Executive Summary of Assisted Reproductive Technologies: Analysis and Recommendations for Public Policy
In 1995, approximately 7.1 percent of the nation's married couples with wives of childbearing age were currently infertile, meaning that they had not conceived after at least twelve months of unprotected intercourse. Approximately 12.9 percent of married couples reported some form of impaired fecundity, i.e., problems in conceiving or carrying a pregnancy to term.
Although no increase has been detected in the overall prevalence of infertility, more couples today than in the past experience difficulty conceiving before they have had any children.
Strategies for preventing infertility include prevention and prompt treatment of sexually transmitted diseases, appropriate contraceptive choices, use of fertility-sparing gynecologic treatments, allotting sufficient time to attempt conception, and public education about infertility.
Some medical treatments for infertility attempt to restore a patient's fertility through medication to treat underlying physiological problems or surgery to correct anatomical barriers to conception.
In recent decades, a variety of assisted reproductive technologies (ARTs) have been developed. These techniques seek to establish pregnancies without correcting the underlying cause of the patient's infertility. In many ARTs, such as in vitro fertilization (IVF) and its variants, fertilization and early embryo development take place in the laboratory.
Some persons with infertility elect to forgo medical intervention in favor of nonbiological approaches to family building, including adoption, or living without children.
Ethical Debates about Infertility and Its Treatment
Some commentators believe that infertility is a disease because it is a deviation from normal function that is distressing and limiting to many people. Others object to the characterization of infertility as a disease because they believe it implies that an inability to become pregnant is a pathological condition requiring medical intervention.
Some commentators oppose all uses of ARTs. Many of these commentators fear that children created through ARTs will be viewed as commodities. Some feminist commentators argue that the availability of ARTs reinforces the view of women as primarily mothers and coerces all infertile women into attempting to become parents.
Other commentators believe that ARTs offer important benefits to infertile individuals and that decisions about the use of these technologies should be left to the individuals involved, with the state playing a limited regulatory role.
A third group of commentators believe that individuals have a right to use ARTs but that other interests outweigh that right in certain circumstances. These commentators express particular concern about the impact of ARTs on children and third party participants such as egg donors and surrogates. Many also question whether substantial resources should be spent on ARTs when existing children lack homes and many basic health care needs remain unmet.
Some organized religions oppose most forms of assisted reproduction. Other denominations accept assisted reproduction within marriage, using the gametes of the husband and wife, but oppose the use of donor gametes. Some organized religions accept the use of donor gametes.
Some religious denominations have expressed particular concern that embryos created through assisted reproduction may be used for experimentation or destroyed.
Psychological studies have documented profound emotional consequences of infertility.
Infertility treatment, particularly ARTs, is accompanied by characteristic indignities, emotional stresses, physical demands, and financial burdens.
Pregnancies conceived through ARTs are generally experienced differently from those that come without substantial delay, doubt, or medical intervention. The transition to parenthood after assisted reproduction also raises distinct emotional issues.
The Constitutional Parameters
Although the Supreme Court has never explicitly recognized an affirmative right to procreate, most commentators agree that such a right can be inferred, at least for married couples, from cases recognizing a constitutional right of privacy.
Some commentators believe that noncoital reproduction should enjoy the same constitutional protection as coital reproduction because it allows people to satisfy the basic drive to have a biologically related family. Others argue that the values supporting the right to coital reproduction do not necessarily extend to the use of ARTs.
Conclusions of the Task Force
The constitutional protection afforded coital reproduction is based on a complex constellation of factors. Noncoital reproduction by a married couple using their own gametes implicates nearly all of these factors. As noncoital reproduction moves away from the model of a married couple using their own gametes, many of the similarities to coital reproduction within marriage begin to disappear. For some types of ARTs, courts may conclude that the values underlying the constitutional right to procreate no longer apply.
Current Dilemmas in Clinical Practice
At least one in three deliveries of ART-generated pregnancies involves a multiple birth. Infants resulting from high-order multiple gestations face an increased risk of prematurity, low birth weight, infant death, and lifelong disability.
Some countries have laws limiting the number of embryos that may be transferred in each cycle of IVF, most commonly three. In the United States, it is routine for practitioners to transfer four or more embryos per cycle. No state has legislated a limit to the number of embryos that may be transferred per cycle. The American Society for Reproductive Medicine (ASRM) has urged practitioners to take steps to minimize the incidence of triplet pregnancies and to eliminate the creation of higher-order multiple pregnancies.
Many commentators have raised concerns about the trend toward using more drugs, stronger drugs, more complex scheduling, and longer hormonal regimens in the course of ART cycles.
Several new ART procedures have been rapidly introduced into clinical practice despite concerns about potential risks and a lack of evidence of effectiveness. ART programs in New York State vary in what procedures they consider to be research and in how information about new procedures is presented to patients.
Pre-implantation genetic diagnosis has been introduced in several ART programs for a variety of specific disorders. Some programs also offer sex selection of embryos; one uses a sperm sorting technique to improve the chance of creating embryos of only one sex.
Conclusions and Recommendations of the Task Force
Multiple Gestation and Use of Medications
ART practitioners have a professional obligation to minimize the likelihood of high-order multiple gestations resulting from the use of ARTs.
Specific limits on the number of embryos and/or oocytes transferred in an ART cycle should not be adopted as a matter of state law at this time. Instead, practitioners should develop a standard of practice that incorporates the ASRM's goal of eliminating the creation of quadruplet and higher-order multiple pregnancies and reducing the number of triplet pregnancies. Professional societies such as the ASRM should develop guidelines that set strict upper limits on the number of embryos and/or oocytes to transfer in specific clinical situations.
