And baby makes three ... or four ... or five: assisted reproduction.

Americans have grown used to media reports describing new ways for infertile couples to have biologically related children. Besides injecting advanced technology into what was previously a natural biological process, the new techniques dramatically expand the opportunities for dividing genetic, gestational, and social parenting among more than the customary two people.

In some instances, Congress and state legislatures have moved to regulate assisted reproduction practices. In general, however, the government has refrained from interfering with the private use of assisted reproductive technologies.

Many observers endorse this handsoff approach as the best way to promote individual freedom in reproductive decision making. Yet the lack of state involvement creates substantial uncertainty regarding a variety of policy issues raised by assisted reproductive technologies. Important decisions are often left to health professionals and clinics, sometimes with negative effects on consumers and their offspring.

This article focuses on consumer policy questions raised by assisted reproduction and discusses the potential role of public and private groups in addressing current uncertainties. Policy formation can occur at the governmental, professional, or clinical level.

In light of the novel and complex nature of assisted reproductive technologies, standards governing their application are likely to emerge at all three levels. Attorneys advising legislatures, public agencies, professional groups, health care facilities, clinic personnel, and consumers of infertility services can play a vital role in shaping policy in this area.

Recent events illustrate the need for policies that protect consumers who are considering infertility treatment options. In California, three physicians currently face criminal, civil, and institutional investigations(1) into allegations that infertility patients were subjected to unauthorized research and that their eggs or embryos were transferred to other couples without their permission.

In Virginia, a physician was convicted and sentenced to five years in prison for fraud and perjury after he misled patients into thinking they were pregnant.(2) He also was accused of fathering as many as 75 children by inseminating women with his own sperm rather than with sperm from the anonymous donors he claimed to be using. Although he was allowed to operate a fertility clinic, he lacked advanced training in infertility medicine and failed to meet professional standards for specializing in this field.

Another case, Stiver v. Parker, is particularly relevant for attorneys. The U.S. Court of Appeals for the Sixth Circuit held that professionals--including two lawyers--involved in arranging a surrogacy contract owed an affirmative duty of protection to the affected parties.(3)

The decision stemmed from a case in which a woman who had agreed to act as a surrogate mother gave birth to a child with serious disabilities. Paternity tests revealed that the child's biological father was the surrogate's husband. Presumably, the woman was already pregnant when she was artificially inseminated with sperm from the man who intended to raise the child.

The surrogate claimed that the child's disabilities were caused by a virus transmitted during the artificial insemination procedure. She charged that the individuals who had arranged the contract failed to screen the sperm provider for infectious disease, which violated their duty of care to the child, the surrogate mother, and the contracting father.

The court held the professionals' special relationship to the contracting parties was sufficient to create a duty to perform screening and other tests designed to minimize the possibility of foreseeable harm to participants and their offspring.(4)

Two other reports further illustrate the importance of screening people who participate in collaborative reproduction. In 1995, a medical investigation concluded that women who undergo donor insemination face a potentially serious threat of HIV infection unless donors are screened for HIV.(5) Although various professional groups and the Centers for Disease Control and Prevention (CDC) now recommend such screening, the rate of compliance is unknown.

In another case, an unmarried man pleaded guilty to third-degree murder in the death of his five-week-old child, who was born through a surrogacy arrangement.(6) The child died from severe injuries inflicted by the defendant in a beating episode. Although the man was single and allegedly had no prior child care experience, the surrogacy program reportedly failed to evaluate or otherwise address his ability to parent the infant alone.

These cases demonstrate problems that can arise in the absence of appropriate policy governing assisted reproduction programs. Although constitutional law principles might rule out state efforts to severely restrict or ban assisted reproduction methods, courts are likely to permit reasonable state regulation based on family, contract, tort, property, and criminal law principles. Restrictions adopted by private health care facilities and other nongovernment entities will generally escape constitutional scrutiny, so private programs enjoy wide latitude in setting policy on assisted reproduction.

The rest of this article examines two aspects of assisted reproduction that merit greater public and private policy attention. Each can have a significant impact on a person's experience with reproductive technologies. They include: (1) the content and delivery of information to people who are considering whether to participate in assisted reproduction; and (2) standards for quality care in infertility treatment. Although these topics are relevant to all medical and surgical interventions to enhance fertility, this analysis addresses the more novel and socially complex forms of assisted reproduction, including in vitro fertilization (IVF) and collaborative arrangements, in which nonpartners provide gametes or gestational services.

