The Task Force and its staff are working on numerous projects, including:
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.
At the request of the Department and stakeholders, 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. The Task Force is in the final stages of a completing a report, which will include suggested oversight mechanisms to ensure the ethical conduct of research, recommended safeguards to protect the rights of vulnerable subjects, and guidance to family members and other surrogates on how to decide whether to enroll their loved ones in research.
Allocation of Ventilators in an Influenza Pandemic
In 2007, the Task Force issued draft guidelines addressing how ventilators should be allocated in the event of a shortage due to a pandemic outbreak of influenza. The report provided clinicians and institutions across the State with an ethical framework and clinical protocol for distributing ventilators in a public health emergency. These 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.
In light of the recent pandemic flu outbreaks and lessons learned from Hurricane Katrina, the Task Force examined contemporary ethical issues, clinical data, and legal theories, and plans to release the second edition of the report in the near future. The revised report will address the ethics of making allocation decisions based on medical history or DNR orders, and whether children should receive priority access to ventilators over adults. The new edition will also include adjustments to the clinical triage protocol for adults to bring it in line with current medical data, as well as creative solutions for liability and indemnity issues arising from adherence to altered standards of care in an emergency. A new section on pediatric issues, which will address the unique challenges of treating children in a public health disaster, will also be added.
To ensure that the revised guidelines reflect the public's values, the Task Force recently obtained CDC grant funds to embark on a public engagement project. The funds will be used to conduct focus groups throughout the State to solicit opinions on the ethical and clinical framework underpinning the guidelines. This public input will be integrated into the planned revision.
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.
The Act's second assignment requires the Task Force to recommend standards and procedures for surrogate decision-making for persons with mental illness or developmental disabilities. This challenging undertaking involves integrating the mechanisms and criteria for surrogate decision-making set forth in the Health Care Decisions Act for Mentally Retarded Persons with those found in the FHCDA in a way that protects the rights and well-being of these individuals while also providing consistent rules for surrogate consent across populations. The Task Force plans to convene a special committee in the near future to examine the second directive.
Empire State Stem Cell Board
In addition to Task Force projects, Task Force staff also provides extensive, on-going support to the Empire State Stem Cell Board (the "Board"), which oversees NYSTEM, the State's program to fund stem cell research.
The Task Force staff has contributed significantly to several of the Board's projects, including providing research on how scientists could show respect for the human embryo when it is utilized in research, aiding the Board in reviewing the ethical and scientific standards for conducting human-animal chimera research, and facilitating and assisting with the development of the Board's historic policy to compensate women who donate their eggs to stem cell research. (See "Statement of the Empire State Stem Cell Board on the Compensation of Oocyte Donors") In addition, staff recently completed drafting model informed consent forms for donations of biological materials, such as eggs or sperm, to stem cell research. (See "ESSCB Model Informed Consent Forms".)