Ethical issues in mental health research: the case for community engagement.

PURPOSE OF REVIEW: To describe community-engaged research (CEnR) and how it may improve the quality of a research study while addressing ethical concerns that communities may have with mental health and substance abuse research. This article includes a review of the literature as well as recommendations from an expert panel convened with funding from the US National Institute of Mental Health. RECENT FINDINGS: CEnR represents a broad spectrum of practices, including representation on institutional ethics committees, attitude research with individuals from the study population, engaging community advisory boards, forming research partnerships with community organizations, and including community members as co-investigators. SUMMARY: CEnR poses some challenges; for example, it requires funding and training for researchers and community members. However, it offers many benefits to researchers and communities, and some form of CEnR is appropriate and feasible in nearly every study involving human participants.

Ethical Issues in Deep Brain Stimulation Research for Treatment-Resistant Depression: Focus on Risk and Consent.

Deep brain stimulation (DBS) is currently in pivotal trials as an intervention for treatment-resistant depression (TRD). Although offering hope for TRD, DBS also provokes ethical concerns-particularly about decision-making capacity of people with depression-among bioethicists, investigators, institutional review boards, and the public. Here, we examine this critical issue of informed consent for DBS research using available evidence regarding decision-making capacity and depression. Further, we explore the implications of the nature of TRD as well as that of the intervention (invasive brain surgery) for informed consent. Based on these analyses, we argue that additional safeguards specific to DBS research for TRD, beyond those that might be used in any higher risk study, are not supported by available empirical evidence. We nevertheless underscore the limited data on such invasive procedures in severely ill psychiatric patients and advocate a research agenda for the systematic study of ethical issues raised by these research endeavors.

"A feeling that you're helping": proxy decision making for Alzheimer's research.

Surrogate (proxy) decision makers must make research decisions for people with dementia who lack decision-making capacity. Proxies' decision-making processes are minimally understood. We randomly assigned 82 proxies of AD patients to informed consent for one of three hypothetical protocols with differing levels of risk and benefit. Proxies answered questions about potential benefits of the described research to the patient and society, as well as about whether they would enroll their relative and why or why not. Proxies interested in enrolling their relative cited the potential for direct benefit to their relative, altruism, and trust in researchers. Those declining cited risks, inconvenience, and stage of illness. Proxies weighed numerous factors, incorporating both substituted judgment and best interests standards in their decision-making processes. Although further empirical work is needed to understand the influences on and adequacy of proxies' decision making regarding research, these findings can help inform policy regarding surrogate consent.

Clinical and ethical considerations in pharmacogenetic testing: views of physicians in 3 "early adopting" departments of psychiatry.

OBJECTIVE: Pharmacogenetic testing for polymorphisms affecting drug response and metabolism is now clinically available, and its use in psychiatry is expected to become more widespread. Currently, few clinical and ethical standards exist for the use of these new tests. As a step toward building consensus about testing, we assessed the attitudes and practices of psychiatrists at 3 academic departments of psychiatry where pharmacogenetic testing is clinically available. We hypothesized that testing would be used primarily in treatment-resistant illness and that clinicians would believe such tests carried little risk. METHOD: Residents and faculty at 3 departments of psychiatry considered to be "early adopters" of pharmacogenetic testing were invited during the academic year 2006-2007 to complete an Internet-based survey, including questions regarding clinical practices and opinions about testing utility, risks, and necessary safeguards. RESULTS: The 75 respondents had ordered pharmacogenetic testing a mean of 20.86 times in the previous 12 months. Testing was judged most useful in cases of treatment-resistant depression and medication intolerance. There was a lack of consensus about the risks of testing, particularly the risk of secondary information about disease susceptibility. Respondents endorsed the use of several safeguards, including confidentiality, pretest and posttest counseling, and informed consent, but consensus about other safeguards was lacking. Women and those who had not ordered testing in the prior year were more concerned about risks and need for safeguards than were men and those who had recently ordered testing. CONCLUSIONS: Physicians at early adopting departments of psychiatry endorsed the clinical utility of pharmacogenetic testing and the use of some patient safeguards, but showed a lack of consensus about other safeguards and risks.

The current state of genetics training in psychiatric residency: views of 235 U.S. educators and trainees.

