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Reproduction and Responsibility:

The Regulation of New Biotechnologies

Table of Contents

The President's Council on Bioethics
Washington, D.C.
March 2004

Chapter Three

screening and Selection for Genetic Conditions and Traits

The ability to screen developing human life for chromosomal abnormalities and genetic disorders has been ours for some time. Individuals and doctors have for many years been able to test fetuses in utero, either through the genetic analysis of cells obtained from amniotic fluid by amniocentesis (in the second trimester) or through genetic analysis of chorionic villus samples obtained from the placenta by biopsy (in the first trimester). The “selection” that follows such testing is achieved by means of abortion; it amounts to “selecting against” a developing fetus with a diagnosed genetic disease or other unwanted trait (for example, maleness or femaleness).

More recently, however, innovations in assisted reproduction and molecular genetics have yielded new ways to test early-stage embryos in vitro for genetic markers and characteristics. After such testing only those embryos with the desired genetic characteristics are transferred to initiate a pregnancy. By comparison with the older form of screening, this approach is more “positively” selective; it amounts more to “choosing in” rather than merely to “weeding out.” Methods to test or screen eggs and sperm before fertilization are also being developed, and at least one type of sperm sorting—sorting by the presence of X or Y chromosomes—is already in use in several clinical trials. These two new techniques for testing early-stage embryos—preimplantation genetic diagnosis (PGD) and sperm sorting—are the subjects of the following discussion.


I. Uses and Techniques

  A.Preimplantation Genetic Diagnosis of Embryos

PGD is a technique that permits clinicians to analyze embryos in vitro for certain genetic (or chromosomal) traits or markers and to select accordingly for purposes of transfer. The early embryo (six to eight cells) is biopsied by removal of one or two cells, and the sample cell(s) is then examined for the presence or absence of the markers of interest. PGD is practiced in approximately fifty clinics worldwide, the majority of them located in the United States. PGD was first used in 1989 as an adjunct to in vitro fertilization (IVF) for treating infertility. Official statistics do not tell us how many children have been conceived following PGD. Estimates vary widely; one recent report suggested that “more than 1,000 babies have been born worldwide.”1

PGD was initially used for sex identification to avoid transfer of embryos with X-linked genetic diseases, such as Lesch Nyhan syndrome, hemophilia, and X-linked mental retardation.2 PGD is now most commonly used to detect aneuploidies (that is, an abnormal number of chromosomes, for example, trisomies and monosomies).3 Some aneuploidies prevent the embryo from implanting, whereas others are associated with disorders such as Down syndrome and Turner syndrome. PGD is used also to detect monogenic diseases such as cystic fibrosis and Tay-Sachs disease. More recently PGD has been used to select embryos that would be compatible tissue donors for older siblings in need of transplants.4 In still other cases PGD has been used for elective (non-medical) sex selection.5  Today at least one-third of individuals who use PGD are otherwise fertile, and this number may increase as the potential uses of PGD expand.6

At present, PGD can identify genetic markers that correlate with (or suggest a predisposition for) more than one hundred diseases, including illnesses that become manifest much later in life, such as early-onset Alzheimer disease.7 As genomic knowledge increases and more genes that correlate with diseases are identified, the applications for PGD will likely increase. In principle any known gene and its variants can be tested for, and with improved methods for amplifying genetic screening on small samples, it may some day be possible to test the single cell removed from the embryo for hundreds of genetic markers. Dr. Francis Collins, director of the National Human Genome Research Institute, recently speculated that within five to seven years the major contributing genes for diabetes, heart disease, cancer, mental illness, Parkinson disease, stroke, and asthma will be identified.8 Many couples with family histories of these diseases may be drawn to PGD, even in the absence of infertility. Moreover, if genetic associations with other, non-medical conditions are identified, PGD might one day be used to screen for positive traits and characteristics such as height, leanness, or temperament.i

