blastocyst, these cells, even under favorable growth conditions, will not develop the trophoblast (the outer layer of cells of the embryo) or other structures needed for continued development. Another way of putting this is to say that stem cells are pluripotent rather than totipotent. It is true that advanced technology might be able to render these cells effectively (if not actually)

totipotent. Research undertaken in Canada in 1993 involving the aggregation of mouse stem cells with a genetically manipulated embryo led to the cells’ subsequent growth and population of the entire organism. However, such manipulations are arguably even less “natural” than is current cloning technology. Insofar as potentiality considerations alone are concerned, therefore, stem cells would not seem to have the same moral status as embryos. For those following this line of reasoning, including those who accord significant moral status to the embryo, stem cells may thus be regarded and treated as any other form of human bodily tissue.

Potentiality is a complex idea, drawing on even more complex and undeveloped notions of “nature” and “the natural.” Rather than entirely clarifying these matters, biology complicates them by indicating the developmental continuum always present in human growth and maturation. Continuing discussion will be needed involving the many viewpoints around the question about how we can best protect the multiple values evoked by research at life’s beginnings. These include values such as our commitment to the protection of human life generally, the promotion of human health, and respect for the views of others in a civil, democratic society.

Conclusion

The pursuit and production of knowledge through scientific research is an undertaking that offers enormous intellectual rewards for researchers while also performing an important social function. The advancement of science has transformed our lives in ways that would have been unpredictable just a half-century ago. Whether stem cell research will have a similar effect remains to be determined, but the promise is so great that it seems wise to consider seriously how best to further such research in a manner that is sensitive to public sensibilities. Public conversations about research and use of human stem cells are well underway. This report is intended to contribute to and inform this ongoing dialogue.

We recognize that science does not exist in isolation from the larger community that feels its effects, whether perceived as good or bad. The work of scientists is, and should be, conditioned and directed by consideration of broader human values. This means that the development of public policy, especially where highly controversial matters are involved, must take all interested sectors of the public into account. It is only through broad-based participation that the values of all stakeholders in the research enterprise can be carefully considered and weighed. We hope that this report has offered an approach that balances the promise of human stem cell research with the public’s genuine concerns about such research in a manner that will lead to a consensus on how best to proceed.

http://www.ctns.org/