Reports and Publications
- Report and Recommendations for Research with Human Subjects who Lack Consent Capacity – January 2014
- Recommendations for Extending the Family Health Care Decisions Act to Medicare and/or Medicaid-Certified and State-Licensed Agencies, Programs, and Settings, June 2013
- Guidelines for Determining Brain Death, with NYSDOH, December 2011
- Recommendation Regarding the Extension of the Family Health Care Decisions Act to Include Hospice, November 2010
- Allocating Ventilators in an Influenza Pandemic, with NYSDOH, March 2007
- Donation After Cardiac Death: Analysis and Recommendations, March 2007
- Dietary Supplements: Balancing Consumer Choice and Safety, October 2005
- Thinking of Becoming an Egg Donor?, October 2002
- Questions and Answers About Infertility and Its Treatment, October 2002
- Genetic Testing and Screening in the Age of Genomic Medicine, November 2000
- Assisted Reproductive Technologies: Analysis and Recommendations for Public Policy, April 1998
- When Death is Sought: Assisted Suicide and Euthanasia in the Medical Context, May 1994
- When Others Must Choose: Deciding for Patients Without Capacity, March 1992
- Do Not Resuscitate Orders, 2d ed., August 1988
- Surrogate Parenting: Analysis and Recommendations for Public Policy, May 1988
- Transplantation in New York State: The Procurement and Distribution of Organs and Tissues, January 1988
- Fetal Extrauterine Survivability, January 1988
- Life-Sustaining Treatment: Making Decisions and Appointing a Health Care Agent, July 1987
- The Determination of Death, July 1986
- The Required Request Law, March 1986
Research Involving Adults who Lack Capacity to Consent
The optimal condition for research involving human subjects is for the participant to provide first-person informed consent. In order to learn about the broad spectrum of diseases that impairs cognition and to seek cures for these conditions, research requires participation from individuals who cannot themselves provide valid informed consent. While both federal and State law contemplates surrogate consent to human subjects research, there is a dearth of rules and guidelines on how to conduct this research in a consistent and ethical manner. The Task Force has undertaken an in-depth analysis of the ethical and legal issues surrounding research involving adults who lack the ability to provide first-person informed consent and released its recommendations in January 2014.
The Report and Recommendations for Research with Human Subjects who Lack Consent Capacity presents and assesses legal and ethical considerations, identifies policy options, and makes recommendations regarding the conduct of human subjects research involving adults who lack consent capacity in New York State. For an overview of commonly asked questions, see the FAQs: New York State Task Force on Life and the Law's Report and Recommendations for Research with Human Subjects who Lack Consent Capacity. The Task Force recommendations are intended to provide guidance for research that is conducted in the State involving individuals who lack consent capacity that is not subject to federal oversight.
Among other recommendations, the report suggests various oversight mechanisms to ensure the ethical conduct of research, recommends additional safeguards to protect the rights of vulnerable subjects, and provides guidance to family members and other surrogates on how to decide whether to enroll their loved ones in research.
The report provides guidance and best practices that will assist institutions, institutional review boards, researchers, and surrogate decision-makers in the ethical conduct of research involving adults who lack the capacity to consent.
Brain Death Determination Guidelines
In 1986, the Task Force issued The Determination of Death, which proposed that the legally-recognized form of death not be limited to cardiac death, but also include brain death. The report provided model regulations on the definition of death, which the Department subsequently promulgated. In recognition of the need for uniform hospital procedures for conducting clinical examinations of brain death, the Department, in conjunction with the Task Force, also released clinical guidelines determining brain death in 2005.
In 2010-2011, the Task Force, together with a panel of expert neurologists, re-examined the State's guidelines. Task Force staff analyzed medical literature and current clinical evidence concerning the diagnosis of brain death, as well as ethical issues, such as protecting patients and families from unnecessary burdens and incorrect diagnoses. The Task Force submitted to the Department for review and adoption comprehensive recommendations for revising the brain death guidelines. In December 2011, the Department issued the revised guidelines and released an accompanying Dear Hospital CEO letter.
Family Health Care Decisions Act - Surrogate Decisions for Incapacitated Patients
When Others Must Choose: Deciding for Patients Without Capacity
The Task Force recognized that comprehensive policies would be needed for decisions about life-sustaining treatment. 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. It also covers 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.
Family Health Care Decisions Act
In 1992, the Task Force released When Others Must Choose: Deciding for Patients Without Capacity, which examined the gap in New York State law regarding surrogate decision-making for health care. The report became the model for the Family Health Care Decisions Act (the "FHCDA"), which establishes a framework to allow surrogate decision-making for patients without capacity when they have not chosen a health care proxy. The FHCDA provides an invaluable tool for surrogate decision-makers to honor the wishes of patients when they cannot speak for themselves, or to act in the best interests of these patients when their wishes are unknown. In March 2010, the FHCDA was enacted.
The State Legislature included in the FHCDA two explicit directives to the Task Force. First, because the FHCDA permits surrogate consent to health care for incapacitated patients only when they are being treated in hospitals or nursing homes, the Legislature requested that the Task Force examine whether the scope of surrogate authority should be expanded to apply to decisions about health care provided in other settings (e.g., physicians' offices or ambulatory care centers). The Task Force recently completed a portion of this project, and submitted to the Legislature two recommendations. Its recommendation that the FHCDA be amended to authorize surrogate decision-making for hospice care formed the basis for legislation passed in July 2011. In 2013, the Task Force submitted its recommendation to the Legislature to extend the FHCDA to decisions regarding health care provided by agencies, programs, and settings that are Medicare and/or Medicaid-certified and State-licensed, and that opt to comply with the requirements of the FHCDA.
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.
New York's innovative guidelines were amongst the first of their kind to be released in the United States and have been widely cited and followed by other states. A summary of the recommendations was published in Disaster Medicine and Public Health Preparedness (See T. Powell, K. Christ and G. Birkhead, Allocation of Ventilators in a Public Health Disaster, Disaster Med. & Pub. Health Preparedness, 2:20-26 (2008).
The guidelines are currently in the process of being revised and a second edition of the report will be released soon.
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.
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.
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.
The Task Force also drafted the following model forms for egg donation and in vitro fertilization for practitioners: Informed Consent for In Vitro Fertilization and Related Procedures- Practitioner's Guide to Using the Model Form , Model Form for Informed Consent for In Vitro Fertilization and Related Procedures (with Description of In Vitro Fertilization and Risks of IVF Procedures), Informed Consent for Egg Donors - Practitioner's Guide to Using the Model Form , and Model Form for Informed Consent for Egg Donors.
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.
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.
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.
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.
The Task Force analyzed 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 in 1988.
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.
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.
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.
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 .
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, which 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.