PGD is a multi-step process requiring considerable technical skill and expertise in the fields of genetics and reproductive medicine. Because the testing is performed on early embryos in vitro, individuals electing to use PGD must undergo all of the phases of IVF described in Chapter 2.ii Typically, embryo biopsy is performed three days after fertilization when the embryo is at the six- to eight-cell stage. The researcher makes a small hole in the zona pellucida (using a sharp pipette, acidic solution, or laser), and then inserts a suction pipette into the opening and removes one or two cells (“blastomeres”). Some researchers wait until the embryo reaches the blastocyst stage (approximately five to six days after fertilization, when the given embryo has grown to approximately one hundred cells) to undertake this biopsy. The procedure is technically less demanding at this stage and more cells can be removed and analyzed. Researchers who biopsy blastocysts remove approximately ten cells from the trophectoderm (the blastocyst’s outer ring of cells that are the precursors of the fetal portion of the placenta).

Once collected, the blastomeres or trophectoderm cells can be analyzed by a variety of means depending on the purpose of the test. PGD for detection of monogenic diseases is performed using a technique called “polymerase chain reaction” (PCR). Sex identity and chromosomal abnormalities are detected using a technique called fluorescence in situ hybridization (FISH). PCR allows clinicians to amplify sections of the DNA sequence, providing them with enough DNA to detect specific gene mutations. In FISH, labeled markers bind to chromosomes, permitting the researcher to observe and enumerate such chromosomes.

In all these procedures, timing is critical. The clinician must complete the analysis before the embryo develops beyond the stage at which it can be successfully transferred. If the biopsy is performed on Day 3, the practitioner has approximately forty-eight hours in which to complete the analysis, verify results, and discuss options with the patient or patients.

The error rate for PGD has been estimated between 1 and 10 percent, depending on the assay used.9 Several technical difficulties maycompromise accuracy. Working with so few cells—in many cases only one or two—leaves little room for technical error. PCR can be problematic. In some instances, for example, one allele fails to amplify to a detectable level. This phenomenon, called “allele dropout,” can lead to misdiagnosis. Contamination of the PGD sample can also lead to misdiagnosis. Technical difficulties associated with FISH may also affect accuracy of diagnosis. Following the transfer of the selected embryos and the initiation of pregnancy, clinicians routinely follow up with chorionic villus sampling and amniocentesis to confirm the results of PGD.

B.Genetic Analysis of Gametes

As well as testing early embryos, researchers are also trying to test and screen gametes (ova and sperm) before fertilization.

1. Preimplantation Genetic Diagnosis of Ova.

As an alternative to embryonic PGD, clinicians can now perform a similar analysis on the developing oocyte, by testing DNA from the polar bodies—nucleus-containing protrusions that are ultimately shed from the maturing oocyte.10  As with cells obtained from embryo biopsy, PCR or FISH can be used to test for, respectively, monogenic diseases or chromosomal abnormalities (most aneuploidies are maternally derived). The utility of polar body analysis is limited, however, in that it reveals only the maternal contribution to the child’s genotype.

2. Sperm Selection.

Another form of gamete screening is sperm sorting. A number of techniques are now under study, all of them aimed at controlling the sexes of the children ultimately conceived from these gametes. Most techniques to sort sperm have proven unreliable. These have included albumin gradients, percoll gradients, sephadex columns, and modified swim-up techniques. One technique currently in clinical trials—commercially called Microsort—has proven more successful. It exploits the difference in total DNA content between X-chromosome (female-producing) sperm and Y-chromosome (male-producing) sperm. The researcher collects the sperm sample and stains it with a fluorescent dye, bisbenzimide, which binds to the DNA in each sperm. A female-producing sperm shines brighter because it has 2.8 percent more DNA than the androgenic sperm, owing to the larger size of the X-chromosome. Using fluorescence-based separating equipment, the researcher sorts the sperm into X-bearing and Y-bearing preparations. The appropriate preparation is selected according to the couple’s preference and used to inseminate the woman. The latest statistics report a 90 percent success rate for conceiving female children and 72 percent success for conceiving male children.

