The ethical acceptability of psychiatric research has been strongly challenged in recent years. This challenge brings an invitation to construct a more refined understanding of the ethical issues in neuropsychiatric investigation, and ultimately to help advance science, to improve clinical care, and to lessen the suffering of millions of people. Through this K02 proposal, I seek to achieve enduring ethics expertise grounded in scientific, policy, and educational aspects of psychiatric investigation through intensive training, consultative, and research experience over 5 years. The integrated training and research plan has three specific aims. First, I will gain expertise in psychiatric research ethics concerning the: (a) theoretical scientific and ethical dimensions of experimental designs (e.g., medication discontinuation, symptom challenge, placebo trials) that employ different methodological procedures and exist on different scales (e.g., pilot studies, large scale multi-center projects); (b) implementation of ethical safeguards in psychiatric research (e.g., obtaining informed consent, assessing decisional capacity, performing research review); (c) ethical issues arising around different vulnerabilities of protocol participants; (d) development of scientific and public policy; and, (e) use of innovative educational methods to train investigators in ethical issues. Second, I will perform three hypothesis-driven preliminary studies laying groundwork for a long-term program of work on questions critical to ethically sound psychiatric investigation. Study 1 will examine whether schizophrenia patients are able to assess ethically important aspects of scientific protocols of varying designs, methods, and size of studies. It will also assess schizophrenia patients' views of ethical safeguards and will characterize the influence of potential vulnerabilities. Study 2 will determine the perspectives of psychiatric investigators regarding the ethical acceptability of scientific protocols related to: (a) their design, methods, and scale of studies; and, (b) the presence or absence of specific ethical safeguards. The study will also identify obstacles to implementing ethical safeguards, and it will explore the needs and preferences of psychiatric investigators for research ethics training. Study 3 will assess the value and effectiveness of educational interventions on core research ethics topics for investigators. Third, linked to Study 3, I will create and evaluate four educational modules based on principles of adult-centered learning aimed at advancing psychiatric investigators' knowledge (e.g. ethics principles, federal regulations), attitudes (e.g., vulnerabilities of study participants, role of ethics safeguards in protection of human subjects), and skills (e.g., ability to assess ethics of a scientific protocol). This work will result in valuable preliminary data that will give rise to R01-level research and education-related proposals. Through the plan for development of my research career, I hope to contribute to the advancement of vital, ethically sound research involving mentally ill people and members of other special and potentially vulnerable, populations.
Showing the most recent 10 out of 36 publications