Information Disclosure

The information provided to couples seeking infertility treatment is an important consumer concern. The strong desire of many infertile people to have children can make them vulnerable to exploitation in the form of costly and burdensome procedures that are often unsuccessful. Clinics have been accused of exploiting this vulnerability by exaggerating their positive results, failing to give consumers a meaningful account of the procedures, negative aspects, and encouraging couples to continue with treatment when it is highly unlikely to succeed.

In response to these charges, the U.S. Congress enacted legislation that requires clinics to report live birth rates according to a uniform definition and instructs the CDC to develop a certification program for clinics.(7) Although the law is meant to protect consumers, it only addresses disclosure of one item relevant to the consent process--the live birth rate. It also fails to include requirements to ensure that the relevant treatment information is disclosed to consumers in a meaningful way.

The act leaves the content and manner of the disclosure largely up to individual practitioners and clinics. Moreover, the statute permits states to delegate inspection and certification responsibilities to professional accreditation organizations. In the end, the law primarily relies on health care professionals and their advisers to design an effective disclosure system.

The American Society for Reproductive Medicine (ASRM), formerly called the American Fertility Society, is a private group that has been most active in attempting to set professional practice standards. ASRM recommends that fertility practitioners provide an accurate account of their program's success rates compared with national averages. The group also advises practitioners to disclose the following information to all consumers:

* whether the clinic is affiliated with an academic center, private practice, or commercial facility;

* the risks, anticipated benefits, and experimental status of all of the proposed procedures;

* information on potential alternatives to proposed procedures;

* information on social support groups and other resources available to infertile people; and

* costs of proposed treatments as well as a notice that health insurance often fails to cover certain services.(8)

The recent allegations of negligence at the California infertility clinic highlight the need to obtain a patient's informed consent to any experimental fertility procedures or transfers of gametes or frozen embryos to other patients. In addition, consumers should be told that conventional IVF and related procedures are linked to higher-than-average rates of multiple gestation. They should also be informed that they may have to decide whether to abort some fetuses to improve the chance that any will survive in reasonable health.

People who participate in collaborative reproductive arrangements must also understand the potential for disputes over parental rights and duties as well as other information a reasonable infertility consumer would want. This could include information on screening program and record-keeping practices.

Finally, programs should choose effective methods of information delivery. Oral and written information can be supplemented with videotaped presentations. Consumers should also be given opportunities to talk with others who have experienced the procedures, including people who have had negative treatment outcomes. Programs that emphasize full, truthful, and effective disclosure are less likely to encounter later difficulties with dissatisfied consumers.

Quality Care Standards

Many other factors bear on the quality of care provided to consumers of assisted reproductive technologies. The ASRM and the American Association of Tissue Banks have issued standards on acceptable training and qualifications for those who provide IVF, sperm bank, embryo storage, and other medical services related to assisted reproduction.(9) These groups also have issued standards for operating assisted reproduction programs. Some state laws set standards governing tissue banks, which may apply to sperm and embryo banks.

Of special concern to consumers is the extent to which programs screen participants. Besides endorsing screening of gamete providers for HIV and other serious infectious diseases, professional groups recommend that gamete providers be evaluated for serious genetic disorders that could be passed on to offspring.(10) Some states require that gamete providers be screened.(11)

A more controversial practice is the psychological and social screening of third parties who provide egg, sperm, or gestational services. Individuals or couples seeking to have children through assisted reproduction may also be subjected to these evaluations. Some states have already enacted legislation requiring psychological and social screening of people who participate in surrogacy arrangements. For example, Virginia law requires that the intended parents "meet the standards of fitness applicable to adoptive parents," and that a prospective surrogate be married and have had at least one child of her own.(12)

Many health care practitioners and clinics have adopted policies that limit the access of unmarried people or people with HIV, criminal records, and substance abuse problems seeking to reproduce through use of the new technologies. While some contend that such policies are unduly paternalistic, others defend them as necessary to protect consumers and their offspring. Screening policies must be carefully evaluated and should require reasonable evidence of risk to offspring as the basis for exclusion.

Patient follow-up and record keeping also affect the health and welfare of infertility treatment consumers and their children. Ongoing monitoring of these people is needed so that researchers can determine the long-term risks and benefits of assisted reproduction.(13) Patients and their children also should be tracked to mitigate any untoward health or psychological problems associated with the technologies or arrangements.