OBJECTIVE: As researchers make progress in understanding genetic aspects of mental illness and its treatment, psychiatrists will increasingly need to understand and interpret genetic information specific to psychiatric disorders. Little is known about the extent to which residency programs are preparing psychiatrists for this new role. This study was designed to explore the current state of genetics education in psychiatric residency. METHODS: U.S. psychiatric residency educators and residents were invited to participate in an Internet-based survey. RESULTS: Out of 509 educators and at least 207 residents contacted, 100 educators and 135 residents from 55 geographically dispersed U.S. psychiatry training programs in diverse settings responded to the survey. Participants rated genetics as somewhat important as a curricular topic but less important than other subjects. Nearly half of the educators reported that their program had few or no faculty with adequate expertise in teaching this subject. Most residents routinely obtained family psychiatric histories when evaluating patients, but most did not feel competent to order and interpret genetic tests or to interpret papers on psychiatric genetics. CONCLUSION: This study presents a sobering picture of the state of genetics education in psychiatric residency training. Potential obstacles to improving genetics education include perceptions of the relative importance of genetics in comparison with other topics and a lack of faculty with appropriate expertise.

Philosophical and ethical issues at the forefront of neuroscience and genetics: an overview for psychiatrists.

This review has touched upon some of the major ethical issues surrounding emerging technologies in neuroscience and genetics. Although at first glance these issues may seem somewhat peripheral to the clinical practice of psychiatry, we suggest that they may have unanticipated effects upon the care of patients with mental illness. Certainly, the philosophical issues surrounding free will are of tremendous consequence to persons who commit crimes while suffering severe symptoms of mental illness. In addition, the opening up of a lucrative new "enhancement" market for the sale of new therapies could divert commercial resources away from the development of therapies for mental illness, although it is also possible that some enhancements will have secondary benefits as treatments for disease. Social acceptance of enhancement therapies could have a beneficial, normalizing effect on public attitudes toward those who receive mental health treatment. On the other hand, a moral backlash against enhancements as "quick fixes" that deprive individuals of authenticity could have a secondary effect of increasing the stigma of mental health treatment. For all of these reasons, it has become increasingly important for psychiatrists to be informed about and active participants in the public conversation about neuroethics. Psychiatric patients appear to have much at stake in these ethical debates, and psychiatrists have valuable expertise to offer as professionals with intimate knowledge of the human mind, its limitations, and its potential.

Genetic testing of stored biological samples: views of 570 U.S. workers.

AIMS: Storing tissue samples for future genetic testing raises practical and ethical issues regarding informed consent and confidentiality. Employed adults' views on this are uniquely valuable but have been little studied. METHODS: This study surveyed 570 employees at a U.S. defense laboratory and an academic medical center regarding their willingness to have tissue stored for future genetic testing, interest in receiving results of future testing and being contacted for consent for future testing, and acceptability of various tissue-storage options. RESULTS: Respondents were somewhat interested in providing samples and significantly less interested in providing traceable samples than untraceable samples. Workers with concerns about having a genetic illness were more interested in providing tissue for future testing. Most participants expressed strong desire to be asked before future genotyping and to receive those test results. Respondents preferred that tissue samples be stored with their doctor, local medical facility, or local research university rather than with their employer, a government agency, or an insurance company. CONCLUSIONS: Employed adults valued future genetic testing as being important to their well-being and strongly preferred reconsenting for future use of stored tissue. These data provide a baseline to measure potential changes in workers' attitudes since the passage of the U.S. Genetic Information Nondiscrimination Act in 2008.

Ethical considerations in psychiatric genetics.

Ethical considerations in psychiatric genetics are highly complex and fluid. This review introduces the reader to the wide range of ethical considerations in this field by examining four characteristics of genetic information. First, genetic information may, to a greater or lesser extent, predict a person's future health. Second, learning about one's genotype may have profound psychosocial consequences. Third, genetic information pertains to a person's biological relatives and thus can affect family members, communities, and population groups. Finally, psychiatric genetics is a rapidly evolving field. None of these characteristics is necessarily "exceptional" or unique to genetics, but they provide a useful framework for teasing apart a complex set of ethical considerations. This article reviews conceptual and empirical data that speak to these four characteristics and then presents a set of conceptual frameworks that can be used to systematically analyze the ethics of psychiatric genetic research and clinical genotyping. Finally, directions for future study are described--including the urgent need to gather data on actual risks and benefits of psychiatric genetic research and clinical applications, so that their utility can be assessed and appropriate ethical safeguards identified.

Psychiatrists' attitudes, knowledge, and experience regarding genetics: a preliminary study.

PURPOSE: This study is the first survey of a random national sample of US psychiatrists to assess attitudes, knowledge, and clinical experience regarding genetics. We hypothesized that clinicians with more recent genetics training would demonstrate more positive attitudes and greater genetics knowledge and experience than those with less recent training. METHODS: A probability sample of US psychiatrists (n = 93) was invited to participate in a mail survey regarding genetic medicine. RESULTS: Forty-five psychiatrists completed the survey (response rate = 48%). All believed that genetics strongly or moderately influenced a person's mental health. Respondents expressed positive attitudes toward incorporating genetics into psychiatric practice, but most did not have recent genetics training or experience in referring patients to genetic counselors or ordering genetic tests. Psychiatrists who had genetics training within the previous 5 years had more experience in providing genetic services. CONCLUSIONS: This survey identified areas of strength (positive attitudes about providing genetic services, belief in the heritability of mental illness) and future targets for educational intervention (general genetics, information about testing and counseling resources). The association between recent training and a greater level of clinical genetics experience suggests that educational efforts may be successful in preparing psychiatrists to provide genetic services in the future.

