Clients dually diagnosed with psychiatric and substance abuse disorders may be adversely affected if they mismanage their Social Security or public support benefits. Assistance managing funds, including assignment of a representative payee, is available but there are no objective assessments of money mismanagement. In this study, a Structured Clinical Interview for Money Mismanagement was administered twice at one-week intervals to 46 clients receiving disability payments and was compared to clinician’s judgment that the client was incapable of managing funds, the frequent basis for payee assignment by the Social Security Administration and Veterans Affairs. Clinician’s judgment and structured interview were concordant on 71% of capability judgments. The interview had high test-retest reliability and was correlated with self-reported money mismanagement and GAF scores, but clinician judgment was not associated with these measures. Results suggest that the interview is sensitive in detecting money mismanagement and raises questions concerning the validity of clinicians’ judgments.
Psychiatric Dual Diagnosis; Substance Abuse; Financial Management; Disability
Quality of life (QoL) in people with schizophrenia and other serious mental illnesses (SMI) is an important outcome goal, yet there is no consistent definition of the construct. We examined three aspects of QoL in persons with SMI: overall life satisfaction, physical health-related QoL (HRQoL), and mental HRQoL. This study had two primary aims: first, to examine whether there are differences in physical and mental HRQoL in persons with SMI, and, second, to investigate the cognitive, clinical, and functional correlates of the three QoL indicators. Participants were 48 persons with SMI who completed assessments of QoL, cognition, functional capacity, psychiatric symptomatology, and medical comorbidity. Results indicate that participants experience similar levels of physical and mental HRQoL, and these two constructs are not related to one another. Physical HRQoL is associated with less medical comorbidity, while mental HRQoL is associated with negative and depressive symptoms. Overall life satisfaction was associated with fewer psychiatric symptoms and less medical comorbidity. This study adds to the important literature defining distinct domains of QoL and supports the necessity of addressing both physical and mental health factors as they relate to recovery and well-being among persons with SMI.
During the past two decades, consumers, providers and policy makers have recognized the role of supported housing intervention for persons diagnosed with serious mental illness (SMI) to be able to live independently in the community. Much of supported housing research to date, however, has been conducted in large urban centers rather than northern and rural communities. Northern conditional and contextual issues such as rural poverty, lack of accessible mental health services, small or non-existing housing markets, lack of a continuum of support or housing services, and in some communities, a poor quality of housing challenge the viability of effective supported housing services. The current research proposal aims to describe and evaluate the processes and outcomes of supported housing programs for persons living with SMI in northern and rural communities from the perspective of clients, their families, and community providers.
This research will use a mixed method design guided by participatory action research. The study will be conducted over two years, in four stages. Stage I will involve setting up the research in each of the four northern sites. In Stage II a descriptive cross-sectional survey will be used to obtain information about the three client outcomes: housing history, quality of life and housing preference. In Stage III two participatory action strategies, focus groups and photo-voice, will be used to explore perceptions of supported housing services. In the last stage findings from the study will be re-presented to the participants, as well as other key community individuals in order to translate them into policy.
Supported housing intervention is a core feature of mental health care, and it requires evaluation. The lack of research in northern and rural SMI populations heightens the relevance of research findings for health service planning. The inclusion of multiple stakeholder groups, using a variety of data collection approaches, contributes to a comprehensive, systems-level examination of supported housing in smaller communities. It is anticipated that the study's findings will not only have utility across Ontario, but also Canada.
Legislation demands the establishment of client councils in Dutch nursing homes and residential care facilities. The members of those councils are residents or their representatives. Client councils have the right to participate in the strategic management of long-term care facilities. More specifically, they need to be consulted regarding organisational issues and a right to consent on issues regarding daily living of residents, including CQ-index research. CQ-index research concerns a method that measures, analyses and report clients' experiences about the quality of care. Research questions were: 'Do client councils exercise their rights to be consulted and to give their consent?' and 'What is the role of client councils in the process of measuring clients' experiences with the CQ-index and what is their opinion about the CQ-index?'
Postal questionnaires were sent to members of 1,540 client councils of Dutch nursing homes and residential care facilities. The questionnaire focussed on background information and client councils' involvement in decision-making and strategic management.
