The History of the Task Force
The History of the Task Force
The New York State Task Force on Life and the Law was created in 1985, charged with devising public policy on a host of issues arising from medical advances, including: the determination of death, the withdrawal and withholding of life-sustaining treatment, organ transplantation, and new technologies and practices to assist reproduction. The Task Force encompasses expertise from many disciplines, and also reflects the wide spectrum of opinion and belief about bioethics issues in New York State. The founding chairman of the Task Force was Dr. David Axelrod. Dr. Richard F. Daines, the New York State Commissioner of Health, is the current chair. The Task Force has a full-time staff of four that conducts research and supports its other activities.
The Task Force is currently the only standing state government commission in the United States with a mandate to recommend public policy on a range of medical/ethical issues. The Task Force seeks to forge a consensus on pressing questions and to translate that consensus into concrete proposals for public policy. Recommendations by the Task Force have led to new legislation or regulation on a wide range of issues, including the determination of death, decisions about cardiopulmonary resuscitation, the health care proxy, organ and tissue transplantation, and surrogate parenting. The work of the Task Force has also been cited by the United States Supreme Court in decisions on assisted suicide.
The Task Force members are prominent physicians, nurses, lawyers, philosophers, bioethicists and representatives of numerous religious communities. Members of the Task Force bring a broad diversity of views to the issues the Task Force addresses.
Although individual members may dissent from the Task Force's recommendations and issue minority reports, the members have exercised this option sparingly over the course of the Task Force's existence; many of the Task Force's recommendations have been unanimous. The members' openness to listening and learning from one another, and their commitment to finding a common moral ground, have provided a foundation for consensus statewide on each of the important issues of public concern they have examined.
Developing Policy
The Task Force begins its inquiry on each issue by conducting extensive research. The Task Force reviews clinical information and the medical literature, and often invites experts to advise the members about innovations and problems. The Task Force also undertakes its own research if information is not otherwise available. For example, when developing policies on life-sustaining treatment, the Task Force surveyed hospitals and nursing homes in New York State to learn about facility policies on decisions to forgo life-sustaining measures, and the prevalence, functions, and composition of ethics committees. This information enabled the Task Force to gauge both the need for change and the extent to which changes, if mandated by law, would require a shift in current practice. Likewise, after its recommendations for legislation on the health care proxy were enacted, the Task Force studied factors affecting use of proxies.
In order to assess the existing legal framework for each issue, the Task Force examines federal and state laws, court cases and regulations. As a body that often recommends new state law, the Task Force also analyzes carefully the constitutional principles that establish the parameters for state policy. In addition, the Task Force reviews the ethics literature, which often provides a general framework for assessing a problem.
The Task Force recommends policy for New York State in the form of proposed legislation, regulation, public education or other measures. The Task Force chooses among these alternatives based on its analysis of existing law and clinical practice, the degree to which change is required, and the likelihood of achieving change via various interventions. The Task Force has proposed six laws; five have passed and one is pending. Its recommendations have also been a catalyst for public and professional education on numerous issues.
Promoting Dialogue
In the course of its work, the Task Force engages in dialogue with diverse professional, religious, and civic organizations. This dialogue enriches the Task Force's deliberative process and promotes further discussion about medical ethics throughout New York State. The Task Force reports, issued along with each set of recommendations, outline the legal, ethical, and clinical context of each issue and explain the basis of the Task Force's recommendations for public policy. These reports inform public debate and focus public attention on a specific direction for state policy.
This public dialogue and cooperation have also facilitated implementation of the Task Force's recommendations. On the do-not-resuscitate and health care proxy laws, for instance, the Task Force and the New York State Department of Health devised a question and answer guidebook for health care providers, in consultation with legal and medical organizations throughout the State. The Task Force also contributed to the creation of a video shown in hospitals to educate patients about the health care proxy. In addition, Task Force staff and members speak frequently at conferences to educate the public and professionals. Finally, the Task Force welcomes insight and information from health care professionals, patients, civic organizations and others about how its proposals are working in practice. The Task Force has modified its recommendations and proposed amendments to laws it devised as a result of this dialogue.
