Laura Weiss Roberts

Psychiatric research ethics: an overview of evolving guidelines and current ethical dilemmas in the study of mental illness

The field of psychiatry has an opportunity to construct a more refined, perhaps more enduring understanding of the ethical basis of mental illness research. The aim of this paper is to help advance this understanding by 1) tracing the evolution of the emerging ethic for biomedical experimentation, including recent recommendations of the Presidents National Bioethics Advisory Commission, and 2) reviewing data and concepts related to compelling ethical questions now faced in the study of mental disorders. Empirical findings on informed consent, the ethical safeguards of institutional review and surrogate decision making, and the relationship between scientific and ethical imperatives are outlined. Psychiatric researchers will increasingly be called upon to justify their scientific approaches and to seek ways of safeguarding the well-being of people with mental illness who participate in experiments. Most importantly, psychiatric investigators will need to demonstrate their appreciation and respect for ethical dimensions of investigation with special populations. Further empirical study and greater sophistication with respect to the distinct ethical issues in psychiatric research are needed. Although such measures present many challenges, they should not interfere with progress in neuropsychiatric science so long as researchers in our field seek to guide the process of reflection and implementation.

Mental disorders, health inequalities and ethics: A global perspective

The global burden of neuropsychiatry diseases and related mental health conditions is enormous, underappreciated and under resourced, particularly in the developing nations. The absence of adequate and quality mental health infrastructure and workforce is increasingly recognized. The ethical implications of inequalities in mental health for people and nations are profound and must be addressed in efforts to fulfil key bioethics principles of medicine and public health: respect for individuals, justice, beneficence, and non-malfeasance. Stigma and discrimination against people living with mental disorders affects their education, employment, access to care and hampers their capacity to contribute to society. Mental health well-being is closely associated to several Millennium Development Goals and economic development sectors including education, labour force participation, and productivity. Limited access to mental health care increases patient and family suffering. Unmet mental health needs have a negative effect on poverty reduction initiatives and economic development. Untreated mental conditions contribute to economic loss because they increase school and work absenteeism and dropout rates, healthcare expenditure, and unemployment. Addressing unmet mental health needs will require development of better mental health infrastructure and workforce and overall integration of mental and physical health services with primary care, especially in the developing nations.

Barriers to healthcare as reported by rural and urban interprofessional providers

Summary The research literature is replete with reports of barriers to care perceived by rural patients seeking healthcare. Less often reported are barriers perceived by the rural healthcare providers themselves. The current study is an extensive survey of over 1,500 healthcare providers randomly selected from two US states with large rural populations, Alaska and New Mexico. Barriers consistently identified across rural and urban regions by all healthcare professionals were Patient Complexity, Resource Limitations, Service Access, Training Constraints, and Patient Avoidance of Care. Findings confirmed that rural areas, however, struggle more with healthcare barriers than urban and small urban areas, especially as related to Resource Limitations, Confidentiality Limitations, Overlapping Roles, Provider Travel, Service Access, and Training Constraints. Almost consistently, the smaller a providers practice community, the greater the reports of barriers, with the most severe barriers reported in small rural communities.

An office on Main Street. Health care dilemmas in small communities.

The health care needs of rural populations often differ from those of their urban counterparts. And the ethical dilemmas that caregivers face are distinctively shaped in rural settings, not only by resource constraints, but by the nature of life in small, close-knit communities as well.

Caring for medical students as patients: Access to services and care- seeking practices of 1,027 students at nine medical schools

Purpose The personal health care of medical students is an important but neglected issue in medical education. Preliminary work suggests that medical student-patients experience special barriers to health care services and report problematic care-seeking practices that merit further inquiry. Method A self-report questionnaire was piloted, revised, and distributed to students at nine medical schools in 1996–97. The survey included questions regarding access to health services, care-seeking practices, and demographic information. Results A total of 1,027 students participated (52% response rate). Ninety percent reported needing care for various health concerns. Fifty-seven percent did not seek care at times, in part due to training demands, and 48% had encountered difficulties in obtaining care. A majority had received treatment at their training institutions, and students commonly pursued informal or “curbside” care from medical colleagues. Almost all participants (96%) were insured. Differences in responses were associated with level of training, gender, and medical school. Conclusion Medical schools shoulder the responsibility not only of educating but also of providing health services for their students. Students encounter barriers to care and engage in problematic care-seeking practices. Greater attention to issues surrounding medical student health may benefit students and their future patients.