The response rate was 34% (n = 524). Most councils consisted of seven members (range: 5 to 12 members). One out of four members participating in the client councils were clients themselves. Although councils have a legal right to be consulted for organisational issues like finance, vision, annual report, and accommodation, less than half the councils (31-46%) reported that they exercised this right. The legal right to consent was perceived by 18 to 36% of the councils regarding client care issues like food and drink, complaints registration, respectful treatment, and activities. For CQ-index research, only 18% of the client councils perceived a right to consent. Their rights to choose an approved contractor -who performs CQ-index research- and indicating improvement priorities, were hardly used.
Client councils play a rather passive role in determining the policy on quality of long-term care. Therefore, specific attention and actions are needed to create a more proactive attitude in councils towards exercising their rights, which are already supported by legislation.
Consumer participation; empowerment; patients' rights; long-term care
Although morally acceptable in theory, preimplantation genetic diagnosis (PGD) for mitochondrial DNA (mtDNA) disorders raises several ethical questions in clinical practice. This paper discusses the major conditions for good clinical practice. Our starting point is that PGD for mtDNA mutations should as far as possible be embedded in a scientific research protocol. For every clinical application of PGD for mtDNA disorders, it is not only important to avoid a ‘high risk of serious harm' to the future child, but also to consider to what extent it would be possible, desirable and proportional to try to reduce the health risks and minimize harm. The first issue we discuss is oocyte sampling, which may point out whether PGD is feasible for a specific couple. The second issue is whether one blastomere represents the genetic composition of the embryo as a whole – and how this could (or should) be investigated. The third issue regards the cutoff points below which embryos are considered to be eligible for transfer. We scrutinize how to determine these cutoff points and how to use these cutoff points in clinical practice – for example, when parents ask to take more or less risks. The fourth issue regards the number of cycles that can (or should) justifiably be carried out to find the best possible embryo. Fifth, we discuss whether follow-up studies should be conducted, particularly the genetic testing of children born after IVF/PGD. Finally, we offer the main information that is required to obtain a truly informed consent.
ethics; PGD; mitochondrial DNA; genetic testing minors
Research ethics consultation programs are being established with a goal of addressing the ethical, societal, and policy considerations associated with biomedical research. A number of these programs are modelled after clinical ethics consultation services that began to be institutionalized in the 1980s. Our objective was to determine biomedical science researchers' perceived need for and utility of research ethics consultation, through examination of their perceptions of whether they and their institutions faced ethical, social or policy issues (outside those mandated by regulation) and examination of willingness to seek advice in addressing these issues. We conducted telephone interviews and focus groups in 2006 with researchers from Stanford University and a mailed survey in December 2006 to 7 research universities in the U.S.
A total of 16 researchers were interviewed (75% response rate), 29 participated in focus groups, and 856 responded to the survey (50% response rate). Approximately half of researchers surveyed (51%) reported that they would find a research ethics consultation service at their institution moderately, very or extremely useful, while over a third (36%) reported that such a service would be useful to them personally. Respondents conducting human subjects research were more likely to find such a service very to extremely useful to them personally than respondents not conducting human subjects research (20% vs 10%; chi2 p<0.001).
Our findings indicate that biomedical researchers do encounter and anticipate encountering ethical and societal questions and concerns and a substantial proportion, especially clinical researchers, would likely use a consultation service if they were aware of it. These findings provide data to inform the development of such consultation programs in general.
Moral case deliberation (MCD) is a form of clinical ethics support in which the ethicist as facilitator aims at supporting professionals with a structured moral inquiry into their moral issues from practice. Cases often affect clients, however, their inclusion in MCD is not common. Client participation often raises questions concerning conditions for equal collaboration and good dialogue. Despite these questions, there is little empirical research regarding client participation in clinical ethics support in general and in MCD in particular. This article aims at describing the experiences and processes of two MCD groups with client participation in a mental healthcare institution. A responsive evaluation was conducted examining stakeholders’ issues concerning client participation. Findings demonstrate that participation initially creates uneasiness. As routine builds up and client participants meet certain criteria, both clients and professionals start thinking beyond ‘us-them’ distinctions, and become more equal partners in dialogue. Still, sentiments of distrust and feelings of not being safe may reoccur. Client participation in MCD thus requires continuous reflection and alertness on relational dynamics and the quality of and conditions for dialogue. Participation puts the essentials of MCD (i.e., dialogue) to the test. Yet, the methodology and features of MCD offer an appropriate platform to introduce client participation in healthcare institutions.