II. Ethical Considerations

PGD, when effective, enables parents to avoid the deep grief and hardship that accompany the birth of a child with dreaded and incurable diseases such as cystic fibrosis and Tay-Sachs. And by screening out embryos with genetic abnormalities before a pregnancy begins, it prevents many women from having to decide whether to abort an abnormal fetus. Yet PGD also raises a number of ethical concerns, similar to but extending beyond the concerns attached to assisted reproduction itself.

A. IVF-Related Concerns

IVF, and typically intracytoplasmic sperm injection (ICSI), are essential to the practice of PGD. Thus, all of the ethical concerns attending these practices of assisted reproduction (discussed in Chapter 2) are likewise concerns here. But the prospect of genetic selection creates a further reason, beyond infertility, to seek and make use of assisted reproductive technologies. In what follows we shall confine our attention to new issues raised by genetic selection (though some of these issues may overlap those raised by the established practice of prenatal diagnosis).  

B. Well-Being of Children

PGD typically requires the removal of one or two cells from a six- to eight-cell embryo. It is not known whether this embryo biopsy affects the development of the child later born.11 PGD has entered clinical practice after only limited trial experience. No comprehensive studies have been published on the effects of PGD on the physical well-being of those involved. Some prospective studies are currently underway in Europe, but it is unclear how well-funded or comprehensive they will be.

C. Increased Control over the Characteristics of Children

PGD gives prospective parents the capacity to screen and select for specific genetic traits in their children. For now, that capacity is limited. Technical limitations on the number of embryos that can be produced in a single PGD cycle and on the number of tests that can be performed on a single blastomere severely restrict the number of characteristics for which practitioners can now test. Similarly, the complexity of the relationship between identifiable single genes and phenotypic characteristics will complicate the development of genetic tests for many traits and characteristics of interest (for example, where traits have polygenic contributions or result from complex gene-environmental interactions). Moreover, one cannot select for genes that are not brought to the embryos by their genetic progenitors; efforts at positive selection will be limited. Thus, the capacity to use PGD to select for a “superior genotype”—a “designer baby”—is in our estimation not on the horizon.iii

The present, more modest, applications of PGD—screening for severe medical conditions, screening for genetic predispositions or risk factors for a given disease, elective sex selection, and selection with an eye to creating a matching tissue donor—do give rise to ethical concerns about possible impacts on children and families. PGD used for these purposes might in some cases treat the resulting child as a means to the parents’ ends. This concern would be amplified should the reasons for embryo screening move from “medical” purposes to non-medical or enhancement purposes, from preventing the birth of a diseased child to trying to “maximize” a child’s genotype for desired characteristics. (This line is, admittedly, hard to draw.)iv Because the prospective child is deliberately selected on qualitative, genetic grounds out of a pool of possible embryonic siblings, PGD risks normalizing the idea that a child’s particular genetic make-up is quite properly a province of parental reproductive choice, or the idea that entrance into the world depends on meeting certain genetic criteria. Even if the prospective parents are guided by their own sense of what would be a good or healthy baby, their selection may in some cases serve their own interests more than the child’s (as in the case, for example, of a deaf couple using PGD in an effort to produce a deaf child). The new technologies, even when used only to screen out and eliminate the sick or “deficient,” may change parents’ attitudes toward their children, increasing both the desire to control and the tacit expectation of certain qualities—an attitude that might intensify as PGD becomes more sophisticated. Children who are selected on non-medical grounds—such as elective sex selection or trait selection—may experience increased pressures to meet parental expectations.

