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1.
Rationale Optimizing the abilities of individuals with psychiatric disorders to provide meaningful informed consent for research has become a heightened concern for psychiatric researchers. Objectives We examined a post-consent test of comprehension given to older patients with psychotic disorders to identify problem areas in the understanding of informed consent for research. Methods One hundred and two middle-aged and older outpatients with schizophrenia or related psychotic disorders and twenty normal comparison subjects were administered a 20-item questionnaire to assess their comprehension of consent for a low-risk research protocol after receiving either a routine (paper-based) or an enhanced (computerized, structured slideshow incorporating greater review) consent procedure. Data on individual questions were analyzed. Results Patients had more difficulty than normal comparison subjects on open-ended questions, including those asking about study procedures, time involved, and potential risks and benefits. Among patients, the enhanced procedure was associated with better performance on questions about potential risks and time required than the routine procedure. Conclusions Problem areas in the understanding of informed consent, such as study procedures and potential risks and benefits, should be the focus of attempts to improve the consent process for patient participants with severe mental illness. Research also should be done to clarify how best to assess understanding of consent, since the wording of questions likely affects the responses.  相似文献   

2.
Rationale American psychiatric residency training programs are now required to teach principles of research ethics. This task is especially pressing in light of evolving guidelines pertaining to human subjects, including psychiatric patients, especially when psychopharmacology is involved. Residents need to understand principles of research ethics and implications of roles of psychiatrists as investigators and clinicians. Objectives We consider major contemporary ethical issues in clinical psychiatric research, with an emphasis on psychopharmacology, and implications of addressing them within residency training programs. Methods We reviewed recent literature on ethical issues in clinical research and on medical education in bioethics. Results This report considers: (1) an overview of current training; (2) perceived needs and rationales for training in research ethics, (3) recommended educational content and methods; (4) issues that require further study (including demonstration of acquired knowledge, practice issues, and the treatment versus-investigation misconception); and (5) conclusions. Recommended components of residency training programs include basic ethical principles; scientific merit and research design; assessment of risks and benefits; selection and informed consent of patient-subjects; and integrity of the clinical investigator, including definition of roles, conflicts-of-interest, and accountability. Evaluation of educational effectiveness for both trainees and faculty is a recommended component of such programs. Conclusions We recommend that psychiatric training include education about ethical aspects of clinical research, with a particular emphasis on psychopharmacology. These activities can efficiently be incorporated into teaching of other aspects of bioethics, research methods, and psychopharmacology. Such education early in professional development should help to clarify roles of clinicians and investigators, improve the planning, conduct and reporting of research, and facilitate career development of much-needed clinical investigators in psychiatry.  相似文献   

3.
Treatment research on adolescent substance use disorders raises a number of important ethical and legal concerns which have not been widely acknowledged. This paper explores these concerns as they relate to fundamental ethical principles in the conduct of human research. The issues discussed include tensions between conflicting regulations governing informed consent for research and treatment of adolescents, the capacity of adolescents to give informed consent, potentially coercive elements related to research on substance use treatment, problems associated with confidentiality and release of information, research vulnerability associated with substance use, and ethical implications of distinctions between effectiveness and efficacy research. Suggestions for ways investigators may address these concerns are provided.  相似文献   

4.
Opioid use disorders are a pressing health concern that disproportionately impacts the United States (U.S.) correctional population. Medication-assisted treatment (MAT) is an evidence-based standard of care for opioid use disorders. Despite its availability in the community, MAT and MAT medications (buprenorphine and methadone) are largely unavailable and/or inaccessible for the treatment of opioid use disorders in U.S. prisons and jails. Given that the ethical principles have served as justification for limiting access to MAT on “moral” grounds, this article examines the implications of current correctional policies through the ethical principles of: (1) beneficence/non-maleficence; (2) distributive justice (equivalence-of-care); and (3) autonomy (informed consent). Special attention is paid to the five components of informed consent (capacity, disclosure, understanding, voluntariness, and access), as this facet has been used most often to justify policies that limit access to MAT in the past. Findings highlight that these core ethical principles support the adoption of correctional policies that include MAT. Furthermore, our findings demonstrate that autonomy is maximized during the informed consent process when MAT is available as a treatment option.  相似文献   