Moral case deliberation; Client participation; Dialogue; Inclusion; Organization
Clinical trials for development of new medications are essential in all fields of medicine. The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. On the other hand, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when the investigational drug may ultimately provide substantial benefit for some patients. At the same time it is the psychiatrist's responsibility to insure that investigators are adequately trained to conduct clinical trials and that stringent regulatory committees supervise the scientific, clinical and ethical aspects of the trials.
Placebo-control; Schizophrenia; Medical ethics; Clinical trials
Adherence to ethical principles in clinical research and practice is becoming topical issue in China, where the prevalence of mental illness is rising, but treatment facilities remain underdeveloped. This paper reports on a study aiming to understand the ethical knowledge and attitudes of Chinese mental health professionals in relation to the process of diagnosis and treatment, informed consent, and privacy protection in clinical trials.
A self-administered survey was completed by 1110 medical staff recruited from Shanghai’s 22 psychiatric hospitals. Simple random selection methods were used to identify target individuals from the computerized registry of staff.
The final sample for analysis consisted 1094 medical staff (including 523 doctors, 542 nurses, 8 pharmacologists and 21 other staff). The majority reported that their medical institutions had not established an Ethics Committee (87.8%) and agreed that Ethics Committees should be set up in their institutions (72.9%). Approximately half (52%) had not received systematic education in ethics, and almost all (89.1%) of the staff thought it was necessary. Nearly all participants (90.0%) knew the Shanghai Mental Health Regulations which was the first local regulations relating to mental health in China, but only 11% and 16.6% respectively knew of the Nuremberg Code and the Declaration of Helsinki. About half (51.8%) thought that the guardian should make the decision as to whether the patient participated in clinical trials or not.
The study indicates that most psychiatric hospitals in Shanghai have no Medical Ethics Committee. More than half the medical staff had not received systematic education and training in medical ethics and they have insufficient knowledge of the ethical issues related to clinical practice and trials. Training in ethics is recommended for medical staff during their training and as ongoing professional development.
Psychiatric hospital; Bioethics; Hospital Ethics Committees; Health Care Surveys; China
Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.
Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.
The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.
Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed?
Background to the debate: An important mechanism for protecting human research participants is the prior approval of a clinical study by a research ethics board, known in the United States as an institutional review board (IRB). Traditionally, IRBs have been run by volunteer committees of scientists and clinicians working in the academic medical centers where the studies they review are being carried out. However, for-profit organizations are increasingly being hired to conduct ethics reviews. Proponents of for-profit IRBs argue that these IRBs are just as capable as academic IRBs at providing high-quality ethics reviews. Critics argue that for-profit IRBs have a conflict of interest because they generate their income from clients who have a direct financial interest in obtaining approval.
Emanuel argues that for-profit ethics review boards can provide high quality reviews, but Lemmens and Elliot believe that such boards have a conflict of interest.
A recent literature review of commentaries and ‘state of the art’ articles from researchers in psychiatric genetics (PMG) offers a consensus about progress in the science of genetics, disappointments in the discovery of new and effective treatments, and a general optimism about the future of the field. I argue that optimism for the field of psychiatric molecular genetics (PMG) is overwrought, and consider progress in the field in reference to a sample estimate of US National Institute of Mental Health funding for this paradigm for the years 2008 and 2009. I conclude that the amounts of financial investment in PMG is questionable from an ethical perspective, given other research and clinical needs in the USA.
psychiatry; mental disorders; molecular genetics; ethics
Many challenging ethical questions come with the scientific efforts to understand the nature and treatment of schizophrenia. The empirical study of ethical aspects of schizophrenia research has sought to clarify and resolve many of these questions. In this article we provide an overview of the existing data-based literature on schizophrenia research ethics and outline directions for future inquiry. We examine 5 broad categories of inquiry into the ethics of schizophrenia research: (1) Scientific designs (eg, placebo-controlled studies and medication-free intervals, prodromal and high-risk research, and genetics research); (2) informed consent and decision-making capacity, including assessment of decisional abilities, as well as intervention studies; (3) understanding and perceptions of risk and benefit (including the therapeutic misconception); (4) influences on research participation (including voluntarism, altruism, and other motivations); and (5) key participant safeguards, such as protocol review and participant advocates. We discuss how empirical work in each of these areas answers certain questions and raises new ones. Finally, we highlight important gaps in our understanding of ethically relevant aspects of schizophrenia research and offer a specific research agenda for empirical ethics.
schizophrenia; bioethics; clinical trials; decision-making capacity; informed consent; empirical studies
With an aging population, and the prevalence of psychiatric illness in the older population expected to rise dramatically in coming decades, advances in geriatric psychiatry research are urgently needed. Ethical issues in the design, conduct, and monitoring of research involving older adults parallel these same issues related to human subjects research generally. Yet a number of special issues relevant to geriatric psychiatry research merit further discussion. These special issues include the assessment of capacity in populations where cognitive disorders are more prevalent, the role of surrogate decision makers, the legal status of surrogate consent, the use of advanced directives for research participation, and research involving suicidal individuals.
