A policy in flux: New York State's evolving approach to human subjects research involving individuals who lack consent capacity.

American history has been rife with human subjects research scandals, particularly those that involve "vulnerable" populations. State and federal laws and regulations often do not provide any special oversight mechanisms or protections to ensure the ethical and safe inclusion of cognitively impaired adults in research. At the New York State level, repeated (and often unsuccessful) efforts have been made to regulate research involving individuals who lack consent capacity. In January 2014, the New York State Task Force on Life and the Law released its Report and Recommendations for Research with Human Subjects Who Lack Consent Capacity, which represents the most recent step in a decades-long process in the state to develop oversight mechanisms that are appropriately sensitive to the fine line between protecting a vulnerable population and impeding the advancement of research. These recommendations may serve as a model for research policy in other states and at the federal level, particularly in light of shifting societal concerns and changing political winds.