Perceptions of African-American health professionals and community members on the participation of children and pregnant women in genetic research.

BACKGROUND: As genetic research gains more prominence in society, ethical concerns and the need for safeguards in the participation of children and pregnant women have increased. This study examined the perspectives of African-American health professional and community members on genetic research involving children and pregnant women. METHODS: We used a mixed-methods approach to collect and analyze survey data and qualitative data from focus groups of community members and structured interviews of health professionals. RESULTS: We found that community members had significantly more favorable attitudes toward participation of children and pregnant women in genetic research than health professionals. Health professionals did not differ significantly from community members in their perceived understanding of genetic research. Emergent themes included limited knowledge of genetic research and distinction of biomedical research and clinical care, ethical concerns about confidentiality and potential harm, and the need to protect children and pregnant women. Participants expressed high interest and favorable attitude towards genetic research, despite limited genetic knowledge and concerns of potential harm to children and pregnant women. Some participants felt that genetic research findings could help dispel stigma and reduce discrimination, especially in mental illness. CONCLUSION: Findings suggest that the recruitment of participants into genetic research should directly address privacy and benefit concerns, and limited knowledge of physical and mental illness genetic research. There is a critical need to invest and engage racial/ethnic communities early, provide education on genetics, mental illness, and translate and share research findings with these communities.

A framework for considering the ethical aspects of psychiatric research protocols.

The ethics of psychiatric research has emerged as a topic of national importance. Attention to this topic has been stimulated by a number of factors, including heightened awareness of the distinct moral problems arising in the care of mental illness, the rapid development of new psychopharmaceutical agents, the emergence of evidence-based approaches in psychiatry, the expansion of clinical trials within the private mental health sector, and recent recommendations offered by the President's National Bioethics Advisory Commission (NBAC). Consequently, clinical practitioners and investigators alike will increasingly be called upon to evaluate the ethical acceptability of psychiatric research protocols encountered in their professional work. In light of this, we present a framework for considering ethical aspects of psychiatric research protocols. This framework gives emphasis to nine elements: (1) scientific issues; (2) research team issues; (3) risk and benefit in protocol design; (4) confidentiality; (5) selection, exclusion, and recruitment considerations; (6) informed consent and decisional capacity; (7) incentives; (8) institutional and peer/professional review issues; and (9) data presentation issues. Case illustrations are provided. It is hoped that enhanced knowledge of the considerations presented in this framework will ultimately improve our ability to help people with mental illness.

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.

Uncertainty and opposition of medical students toward assisted death practices.

To explore medical students' views of assisted death practices in patient cases that describe different degrees and types of physical and mental suffering, an anonymous survey was administered to all students at one medical school. Respondents were asked about the acceptability of assisted death activities in five patient vignettes and withdrawal of life support in a sixth vignette. In the vignettes, actions were performed by four possible agents: the medical student personally; a referral physician; physicians in general; or non-physicians. Of 306 medical students, 166 (54%) participated. Respondents expressed opposition or uncertainty about assisted death practices in the five patient cases that illustrated severe forms of suffering which were secondary to amyotrophic lateral sclerosis, treatment-resistant depressive and somatoform disorders, antisocial and sexually violent behavior, or AIDS. Students supported the withdrawal of life support in the sixth vignette depicting exceptional futility secondary to AIDS. Students were especially opposed to their own involvement and to the participation of non-physicians in assisted death activities. Differences in views related to sex, religious beliefs, and personal philosophy were found. Medical students do not embrace assisted death practices, although they exhibit tolerance regarding the choices of medical colleagues. How these attributes of medical students will translate into future behaviors toward patients and peers remains uncertain. Medical educators must strive to understand the perspectives of physicians-in-training. Expanded, empirically informed education that is attuned to the attitudes of medical students may be helpful in fulfilling the responsibility of imparting optimal clinical care skills.

Placebos and paradoxes in psychiatric research: an ethics perspective.

The use of placebos in clinical trials, particularly in research with mentally ill people, has emerged as a subject of considerable controversy. We first outline ethical aspects of the primary scientific arguments for and against placebo use in research. Three examples of paradoxical aspects of the ethical use of placebos are discussed: involvement of relatively more vulnerable populations, use of apparently "less than standard" therapy, and the omission of information in placebo comparisons. In the current scientific and regulatory context, placebo use in psychiatric research may be necessary for scientific reasons, and when certain conditions are present, it may be justified on ethical grounds. Four key recommendations to facilitate the ethical use of placebos in research trials are presented. We conclude that placebo trials should be undertaken only after careful evaluation of alternative scientific strategies and, as with all human research, with great respect and genuine consideration for the individuals who choose to participate in these protocols.

Perceptions of academic vulnerability associated with personal illness: a study of 1,027 students at nine medical schools. Collaborative Research Group on Medical Student Health.

