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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Scientist Development Award - Research (K02)
Project #
5K02MH001918-03
Application #
6391628
Study Section
Special Emphasis Panel (ZRG1-SNEM-4 (02))
Program Officer
Cuerdon, Timothy
Project Start
1999-09-30
Project End
2004-08-31
Budget Start
2001-09-01
Budget End
2002-08-31
Support Year
3
Fiscal Year
2001
Total Cost
$141,850
Indirect Cost
Name
University of New Mexico
Department
Psychiatry
Type
Schools of Medicine
DUNS #
829868723
City
Albuquerque
State
NM
Country
United States
Zip Code
87131
Roberts, Laura Weiss; Kim, Jane Paik (2016) Are individuals living with mental illness and their preferred alternative decision-makers attuned and aligned in their attitudes regarding treatment decisions? J Psychiatr Res 78:42-7
Roberts, Laura Weiss; Kim, Jane Paik (2015) Attunement and alignment of people with schizophrenia and their preferred alternative decision-makers: An exploratory pilot study comparing treatment and research decisions. J Psychiatr Res 71:70-7
Chipp, Cody; Dewane, Sarah; Brems, Christiane et al. (2011) ""If only someone had told me…"": lessons from rural providers. J Rural Health 27:122-30
Roberts, Laura Weiss; Johnson, Mark E; Brems, Christiane et al. (2008) When providers and patients come from different backgrounds: perceived value of additional training on ethical care practices. Transcult Psychiatry 45:553-65
Horwitz, Russell H; Roberts, Laura Weiss; Warner, Teddy D (2008) Mexican immigrant women's perceptions of health care access for stigmatizing illnesses: a focus group study in Albuquerque, New Mexico. J Health Care Poor Underserved 19:857-73
Chipp, Cody L; Johnson, Mark E; Brems, Christiane et al. (2008) Adaptations to health care barriers as reported by rural and urban providers. J Health Care Poor Underserved 19:532-49
Brems, Christiane; Johnson, Mark E; Warner, Teddy D et al. (2007) Exploring differences in caseloads of rural and urban healthcare providers in Alaska and New Mexico. Public Health 121:3-17
Roberts, Laura Weiss; Johnson, Mark E; Brems, Christiane et al. (2007) Ethical disparities: challenges encountered by multidisciplinary providers in fulfilling ethical standards in the care of rural and minority people. J Rural Health 23 Suppl:89-97
Dunn, Laura B; Candilis, Philip J; Roberts, Laura Weiss (2006) Emerging empirical evidence on the ethics of schizophrenia research. Schizophr Bull 32:47-68
Roberts, Laura Weiss; Hammond, Katherine Green; Hoop, Jinger (2006) An inverse relationship between perceived harm and participation willingness in schizophrenia research protocols. Am J Psychiatry 163:2002-4

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