The use of PGD to identify a prospective child as a tissue donor match (currently a very rare practice) poses an additional ethical concern: the deliberate creation and selection of a particular child as a means for the benefit of another.v It is, of course, likely that in most families such children would be loved by their parents and by the siblings who would benefit directly from their tissue donation. But even here there is a dramatic shift in how the new PGD-selected donor-child is conceived and regarded by the parents and family. Is it proper to assign to an unconceived child the burden of being a savior of a sibling, and then give that child life on condition that he or she fulfill that role?

A closely related ethical concern is that this sort of selection could reduce the scope of reproductive choice. As the aggregate effect of parental choices reshapes society’s understanding of “normal” or “acceptable” phenotypes, parents might feel social pressure to undergo PGD, as many pregnant women now are pressured to undergo amniocentesis. In addition, parents might feel pressured to use PGD for financial reasons; it is conceivable that HMOs or health plans that cover IVF might someday require PGD for selection against certain potentially costly diseases.

Some see these ethical concerns as unjustified or premature. They believe that expanding our control over human reproduction is an extension of the parental responsibility to care for one’s offspring, and that PGD will be used almost exclusively to prevent the births of diseased children. They argue that the prospect of using PGD for “enhancement” purposes is unlikely, since the burdens of undergoing IVF and PGD would outweigh the limited possibility of selecting an embryo that is genetically superior. The possibility of so selecting will be limited both by the genetic complexity of human traits like intelligence, and by the vast number of embryos that would be required in order to make the choice for a “better” genetic baby a meaningful one.

Whether and to what extent either the concerns or the reassurances about PGD are justified is in many cases an empirical question, surely worth considering and monitoring.

D. PGD for Late-Onset Disease

PGD can be used not only to identify abnormalities that would lead to certain and immediate diseases (like Tay-Sachs or Down syndrome), but can also be used to identify an increased susceptibility to particular diseases later in life. Is PGD justified to avoid the birth of a child who will be likely to live “only” thirty years? Is it justified to avoid the birth of a child who is especially susceptible to a late-onset disease like breast cancer or Alzheimer disease? Questions like these will need to be confronted as the ability to make biological and genetic predictions about unimplanted embryos continues to grow.

E. Eugenics and Inequality

For some critics, PGD calls to mind the specter of “eugenics”; it is seen as a technology that facilitates the selection of “better” children. Some worry that as PGD becomes more widespread, it will serve to further stigmatize the disabled and promote the notion that some lives are not worth living or are better off prevented in the first place. This is in a sense nothing new—amniocentesis and prenatal diagnosis are common and have already raised similar concerns. What is novel about PGD, though, is that it can be used to select “for” desirable traits, not just “against” markers for disease.

Other commentators worry that widespread use of PGD (so long as it is not covered by insurance or subsidized by taxpayers) could widen and worsen the gap between the “haves” and the “have-nots” in society, as access to PGD, like access to IVF itself, is restricted to those who can afford it. Furthermore, techniques that permit parents to screen and select their children’s genetic make-up might produce a new kind of inequality between parents and children. Such techniques would allow parents not simply to give life to their offspring, but to choose (or try to choose) what kind of offspring they have. Of course, through education and upbringing parents have always had an enormous influence on the lives of their children, but inasmuch as the consequences of genetic screening and selection are imposed before birth and are biologically permanent, the inegalitarian effects of the new technology are novel and potentially significant. Biology is not destiny, but one’s genetic make-up is surely crucial to one’s life; if selected deliberately in advance by others, it might shape or limit a child’s self-understanding and sense of future possibilities. The ability to affect the genetic make-up of the next generation may also exacerbate the tendency to assign too much importance to genetic make-up, and so may promote an excessively reductionist view of human life. These new practices may lend undue credence to the notion that human characteristics and conditions are simply or predominantly genetically determined—a too-narrow understanding of human freedom, agency, and experience, and a simplistic understanding of human biology.