Reports and Recommendations
The Determination of Death
In 1985, the Task Force began its work by examining the determination of death. A 1984 decision by the New York Court of Appeals (People v. Eulo) recognized that the total and irreversible cessation of brain function satisfied the standard for determining death under New York law. However, in the absence of legislation supporting the brain death standard, health care providers remained concerned and uncertain about the standard. As a result, hospital practices in determining death varied widely throughout the State.
The Task Force's 1986 report, The Determination of Death, proposed that both the brain death standard and the traditional standard of cessation of heart and lung activity should be recognized for the legal determination of death in New York State. The Task Force concluded that legislation to establish brain death as a legal standard in New York was not necessary in light of the Court of Appeals' decision. The Task Force instead proposed regulations to ensure that the standard would be uniformly applied in health care facilities and to provide additional guidance about the determination of brain death.
As part of its deliberations, the Task Force examined the questions raised by persons who object to the brain death standard on religious or moral grounds. The Task Force recommended that responses to individuals with religious or moral objections would best be addressed by health care facilities at the community level. It therefore proposed that hospitals should develop policies, in consultation with community representatives, that would reasonably accommodate the beliefs of those who reject the brain death standard on religious or moral grounds. In July 1987, the New York State Hospital Review and Planning Council adopted the regulations developed by the Task Force.
Do-Not-Resuscitate Orders
One important focus of the Task Force's work has been decisions to stop or withhold life-sustaining measures. The Task Force first addressed decisions to withhold cardiopulmonary resuscitation (CPR), commonly formulated as do-not-resuscitate (DNR) orders. This issue became the subject of widespread concern in New York in the wake of several highly publicized cases in which DNR orders were entered and maintained secretly. The Task Force concluded that uncertainties in existing law, especially for patients who lacked decision-making capacity, led to overtreatment and failure to enter DNR orders when appropriate in many cases.
In April 1986, the Task Force released its report and recommendations (including a proposal for legislation), entitled Do-Not-Resuscitate Orders. The legislation set forth procedures for entering DNR orders for patients with decision-making capacity and policies authorizing family members to decide for incapacitated patients and for children. By including a category of "close friend" on the surrogate list, the legislation also enabled non-family members close to the patient to decide, a policy now prevalent in many state laws on treatment decisions. In addition, the proposed legislation required health care facilities to develop a process to mediate disputes about DNR orders and to establish procedures for honoring orders for patients transferred between facilities. These policies have also served as a model for other states.
In July 1987, the New York State legislature enacted a statute based on the Task Force's recommendations. The law became effective in June 1988 in hospitals, nursing homes and mental health facilities throughout New York State. Studies of current practice suggest that the law has created far more openness about DNR decisions and increased surrogate participation in the decision-making process.
Based on public comments and its reflection on developments in clinical practice, the Task Force proposed amendments to the DNR law in March 1991. The amendments were designed to improve the process for entering DNR orders in inpatient settings and to extend the legislation to outpatient or "non-hospital" DNR orders which would be honored by emergency medical service personnel for patients cared for at home or in other community settings. The Task Force devised the policies for outpatient DNR orders in consultation with patient advocates and state and city organizations representing emergency medical service personnel. The Legislature passed the amendments in July 1991, making New York the second state in the nation to establish policies for non-hospital DNR orders. In addition, a second edition of the Task Force's DNR report was released in 1992.
Organ and Tissue Transplantation
The Task Force first examined the subject of organ and tissue transplantation in 1986 when it formulated policies to implement New York's required request law which requires hospital personnel to ask family members to consent to organ and tissue donation for all suitable donors. Among other recommendations, the Task Force suggested that those who request donations receive special training, and that medical guidelines should be developed for screening organ and tissue donors. The Task Force also recognized the need to assess the system for procuring and distributing organs and tissues more broadly.
The Task Force completed that assessment in 1988 and released a report entitled Transplantation in New York State: The Procurement and Distribution of Organs and Tissues. Many of the Task Force's findings and recommendations addressed problems that were prevalent nationally, including competition among organ and tissue procurement agencies, the lack of public health standards to screen organ and tissue donors, the need to assure equity in the distribution of scarce organs, and the absence of public oversight for tissue banking and procurement.