Psychiatrists' attitudes regarding genetic testing and patient safeguards: a preliminary study.

AIMS: A probability sample of U.S. psychiatrists (n = 93) was invited to complete a mail survey regarding the likely impact of genetic testing on psychiatry; the clinical utility of pharmacogenetic, diagnostic, and susceptibility genetic testing; and 14 proposed ethical and legal safeguards for clinical genetic testing. RESULTS: Forty-five psychiatrists participated in the survey (response rate = 48%). The majority (80% and 60%, respectively) believed that genetic testing would benefit many psychiatric patients and would dramatically change the way psychiatry is practiced. Many psychiatrists (73-85%) also stated that pharmacogenetic, diagnostic, and susceptibility tests for common psychiatric disorders would be somewhat useful or extremely useful in the clinical setting. Nearly all (98-100%) believed that psychiatrists should obtain informed consent before genetic testing, should keep test results confidential, should provide pre- and posttest counseling, and should demonstrate competence in interpreting test results. Nearly all (96-100%) supported laws and regulations to prevent discrimination based on genetic test results and to protect consumers from misleading advertisements for testing. Ninety-one percent endorsed restrictions on the sale of genetic tests directly to consumers. CONCLUSIONS: This probability sample of U.S. psychiatrists expressed a strongly positive view of genetic testing in psychiatry, while voicing nearly unanimous support for seven ethical and legal safeguards.

Ethical issues in psychiatric research on children and adolescents.

Psychiatric research on children and adolescents is ethically justified by the need to reduce the burden that mental illnesses place on young people, their families, and society. Such research must be conducted with careful attention to the ethical principles of beneficence, justice, and respect for persons. Child and adolescent psychiatrists who collaborate on research trials or advise patients and families about research participation should consider nine domains when evaluating the ethical acceptability of particular protocols. These domains include scientific merit and design; expertise, commitment, and integrity; risks and benefits; confidentiality; participant selection and recruitment; informed consent and decisional capacity; incentives; institution and peer/professional review; and data presentation. Special ethical issues in child and adolescent psychiatry research concern the use of randomized, controlled treatment trials; the informed consent process for research involving adolescents; the therapeutic misconception; and conflicts of interest in physician referrals.

Views of people with schizophrenia regarding aspects of research: study size and funding sources.

Serious mental illness research poses many ethical questions, including important considerations pertaining to how large a study is and its source of funding. Little is known about how people with schizophrenia understand these ethical considerations and whether these factors may influence their decisions to participate in research. Structured interviews were conducted with 60 people with schizophrenia. Participants were asked about levels of suffering and the importance of research for healthy people and for people with serious illnesses. Participants also rated helpfulness and harmfulness to society, and their likelihood of participating in studies involving 10 subjects, 1000 subjects, 1 research institution, or 10 research institutions and in studies funded by various organizations. Participants viewed all types of research positively and indicated willingness to volunteer. Likelihood of participating in research was correlated with perceived helpfulness to society and inversely correlated with perceived harmfulness. Research by pharmaceutical companies was seen as less helpful to society than research sponsored by federal or state government or by private foundations. Larger studies conducted at multiple sites were seen as more helpful to society than smaller studies or those at single sites. Larger studies conducted at single sites, however, were seen as more harmful. Respondents endorsed a positive view of medical research and expressed a willingness to participate in projects of all scales with diverse funding sources. The pattern of responses suggests the capacity for a nuanced understanding of ethically salient aspects of medical research by individuals with schizophrenia.

Hidden ethical dilemmas in psychiatric residency training: the psychiatry resident as dual agent.

In addition to learning about confidentiality, civil commitment, informed consent, and other ethical issues, psychiatry residents must deal with less visible ethical dilemmas that arise from the training process itself. Residents grapple with three inherent conflicting duties between their dual roles as physician and learner, as physician and supervisee, and as physician and employee of a training institution. These conflicts must be negotiated at a time of high stress, when residents are plagued with self-doubt, fear, fatigue, and other vulnerabilities that can lead good doctors to make ethically dubious decisions. While such conflicts and stressors are common to residency training in most specialties, they may be heightened in psychiatric residency. This paper proposes a model for understanding covert elements of ethical decision making during psychiatric residency and recommends strategies training programs can use to help residents navigate an ethical minefield.