The New York State Department of Health should monitor outcome data from ART programs in New York State to determine whether programs are meeting the ASRM's goal of reducing multiple gestations.
All physicians who prescribe fertility drugs should be aware of the possibility that the drugs will result in multiple gestations and should follow the guidelines for safe usage provided by drug manufacturers and professional organizations.
The availability of fetal reduction should not be used as a justification for creating a significant likelihood of a high-order multiple gestation.
Physicians should discuss fetal reduction with patients prior to the use of ARTs. If the procedure is unavailable or unacceptable to the patient, the physician and patient should consider treatment options that, to the maximum extent possible, eliminate the likelihood of high-order multiple gestations, even if those options reduce the likelihood that the patient will become pregnant.
The informed consent process and the reporting of outcome information should be structured to alert patients to the risks associated with multiple gestations.
ART practitioners should reassess the necessity and prudence of stimulation procedures involving the routine use of high doses of powerful drugs.
Introduction of New Procedures
New assisted reproductive procedures of unproven safety and efficacy should generally be introduced through a formal research protocol, reviewed by an institutional review board (IRB). They should not be advertised or promoted as accepted treatments.
Patients should be fully informed of a program's experience with any clinical procedure. Programs offering procedures for the first time should consider submitting their protocol and informed consent documents to an IRB or ethics committee for approval. In addition, programs should consider waiving charges for any "experimental" piece of treatment until the program has a successful track record with the procedure.
Patient Screening and Selection
Some ART practitioners have been criticized for willfully screening out more difficult patients in order to treat only those who are most likely to be successful. Others have been criticized for accepting patients who wish to proceed despite a low chance of success.
Some ART practitioners in New York State have turned away prospective patients because of concerns about psychological stability or parental fitness. Commentators disagree about the appropriateness of requiring prospective ART patients to undergo psychological screening.
Most programs in New York State told the Task Force that they do not exclude unmarried women, including lesbian couples. Commentators disagree about whether physicians should provide assisted reproduction to unmarried women, based largely on differing assessments of the impact on children of being raised in families headed by single parents or lesbian couples. No federal law prohibits discrimination on the basis of marital status or sexual orientation in the provision of medical services, although some states and localities have such laws.
Most ART programs in New York State recommend or require HIV and other infectious disease testing of prospective patients. However, programs do not routinely take genetic histories, recommend genetic counseling, or encourage genetic testing for infertility patients using their own gametes. Some commentators believe that denying ARTs to individuals based on their HIV status or other medical conditions constitutes unlawful disability discrimination.
Practitioners take into account a variety of patient behaviors in deciding whether to provide assisted reproductive services, including a patient's use of alcohol or drugs.
Most ART programs in New York State do not treat women above a certain age, most commonly 55. Many commentators have expressed serious reservations about providing assisted reproductive services to older women, based on the increased likelihood of pregnancy complications and the risk that the woman will become ill or die early in her child's life. No federal law prohibits discrimination on the basis of age in the provision of medical services, although some states and localities have such laws.
A variety of federal, state, and local laws prohibit the denial of assisted reproductive services on the basis of race, religion, or national origin.
Conclusions and Recommendations of the Task Force
Physicians offering assisted reproduction are under no legal or ethical obligation to treat every individual or couple who requests their services.
In deciding whether to provide assisted reproductive services to a prospective patient, physicians are entitled to consider the welfare of any child who might be born as a result of the procedure.
Directors of ART programs should develop policies for responding to conscience objections by nurses, laboratory technicians, and other personnel.
Physicians offering assisted reproductive services should develop written policies setting forth their standards and procedures for the screening of patients and their partners.
Before performing any screening tests, physicians should inform prospective patients whether the program will retain the results of those tests if the patient is not accepted for treatment. Programs that retain the results of screening tests should treat the information as strictly confidential.
Likelihood of Success
Practitioners should avoid using aggressive infertility treatments if there is a reasonable likelihood that the patient can become pregnant through less costly, risky, or burdensome means. Physicians may legitimately decline to provide assisted reproductive services based on a judgment that the patient has a particularly poor chance of becoming pregnant as a result of treatment.
Psychological Stability and Parental Fitness
Physicians who rely on psychological screening of potential patients should recognize that such screening is often prone to mistake and abuse. Physicians should ensure that similar standards for psychological screening are applied to all patients and that these standards are not based on arbitrary biases or stereotypes. Psychological screening to assess parenting ability should be limited to the identification of circumstances obviously inconsistent with responsible parenting. When psychological screening reveals a diagnosable mental illness, physicians should make individualized judgments about the effect of that illness on the patient's decision-making capacity, ability to comply with treatment requirements, and likely parenting ability.
Marital Status and Sexual Orientation
The law should neither prohibit nor require the provision of assisted reproductive services to unmarried individuals, including lesbian couples.
HIV Status and Other Medical Conditions
Before providing assisted reproductive services, physicians should seek to determine whether the patient has any medical condition that makes pregnancy dangerous or is at risk of transmitting any seriously disabling medical condition to the resulting child.
All ART patients and their partners should undergo testing for HIV and other infectious diseases relevant to the course and outcome of the pregnancy. Physicians should also encourage prospective patients and their partners to undergo genetic counseling if they are deemed to be at risk for the transmission of serious genetic diseases.