In order to promote the effective and fair distribution of organs, the Task Force recommended:
- consolidation among procurement agencies and transplant waiting lists;
- equitable standards for distributing organs based on patient-related criteria, rather than "ownership" of the organs according to hospital affiliations or "claims"; and
- a ban on allowing patients to place themselves on several transplant lists, thereby gaining an advantage over others waiting. The Task Force also proposed licensing for all tissue banks in the State, and creation of a transplant council to advise the Department of Health about specific standards for donor screening, the distribution of organs, and other issues.
In July 1990, the Legislature passed a bill to implement the Task Force's recommendations. The Transplant Council proposed by the Task Force has met on an on going basis since November 1991. In 1993, the Food and Drug Administration formulated standards for tissue banks, responding on a national level to the public health concerns that prompted the Task Force's recommendations.
The Health Care Proxy
The Task Force released Life-Sustaining Treatment: Making Decisions and Appointing a Health Care Agent in September 1987. The Task Force recommended the appointment of a person to act as health care agent as the most effective way to protect the patient's wishes and interests, and proposed health care proxy legislation.
The health care proxy bill garnered the support of over 35 civic, professional, and religious organizations, and has been widely publicized since it became law in July 1990. The law grants competent adults the right to appoint someone they trust to decide about treatment, including life-sustaining measures, in the event they lose decision making capacity. Individuals may leave treatment instructions to guide their agents' decisions. Under the law, health care providers must honor the agent's decisions to the same extent as if the patient had made the decision directly.
The Task Force's proposal has served as a model for health care proxy legislation in other states, including Vermont and Massachusetts. Since New York's health care proxy law was passed, the Task Force has undertaken projects to inform the public and health care professionals about its provisions. In consultation with numerous medical and legal organizations statewide, the Task Force issued a guidebook to educate health care professionals about the law. In addition, together with the New York State Department of Health, the Task Force has distributed thousands of proxy forms.
Fetal Extrauterine Survivability
In 1987, the Task Force prepared a report discussing the threshold for fetal viability. The Task Force convened a panel of medical experts, including leading scientists and clinicians in the fields of reproductive biology, fetal biology, obstetrics, neuroscience, and neonatology. The panel concluded that, based on medical interventions then available, an anatomic threshold of development occurred at around 23-24 weeks of gestation. Before that time, the fetal organs, especially the lungs, are not sufficiently developed to permit extrauterine survival, even with the most sophisticated technology then available.
The report, entitled Fetal Extrauterine Survivability, does not comment on the ethical or social implications of the medical findings, but seeks to inform public debate by presenting medical knowledge in an objective manner. The report was the only one of its kind that brought together the expertise of different medical disciplines to reach a judgment about fetal viability. Justice Blackmun relied on the report in his opinion in the United States Supreme Court case Webster v. Reproductive Health Services.
Surrogate Parenting
The Task Force addressed surrogate parenting, exploring relevant family law principles, available data about infertility, the constitutional rights of the parties involved, and information about the practice in New York and nationally. After a year of study and deliberation, the Task Force released a report entitled Surrogate Parenting: Analysis and Recommendations for Public Policy.
The Task Force unanimously recommended that public policy should prohibit commercial surrogate parenting. The members concluded that the practice could not be distinguished from the sale of children and that it placed children at significant risk of harm. They also agreed that surrogacy undermines the dignity of women, children, and human reproduction. The Task Force rejected the notion that rights as fundamental as the right of a parent to a relationship with his or her child should be bought and sold or waived irrevocably in advance of the child's birth.
Legislation based on the Task Force's proposal was enacted in 1992. The legislation embraces existing family law principles, rather than contract law, as the touchstone for public policy on surrogate parenting. As recommended by the Task Force, the law declares surrogacy contracts void in New York, and bans the payment of fees to women who serve as surrogates and to individuals who act as brokers for the arrangements. The law does not bar surrogate arrangements that are voluntary and non-commercial; consistent with existing New York adoption law, a woman can voluntarily relinquish her child after birth. Under the legislation, the intended parents can reimburse the birth mother for reasonable medical expenses arising from pregnancy and childbirth, but cannot pay her for relinquishing the child.
