New York State Task Force on the Life and Law Releases Recommendations for Research with Human Subjects Who Lack Consent Capacity

The New York State Task Force on Life and the Law (Task Force) was charged by the New York State Department of Health (NYSDOH) with analyzing the legal and ethical implications of involving adults in research who do not have the capacity to consent to participate. This report responds to appeals from Institutional Review Boards (IRBs), investigators, and research institutions seeking guidance from NYSDOH and the Task Force on the issue.

The Task Force's efforts included the distribution of a survey to approximately 300 New York-based IRB chairs and members requesting information about their institutions' practices, if any, for conducting research involving the cognitively impaired, and their views on the regulatory landscape. Survey responses provided a detailed and useful qualitative account of research practices in New York, and indicated a need for guidelines to ensure consistently ethical research practices.

About the New York State Task Force on Life and the Law

Established in 1985 by Governor Mario Cuomo, the New York State Task Force on Life and the Law consists of approximately 23 Governor-appointed experts who volunteer their time to assist the State in developing public policy on issues arising at the interface of medicine, law, and ethics. Chaired by New York State's Commissioner of Health, the Task Force is comprised of leaders in the fields of religion, philosophy, law, medicine, nursing, and bioethics. The Task Force has produced influential reports on cutting-edge bioethics issues, including the withholding and withdrawing of life-sustaining treatment, assisted reproductive technologies, organ transplantation, dietary supplements, assisted suicide, genetic testing, and the allocation of ventilators in an influenza pandemic.

Numerous Task Force recommendations have been adopted as legislation or regulation in New York and have impacted greatly the delivery of health care in the State, including those related to the determination of death, do-not-resuscitate (DNR) orders, health care proxies, organ and tissue transplantation, genetic testing, assisted reproductive technology, surrogate parenting, and palliative care. In addition, other states, including Georgia, Illinois, Massachusetts, and Vermont, have embraced the Task Force's recommendations as models for legislation. In 2010, the State Legislature passed the Family Health Care Decisions Act (FHCDA), which establishes a statutory framework for surrogate consent to health care for patients who lack decision-making capacity, and was modeled on the Task Force's report, When Others Must Choose: Deciding for Patients Without Capacity. More recently, the New York State Legislature amended the FHCDA to authorize surrogate decision-making for hospice care, based on a recommendation by the Task Force.

The Task Force's reports have been cited in a number of seminal federal and state court decisions. The United States Supreme Court's 1997 opinions of Washington v. Glucksberg and Vacco v. Quill referred to the Task Force's report on physician-assisted suicide more than thirty times. Task Force reports on reproductive technology have also been incorporated into court decisions. In Webster v. Reproductive Health Services, the United States Court of Appeals for the Eighth Circuit relied on a Task Force report on fetal extrauterine survivability. The California Supreme Court quoted significantly the Task Force's report on surrogate parenting in Johnson v. Calvert. In the New York Court of Appeals decision of Kass v. Kass, a landmark case regarding the custody of frozen embryos created prior to the couple's divorce, the opinion drew on a report by the Task Force on assisted reproductive technology.

The Task Force's members and staff frequently serve as speakers at professional conferences and organizations, including the American Society of Law, Medicine and Ethics, the New York Academy of Medicine, the White House Conference on Aging and Developmental Disabilities, the New York City Health and Hospitals Corporation, the American Medical Association, the American Society for Bioethics and Humanities, Public Responsibility in Medicine and Research, the Institute of Medicine, and New York City, State, and American Bar Associations, among others.