Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants’ locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant’s real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by (...) a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas. (shrink)

Artificial intelligence surveillance can be used to diagnose individual cases, track the spread of Covid‐19, and help provide care. The use of AI for surveillance purposes (such as detecting new Covid‐19 cases and gathering data from healthy and ill individuals) in a pandemic raises multiple concerns ranging from privacy to discrimination to access to care. Luckily, there exist several frameworks that can help guide stakeholders, especially physicians but also AI developers and public health officials, as they navigate these treacherous shoals. (...) While these frameworks were not explicitly designed for AI surveillance during a pandemic, they can be adapted to help address concerns regarding privacy, human rights, and due process and equality. In a time where the rapid implementation of all tools available is critical to ending a pandemic, physicians, public health officials, and technology companies should understand the criteria for the ethical implementation of AI surveillance. (shrink)

Employers and governments are interested in the use of serological testing to allow people to return to work before there is a vaccine for SARS-CoV-2. We articulate the preconditions needed for the implementation of antibody testing, including the role of the U.S. Food & Drug Administration.

For the average person, genetic testing has two very different faces. The rise of genetic testing is often promoted as the democratization of genetics by enabling individuals to gain insights into their unique makeup. At the same time, many have raised concerns that genetic testing and sequencing reveal intensely personal and private information. As these technologies become increasingly available as consumer products, the ethical, legal, and regulatory challenges presented by genomics are ever looming. Assembling multidisciplinary experts, this volume evaluates the (...) different models used to deliver consumer genetics and considers a number of key questions: How should we mediate privacy and other ethical concerns around genetic databases? Does aggregating data from genetic testing turn people into products by commercializing their data? How might this data reduce or exacerbate existing healthcare disparities? Contributing authors also provide guidance on protecting consumer privacy and safety while promoting innovation. (shrink)

In May of 2006, the Abigail Alliance for Better Access to Development Drugs appeared to have won a victory when a divided panel of the Court of Appeals for the District of Columbia Circuit ruled that “terminally ill, mentally competent adult patients” had a constitutionally protected right to access investigational medications. This victory was short lived, however. On August 7, 2007, the D.C. Circuit sitting en banc reversed this earlier decision, marking a setback in Abigail's campaign for removal of the (...) regulatory barriers that currently prevent terminally ill patients from gaining early access to investigational drugs. This loss represents a big blow for Abigail's cause, because there is no guarantee that they will have another day in court, and attaining their goal through other branches of the government remains uncertain. (shrink)

In May of 2006, the Abigail Alliance for Better Access to Development Drugs appeared to have won a victory when a divided panel of the Court of Appeals for the District of Columbia Circuit ruled that “terminally ill, mentally competent adult patients” had a constitutionally protected right to access investigational medications. This victory was short lived, however. On August 7, 2007, the D.C. Circuit sitting en banc reversed this earlier decision, marking a setback in Abigail's campaign for removal of the (...) regulatory barriers that currently prevent terminally ill patients from gaining early access to investigational drugs. This loss represents a big blow for Abigail's cause, because there is no guarantee that they will have another day in court, and attaining their goal through other branches of the government remains uncertain. (shrink)

The New Jersey Supreme Court has continually avoided making moral judgments about the value of life and emphasized that such decision making should be the province of the potential parents. Recently, in Acuna v. Turkish, the court elaborated on the limitations of the decision-making right of the potential parents, and its decision demonstrated that New Jersey courts were only willing to require physicians to disclose all relevant medical information, and not moral statements that had not been agreed upon by the (...) state's medical community, people, or legislature. Acuna might be read as a departure from the trend displayed by New Jersey courts in “wrongful birth” and “wrongful life” actions toward empowering potential parents to decide if they want to bring the pregnancy to term. However, the decision actually fits squarely within this trend in that the reluctance to expand the information to which potential parents are entitled from their physicians can be directly tied to the reluctance of the New Jersey Supreme Court to weigh in on the value of life in wrongful birth and wrongful life suits. (shrink)

In order for the Food and Drug Administration to receive the trust and deference it needs to accomplish its mission, it must be seen as relatively impervious to political manipulation. For most of the FDA’s history, it has been seen as an institution driven by scientific expertise, not by political maneuvering. However, the FDA was increasingly criticized during the Bush administration for politicizing decisions such as rejecting an application to grant the “morning after pill,” known as Plan B, over-the-counter status (...) for women of all ages. After an atypical approval process, the FDA approved OTC Plan B use only for women over the age of 18. Because some groups perceive the morning after pill as a form of abortion, the politically appointed leadership of the FDA was suspected of dramatically departing from normal FDA procedures in order to ensure that the application would not be approved. (shrink)

In order for the Food and Drug Administration to receive the trust and deference it needs to accomplish its mission, it must be seen as relatively impervious to political manipulation. For most of the FDA’s history, it has been seen as an institution driven by scientific expertise, not by political maneuvering. However, the FDA was increasingly criticized during the Bush administration for politicizing decisions such as rejecting an application to grant the “morning after pill,” known as Plan B, over-the-counter status (...) for women of all ages. After an atypical approval process, the FDA approved OTC Plan B use only for women over the age of 18. Because some groups perceive the morning after pill as a form of abortion, the politically appointed leadership of the FDA was suspected of dramatically departing from normal FDA procedures in order to ensure that the application would not be approved. (shrink)