Surrogate Decisions for Incapacitated Patients
At the time the Task Force devised its proposed legislation for DNR orders, it recognized that comprehensive policies would be needed for decisions about life-sustaining treatment generally, not just for CPR. This need is particularly pressing in New York, where the Court of Appeals has held that life-sustaining treatment may not be withheld or withdrawn from incapacitated patients without "clear and convincing evidence" of the patient's wishes. As interpreted by the Court, patients must provide specific instructions about the treatments they do not want and the medical circumstances under which they would refuse the treatments. The standard has proven unworkable in medical practice; it leaves families helpless to stop life-sustaining treatment for incapacitated patients who have not left specific advance instructions about treatment or signed a health care proxy. Decisions about CPR, covered by New York's DNR law, are the only exceptions to the clear and convincing standard for patients who have not signed a health care proxy.
In April 1992, the Task Force issued a report examining the ethical issues posed in making decisions for incapacitated patients and the growing body of clinical data about such decisions. Entitled When Others Must Choose: Deciding For Patients Without Capacity, the report set forth a proposal for legislation authorizing family members and others close to the patient to decide about treatment for all incapacitated patients who have not signed a health care proxy or left specific oral or written treatment instructions.
The proposed legislation would authorize family members and others close to the patient to decide about treatment for incapacitated patients in accord with each patient's wishes. If the patient's wishes are not reasonably known decisions must be made in accord with the patient's best interests. Special standards would apply to decisions to forgo life-sustaining measures. In addition to establishing policies for patients with available surrogates, the legislation would also cover incapacitated patients who have no family or friends to decide for them, a particularly vulnerable patient population whose needs are generally not addressed by state laws on medical decisions. The proposed legislation would establish a facility based process for decisions for these patients, with the nature of the process dependent on the type of treatment under consideration.
Assisted Suicide and Euthanasia
The growing public desire for control at life's end made assisted suicide and euthanasia issues of serious and widespread public concern. The Task Force chose to examine the practices in order to contribute to the debate unfolding in New York and nationally.
The results of that examination are presented in the Task Force's report, When Death Is Sought: Assisted Suicide and Euthanasia in the Medical Context, issued in May 1994. In that report, the Task Force unanimously recommended that New York laws prohibiting assisted suicide and euthanasia should not be changed. The report begins by examining the epidemiology of suicide, including the reasons that people commit suicide, the capacity of medicine to respond to some of those underlying reasons, and its widespread failure to do so. The report also analyzes in depth the criminal and common law that applies to suicide assistance and euthanasia, as well as the constitutional law. The second half of the report explains the Task Force's conclusion that the existing legal prohibition on assisted suicide should not be changed. In addition, it sets forth the principles that should animate professional medical standards in this area, and proposes policies to enhance the treatment provided to dying and incurably ill patients. The Task Force also presents specific recommendations for modifying New York statutes and regulations on controlled substances, to increase the availability of medically necessary analgesic medications, including opioids.
In essence, the Task Force proposed a clear line for public policy and medical practice between forgoing medical interventions and assisting suicide or euthanasia. Decisions to forgo treatment are an integral part of medical practice. By contrast, American society has never sanctioned assisted suicide or mercy killing. The Task Force concluded that legalizing the practices would be profoundly dangerous for many patients who are ill and vulnerable, especially in light of the widespread failure of American medicine to treat pain adequately or to diagnose and treat depression. Untreated pain and depression are the two most common factors that lead terminally ill patients to think about suicide. The risks would be most extraordinary for individuals whose autonomy and well-being are already compromised by poverty, lack of access to good medical care, or membership in a stigmatized social group.
Assisted Reproductive Technologies
The Task Force produced Assisted Reproductive Technologies: Analysis and Recommendations for Public Policy in 1998. The Task Force concluded that physicians offering assisted reproduction are under no legal or ethical obligation to treat every individual or couple who requests their services. It also concluded that physicians are entitled to consider the welfare of any child who might be born as a result of an assisted reproduction procedure. Physicians should also develop written policies setting forth their standards and procedures for the screening of patients and their partners.
Regarding multiple gestations, the report concluded that ART practitioners have a professional obligation to minimize the likelihood of 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.
Genetic Testing and Screening
The 2000 Task Force report Genetic Testing and Screening in the Age of Genomic Medicine identifies barriers to the appropriate uses of genetic testing and makes recommendations to reduce these barriers. Barriers include concerns about misuse of genetic information in insurance and employment, inadequate genetics knowledge of health care providers, and insufficient oversight of clinical genetic testing laboratories.