F. Parents and Children

The introduction of rigorous genetic screening into childbearing might set a new standard for what counts as an acceptable birth. The attitude of parents toward their child may be subtly shifted from unconditional acceptance toward critical scrutiny: the very first act of parenting could become not the unreserved welcoming of an arriving child, but the judging of his or her fitness, while still an embryo, to become one’s child, all by the standards of contemporary genetic screening. Moreover, as the screening technology itself is further refined, becoming better able to pick out serious but not life-threatening genetic conditions (from dwarfism and deafness to dyslexia and asthma) and then to distinguish genetic markers for desirable traits, the standards for what constitutes an acceptable birth may grow more exacting.

III. Regulation

There is now no direct regulation of either PGD or sperm sorting as such. There are, however, sources of regulation, described below, that touch or might conceivably touch these practices to some extent.

A. Federal Regulation

CLIA, the Clinical Laboratory Improvement Amendments, which as previously noted regulates laboratories that perform diagnostic tests for health assessment on human specimens, does not apply to tests performed in the context of IVF including PGD. Because these are the contexts in which PGD and related techniques for selection are practiced, CLIA is inapplicable. If, in the future, CLIA were deemed applicable to PGD and related activities, it would function to ensure quality assurance and control, as described in Chapter 2.

Similarly, the FDA has a limited role in the regulation of PGD and related activities. The FDA governs any articles that may be used in these activities, ensuring that they are safe and effective for their intended uses. Specifically, the FDA regulates (as devices) any test kits that are manufactured and sold for purposes of genetic testing. However, it seems that there are today no such kits for PGD or the related activities discussed above. Most labs use assays that they develop themselves.

To the extent that PGD and related activities occur in the research setting, they may be subject to the human-subjects protections discussed in Chapter 5 (Institutional Review Board [IRB] approval, informed consent, etc.). That is, under certain circumstances, the donors of embryos or reproductive tissue for such experiments would be considered “human subjects” and protected accordingly. But insofar as PGD is regarded as part of standard medical practice, no such oversight would obtain.

B. State Laws

There are currently no state laws that directly govern PGD or related practices. Some statutes that govern embryo research may touch these activities, as discussed in Chapter 5. In the main, however, there is no significant state regulation.

C. Tort Litigation

As in the case of standard assisted reproduction, individuals can use litigation as a means of regulating the practice of PGD and related activities. To prevail on a theory of malpractice, a plaintiff would have to demonstrate that a clinician owed a duty to the plaintiff, which the clinician breached resulting in injury. The viability of tort claims as an effective regulatory mechanism remains to be seen, though one might imagine the difficulties inherent in demonstrating causation and harm.

There seem to be only two reported cases in which malpractice suits have been brought against practitioners of PGD for negligence and fraud. In one of the cases, Paretta v. Medical Offices for Human Reproduction,12 a couple sued an IVF clinician for medical malpractice for his failure to perform PGD on an embryo to test for cystic fibrosis, when he knew that the ova donor was a carrier for the disease. The defendant moved for summary judgment (that is, a ruling from the court that, in light of undisputed material facts, the defendant is entitled to judgment in his favor as a matter of law). The court held that a right of recovery did not exist for the child’s birth with cystic fibrosis or for the parents for emotional distress, because to rule otherwise would “give children conceived with technology more rights and expectations than those conceived without such assistance.” However, the court ruled that a right of recovery did exist for the monetary expenses incurred for the infant’s treatment and care. Remaining questions such as whether the clinician was grossly negligent or fraudulent “in failing to prevent the patient and her husband from bearing a child, conceived through in-vitro fertilization, that had cystic fibrosis” involved disputes of important facts that could not be resolved in the context of a motion for summary judgment. The court refused to rule out, however, the possibility that, if successful, the plaintiffs might ultimately be entitled to monetary losses resulting from the mother’s decision to stay home to provide special care to the sick child.