5.
The legal doctrine of informed consent dictates that all patients must be informed of the procedures, risks and benefits of any recommended treatment and available alternatives, and that patients' decisions must be informed, voluntary and competent. Assessing whether or not one's patient is competent to make treatment decisions, however, is a complex task even for highly trained clinicians. Although all patients are presumed to be competent unless demonstrated otherwise, the rate of incompetence is increased in a number of patient populations such as the elderly, psychotic patients, the mentally retarded and individuals with severe medical disorders (e.g., cancer, AIDS). This paper offers guidelines for assessing the decision-making capacity among medical and psychiatric patients, as well as discussing disposition issues when decision-making abilities are indeed impaired.  相似文献   

6.
Modern medicine would be unthinkable without the possibility of administering pharmaceuticals and other evidence-based interventions. The development of these interventions requires scientific research, ultimately with human subjects. This venture raises ethical, legal and human rights issues, which are addressed in numerous national and international declarations and regulations. In these documents, special attention is usually directed towards research involving vulnerable groups, such as children, pregnant women, unemployed persons, refugees, patients with psychiatric disorders, dementia or mental retardation, and those who are dying. In relation to patients with psychiatric disorders, two important and mutually connected ethical questions can be posed. Firstly, is research with persons who have severe psychiatric illnesses permissible? And, secondly, how can the mental capacity of prospective research subjects be assessed? We investigate these questions using the Dutch legal system as an example. Regarding the first question, the Dutch Medical-Scientific Research on Human Subjects Act (1998) presents a detailed regulation that is in line with relevant international documents, such as the Convention on Human Rights and Biomedicine (1997). In the Dutch statute, the possibilities for research involving subjects who lack mental capacity are limited, but not completely excluded. Under certain conditions, two types of research are exempted from the general prohibition of research with such subjects that is included in article 4 of the statute. These two types are (i) therapeutic research and (ii) non-therapeutic research that could not take place without the participation of subjects from the category to which the mentally incapacitated person belongs. The conditions pertain to ethical and scientific review, insurance, written proxy consent and respect for resistance by the subject. An extra condition for the permissibility of non-therapeutic research is that the risks for the prospective subject are negligible and the burdens minimal. Although the Dutch regulation obviously does not solve all problems, it is relatively clear when compared with the situation in other European countries, such as Belgium, France, Germany, and England and Wales. Regarding the second question, two basic factors need to be considered when defining 'mental capacity'. These relate to the assumption of competence and to the task-specificity of capacity. The crucial issue in assessing mental capacity is not whether a psychiatric diagnosis is present, but whether the patient has the mental abilities required to make the decision at hand in a meaningful way. In establishing an appropriate standard for capacity assessment, several interests have to be weighed. The ethical demands of protection of subjects and stimulation of scientific research may be balanced by attempting to enhance patients' mental capacity. The procedure of 'experienced consent' seems promising in this regard, although this approach entails its own ethical problems.  相似文献   

7.

Purpose

The aim of this study was to measure persistence with pharmacological treatment in the specialist mental healthcare of patients with schizophrenia, bipolar disorder, and unipolar depression in Lombardy, a region of 10 million inhabitants located in the northernmost part of Italy.

Methods

The data concerning psychiatric care used in this study were retrieved from the regional Psychiatric Information System, while information on drug treatment was retrieved from the regional administrative database. Time to lack of persistence with initial pharmacological treatment was the outcome measure.

Results

A total of 11,797 patients, followed in the specialist mental healthcare system, started a new pharmacological treatment for depression, schizophrenia, or bipolar disorder during 2007. Overall, 8,500 patients (72.1%) discontinued treatment during the 12?month follow-up, with a median duration of 101?days. Very similar discontinuation rates were observed in patients with unipolar depression, schizophrenia, and bipolar disorder. In the multivariate analysis, operational definitions of continuity and intensity of care were the most robust determinants of persistence with drug treatment in each of the three cohorts of psychiatric diagnoses.

Conclusions

High rates of treatment discontinuation were found in a population of patients with severe mental disorders followed in the specialist mental healthcare system of an Italian region, with no differences among patients with unipolar major depression, schizophrenia, and bipolar disorder. These findings corroborate the notion that the problem of treatment discontinuation in psychiatric disorders is a factor related to the capacity of the mental health system to assure and maintain continuity and intensity of care.  相似文献   