The Task Force notes that there are grave misunderstandings among the general public about the role of genes in health and disease. These concerns led the Task Force to make recommendations to promote public and professional education, genetic counseling as part of the informed consent process, oversight of genetics research using samples obtained in the course of clinical care, and community involvement in policy decisions.
Infertility Treatment and Egg Donation
Following the release of its report on assisted reproductive technologies in 1998, the Task Force became increasingly aware of the need for accessible and reliable consumer information on both egg donation and infertility treatment. Drawing upon its previous work, as well as the expertise of an advisory panel convened for the purpose, in 2002 the Task Force produced two consumer-oriented publications entitled Thinking of Becoming an Egg Donor? and Questions and Answers about Infertility Treatment. These have been distributed to infertility clinics, women's health care organizations, academic health centers, research institutions, and journalists in New York State and nationwide. The hope is to provide a starting point to assist women and couples in navigating the thicket of sometimes-contradictory information on these procedures.
Dietary Supplements: Balancing Consumer Choice & Safety
The Task Force released Dietary Supplements: Balancing Consumer Choice & Safety (PDF, 6MB, 108pg.) in 2005. Task Force concerns about consumer awareness and regulation of the multi-billion dollar dietary supplement industry stemmed from one fundamental issue in medical ethics: informed choice. Informed choice depends upon access to adequate and accurate information, and occurs within a context of beliefs about the safety of available options. The Task Force found that consumer beliefs about dietary supplements, particularly supplement safety, may be misguided.
The report includes an assessment of data related to dietary supplements and a review of their safety. The current federal regulatory context is examined, as well as state-level initiatives. Finally, the report summarizes recommendations for New York State regarding dietary supplements.
Allocation of Ventilators in an Influenza Pandemic
In response to concerns about the possibility of an avian influenza pandemic, the Task Force developed recommendations for the allocation of ventilators over the course of a potential outbreak; this draft guidance document was released for public comment in March 2007. Though scientists do not know with certainty whether or when a pandemic will occur, the better prepared New York State is, the greater its chances of reducing morbidity, mortality and economic consequences. Even if the vast number of ventilators needed for a large scale pandemic were purchased, a sufficient number of trained staff would not be available to operate them. If the most severe forecast becomes a reality, New York State and the rest of the country will need to confront the rationing of ventilators.
An ethical framework must guide recommendations for allocating ventilators. The core challenge is to maintain a proper balance between two key ethical concepts, the duty of care for patients and the duty to use scarce resources wisely. The Task Force's recommendations included requirements that clinical evaluation be based upon universally applied objective criteria and that patients be equally subject to triage guidelines, regardless of their disease category or role in the community. The Task Force also stressed the need for state-wide consistency to prevent inequalities between care facilities, the development of legal protections for providers who comply with the guidelines, and the availability of palliative care.
Donation After Cardiac Death: Analysis and Recommendations from the New York State Task Force on Life & the Law
The shortage of viable organs for donation has fostered numerous proposals for increasing supply. One proposal that has garnered interest is Donation after Cardiac Death (DCD). DCD is a process by which patients donate their organs and tissues after being declared dead by cardiopulmonary criteria, as opposed to neurological criteria. The United Network of Organ Sharing (UNOS) has encouraged the development of DCD policies, and the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) has required all hospitals to have a DCD policy in place as of January 1, 2007. Both the federal government and the Institute of Medicine (IOM) have recommended the increased use of DCD.
In conjunction with the New York State Department of Health, The Task Force in May 2007 released a report analyzing the practice of DCD to assist facilities in the development of consistent and appropriate policies. The report, Donation After Cardiac Death: Analysis and Recommendations from the New York State Task Force on Life & the Law, analyzed the history of DCD, reviewed available literature, and examined the ethical propriety of DCD. Recommendations included the need for hospital DCD policies to clarify that health care agents are authorized to consent to pre-mortem DCD procedures, and the imposition of a 5-minute waiting period between cardiopulmonary arrest and the declaration of death in DCD protocols. Lastly, the Task Force recommended that hospital policies should support the use of heparin, but should not currently support the insertion of additional medical devices or application of additional medications solely for the purpose of vasodilatation to promote organ preservation.