Physicians may legitimately decline to provide assisted reproductive services to individuals with medical conditions that make pregnancy dangerous or that are otherwise likely to cause harm to the resulting child. Physicians may also decline to provide assisted reproductive services to individuals who refuse to undergo testing to determine the existence of relevant medical conditions.
Physicians offering assisted reproductive services should question prospective patients about behaviors associated with a high risk of pregnancy complications, including current drug, alcohol, and tobacco use. Physicians may legitimately decline to provide assisted reproductive services to individuals whose behavior creates a high risk of pregnancy complications or otherwise causes a risks of harm to the resulting child.
The provision of assisted reproduction to women in their fifties and older should be approached with extreme caution, in light of the risks to both the woman and the best interests of any resulting offspring. Before providing assisted reproductive services to older women, physicians should engage the woman in a discussion about these risks. They should also make an individualized assessment of the effect of the patient's age and medical conditions on the likelihood of pregnancy complications.
Race, Religion, and National Origin
As with other medical treatments, physicians may not refuse to provide assisted reproductive services on the basis of race, color, creed, religion, or national origin.
Informed Consent and Counseling
Professional organizations and commentators have concluded that the process of obtaining informed consent to assisted reproduction is often inadequate.
The Task Force's review of consent forms used by ART programs in New York State revealed wide variability in the source and detail of success rates presented to patients, as well as in the information about risks associated with the procedures. Many consent forms do not mention, or do not fully explain, known or suspected risks associated with the drugs used for ovarian stimulation. While most of the forms indicate that assisted reproduction may result in multiple gestation, a significant number do not mention that multiple gestations entail considerable risks. Few consent forms mention the possibility that fetal reduction may be recommended in the event of a high-order multiple gestation.
Conclusions and Recommendations of the Task Force
The process of obtaining informed consent — a critical element in all areas of medicine — is especially important in the field of assisted reproduction. Unlike most medical procedures, the risks associated with assisted reproduction extend not only to the patient undergoing the procedure but also to any offspring who may result. In addition, assisted reproduction is an elective procedure offered to particularly vulnerable patients, most of whom will not have a successful outcome.
The process of obtaining informed consent to assisted reproduction is seriously deficient. There is considerable evidence that physicians provide incomplete or misleading information about benefits and risks, particularly the risks associated with multiple gestation.
To ensure that all patients receive appropriate information about benefits, risks, and alternatives, New York should enact legislation establishing minimum standards for obtaining informed consent to ARTs. The legislation should require physicians to provide patients with the program's most recent published outcome statistics, as well as written information about the nature of the procedure; the likelihood that the patient will become pregnant; the anticipated price of the procedure; the risks, including those associated with any drugs to be used, egg retrieval and embryo and/or oocyte transfer, and the transfer of multiple embryos and/or oocytes; the reasonably foreseeable psychological ramifications of the procedure; the program's experience performing the particular procedure; and alternatives to the procedure, including the alternative of nontreatment.
ART programs should offer counseling or referrals for counseling to patients both before treatment begins and as particular issues arise during the course of treatment.
Gamete and Embryo Donation
Pursuant to legislation proposed by the Task Force, New York State has extensive regulations governing the medical screening of semen donors. Under the regulations, egg donors are subject to general screening requirements applicable to all living tissue donors; pending amendments to the regulations include more specific screening requirements for egg donors. In addition, the American Association of Tissue Banks (AATB) and the ASRM have established detailed standards for screening gamete donors.
New York State's gamete bank regulations require practitioners to conduct multiple laboratory tests for infectious diseases and to obtain family medical histories from all donors. The regulations do not require donors to undergo carrier testing for any genetic disorders. The AATB and ASRM's standards for donor screening require carrier testing for genetic disorders common in the donor's ethnic group.
Direct payment for gametes and embryos is discouraged by most ethicists and professional organizations and is prohibited by law in some states, including New York. However, payment for the donor's time and inconvenience is generally considered acceptable.
The Task Force's review of egg donor consent forms from programs in New York State revealed wide variability in the nature and detail of information regarding the medical risks of donation. At some programs, IVF patients and egg donors are given different risk data on the same medications and procedures.
In recent years, hospitals have begun to report requests from spouses and/or parents to retrieve sperm from deceased individuals or unconscious patients who are dying.
Egg and embryo donation without consent are the subject of serious allegations against ART practitioners in California. The state declined to prosecute the physicians for theft because it was uncertain whether the value of the stolen material met the jurisdictional threshold for a felony theft prosecution under California law. In response, the state legislature enacted both civil and criminal statutes designed to prevent the misappropriation of gametes and embryos.
At some programs, recipients of donor eggs must accept full responsibility for the costs of medical complications associated with donation. At others, donors must accept full financial responsibility for the treatment of some or all complications.
Gamete and embryo donation increases the risk of inadvertent consanguinity because offspring conceived with gametes from the same source may meet and, unaware of their genetic relationship, reproduce.
Conclusions and Recommendations of the Task Force
Recruiting Egg Donors
Although obtaining donor eggs from healthy women recruited specifically for egg donation raises troubling ethical issues, this practice should not be prohibited by state law. Instead, protecting women from the health risks associated with egg donation is best achieved by ensuring that potential donors are provided with sufficient information to make an informed decision about donation.
New York State should not enact laws limiting the number of times a woman may donate eggs. However, egg donation programs should take steps to reduce the potential hazards of multiple donations, including asking donors about previous donations and informing them of the risks associated with multiple donations. Programs should not obtain a donor's consent to more than one cycle of egg donation at a time.
