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- W1716402327 abstract "Although research involving adults lacking consent capacity is permitted in New York State, until recently it was limited because of uncertainty about who could provide surrogate consent to participation. In 2010, the Family Health Care Decisions Act changed the legal landscape by permitting surrogate consent to health care and potentially opened up the field of research requiring surrogate consent. However, there remain few – if any – rules and little guidance at both the federal and state level to ensure consistently ethical conduct of research involving adults lacking consent capacity. Without safeguards that are both adequate and robust but not overly burdensome, this will remain a challenge to the conduct of ethical research. Thus, IRBs, investigators, and research institutions have appealed to the New York State Task Force on Life and the Law for guidance on how to conduct research involving this vulnerable population. To address the significant inconsistency in the oversight and conduct of research, the Task Force drafted a set of legal and ethical guidance regarding the conduct of research in New York State involving adults who lack consent capacity. This article addresses the development and key content of the guidance, which may serve as a model for research in other states and at the federal level. An underlying goal of the work is to ensure that research protocols are available to all individuals, including this population, so that they may also experience the benefits of research and share its risks and burdens as their non-cognitively impaired peers, while also ensuring the appropriate level of protections. Thus, the report provides guidance and best practices that will assist institutions, researchers, IRBs, and surrogate decision-makers in the ethical conduct and responsibilities of research involving the cognitively impaired. Without such guidance, either research will occur without appropriate protections and safeguards, or important research may not occur." @default.
- W1716402327 created "2016-06-24" @default.
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- W1716402327 date "2014-05-13" @default.
- W1716402327 modified "2023-09-28" @default.
- W1716402327 title "'Of Vital Importance': The New York State Task Force on Life and the Law's Report and Recommendations for Research with Human Subjects Who Lack Consent Capacity" @default.
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