Tardive dyskinesia (TD) is a serious adverse effect often associated with the first generation antipsychotic medications used in the management of mental health disorders such as schizophrenia. Pharmacogenomics is the study of human genomic variation in relation to individual and population variability in medication response and side effects. Neuropsychiatry is one of the clinical domains in which pharmacogenomic approaches have been extensively studied. In the late 1990s, the Glycine9 (Gly9) allele of the Serine-9-Glycine (Ser9Gly) polymorphism in dopamine D3 receptor gene (DRD3) was found to be associated with both a liability to, and worsened severity of, TD in schizophrenic patients treated with typical antipsychotics. This initial discovery has been subsequently replicated and testing for the Ser9Gly polymorphism has now become commercially available. The question that currently presents itself is whether its use should be encouraged for patients who may be prescribed a typical or atypical antipsychotic medication. However, the translation of this new technology to clinical practice presents multiple social, ethical and policy challenges. Though pharmacogenomic testing holds much promise in this scenario, many important questions remain to be answered before its widespread use can be medically and ethically justified. This article highlights the key advances in our understanding of the role of human genetic variation in the D3 receptor in relation to TD. Then, issues of uncertainty, consent, confidentiality, and access are considered with respect to the use of DRD3 polymorphism testing in risk stratification for susceptibility to tardive dyskinesia. We propose three recommendations that may help bring this technology into the clinic: 1) prospective pharmacogenomic studies of DRD3 polymorphism and TD risk should be conducted; 2) the design of such studies should be influenced by scientists, ethicists and policy makers to protect potentially vulnerable patients; and 3) appropriate knowledge transfer to front-line health care workers must take place.
PMID: 22282718 CAMSID: cams2028
DRD3; ethics; pharmacogenomics; prospective policy; tardive dyskinesia
Conduct disorder (CD) and antisocial personality disorder (ASPD) are established risk factors for substance use disorders in both the general population and among persons with schizophrenia and other severe mental illnesses. Among clients with substance use disorders in the general population, CD and ASPD are associated with more severe problems and criminal justice involvement, but little research has examined their correlates in clients with dual disorders. To address this question, we compared the demographic, substance abuse, clinical, homelessness, sexual risk, and criminal justice characteristics of 178 dual disorder clients living in 2 urban areas between 4 groups: No CD/ASPD, CD Only, Adult ASPD Only, and Full ASPD. Clients in the Adult ASPD Only group tended to have the most severe drug abuse severity, the most extensive homelessness, and the most lifetime sexual partners, followed by the Full ASPD group, compared with the other 2 groups. However, clients with Full ASPD had the most criminal justice involvement, especially with respect to violent charges and convictions. The results suggest that a late-onset ASPD subtype may develop in clients with severe mental illness secondary to substance abuse, but that much criminal behavior in clients with dual disorders may be due to the early onset of the full ASPD syndrome in this population and not the effects of substance use disorders.
conduct disorder; antisocial personality disorder; dual disorders; substance abuse; schizophrenia/homelessness
An essential aspect of research on schizophrenia is ensuring that worthwhile scientific studies are done in a way that does not place vulnerable individuals at unreasonable risk. It is important to educate researchers, advocates, potential participants, reviewers, IRBs, and the general public about ethical principles and controversial issues as they impact research on schizophrenia. Federal regulations mandate IRB consideration of “the special problems of research involving… mentally disabled persons…” (45CFR46.111a3). In recent years, there has been a greater focus on subject monitoring to improve safeguards and minimize risks. The process of informed consent is also going through a process of evolution, in order to help ensure that participants are as aware as possible of key aspects of a study, including risks, benefits, alternatives, purpose and design, etc. We focus here on a few of the issues that are current, are relevant to schizophrenia research, and merit additional empirical study. They include medication discontinuation and placebo control designs, compensation for participation, and capacity to consent.