Creating Donor Embryos
New York's gamete bank regulations should provide that facilities may not create embryos for donation by fertilizing donor eggs with donor sperm except when done at the request of specific patients who intend to use the embryos for their own treatment.
Screening Gamete and Embryo Donors
Existing New York State regulations governing the screening of semen donors provide critical health protections to individuals undergoing assisted reproduction with donor semen. Amendments to these regulations, which would clarify the screening and testing requirements applicable to egg and embryo donors, should be adopted as soon as possible.
New York's gamete bank regulations should require carrier testing of prospective donors for deleterious genes common in the donor's ethnic group. No genetic or infectious disease testing of gamete donors should take place without the donor's informed consent.
New York's gamete bank regulations should require gamete banks to give donors the option of receiving the results of any screening tests that are performed.
Known donors should be subject to the same screening standards that apply to other gamete donors. Recipients of gametes from known donors should not have the option of waiving particular screening tests.
Infectious disease and genetic screening for embryo donors should be as thorough as that required for gamete donors.
Payment for Gametes and Embryos
Gametes and embryos should not be bought and sold, but gamete and embryo donors should be offered compensation for the time and inconvenience associated with donation. Payments to egg donors should not be so high as to become coercive or so low that they provide inadequate reimbursement for time and inconvenience.
New York's statutory prohibition of payment for gametes should not be interpreted to preclude women from receiving appropriate compensation for donating some of the eggs produced in the course of their own treatment.
Payments to egg donors should not be based on the number or quality of eggs retrieved.
Informed Consent and Counseling of Donors
New York's gamete bank regulations should require facilities that procure donor gametes and embryos to notify donors of their potential parental rights and responsibilities.
New York's gamete bank regulations should require facilities that procure donor gametes to notify donors of all of the ways in which embryos created with their gametes might be used. In general, gamete banks should not accept gametes from donors who object to any of these uses. If gamete banks accept gametes with restrictions on the manner in which any resulting embryos can be used, they should make a good faith effort to ensure that those restrictions are respected, but they should inform donors that they cannot guarantee that the recipients of the gametes will abide by the donor's restrictions.
Standards for informed consent to egg donation should be comparable to standards for informed consent to nontherapeutic medical research.
At a minimum, egg donors should be given no less information about the medical procedures associated with donation than patients considering the same procedures as a component of their own treatment.
Information about the potential risks associated with all phases of egg donation should be given to prospective donors before screening tests have been performed and before the donor has been matched to a recipient. Egg donors should be permitted to withdraw their consent to donation at any time until their eggs have been retrieved.
New York's gamete bank regulations should require programs to inform egg donors of the extent of the donor's responsibility for the costs of medical complications associated with the donation.
When known egg donors are used, informed consent to donation should take place outside the presence of the recipient. Physicians should attempt to determine whether known donors are motivated by undue pressure or coercion; in such cases, the physician should decline to proceed with the donation. When applicable, the informed consent process should include a discussion of the psychological and social ramifications of egg donation within families.
Gametes should generally not be retrieved without informed consent. New York should enact legislation prohibiting the retrieval of gametes from deceased persons or living individuals incapable of providing informed consent, unless the individual consented to the retrieval of gametes under the particular circumstances, in writing, when able to do so, or the person seeking to retrieve the gametes establishes extraordinary circumstances in a judicial proceeding.
Informed Consent and Counseling of Recipients
Physicians should inform recipients of donor gametes of any information in the donor's medical history that was obtained by questioning the donor, rather than by performing diagnostic tests, and that the validity of such information has not been confirmed.
Recipients of donor eggs should be informed that testing the donor for HIV at the time of donation does not reveal whether the donor acquired HIV in the months immediately preceding the test. Recipients of donor eggs should be given the option of using the eggs immediately or freezing any embryos created with the eggs until a confirmatory test can be performed.
New York's gamete bank regulations should require physicians who perform assisted reproduction with donor gametes or embryos to inform patients of the donors' potential parental rights and responsibilities under existing law.
Counseling of individuals who receive donor gametes and embryos should include a discussion of the issues surrounding the provision of information about the donation to any resulting children.
Gamete and Embryo Theft
To deter and punish cases of intentional gamete and embryo theft, New York should enact legislation making it a crime to knowingly transfer one person's gametes or embryos into anyone other than that person or that person's spouse without the written consent of the donor and recipient, or to knowingly use gametes or embryos for any other purpose not indicated in writing by the individual from whom the gametes or embryos were obtained.
Disclosure of Outcomes to Donors
Gamete banks should not be obligated to inform donors whether the donation resulted in a pregnancy or live birth but should be permitted to do so if they choose, provided they maintain the recipient's confidentiality. Donors should be informed of the gamete bank's policy about disclosure of outcomes before the process of donation begins.
New York's gamete bank regulations should require gamete banks that learn of adverse outcomes in the infant or infectious disease in the recipient to notify the individuals from whom the gametes or embryos were obtained if there is any possibility that the donor's gametes or embryos contributed to the adverse event.
There is an urgent need for carefully designed research to establish the number of times an individual or couple can donate gametes or embryos without creating a substantial risk of inadvertent consanguinity.
Gamete banks should develop and enforce policies designed to limit the number of times gametes from a particular donor can be used to establish a pregnancy. In addition, they should ask prospective donors about previous donations at other facilities and counsel them about the risks associated with multiple donations.
Informing children resulting from gamete and embryo donation of their genetic origins is an important protection against inadvertent consanguinity.
