Overcoming barriers to informed consent in neurological research: Perspectives from a national survey.

The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others.

The Need for Specialized Oncology Training for Clinical Ethicists.

Numerous ethical issues are raised in cancer treatment and research. Informed consent is challenging due to complex treatment modalities and prognostic uncertainty. Busy oncology clinics limit the ability of oncologists to spend time reinforcing patient understanding and facilitating end-of-life planning. Despite these issues and the ethics consultations they generate, clinical ethicists receive little if any focused education about cancer and its treatment. As the field of clinical ethics develops standards for training, we argue that a basic knowledge of cancer should be included and offer an example of what cancer ethics training components might look like. We further suggest some specific steps to increase collaboration between clinical ethicists and oncology providers in the outpatient setting to facilitate informed consent and proactively identify ethical issues.