213 - ECT-AD: Ethics and informed consent issues

Agitation is experienced by over 90% of individuals with Alzheimer’s disease (AD) which increases morbidity and mortality and contribute to caregiver burden. There are no FDA-approved treatments for severe agitation in people with advanced dementia. Behavioral interventions are first-line management strategies but are not effective in the most severely agitated patients. Off-label use of psychotropic medications have limited efficacy and risk for adverse effects. New management strategies for severe agitation in AD refractory to psychopharmacologic and behavioral interventions are timely and warranted. Preliminary studies provide evidence for the safety and efficacy of acute electroconvulsive therapy (ECT) in reducing agitation in this population.The ECT-AD study is a multi-site NIH-funded randomized single-blind randomized controlled trial to investigate the safety and efficacy of ECT in severe and treatment refractory agitation and aggression in AD. In a vulnerable population with advanced dementia and lack of capacity to provide informed consent, there are ethical and consent issues that need to be considered. In this presentation, we will describe the human research subject aspects of working with this population, the process of informed consent and variation of state laws, and efforts to ensure participant safety and minimize undue influence or coercion.

Listening Like a Computer: Attentional Tensions and Mechanized Care in Psychiatric Digital Phenotyping

This article explores negotiations over the humanistic versus mechanized components of care through an ethnographic account of digital phenotyping research. I focus on a US-based team of psychiatric and engineering professionals assembling a smartphone application that they hope will analyze minute changes in the sounds of speech during phone calls to predict when a user with bipolar disorder will have a manic or depressive episode. Contrary to conventional depictions of psychiatry as essentially humanistic, the discourse surrounding digital phenotyping positions the machine as a necessary addition to mental health care precisely because of its more-than-human sensory, attentional capacities. The bipolar research team likewise portrays their app as capable of pinpointing sonic signs of mental illness that humans, too distracted by semantic meaning, otherwise ignore. Nevertheless, the team members tasked with processing the team’s data (audio recordings of human research subject speech) must craft and perform a selectively attentive machinic subject position, which they call “listening like a computer”: a paradoxical mode of attention (to speech sound) and inattention (to speech meaning). By tracing the team’s discursive and on-the-ground enactments of care and attention as both humanistic and machinic, I tune a critical ear to the posthuman promises of digital phenotyping.

How to strengthen clinical research in Shenzhen, China: qualitative study

ObjectivesTo better understand the strengths and weaknesses, and to propose policy recommendations, regarding conducting high-quality clinical research in Shenzhen, China.DesignA qualitative study conducted from August to November 2016 using a semistructured interview format involving both focus group interviews and individual interviews.SettingShenzhen, China.ParticipantsStratified purposive and convenience sampling were used. Thirty individuals experienced in conducting and managing clinical research were selected from key stakeholder groups, comprising 11 from local hospitals, 14 from pharmaceutical/medical device companies and 5 from government agencies.MethodsA semistructured interview guide was developed by the study group and used by experienced interviewers in focus group discussions and individual interviews. The interviewees were encouraged to share their opinions freely and discuss their own topics of interest during the interviews. Thematic analysis was used for analysis and all data were coded and extracted using NVivo V.11.0 software.ResultsFavourable driving factors for clinical research in Shenzhen identified by all stakeholders included the recent trend of increased governmental funding for clinical research, supportive governmental policies, wide recognition of the value of clinical research and high demands from local industry. The major challenges include a lack of technical infrastructure, weak human research subject protection and a lack of capable research resources.ConclusionsDespite the established strengths, Shenzhen still needs to develop suitable technical platforms, human resources training programmes and strong human research subject protection programmes pertaining to clinical research. This would facilitate the establishment of a functional system that can be expected to lead to increased medical research innovation in Shenzhen.

Informed Consent for the Human Research Subject with a Neurologic Disorder

The doctrine of informed consent sits at the intersection of law, ethics, and neuroscience, posing unique challenges for human subject research involving neurological patients. These challenges are compounded by the variegated nature of both neurological injury and the law governing research consent. This article provides a framework for investigators likely to encounter subjects with some degree of neurological impairment, whose capacity to consent requires scrupulous assessment prior to enrollment in research trials. We consider several researches and disease contexts—from emergency epilepsy research to long-term dementia research—and clarify the ethical and legal principles governing consent for participation in each. We additionally explore empirical research on consent capacity and survey several areas of emerging ethical import that will require the attention of investigators in decades to come.

Prisoners as Living Donors: A Vulnerabilities Analysis

Although national guidelines exist for evaluating the eligibility of potential living donors and for procuring their informed consent, no special protections or considerations exist for potential living donors who are incarcerated. Human research subject protections in the United States are codified in the Federal Regulations, 45 CFR 46, and special protections are given to prisoners. Living donor transplantation has parallels with human subject research in that both activities are performed with the primary goal of benefiting third parties. In this article, we describe what special considerations should be provided to prisoners as potential living donors using a vulnerabilities approach adapted from the human research subject protection literature.