New York's gamete bank regulations should require facilities that accept gametes from known donors to ensure that the donor is not a blood relation of the other gamete-provider to a degree that would constitute incest under New York law.
The Storage and Disposition of Frozen Gametes and Embryos
The cryopreservation of semen and embryos is standard practice. Researchers have begun to achieve some success with the cryopreservation of oocytes, although these techniques are not yet part of standard clinical practice.
Facilities that cryopreserve gametes and embryos in New York State are subject to licensing requirements that dictate acceptable equipment and storage conditions and require adherence to relevant professional guidelines. No maximum storage time is specified in New York State regulations or in professional guidelines on gamete and embryo cryopreservation.
New York State regulations do not give semen donors any decision-making authority over their gametes during the time they are cryopreserved and awaiting distribution.
Many gamete banks' storage agreements state that semen deposited for personal use will be destroyed after the man dies, unless he left specific instructions authorizing the posthumous use of his semen. Some gamete banks, however, will release a man's stored semen to his widow even in the absence of specific instructions.
Some IVF programs in New York State require couples to indicate their wishes for the disposition of frozen embryos at the time the embryos are created. Programs generally offer couples the option of donating excess embryos to another couple, destroying the embryos, or donating them to research.
Couples who create embryos with both partners' gametes are generally granted joint decision-making authority over the disposition of cryopreserved embryos. Most programs also grant both partners joint decision-making authority over the disposition of embryos created with donor sperm or eggs.
When excess embryos from one couple are donated to another couple, questions may arise about the storage and disposition of embryos not used by the recipient couple in their first ART cycle. Consent forms used for recipients of donor embryos in programs in New York State do not indicate who has decision-making authority over these embryos.
The ASRM has concluded that it is ethically acceptable for a program to consider embryos to have been abandoned if more than five years have passed since contact with a couple, diligent efforts have been made by telephone and registered mail to contact the couple at their last known address, and no written instructions from the couple exist concerning disposition. According to the ASRM, if embryos are abandoned they may be removed from storage and thawed. However, programs should not use abandoned embryos for research or donate them to other couples.
When couples freeze extra embryos originally created for assisted reproduction, conflicts can arise if one partner wants to use or donate the embryos and the other does not. The few judicial opinions addressing these disputes have suggested that advance disposition agreements signed by both partners could avoid these situations, although one court found that such an agreement should not be applied because of significantly changed circumstances. In the absence of an applicable advance agreement, courts have sought to balance the interests of the partner seeking to procreate against those of the partner seeking to avoid procreation.
No court has yet addressed a case in which a surviving partner has sought to alter a joint agreement on the use of stored embryos after the death of the other partner.
Conclusions and Recommendations of the Task Force
The Cryopreservation Process
Existing New York State regulations provide sufficient oversight of the storage and tracking of frozen semen. Pending amendments to the regulations, which would extend the storage and tracking procedures to frozen embryos, should be adopted as soon as possible.
Limits on the length of storage of frozen gametes and embryos should not be adopted as a matter of state law. However, facilities offering cryopreservation should be free to adopt such limits as a matter of their own institutional policy. Any such limits should be made clear at the time gametes or embryos are frozen.
Disposition of Frozen Gametes
New York's gamete bank regulations should guarantee gamete donors the right to withdraw their consent to the donation of frozen gametes until a specific individual has begun an assisted reproduction cycle in reliance on the availability of gametes from that donor.
New York's gamete bank regulations should require gamete banks to ask individuals storing gametes for future use with an intimate partner to specify their instructions for the disposition of their gametes after death. The regulations should require gamete banks to use their best efforts to ensure that these instructions are followed.
Disposition of Frozen Embryos
Individuals or couples who have excess embryos no longer desired for assisted reproduction have a strong interest in controlling the fate of those embryos. The goal of state law in this area should not be to dictate the manner in which the embryos are used but to identify the individuals who have the greatest interest in making decisions about the embryos and to ensure that these individuals' wishes are respected.
Facilities that store frozen embryos should not seek to prevent individuals with decision-making authority over the embryos from transferring them to another facility.
New York's gamete bank regulations should provide that no embryo may be transferred for implantation, destroyed, or used for research without the consent of the individuals with decision-making authority over the embryo (as those individuals are defined below). When two people have joint decision-making authority over a frozen embryo, one person's objection to transferring the embryo for implantation, destroying it, or using it for research should take precedence over the other person's consent.
The regulations should provide that, before embryos are created, the individuals who will have decision-making authority over the embryos must indicate their instructions for the disposition of any excess embryos in the event of death, permanent loss of decision-making capacity, divorce, termination of the facility's storage period, or loss of contact with the storage facility.
The regulations should also guarantee these individuals the right to revise their disposition instructions; in such cases, their current wishes should take precedence over any instructions left in advance. However, storage facilities should abide by disposition instructions expressed in advance unless they receive actual notice of a change in instructions.
Determining Decision-Making Authority
New York's gamete bank regulations should provide that couples who create embryos with both partners' gametes have joint decision-making authority over the use of the embryos. The regulations should also provide that couples who create embryos with the gametes of one partner and donor gametes have joint decision-making authority over the use of the embryos during marriage; after divorce, the partner whose gametes were used to create the embryo should have full authority over disposition decisions.
If one partner dies or permanently loses decision-making capacity, the other partner's disposition authority over the embryos should generally be subject to any instructions left by the deceased or incapacitated partner (unless the partner who died did not contribute gametes to the creation of the embryo). New York's gamete bank regulations should provide that frozen embryos may not be transferred for implantation, destroyed, or used for research if doing so would be inconsistent with the previously-expressed instructions of the deceased or incapacitated partner unless a court finds that extraordinary circumstances justifying a departure from the instructions exist.