research ethics; schizophrenia; placebo; consent capacity
Millions of people undergo displacement in the world. Internally displaced people (IDP) are especially vulnerable as they are not protected by special legislation in contrast to other migrants. Research conducted among IDPs must be correspondingly sensitive in dealing with ethical issues that may arise. Muslim IDPs in Puttalam district in the North-Western province of Sri Lanka were initially displaced from Northern Sri Lanka due to the conflict in 1991. In the backdrop of a study exploring the prevalence of common mental disorders among the IDPs, researchers encountered various ethical challenges. These included inter-related issues of autonomy, non-maleficence, beneficence, confidentiality and informed consent, and how these were tailored in a culture-specific way to a population that has increased vulnerability. This paper analyses how these ethical issues were perceived, detected and managed by the researchers, and the role of ethics review committees in mental health research concerning IDPs. The relevance of guidelines and methodologies in the context of an atypical study population and the benefit versus risk potential of research for IDPs are also discussed. The limitations that were encountered while dealing with ethical challenges during the study are discussed. The concept of post-research ethical conduct audit is suggested to be considered as a potential step to minimize the exploitation of vulnerable populations such as IDPs in mental health research.
Sri Lanka; Bioethics; Ethical challenges; Internally displaced people; Mental health research; Post-research ethics audit; Practical ethics; Developing world
Individuals with serious mental illness (SMI: e.g., schizophrenia, bipolar disorder) experience disparities in mortality relative tothe general population, mainly because of medical conditions (i.e., cardiometabolic disease).We assessed whether VA patients with SMI and receiving care from VA mental health facilities with colocated medical care were more likely to receive cardiometabolic risk assessments in accordance with clinical practice guidelines than patients from non-colocated facilities.
Patients with SMI identified prescribed second-generation antipsychotic medications in fiscal year (FY) 2007receiving care from VA mental health facilities completing the VA Mental Health Program Surveywere included. VA administrative data were ascertained to assess receipt of the following tests every 6 months in FY 2007: BMI, blood pressure, lipid profile, and fasting glucose.
Out of 40,600 patients with SMI prescribed second-generation antipsychotics, 29% received all cardiometabolic tests (lipid, glucose, BMI and blood pressure). While 79% and 76% received blood pressure and BMI assessments, respectively, only 37% received a lipid test. Patients from colocated sites were more likely to receive all cardiometabolic tests (OR=1.26, 95% CI: 1.18–1.35, p<0.001).
Colocated general medical providers in mental health clinicsare more likely to provide cardiometabolic assessments for patients with SMI prescribed second-generation antipsychotics.
Mental disorders; quality of care; cardiovascular disease; integrated care
There is a lack of consensus on how to evaluate the risk of research studies conducted with persons who have psychiatric disorders. The authors reviewed research on vulnerability, risk, and procedures to mitigate risk in studies with this population to help inform evaluation of such research.
Searches of MEDLINE (1966–2006), PsycINFO (1967–2006), and Google Scholar used combinations of the terms mental illness, vulnerable, psychiatric, schizophrenia, and depression combined with terms such as research risk, vulnerability, research harm, capacity, risk, and mitigation of risk. Articles were identified from reference lists, and additional searches used terms from identified articles.
Evidence for two types of vulnerability—capacity based and power based—is presented, which supports the notion of vulnerability as a state, rather than a trait, among persons with psychiatric disorders. Three categories of risk are described—minimal risk, minor increment over minimal risk, and greater than minor increment. Evidence shows that many common types of studies pose risk in the first two categories when conducted with this population. The literature also describes procedures for reducing vulnerability and mitigating risk that should be considered in study evaluations. The authors offer a framework for evaluating the category of risk posed by a study.
Although more research is needed, there is sufficient evidence that many common types of research present minimal risk or only a minor increment over minimal risk for large segments of the population of persons with psychiatric disorders, as they do for persons in the general population.
Researchers in primary care share the general ethical obligations of all researchers. However, these obligations may raise different issues in the unique context of primary care. Current professional ethical guidance for primary care research is complex and fragmentary. The newly introduced research governance framework does not specifically address primary care research, and recent changes in legal requirements have significant implications for research. In this paper, ethical issues arising from research in primary care are considered, current standards and resources are described, and strategies for supporting ethical practice are discussed. Four ethical issues are discussed: consent and competence; confidentiality; power relations; and procedural issues. In the final part of the paper, broad strategies to support ethical practice in primary care research are recommended. These include education and resources, greater clarity of relevant standards, financial support, a greater role for primary care networks, and greater public debate.