8.
Bayer A  Fish M 《Drugs & aging》2003,20(15):1087-1097
The ethical principles of beneficence (or non-maleficence), respect for persons and justice apply to both good medical practice and clinical research. Doctors have a duty to offer to their patients, of all ages, the opportunity to take part in clinical trials and to ensure that research is appropriately designed and conducted.Barriers to participation of elderly patients in clinical trials include complex protocols with onerous outcome measures, a research focus on aggressive therapies with substantial toxicity, restrictive entry criteria unnecessarily excluding concurrent conditions and medication, patients' and families' limited expectations of benefits and lack of financial, logistic and social support.Participation is encouraged when attitudes of care staff towards research are positive, altruistic motives are acknowledged, approval of family members is gained and protocols are designed for patient rather than staff convenience. Special consideration should be given to ensuring that patient consent is fully informed and freely given.Elderly patients may have more difficulty comprehending consent information and particular attention should be given to compensating for communication and sensory deficits, improving readability of information sheets and consent forms, and considering the use of innovative consent procedures. Those with cognitive impairment and the institutionalised are vulnerable to exploitation and require special consideration and management.  相似文献   

9.
In the early drug development process for cancer therapy, several ethical dilemmas result from the use of cancer patients with advanced disease as the subjects of research in clinical trials studying agents of unknown toxicity and/or efficacy. Although several accepted ethical principles guide the behavior of involved physicians and investigators, many of these principles are allowed to be violated in order to achieve the overall goal of clinical research in improving medical care for future patients. Informed consent has been a process viewed by many as a mechanism which protects potentially vulnerable patients from harm in the clinical trial process. However, the ability of the traditionally regulated process of obtaining informed consent for clinical research may be inadequate to ensure appropriate understanding of the purposes and the goals of early clinical trial research by potentially vulnerable advanced cancer patients. This creates further dilemmas with regard to physician-investigator and patient-subject communications. In the setting of phase I trials, where the specific goal of the research is to obtain toxicity information regarding a new potential anticancer agent, many heightened ethical conflicts are present. The fact that patients do not participate in these studies as a result of altruism, and that their main goals of participation are intensely therapeutic, create issues that may be in direct conflict with the research purpose of phase I trials. As well, the presence of therapeutic intentions on the part of involved physician-investigators creates challenging issues when one realizes the very low likelihood of benefit for individual patients participating in these studies. Within the phase II setting, the statistical constraints placed on new drug trials and, again, the low likelihood of benefit for participating-subjects, also creates challenging dilemmas. These statistical requirements may be in direct conflict with involved clinicians' attitudes and beliefs regarding potential efficacy of an agent in this setting. As well, these issues become problematic when thinking about the desired structure and outcome for informed consent in phase II anticancer trials. The ability to conduct clinical research on advanced cancer patients using agents of unknown efficacy and toxicity is a daunting privilege granted to physicians and accompanying institutions. The weight of this privilege should not be underestimated, and involved physician-investigators should be aware of the significant ethical challenges involved in appropriately and successfully conducting this form of research.  相似文献   

10.
11.
Enhancing informed consent for research and treatment.   总被引:4,自引:0,他引:4  
Increased scrutiny of informed consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding of informed consent. A number of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible "predictors" of understanding of consent, such as subject characteristics, psychiatric symptoms, and cognitive impairment. Deficits in patients' understanding of informed consent may be partially related to poorly conceived, written, or organized informed consent materials; these deficits may be remediable with educational interventions. We find that effective interventions include corrected feedback, multiple learning trials, and more organized or simplified consent forms. Educational levels of patients generally correlate with levels of understanding. Even among individuals with psychiatric illness or cognitive impairment, deficits in understanding can be remedied with certain educational interventions. A variety of interventions can enhance understanding of informed consent.  相似文献   

12.
Most of the literature on informed consent in pharmaceutical drug research works on the assumption that informed consent is something that is homogeneous and thus can be rendered procedurally universal. This may be justifiable to a certain extent owing to the fact these are all drug trials anyway. Nevertheless, in spite of this general similarity, we also know that the clinical drug development phases are characteristically different, and that phase IV is very different from the other phases because, owing to its postmarketing nature, it is much more varied in scope and in type. Thus, it is worthwhile looking into the ethical nuances relevant to the informed consent process in phase IV non-interventional drug research. We shall deal with the issues on the necessity of informed consent for this type of research and then discuss the possibilities for an opt-out system. We conclude that informed consent is necessary for non-interventional studies, and thus any form of waiving of rights of participants to informed consent must have a valid substantial justification. The distinct character of phase IV accounts for the difference in content of the informed consent document compared to that of earlier phases, and both opt-in and opt-out procedures are ethically justifiable as long as the participant's participation remains informed and voluntary.  相似文献   