When couples create embryos entirely with donor gametes, both partners should retain joint decision-making authority over the embryos during marriage. After divorce, either partner should have the right to use the embryos to create a child, but no embryo should be destroyed, used in research, or donated to another person over either partner's objection.
Any disposition questions surrounding frozen embryos that have been designated for donation but not yet used by a recipient should be decided in accordance with the instructions of the embryo donors. New York's gamete bank regulations should guarantee individuals who agree to donate excess frozen embryos the right to withdraw their consent to donation until a specific recipient has begun an assisted reproduction cycle in reliance on the availability of embryos from those donors.
New York's gamete bank regulations should require storage facilities to establish policies for the disposition of abandoned embryos and to inform individuals of these policies at the time embryos are frozen. The regulations should prohibit facilities from donating abandoned embryos to other infertility patients or using them in scientific research.
Determining Parental Rights and Responsibilities
New York's Domestic Relations Law states that when a married woman is artificially inseminated with donor semen the woman's husband is the legal father of any child who results, provided the procedure was performed by a licensed physician with the husband's consent.
No statute in New York addresses the parental rights and responsibilities of men who donate semen to unmarried women. A recent appellate court decision, however, suggests that such men may retain the rights of biological parents, at least under some circumstances. It is also possible that men who donate semen to unmarried women could be liable for supporting any resulting children. In contrast to New York, some states have enacted statutes that divest all semen donors of parental rights and responsibilities, regardless of the mother's marital status.
New York's surrogate parenting law declares surrogacy contracts void and bans the payment of fees to women who serve as surrogates and to individuals who act as brokers for the arrangements. However, the law does not bar surrogate parenting arrangements that are voluntary and noncommercial.
In a genetic/gestational surrogate parenting arrangement, where the "surrogate" undergoes assisted insemination with the intended father's semen, the surrogate is the child's biological mother in all respects. If she changes her mind and decides not to relinquish the child, she retains the legal rights and responsibilities of any mother.
In a gestational surrogate parenting arrangement, where the surrogate gestates an embryo created with the gametes of the intended mother and father, the child has two biological mothers — the surrogate (who gestated the child) and the intended mother (who is the child's genetic parent). New York's surrogate parenting law does not indicate how disputes between these two women should be resolved. In a few states, courts have held that the genetic mother, not the gestational surrogate, is the sole legal mother of children resulting from gestational surrogacy arrangements.
Five states have adopted legislation providing that a woman who gives birth to a child conceived with a donor egg is the child's legal mother. Although New York does not have such a statute, an appellate court in New York has concluded that when a child is conceived with a donor egg the birth mother is the child's mother as a matter of law.
Only a handful of states have enacted legislation governing the determination of parental rights and responsibilities in cases of embryo donation.
Under New York law, an individual's children, for purposes of inheritance, includes children "conceived before, but born alive after" a disposition of property through a will becomes effective. This language could be construed to cover children born after implantation of an embryo created with gametes of individuals who have since died.
Conclusions and Recommendations of the Task Force
Children Conceived with Donor Sperm
New York's Domestic Relations Law should be amended to provide that when a married woman undergoes any assisted reproductive procedure using donor semen, the woman's husband is the legal father of any child who results, provided the procedure was performed by a licensed physician with the husband's consent.
New York law should establish a mechanism for men who donate semen to gamete banks for use in assisted reproduction to consent, in writing, to relinquishing their parental rights and responsibilities at the time of donation. Such consents should be effective at the time of donation and should not depend on circumstances that arise in the future, including the marital status of the woman who ultimately uses the semen.
Children Conceived with Donor Eggs
New York law should provide a mechanism for women who donate eggs for use in assisted reproduction to consent, in writing, to relinquishing their parental rights and responsibilities at the time of donation.
New York law should provide that a woman who gives birth to a child is the child's legal mother, even if the child was not conceived with the woman's egg.
Children Resulting from Embryo Donation
New York law should provide a mechanism for embryo donors to consent in writing to relinquishing their parental rights and responsibilities at the time of donation.
Children Resulting from Gestational Surrogacy Arrangements
The determination of maternal rights and responsibilities in gestational surrogacy arrangements should reflect both the genetic and gestational contributions to motherhood.
If both the genetic mother and the birth mother agree, after the child is born, that the genetic mother should be recognized as the child's sole legal mother, the law should provide a mechanism for achieving that result efficiently, without the need for a formal adoption proceeding.
When both the birth mother and the genetic mother assert parental rights, each woman should have standing as a biological parent to seek custody and other rights with respect to the child. Courts should resolve disputes between the two women as they would any dispute between biological parents — based on the best interests of the child. Generally, only one biological mother should be awarded custody and other maternal rights. However, the other mother's status as a biological parent should not be terminated unless circumstances ordinarily justifying the involuntary termination of parental status are shown to exist.
If the intended parents in a gestational surrogacy arrangement change their minds and are unwilling to assume responsibility for the child, the birth mother should have the right to obtain a declaration of the legal obligations of both the genetic mother and the father. However, the birth mother should recognize her own potential responsibilities as a biological parent.
Children Conceived or Gestated after a Parent's Death
New York law should provide that an individual who dies before implantation of an embryo, or before a child is conceived other than through sexual intercourse, using the individual's egg or sperm, is not a parent of the resulting child.