D. Professional Self-Regulation

The chief sources of guidance and regulation for the practice of PGD and related activities the guidelines propounded by professional societies. The American Society for Reproductive Medicine (ASRM) provides guidance to clinicians who practice PGD and related activities. Its practice committee has published extensive guidelines on the practice of PGD, indicating that it should be treated as a clinical (rather than experimental) Thus, it may be practiced without oversight by an institutional review board (IRB) or the substantial equivalent. Additionally, the ethics committee of ASRM has published a report entitled “Sex Selection and PGD”13 that deems sex selection in this context as ethically acceptable for medical indications, but discourages purely elective use on the grounds that it might promote gender discrimination and other harms. It is not clear what is meant by the injunction to “actively discourage” this use, but at the time of this writing there are Society for Assisted Reproductive Technology (SART) member clinics that advertise the use of PGD for elective sex selection, even though SART requires, as a condition for membership, adherence to ASRM guidelines, including ethics opinions.

A related ASRM ethics opinion, entitled “Preconception Gender Selection for Nonmedical Reasons,”14 deals with sperm sorting for sex selection. It discusses the same ethical concerns as in “Sex Selection and PGD” but reasons to a different conclusion, namely, that such practices (achieved through techniques such as Microsort) are ethically acceptable for couples seeking “gender variety in their family, i.e., only to have a child of the gender opposite an existing child or children,”vii 15 provided couples understand the risks and affirm that they will accept a child of the opposite sex, should the procedure fail. ASRM notes, however, that the techniques for preconception sex selection are experimental, and should be treated accordingly. The American College of Obstetricians and Gynecologists echoes the views of ASRM, declaring PGD for sex selection acceptable if it is for medical indications, but rejects as unethical its use for purely elective purposes.

The American Medical Association’s Code of Medical Ethics explicitly states that it is “unethical to engage in selection on the basis of non-disease related characteristics or traits.” None of these opinions have more than hortatory power. In the absence of public policy governing the permissible uses of the sex selection of children, it is likely that a small number of medical specialists will continue to engage in and perhaps normalize this practice.

The American College of Medical Genetics provides voluntary guidelines for quality control and quality assurance of laboratories performing genetic testing. It does not, however, regulate PGD or related activities as such.

IV. Conclusion

While its use is now limited, the advent of PGD is significant. PGD represents the first fusion of genomics and assisted reproduction and the first reproductive technology that allows would-be parents to screen and select the genetic characteristics of their potential offspring, to a limited but growing degree. It is striking that this new capacity arrived with little fanfare—entering into routine practice essentially unmonitored, unstudied, and unregulated. There is now no governmental body, state or federal, monitoring or regulating PGD.viii There are no regulatory efforts to address the well-being of children born after PGD or to assess the risks presented to them by embryo biopsy. There are practice guidelines issued by professional societies on the use of PGD for elective sex selection, but these are statements of principle rather than enforced standards.ix There are also neither governmental nor nongovernmental guidelines regarding the boundary between using PGD in efforts to produce a disease-free child and using it in efforts to select genetic traits that go “beyond therapy”—that is, traits that are useful to older siblings or simply desirable to the would-be parent.



i. During his presentation to the Council in December 2002, Dr. Collins speculated that one such application of PGD would be to screen for genetic markers correlated with higher IQ levels. While he expressed skepticism that such tests would be effective or reliable, he did think the demand for such tests would be high.

ii. ICSI is the preferred technique for insemination in this context. PGD following ICSI yields the most accurate results, because there are no excess sperm imbedded in the zona pellucida of the fertilized ovum that might contaminate or otherwise affect the accuracy of the analysis of the biopsied cells.

iii. For an extensive discussion of the reasons why so-called “designer babies” do not seem to us at all scientifically plausible in the foreseeable future, see the Council’s 2003 report, Beyond Therapy: Biotechnology and the Pursuit of Happiness, especially pp. 37-40.