Persons with severe mental illness (SMI) have reduced workforce participation, which leads to significant economic and social disadvantage. This theoretical review introduces the strategies that have been implemented to address this issue. These include Individual Placement and Support (IPS) services, the most widely researched form of supported employment, to which cognitive remediation has more recently been recognised in the USA, as an intervention to improve employment outcomes by addressing the cognitive impairments often experienced by people with SMI. The authors review the international literature and discuss specifically the Australian context. They suggest that Australia is in a prime position to engage clients in such a dual intervention, having had recent success with increasing access to supported employment programs and workforce reentry, through implementation of the Health Optimisation Program for Employment (HOPE). Such programs assist with gaining and maintaining employment. However, they do not address the cognitive issues that often prevent persons with SMI from effectively participating in work. Thus, optimising current interventions, with work-focused cognitive skills development is critical to enhancing employment rates that remain low for persons with SMI.
Routine management of geriatric problems often raises ethical problems, particularly regarding autonomy of the old person. The carers or children may be unaware of the sensitivity of role reversal in dealing with the financial affairs; the need for a residential carer may compromise the old person's privacy. Attending a day centre confers much benefit, but one must understand the old person's resistance to change in the proposal of a new daily regimen. Similarly his or her autonomy must be the priority in planning for admittance to an old age home, and not the assumption that the family knows best. A common dilemma is the assessment of an old person's competency in decision making, either about management of his affairs, or regarding consent to treatment, or participation in research. Because cognitive capacity is not always identical with competency, meaningful tools have recently been developed in which the emphasis is on the specific situation to be investigated.
Health care disparities and well documented for people living in rural areas and for people who are members of ethnic minorities.
Our goal was to determine whether providers report greater difficulty in providing care for rural than urban residents and for ethnic minorities than patients/clients in general in 4 practice areas of ethical relevance attaining treatment adherence, assuring confidentiality, establishing therapeutic alliance, and engaging in informed consent processes.
We received survey responses from 1,558 multidisciplinary medical and behavioral providers across rural and non-rural areas of New Mexico and Alaska in 2004 to assess a wide range of issues in providing health care.
Providers reported some difficulties in fulfilling various ethical practices for all types of patients, but not more difficulty when caring for minority compared to nonminority patients/clients. However, they do report more frequent additional problems related to the practice issues of treatment adherence, therapeutic alliance, informed consent, and confidentiality with minority patients than others. Difficulties and more frequent additional problems are greater for providers in rural than in non-rural areas. Results generalize across both Alaska and New Mexico with few differences.
We obtained evidence for disparity in care for patients/clients who were minority group members, and clear evidence of disparity for people residing in rural compared to non-rural areas of 2 states with large rural areas.
Understanding the perception of patients on research ethics issues related to biobanking is important to enrich ethical discourse and help inform policy.
We examined the views of leukemia patients undergoing treatment in clinics located in the Princess Margaret Hospital in Toronto, Ontario, Canada. An initial written survey was provided to 100 patients (64.1% response rate) followed by a follow-up survey (62.5% response rate) covering the topics of informed consent, withdrawal, anonymity, incidental findings and the return of results, ownership, and trust.
The majority (59.6%) preferred one-time consent, 30.3% desired a tiered consent approach that provides multiple options, and 10.1% preferred re-consent for future research. When asked different questions on re-consent, most (58%) reported that re-consent was a waste of time and money, but 51.7% indicated they would feel respected and involved if asked to re-consent. The majority of patients (62.2%) stated they had a right to withdraw their consent, but many changed their mind in the follow-up survey explaining that they should not have the right to withdraw consent. Nearly all of the patients (98%) desired being informed of incidental health findings and explained that the information was useful. Of these, 67.3% of patients preferred that researchers inform them and their doctors of the results. The majority of patients (62.2%) stated that the research institution owns the samples whereas 19.4% stated that the participants owned their samples. Patients had a great deal of trust in doctors, hospitals and government-funded university researchers, moderate levels of trust for provincial governments and industry-funded university researchers, and low levels of trust towards industry and insurance companies.
Many cancer patients surveyed preferred a one-time consent although others desired some form of control. The majority of participants wanted a continuing right to withdraw consent and nearly all wanted to be informed of incidental findings related to their health. Patients had a great deal of trust in their medical professionals and publically-funded researchers as opposed to profit-based industries and insurance companies.
Biobank; Tissue repository; Cancer patient perspectives; Consent; Withdrawal; Anonymity; Incidental findings; Return of results; Ownership; Trust