Informing Children of Their Genetic Origins
Many commentators believe that keeping the use of donor gametes a secret is harmful to children.
Most commentators agree that children conceived with donor gametes should have access to nonidentifying information about the donors. There is less consensus on whether children have a right to obtain identifying information about donors.
In New York, licensed semen banks are required to supply relevant nonidentifying information about donors to facilities that perform assisted reproductive procedures with donor semen. This information must be used to counsel the recipient and must remain on file for a minimum of twenty-five years if a live birth results. Pending amendments to the regulations would extend these requirements to egg and embryo donation. There is no mechanism in the regulations for offspring resulting from gamete or embryo donation to gain access to donor information directly.
Conclusions and Recommendations of the Task Force
Children resulting from gamete and embryo donation have a right to nonidentifying medical and genetic information about the donors. New York's gamete bank regulations should require banks to make this information available at the child's request when the child reaches the age of majority, or earlier with the consent of the child's parents. Gamete banks should encourage donors to update the medical information on file with the bank whenever they have additional information relevant to the health of their offspring.
New York's gamete bank regulations should require banks to retain donor records for at least sixty years when the donation results in a live birth. The regulations should also require gamete banks that go out of business to submit a plan for the continued storage of donor records to the Department of Health for approval.
New York's gamete bank regulations should require banks to ask individuals who donate gametes and embryos whether they would consent to the release of identifying information about themselves to any resulting children. If such consent has been provided, identifying information should be made available at the child's request when the child reaches the age of majority, or earlier with the consent of the child's parents. If such consent has not been provided, identifying information should not be made available. Before selecting gametes or embryos from a particular donor, recipients should be told whether the donor has consented to the release of identifying information to any resulting children.
New York's voluntary adoption registry should be extended to allow registration by gamete and embryo donors and children resulting from gamete and embryo donation.
Most commentators support clinical embryo research designed to provide a direct benefit to a particular embryo, but the ethical acceptability of basic embryo research that will result in the embryos' destruction is the subject of considerable dispute.
In 1994, the National Institutes of Health's Human Embryo Research Panel recommended federal funding of certain types of embryo research. In response to the report, Congress enacted legislation barring the use of federal funds for human embryo research.
Some states have laws banning fetal research, some of which might apply to research on IVF-created embryos. A few states have statutes that specifically prohibit research on IVF-created embryos, although one such statute has been invalidated on constitutional grounds. One state specifically permits embryo research.
There are several types of laboratory manipulations that have been described as cloning. The most controversial type of cloning involves the creation of genetic replicas of existing or previously existing children or adults ("somatic cell nuclear transfer cloning"). In February 1997, scientists in Scotland announced that they had successfully cloned an adult sheep through this procedure. Commentators disagree about the ethical acceptability of attempting to clone a human being.
Conclusions and Recommendations of the Task Force
Research designed to provide a direct benefit to embryos that will be transferred for implantation is ethically acceptable, as long as it involves only minimal risk. No such research should occur without the approval of an IRB and the informed consent of the individuals with decision-making authority over the embryos.
Nontherapeutic embryo research that will result in the embryos' destruction raises more difficult issues. Some Task Force members believe that such research, when appropriately limited and carefully monitored, can be ethically acceptable if there is a significant likelihood that it can lead to important medical advances that could not otherwise be achieved. Others believe that this type of research is unacceptable in all cases. Given the members' diverse views on the subject, and the fact that the issue is currently receiving significant attention at the federal level, the Task Force does not recommend any legislative or regulatory actions for New York State at this time.
All of the Task Force members agree that attempting to create a child through somatic cell nuclear transfer cloning would be ethically unacceptable at the present time, given the existence of substantial doubts about the procedure's safety. However, the members hold differing positions on whether it would be ethically acceptable to use this procedure to create children if and when the safety concerns are addressed. Because of the members' diverse opinions, the fact that the use of this technology is not yet possible in humans, and the likelihood that federal legislation in this area will soon be enacted, the Task Force does not recommend any legislative or regulatory actions for New York State at this time.
Reporting Information about Outcomes
Commentators have accused ART practitioners of using a variety of techniques to inflate their success rates, including statistical manipulations, discriminatory patient selection, and inappropriate choice of procedures.
In 1989, the Society for Assisted Reproductive Technology (SART) established a data collection and reporting program available to all assisted reproduction facilities in the United States. The SART program published data about success rates, multiple births, infant outcomes, and maternal complications in both national and clinic-specific formats.
The voluntary SART program has now been replaced by a mandatory reporting program established pursuant to federal law, the Fertility Clinic Success Rate and Certification Act. The act requires all ART programs to report their success rates annually to the Centers for Disease Control and Prevention (CDC). In December 1997, the CDC published its first success rate report pursuant to the act, based on data from cycles initiated in 1995. The CDC's report was produced in collaboration with SART and RESOLVE, a nationwide infertility support and advocacy organization.
Conclusions and Recommendations of the Task Force
Comprehensive, understandable, and accurate reporting of outcome information is an important component of the practice of assisted reproduction but should not be the sole factor used in gauging a program's performance.
Published outcome information should emphasize the number of live births per stimulation cycle, taking into account factors such as age, number of previous attempts, and patient diagnosis. In addition, the data should provide clear information about multiple pregnancies and fetal reductions, pregnancy complications, congenital malformations, infant birthweights, and the number of embryos transferred per cycle.