13.
《Journal of dual diagnosis》2013,9(3-4):151-175
ABSTRACT

Most individuals with schizophrenia are tobacco smokers, and smoking is associated with increased morbidity and mortality, changes in psychiatric medication metabolism, increased psychiatric hospitalizations, and increased risk for other substance use. Since individuals with schizophrenia receive most of their clinical care within psychiatric settings, there is a need to integrate tobacco assessment and smoking cessation treatment within the mental health system. Better addressing of tobacco will require program-level changes as well as broader system-level changes. Organizational change strategies can be effective in addressing the barriers to integrated care. Broader system-level changes include initiatives by national organizations to enhance training and create consensus on implementing change, establishing networks with existing tobacco control efforts, and increasing funding for treatment and research for this population. The purpose of this article is to address the barriers to change and share strategies to better address tobacco and integrate treatment into routine practice.  相似文献   

14.
在精神医学临床研究中,精心设计并合理应用知情同意书能更好地发挥其对受试者的保护作用。本文对精神医学受试者知情同意书的设计进行简要介绍,阐述如何在研究中合理应用知情同意书,以期为我国精神医学临床研究中受试者知情同意书的设计与应用提供参考。  相似文献   

15.
Abstract

Most of the literature on informed consent in pharmaceutical drug research works on the assumption that informed consent is something that is homogeneous and thus can be rendered procedurally universal. This may be justifiable to a certain extent owing to the fact these are all drug trials anyway. Nevertheless, in spite of this general similarity, we also know that the clinical drug development phases are characteristically different, and that phase IV is very different from the other phases because, owing to its postmarketing nature, it is much more varied in scope and in type. Thus, it is worthwhile looking into the ethical nuances relevant to the informed consent process in phase IV non-interventional drug research. We shall deal with the issues on the necessity of informed consent for this type of research and then discuss the possibilities for an opt-out system. We conclude that informed consent is necessary for non-interventional studies, and thus any form of waiving of rights of participants to informed consent must have a valid substantial justification. The distinct character of phase IV accounts for the difference in content of the informed consent document compared to that of earlier phases, and both opt-in and opt-out procedures are ethically justifiable as long as the participant’s participation remains informed and voluntary.  相似文献   

16.
The aim of this study was to assess the similarities and differences of patients with co-existing psychiatric and substance use disorders attending treatment in either a mental health setting or a substance abuse treatment setting. A total of 129 patients were assessed, including 65 individuals from the substance abuse treatment center and 64 individuals from the mental health program. Treatment records were reviewed for diagnoses and sociodemographic data. While the two groups were highly similar with regard to age and ethnicity, there were significant differences in psychiatric profile, with the substance abuse treatment group having less severe diagnoses and no patients with schizophrenia, while the mental health treatment group had a majority of patients with schizophrenia. Other differences in the two groups, such as marital and parental status, disability status, and medical problems appeared to be directly linked with the aforementioned diagnostic profile. These data suggest important differences in characteristics of patients with comorbid disorders that appear to be dependent on the type of treatment program they attend. For the most effective management, integrated treatment programs should be aware of these differences and tailor service provision accordingly.  相似文献   

17.
With more than 3 million persons receiving substance abuse treatment per year in the United States and with increasing interest in treatment outcomes, there is a need for closer attention to all aspects of the treatment process. However, minimal attention has been given to informed consent as a way of enlisting client engagement and active participation in treatment. Although there is some literature on informed consent in substance abuse research, the literature on informed consent to undergo substance abuse treatment is very limited. Incorporating informed consent into substance abuse treatment is recommended as part of motivational interviewing. Standard treatment consent issues include (1) the clinical characteristics of the problem, including diagnosis; (2) treatment recommendations; (3) the risks and benefits of treatment; (4) the financial costs of the intervention; (5) alternative services or interventions should a client refuse the recommended form of care; and (6) freedom to choose or refuse treatment. This article provides a background for informed consent procedures to facilitate client engagement in substance abuse treatment and suggests needs for future research on informed consent to undergo substance abuse treatment.  相似文献   

18.
19.
Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.  相似文献   

20.
我国《执业医师法》与《侵权责任法》中均明确规定了患者在接受医疗服务过程中享有知情同意权。然而在实际医疗过程中,知情同意仅仅成为了有患者签名的"合同书",为医师提供程序上的保护。为了更好地处理好医学技术与医学伦理二者之间的关系,应从知情同意的伦理学理论、现实意义及伦理学实践中,探究落实患者知情同意权的原则,行使与履行好医患双方的权利与义务,提高医学伦理学的认知与实践。  相似文献   

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