About one quarter of the more than 69,000 medical students in this country suffer symptoms of mental illness, including 7% to 18% with substance use disorders. Subjective distress and physical health needs of medical students are also common and have been linked to training stresses. This first large-scale study of medical student health care examined students' physical and mental health concerns and their perceptions of academic vulnerability associated with personal illness. A 7-page, confidential written survey was given to 1,964 students at nine US medical schools in 1996 and 1997. A total of 1,027 students participated (52% response rate). Nearly all (90%) reported needing care for various health concerns, including 47% having at least one mental health or substance-related health issue. A majority of students expressed a preference for health care outside their training institution, largely due to confidentiality concerns, and 90% preferred health insurance allowing off-site care. Students expressed varying levels of concern about academic jeopardy in association with personal illness, with physical health problems such as arthritis causing the least concern and alcohol and drug abuse triggering the most concern. Consistent differences were detected in these views based on respondent's gender, training level, and institution. Most medical students perceive the need for personal health care. Nevertheless, fear of academic reprisal may prevent medical students from seeking necessary care for their health problems during training. This phenomenon may be linked in important but poorly recognized ways to emerging illness and to impairment among medical students and physicians. Women, minority, and clinical students appear more sensitive to the connection between health and academic vulnerability. Constructive implications for medical school curricula, policies, and health care services are discussed.

Perceptions of the ethical acceptability of using medical examiner autopsies for research and education: a survey of forensic pathologists.

BACKGROUND: Forensic pathologists face difficult moral questions in their practices each day. Consistent ethical and legal guidelines for autopsy tissue use extending beyond usual clinical and legal imperatives have not been developed in this country. OBJECTIVE: To obtain the perceptions of medical examiners regarding the ethical acceptability of autopsy tissue use for research and education. METHOD: A written, self-report questionnaire was developed and piloted by a multidisciplinary team at the University of New Mexico, Albuquerque. All individuals who attended a platform presentation at the National Association of Medical Examiners Annual Meeting in September 1997 were invited to participate. RESULTS: Ninety-one individuals completed the survey (40% of all conference registrants and approximately 75% of presentation attendees). Sixty-three percent of respondents had encountered an ethical dilemma surrounding autopsy tissue use, and one third reported some professional ethics experience. Perspectives varied greatly concerning the ethical acceptability of using autopsy tissues to demonstrate or practice techniques (eg, intubation, brachial plexus dissection) and of fulfilling requests to supply varying kinds and quantities of tissues for research and education. Most respondents indicated that consent by family members was important in tissue use decisions. Respondents agreed on the importance of basic values in education and research, such as integrity, scientific or educational merit, and formal institutional approval of a project. Characteristics of the decedent did not influence decisions to release tissues, except when the individual had died from a mysterious or very rare illness. Attributes of medical examiners, with the exception of sex, also did not consistently predict responses. CONCLUSION: Significant diversity exists in beliefs among medical examiners regarding perceptions of the appropriate use of autopsy tissues for education and research. There is need for further inquiry and dialogue so that enduring policy solutions regarding human tissue use for education and research may be developed.

Medical students' evolving perspectives on their personal health care: clinical and educational implications of a longitudinal study.

The mental and physical health care issues of medical students are increasingly recognized as both prevalent and complex. Emotional distress, symptoms of mental illness, and maladaptive substance use are widespread and may often be driven by training-related stressors. The data suggest that nearly all medical students identify physical health concerns as well. The care of medical students as patients is complex because of problems associated with the stigma of various illnesses and the dual role of trainee and patient in medical school. A written confidential survey assessed students longitudinally near the end of their first and third years of training regarding their perceived health care needs, health concerns, attitudes toward care, access to services, and care-seeking practices (161 items). A subset of students (n = 33) were reassessed 1 month after the second survey to measure reliability. McNemar's chi-square (chi2) tests, repeated-measures multivariate analysis of variance (MANOVA), and K and Pearson correlations were used to evaluate outcomes. Almost all students reported health care needs during both training phases, and their mental and physical health concerns were stable over time. However, the preference for obtaining health care at a site other than their training institution and concerns about confidentiality increased, although students were marginally more likely to obtain care at their medical school during clinical versus preclinical training. The students' tendency to seek informal care from colleagues remained consistent, as did their high level of concern about professional jeopardy relating to personal health issues. Their tendency to accept the dual patient-student role depended on the particular health care issue; they expressed a strong tendency to protect other students' confidentiality, even in cases of potential significant impairment. Responses were reliable across a 1-month retest interval. We conclude that medical students' perspectives on their mental and physical health care across the transition from preclinical to clinical training reveal the importance of pursuing, not neglecting, a number of clinical and educational initiatives. Through their specialized expertise, psychiatrists may help to ensure sound mental and physical health care for the more than 69,000 medical students in training in this country.

Caring for medical students as patients: access to services and care-seeking practices of 1,027 students at nine medical schools. Collaborative Research Group on Medical Student Healthcare.

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.

Perspectives of patients with schizophrenia and psychiatrists regarding ethically important aspects of research participation.