Partly out of a desire to protect the anonymity of gamete providers, some programs have engaged in poor record-keeping practices. According to current professional standards, clinicians should maintain records on providers so that future health needs of their biological offspring can be adequately addressed.

In most cases, nonidentifying information on the gamete provider's genetic and medical history will suffice. In rare cases, such as a child's need for a bone marrow or other transplant, the child's biological parent may need to be contacted to inquire about potential donation.

Monitoring and recordkeeping are necessary to protect other people as well. If a gamete provider passes on a serious genetic or other health problem to biological offspring, that provider should not be used again. Moreover, sometimes this information is relevant to a gamete provider's own health and future reproductive choices.(14)

One as yet unresolved issue is whether children born through collaborative reproduction arrangements should have access to information on their biological parents to satisfy their psychological need to know more about their origins. To date, professional groups have supported the release of nonidentifying information on gamete providers in these circumstances.(15)

The reluctance to provide data that would permit a child to locate a biological parent stems from the desire to maintain an adequate pool of gamete providers and to uphold the confidentiality customarily promised to them. Recently, however, Sweden and at least one U.S. sperm bank have adopted systems in which men who provide sperm do so knowing that the sperm bank will fulfill any future requests of adult offspring to receive identifying information relating to their biological fathers.(16)

Role of Attorneys

Attorneys who advise people and institutions participating in assisted reproduction should raise the matters discussed in this article with their clients. They should also help formulate and implement defensible policies whenever possible. Stiver suggests that lawyers should also consider their own professional responsibilities to clients who take part in new reproductive arrangements.

Although federal and state efforts to regulate this area may increase in the future, substantial opportunities for policy formation by professional organizations and clinics are likely to remain. A proactive approach to consumer policy formation is the best way to minimize unnecessary harm in the current quest to help infertile people have children.

Notes

(1) Diane Gianelli, Fraud Scandal Closes California Fertility Clinic, AM. MED. NEWS, June 19, 1995, at 1. (2) U.S. v. Jacobson, 785 F. Supp. 563 (E.D. Va. 1992), cert. denied, 114 S. Ct. 1643 (1994). (3) 975 F.2d 261 (6th Cir. 1992). (4) Id. at 270. (5) Maria R. Araneta et al., HIV Transmission Through Donor Insemination, 273 JAMA 854 (1995). (6) Man Pleads Guilty to Killing Surrogate Son, N.Y. TIMES, Aug. 9, 1995, at A10; Tamar Lewin, Man Accused of Killing Son Borne by a Surrogate Mother, N.Y. TIMES, Jan. 19, 1995, at A16. (7) 42 U.S.C.A. [sections]263a-1-7 (Supp. 1995). (8) Etnics Committee, American Fertility Society, Quality Assurance in Reproductive Technologies 62 FERTILITY & STERILITY 81S (1994). (9) See, e.g., American Fertility Society, Revised Minimum Standards for In Vitro Fertilization, Gamete Intrafallopian Transfer, and Related Procedures, 62 FERTILITY & STERILITY 108S (1994) (10) See, e.g., American Fertility Society, Minimal Genetic Screening for Gamete Donors, 62 FERTILITY & STERILITY 99S (1994); American Fertility Society, Guidelines for Gamete Donation, 62 FERTILITY & STERILITY 100S (1994); COUNCIL ON ETHICAL AND JUDICIAL AFFAIRS, AMERICAN MEDICAL ASSOCIATION CODE OF MEDICAL ETHICS 7 (1994) [hereafter AMA CODE]. (11) See, e.g., N.H. REV. STAT. ANN. [sections]168-B:14 (1994). (12) See, e.g., VA. CODE ANN. [sections]20-160 (Michie 1994). (13) Ethics Committee, American Fertility Society, supra note 8, at 82S. (14) See AMA CODE, supra note 10, at 8. (15) See, e.g., American Fertility Society, Guidelines for Gamete Donation, supra note 10, at 104S. (16) See Hollace S.W. Swanson, Donor Anonymity in Artificial Insemination: Is It Still Necessary? 27 COLUM. J.L. PROBS. 151 (1993).

Rebecca Dresser is a professor of law at Case Western Reserve University in Cleveland. Peter Joy and John Robertson provided helpful comments on an earlier draft of this article.