Reporting of outcomes will be most effective if it is mandatory and conducted on a national level. The CDC's reporting program should adequately achieve this goal, making further action by state governments unnecessary. The Department of Health should monitor the information reported to the CDC by ART programs in the state.
ART programs should be required to present their outcome statistics, as published by the CDC, to prospective patients in an understandable manner. When providing outcome information to potential patients in the clinical setting, programs should comply with the guidelines for advertising outlined in this report.
The Task Force supports the CDC's efforts to develop a system for validating reported outcome data. The benefits of providing more reliable information to prospective patients outweigh the slight increase in costs that such a system might entail.
Certification and Licensure
Most of the standards for ART programs are set by relevant professional organizations, including SART, the AATB, the College of American Pathologists, and the American Board of Bioanalysis.
Laboratories that perform the diagnostic tests related to assisted reproduction, such as semen or hormonal analysis, must be certified under the federal Clinical Laboratories Improvement Act (CLIA). Some states, including New York, also have certification requirements for clinical laboratories. Clinical laboratory certification requirements do not apply to assisted reproduction techniques that are viewed as procedures rather than diagnostic tests.
New York State has the most comprehensive regulations in the nation governing the practice of gamete donation and storage. Facilities involved in all aspects of gamete donation must be licensed as "gamete banks," including out-of-state facilities that ship donor gametes to New York State. Pending amendments to the regulations would clarify the application of the licensing requirements to facilities involved in egg and embryo donation.
Pursuant to the Fertility Clinic Success Rate and Certification Act, the CDC is developing model standards for state certification of embryo laboratories.
Conclusions and Recommendations of the Task Force
To provide maximum oversight of the laboratory procedures involved in assisted reproduction, New York should participate in the certification program for embryo laboratories currently under development by the CDC. Although not required under federal law, New York State should make certification under the CDC program mandatory for all assisted reproduction laboratories operating in the state. The Department of Health should oversee the certification program itself, rather than delegating administrative authority to a private accreditation organization.
New York's gamete bank regulations create a powerful mechanism for overseeing the practice of gamete and embryo donation. To clarify the application of the regulations to egg and embryo donation, the Department of Health should adopt draft amendments to the regulations currently under review.
The Commercial Dimensions of Assisted Reproduction
Many ART programs advertise for patients; some include success rates in their advertisements. Since 1991, the Federal Trade Commission (FTC) has entered into five cease-and-desist consent orders with ART programs based on advertising the FTC concluded was inaccurate.
Programs in New York State typically ask for full payment prior to initiating an ART cycle. In other areas of the country, programs have developed a variety of innovative payment plans, the most controversial of which promise patients some or all of their money back if the procedure is not successful. Some commentators maintain that money-back payment plans are unethical.
Insurance coverage for reproductive health services has traditionally been much narrower than coverage for other types of health care. While more than half of all insurers cover at least some forms of infertility treatment, few companies cover IVF. Six states have enacted statutes that require health insurance policies to provide some level of coverage for IVF.
Some commentators maintain that society has an ethical obligation to reduce the effect of individual wealth on access to ARTs. Other commentators view governmental support for assisted reproduction as a misuse of resources.
Conclusions and Recommendations of the Task Force
Medical professionals, including those who offer assisted reproductive services, have a special obligation to avoid false, deceptive, or misleading advertising. Advertisements that quote success rates should clearly indicate the percentage of live births per stimulation cycle, as reported in published data covering a period of at least one year. State and local consumer protection agencies should monitor advertising for assisted reproductive services and respond aggressively to false, deceptive, or misleading claims.
Money-Back Payment Plans
Payment plans that offer unsuccessful patients a portion of their money back create significant ethical concerns. Physicians whose payment depends on the success of treatment have an incentive to accept only those patients with a strong chance of success (perhaps patients who do not qualify as infertile under generally accepted standards) and to turn away needy patients whose outcome may be less certain. In addition, when payment is linked to outcome, physicians may encourage patients to accept aggressive treatments that increase the chance of success without due regard for the risk those treatments may entail. Nonetheless, while the Task Force members are deeply troubled by the risks created by money-back payment plans, they do not believe that these plans are inherently unethical in all cases.
Programs that offer money-back payment plans should clearly inform patients of all essential terms of the plan. No plan should require patients to provide a blanket consent to all treatments and procedures recommended by their physician.
Patients enrolled in money-back payment plans should receive a prorated refund if they withdraw from treatment before they have completed all of the cycles covered under the plan.
The most appropriate definition of "success" in the context of money-back payment plans is a live birth. The condition of the child should never be a factor in the definition of success.
Assisted reproduction, when used to overcome infertility, is a form of medical treatment. Whether assisted reproduction should be covered as a standard health insurance benefit should be determined in light of the same factors that apply to other forms of medical treatment, such as effectiveness, cost, the degree of suffering associated with the particular condition, and the availability of alternative measures to relieve that suffering.
Assuming sufficient resources to pay for all individuals' health care, there would be a strong argument for including some coverage for assisted reproduction in a standard health insurance package.
Unfortunately, New York, like many other states, is confronted with widespread gaps in access to basic health care. The question for public policy in New York today is not whether assisted reproduction should be included in a basic package of benefits under a hypothetical system of universal access to health care. Instead, the question is whether New York should mandate coverage for assisted reproduction when insurance policies routinely exclude coverage for a broad range of basic health care services and when many New Yorkers have no health insurance coverage at all. While the Task Force is sympathetic to the need for broader access to insurance coverage for assisted reproduction, it can find no persuasive reason for giving assisted reproduction special priority as a matter of state law.