OBJECTIVE: Significant controversy surrounds the ethics of psychiatric research. Nevertheless, few data have been gathered to improve our understanding of how individuals with serious mental illness and psychiatrists view ethically important aspects of biomedical research participation. METHOD: The authors assessed views of clinically diagnosed patients with schizophrenia from three sites by means of structured interviews and views of psychiatrists at two sites with written surveys regarding attitudes affecting motivation to participate in biomedical research, attitudes related to autonomy and influences on participation decisions, and attitudes toward the inclusion of vulnerable populations in research. The schizophrenia patients were asked to indicate their personal views; the psychiatrists were asked to provide their personal views and to predict schizophrenia patients' views. Responses were compared by using repeated measures multivariate analysis of variance. RESULTS: Sixty-three patients with schizophrenia and 73 psychiatry faculty and residents participated. Overall, responses to 23 rated attitudes revealed remarkably similar rank orders and several areas of agreement between patients and psychiatrists. Both groups strongly supported schizophrenia research and autonomous decision making by participants. They saw helping others and helping science as important reasons for protocol participation. Patients endorsed the feeling of hope associated with research involvement, a perspective underestimated by psychiatrists. Psychiatrists also underestimated the patients' acceptance of physician, investigator, and family influences on participation decisions. Psychiatrists agreed more strongly than patients that vulnerable populations should be included in research. CONCLUSIONS: This study helps to characterize previously neglected attitudes of psychiatric patients and clinicians toward ethically important aspects of biomedical research participation. Schizophrenia patients offered highly discerning views, and interesting similarities and differences emerged in comparing responses of patients and psychiatrists.

Assessing medical students' competence in obtaining informed consent.

BACKGROUND: Medical schools increasingly place emphasis on preparing students to perform routine, ethically important clinical activities with sensitivity and acumen. A method for evaluating students' skills in obtaining informed consent that was created at our institution is described. METHODS: Formal assessment of medical students' professional attitudes, values, and ethics skills occurs in the context of three required and developmentally attuned comprehensive examinations. A videotaped station tested senior medical students' ability to obtain informed consent from a standardized patient who expresses concern about undergoing cardiac catheterization. Two checklists were completed by the patient. Videotapes were reviewed by a faculty member, and students' reactions to the assessment experience were documented. RESULTS: Seventy-one senior students participated, and all performed well. Mean scores of 6.3 out of 7 (range 5 to 7, SD = 0.5) on the informed consent checklist and 8.7 out of 9 (range 6 to 9, SD = 0.5) on the communication skills checklist were obtained. Students endorsed the importance of the skills tested. CONCLUSIONS: This method of examining medical students' abilities to obtain informed consent has several positive features and holds promise as an ethics competence assessment tool.

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 President's 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.

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.

Frontier ethics: mental health care needs and ethical dilemmas in rural communities.

Roughly 15 million of the 62 million rural U.S. residents struggle with mental illness and substance abuse. These rural dwellers have significant health care needs but commonly experience obstacles to obtaining adequate psychiatric services. Important but little-recognized ethical dilemmas also affect rural mental health care delivery. Six attributes of isolated settings with limited resources appear to intensify these ethical dilemmas: overlapping relationships, conflicting roles, and altered therapeutic boundaries between caregivers, patients, and families; challenges in preserving patient confidentiality; heightened cultural dimensions of mental health care; "generalist" care and multidisciplinary team issues; limited resources for consultation about clinical ethics; and greater stresses experienced by rural caregivers. The authors describe these features of rural mental health care and provide vignettes illustrating dilemmas encountered in the predominantly rural and frontier states of Alaska and New Mexico. They also outline constructive approaches to rural ethical dilemmas in mental health care.

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.

Ethics in psychiatric research : resources for faculty development and resident education.

Controversy has arisen in recent years about the participation of psychiatric patients in questionably ethical research protocols. Consequently, academic psychiatrists have been called upon to enrich their understanding of the ethical aspects of research and to teach residents more intensively about these issues in scientific methodology. Toward these ends, the authors have assembled an extensive resource listing in the area of psychiatric research ethics. Articles were identified through MEDLINE and BIOETHICS LINE computerized searches and the authors' review of relevant literature through 1996. Emphasis was placed on those pieces with special historical value, empirical studies, and papers that provide background on the current controversies in psychiatric research ethics. The references were organized into five logical categories. Based on the resource review, the authors briefly discuss areas related to research ethics that merit greater attention in academic psychiatry.

Attitudes of consultation-liaison psychiatrists toward physician-assisted death practices.

The objective of this study was to investigate the views of consultation-liaison (C-L) psychiatrists on assisted-death practices. A 33-question anonymous survey was distributed at the Academy of Psychosomatic Medicine Annual Meeting in November 1995. The instrument explored perceptions of acceptability of assisted death in six hypothetical patient situations as performed by four possible agents. The response rate was 48% (184 conference attendees participated, i.e., completed and returned the surveys). With little variability, the respondents were unwilling to perform assisted death personally and also did not support assisted death as performed by nonphysicians. The respondents were somewhat more accepting of referral or other physicians' involvement in such practices. Assisted death was viewed differently than withdrawal of life support. Several variables were analyzed for their influences on the views expressed. The C-L psychiatrists in this study expressed opposition to assisted death practices. Their views varied somewhat depending on the patient vignette and the agent of death assistance. The authors conclude that C-L psychiatrists may wish to develop their present therapeutic and evaluative role in patient care to alleviate suffering, without hastening patient death.