Ethics in Psychiatric Research: A Review of 25 Years of NIH-Funded Empirical Research Projects

Abstract

Background This paper reviews the past 25 years of empirical research funded by the National Institutes of Health (NIH) on matters of ethics in psychiatric research. Methods Using the NIH RePORTER and Medline databases, we identified 43 grants and 77 publications that involved the empirical study of a matter of ethics in research involving mental health service users. Results These articles provide original and useful information on important topics, most especially the capacity to consent and the voluntariness of consent. For example, participants who share a diagnosis vary widely in levels of cognitive impairment that correlate with decisional capacity, and capacity to consent can be enhanced easily using iterative consent processes. Few articles address matters of justice or benefits in research, particularly from the perspectives of participants. No articles address matters of privacy, confidentiality, or researcher professionalism. Conclusions Despite the usefulness of data from the studies conducted to date, current research on research ethics in psychiatry does not adequately address the concerns of service users as expressed in recent publications.

Using iterative learning to improve understanding during the informed consent process in a South African psychiatric genomics study

“…Three key points emerge from these results. First, congruent with existing literature from HICs [ 5 , 17 ] our findings support the growing evidence demonstrating the ability to improve decisional capacity through an iterative learning process using the UBACC. The UBACC proved an effective tool for improving understanding of SAX research study elements during recruitment of both cases and controls in our LMIC setting.…”

“…Studies in HICs show that understanding of informed consent materials can be improved through an iterative learning process of firstly presenting the study information, secondly assessing a participant’s understanding of the study elements, and finally revisiting and revising poorly understood elements [ 5 – 7 ]. Participant understanding has been shown to be reliably assessed using the University of California, San Diego Brief Assessment of Capacity to Consent Questionnaire (UBACC), which was originally developed as a 10-item screening tool for decisional capacity in participants being recruited for schizophrenia research [ 8 ].…”

Informed Consent to Research with Cognitively Impaired Adults: Transdisciplinary Challenges and Opportunities

“…Studies have found that use of a simplified consent form—one using figures and plain language—can improve understanding (Dunn & Jeste, 2001; Kim & Kim, 2015). Others have found that an iterative process of assessing understanding, identifying areas of misunderstanding, and providing corrective feedback can lead to significant improvements in the understanding and appreciation of information (DuBois, Bante, & Hadley, 2011; Nishimura et al, 2013). However, as cognitive impairments grow more severe, such an approach may be inadequate.…”

Addressing Risks to Advance Mental Health Research

“…For example, mental health consumers tend to prioritize more than researchers a focus on alternative treatment modalities (such as nutritional or self-help modalities), iatrogenic harms, and qualitative research. 99,100 …”