iv. The difficulty of distinguishing between therapy and non-medical treatment is demonstrated with the following example: In July 2003, an Australian couple screened their embryos to guarantee a child with perfect hearing. It is the first time an embryo was screened to guard against a non-life-threatening condition. (The Age, July 10, 2003.) For a more extensive discussion of this subject, see the Council’s 2003 report, Beyond Therapy: Biotechnology and the Pursuit of Happiness, Chapter 2, “Better Children,” especially pp. 27-70.

v. In August 1997, Adam Nash was born after being screened to ensure he would be a correct tissue match, and therefore could serve as a bone-marrow donor, for his older sister who suffered from Fanconi anemia. (Genomics and Genetics Weekly, February 14, 2003.)

vi. This is in contrast to the ethical opinion of the American Academy of Pediatrics (1994), which deems PGD an “experimental” procedure.

vii. The ASRM ethics committee report further advised that “[i]f the social, psychological, and demographic effects of those uses of preconception gender selection have been found acceptable, then other nonmedical uses of preconception selection might be considered.”

viii. When used as an adjunct to assisted reproduction, PGD is regulated within the larger regulatory framework applicable to that domain (discussed in Chapter 2). When used for purely research purposes, the regulation of PGD is subsumed under the framework for regulating embryo research (discussed in Chapter 5). But PGD is not regulated or monitored in any way or by any public authority that addresses what is novel or distinct about the practice itself: screening and selecting the genetic characteristics of offspring (when they are still embryos).

ix. There is demographic evidence that choosing the sex of children is increasing in the United States—largely by using sonography and abortion. No governmental or private institution to the best of our knowledge is monitoring such uses or such demographic effects.



1. Genetics and Public Policy Center, “Preimplantation Genetic Diagnosis: A Discussion of Challenges, Concerns, and Preliminary Policy Options Related to the Genetic Testing of Human Embryos,” Washington, D.C. (2004).

2. American Society for Reproductive Medicine, Practice Committee Report, “Preimplantation Genetic Diagnosis,” June 2001, Practice/preimplantation.pdf (accessed June 3, 2003).

3. International Center for Technology Assessment, written comments to the President’s Council on Bioethics, May 2003.

4. Pennings, G., et al., “Ethical consideration on preimplantation genetic diagnosis for HLA typing to match a future child as a donor of haematopoietic stem cells to a sibling,” Human Reproduction 17: 534-538 (2002).

5. American Society for Reproductive Medicine, Ethics Committee Report, “Sex selection and preimplantation genetic diagnosis,” Fertility and Sterility 72: 595-598 (1999).

6. Schatten, G., presentation at the December 13, 2002, meeting of the President’s Council on Bioethics, Washington, D.C., available at

7. Verlinsky, Y., et al., “Preimplantation diagnosis for early-onset Alzheimer disease caused by V717L mutation,” Journal of the American Medical Association 287: 1018-1021 (2002).

8. Collins, F., presentation at the December 13, 2002, meeting of the President’s Council on Bioethics, Washington, D.C., available at

9.  ASRM Patient Education Committee, “Patient Fact Sheet: Preimplantation Genetic Diagnosis,” December 1996, (accessed September 9, 2003).

10. Munne, S., et al., “First Pregnancies after Polar Body Biopsy for Testing of Chromosome Translocations,” presentation at the ASRM annual meeting, Boston, Massachusetts, November 2-6, 1996; Smith, S., et al., “Birth after Polar Body Biopsy Using Acidified Tyrode’s Medium Followed by ICSI,” presentation at the ASRM annual meeting, Cincinnati, Ohio, October 18-22, 1997.

11. Schatten, G., “Safeguarding ART,” op. cit.

12.   No. 122555/00, 2003 WL 1922819 (N.Y. Supp.) (slip opinion).

13.  Ethics Committee of the American Society for Reproductive Medicine, “Sex Selection and PGD,” Fertility and Sterility 72: 595-598 (1999).

14.  ASRM Ethics Committee Report, “Preconception Gender Selection for Nonmedical Reasons,” May 2001, pp. 861-864.

15. Ibid., p.863.

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