The ethical basis of psychiatric research: Conceptual issues and empirical findings

The study objective was to clarify the ethical basis of psychiatric research by outlining conceptual issues and empirical findings related to the ethics of human experimentation. A systematic review of scholarly and empirical literature covering three decades was performed. The ethics of human research has come to be understood in relation to the principles of respect for persons, beneficence, justice, and the ideal of informed consent. Subjects who cannot fully participate in informed-consent processes are especially vulnerable to exploitation. Current dilemmas stem from insufficient attention to the vulnerabilities of mentally ill research participants, problems in applying ethical concepts and guidelines to psychiatric research, and claims of research misconduct. Empirical studies indicate that (1) psychiatric symptoms significantly affect informed consent, (2) psychiatric patients may possess certain strengths with respect to research involvement, (3) proxy decision-making is problematic, (4) informed consent is also difficult to attain with the medically ill and others, (5) patients are motivated to participate in research by the hope of personal benefit, (6) ethical aspects of research are poorly documented, and (7) institutional review processes may not be adequate to protect vulnerable subjects. Psychiatric research can be performed ethically, according to standards set throughout the biomedical and behavioral sciences, so long as researchers and institutions are respectful of special ethical issues in human experimentation and strive to include vulnerable study participants fully in research decisions. However, many gaps in the empirical literature exist regarding the specific nature and implementation of ethics principles in psychiatric research. Efforts to advance both science and ethics, including the study of ethical dimensions of human research itself, are essential for the future of psychiatry.

An Invitation for Medical Educators to Focus on Ethical and Policy Issues in Research and Scholarly Practice

Medical education research and medical education practice both involve being methodical, innovative, self-observing, forward-looking, and open to peer review, and both are scholarly activities. For these reasons, distinguishing between these two activities is often difficult. There are three important reasons to clarify the distinctions: the moral difference between education research and education practice; federal regulations governing education research that require more safeguards than often exist in education practice; and the fact that student participants in research have characteristics in common with members of special populations. The authors explain why attention to issues of safeguards in education research and practice is likely to grow at academic health centers, yet maintain that these issues are neglected in the medical education literature. They demonstrate this with findings from their review of 424 education research reports published in 1988 and 1989 and in 1998 and 1999 in two major medical education journals. Each article was evaluated for documentation of six ethically important safeguards and features (e.g., informed consent). The rates of reporting the six features and safeguards were relatively low (3–27%). Nearly half (47%) of the empirical reports offered no indication of ethically important safeguards or features, and no article mentioned all six. Furthermore, those rates did not increase substantially after ten years. The authors discuss a number of implications of their findings for faculty, training institutions, students, and editors and peer reviewers, and conclude with the hope that their findings will raise awareness of these neglected issues in medical education and will stimulate all those involved to reflect upon the issues and set standards on the ethical aspects of research and scholarly practice.

Machine Learning and the Profession of Medicine

This Viewpoint discusses the opportunities and ethical implications of using machine learning technologies, which can rapidly collect and learn from large amounts of personal data, to provide individalized patient care.

Conducting Empirical Research on Informed Consent: Challenges and Questions

She informed consent projects (ICPs) we describe here were designed to produce (1) new and improved methods for the informed consent process, (z) methods for confronting the challenges of obtaining consent for special or vulnerable populations, and (3) data to help inform and guide public policy development (Table 1). From the outset, the project investigators identified a number of conceptual and practical concerns and challenges in conducting empirical research on informed consent. These concerns and challenges were shared by all the investigators, despite the significant variability in the research methods used and the populations studied. Experienced researchers will recognize that some of these concerns and challenges are common to many kinds of research involving human subjects. Some, however, are unique to research on informed consent. We describe these matters for the purpose of fostering ongoing dialogue about the challenges researchers face in studying the informed consent process. Common Research Challenges

Ethical dimensions of psychiatric research: a constructive, criterion-based approach to protocol preparation. The research protocol ethics assessment tool (RePEAT)

Preparing experimental protocols that are ethically sound, possess scientific merit, and meet institutional and national standards for human subject protections is a key responsibility of psychiatric investigators. This task has become increasingly complex due to developments in biomedical science, bioethics, and society at large. Practical and constructive approaches to help investigators in their efforts to create protocols that are ethically acceptable have nevertheless received little attention. To better address this gap, the Research Protocol Ethics Assessment Tool (RePEAT) was developed as an educational instrument to help assure that ethically important elements, including scientific design features, are explicitly addressed by investigators in their work with protocols involving human participants. The RePEAT is a brief evaluative checklist that reflects rigorous ethical standards, particularly with respect to criteria for studies that may involve individuals with compromised decisional abilities. For this reason, it may be especially beneficial as a self-assessment tool for investigators and protocol reviewers in psychiatry. To stimulate education and dialogue, this report presents the RePEAT and outlines its content, format, use, and limitations.