Informed consent and assent in human subject research.

Informed consent is an important aspect of human subject research, designed to uphold individual autonomy and the moral principle of respect for persons. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research articulates three distinct elements of informed consent as "information, comprehension, and voluntariness." These elements are discussed as they apply to informed consent. This article then discusses the concept of child assent. Finally, informed consent as it applies to public health research is discussed.     

'Informed consent' in public health activities: based on the universal declaration on bioethics and human rights, UNESCO

OBJECTIVES: The objective of this paper is to discuss the importance of obtaining informed consent for conducting epidemiological studies and public health activities, based on the Report of the UNESCO's Working Group on Informed Consent. METHODS: The Report of the UNESCO's Working Group on Informed Consent was reviewed and discussed in connection with the ethical considerations of public health activities and epidemiological research. RESULTS: It was at the Nuremberg Trial for the German war criminals of the Second World War that the principle of 'consent' was first stated as a consequence of the medical abuses carried out during the War. As a result of the Trial, the Nuremberg Code came out in 1947. Since then, various international declarations or ethical principles on 'informed consent' have been developed and published. These ethical principles on 'informed consent' have mostly to do with the clinical research that involves human subjects, and not with epidemiological studies and public health activities. However, UNESCO recently issued a comprehensive Report on Informed Consent based on the Universal Declaration on Bioethics and Human Rights adopted in 2005, and this included detailed guidelines on informed consent in epidemiological studies and public health activities. CONCLUSIONS: Universal Declaration on Bioethics and Human Rights emphasizes the principle of autonomy to protect the human rights of the human subjects involved in any public health activities and epidemiological research. As a practical guideline, obtaining informed consent is strongly recommended.     

Autonomy and informed consent: A mistaken association?

For decades, the greater part of efforts to improve regulatory frameworks for research ethics has focused on informed consent procedures; their design, codification and regulation. Why is informed consent thought to be so important? Since the publication of the Belmont Report in 1979, the standard response has been that obtaining informed consent is a way of treating individuals as autonomous agents. Despite its political success, the philosophical validity of this Belmont view cannot be taken for granted. If the Belmont view is to be based on a conception of autonomy that generates moral justification, it will either have to be reinterpreted along Kantian lines or coupled with a something like Mill’s conception of individuality. The Kantian interpretation would be a radical reinterpretation of the Belmont view, while the Millian justification is incompatible with the liberal requirement that justification for public policy should be neutral between controversial conceptions of the good. This consequence might be avoided by replacing Mill’s conception of individuality with a procedural conception of autonomy, but I argue that the resulting view would in fact fail to support a non-Kantian, autonomy-based justification of informed consent. These difficulties suggest that insofar as informed consent is justified by respect for persons and considerations of autonomy, as the Belmont report maintained, the justification should be along the lines of Kantian autonomy and not individual autonomy.     

知情同意原则及其对医院管理的启示

随着社会与医学进步，知情同意作为医疗实践的一个基本原则越来越为人们所接受和认可，但是从目前的实际情况来看，在我国要想真正实现的知情同意权还存在诸多困难，医院在实施知情同意的过程中还存在种种制约因素，本文拟从医院管理的角度提出相应的管理措施。     

Simulated Patient Studies: An Ethical Analysis

Context: In connection with health care reform, the U.S. Department of Health and Human Services commissioned a “mystery shopper,” or simulated patient study, to measure access to primary care. But the study was shelved because of public controversy over “government spying” on doctors. Opponents of the study also raised ethical concerns about the use of deception with human subjects without soliciting their informed consent. Methods: We undertook an ethical analysis of the use of simulated patient techniques in health services research, with a particular focus on research measuring access to care. Using a case study, we explored relevant methodological considerations and ethical principles relating to deceptive research without informed consent, as well as U.S. federal regulations permitting exceptions to consent. Findings: Several relevant considerations both favor and oppose soliciting consent for simulated patient studies. Making research participation conditional on informed consent protects the autonomy of research subjects and shields them from unreasonable exposure to research risks. However, scientific validity is also an important ethical principle of human subjects research, as the net risks to subjects must be justified by the value to society of the knowledge to be gained. The use of simulated patients to monitor access is a naturalistic and scientifically sound experimental design that can answer important policy‐relevant questions, with minimal risks to human subjects. As interaction between researchers and subjects increases, however, so does the need for consent. Conclusions: As long as adequate protections of confidentiality of research data are in place, minimally intrusive simulated patient research that gathers policy‐relevant data on the health system without the consent of individuals working in that system can be ethically justified when the risks and burdens to research subjects are minimal and the research has the potential to generate socially valuable knowledge.     

医疗紧急情况下知情同意的代理相关法律问题

传统的知情同意原假设是,如果病人没有充分的自主,医疗干预便不能实施,医师在知情同意中的重心是建议者而非治疗者的角色。但是在医疗紧急情况下,本着生命优先、救死扶伤的原则,知情同意严格程序形式需要作出让步,病人的昏迷状态或者濒危状态使得其无法具有自主的能力,就需要通过代理实现同意功能的延伸。紧急情况下将会遇到的非本人的其他主体能否代理、有无能力代理、会否滥用代理权等一系列相关的法律问题。     

Relational autonomy in informed consent (RAIC) as an ethics of care approach to the concept of informed consent

The perspectives of the dominant Western ethical theories, have dominated the concepts of autonomy and informed consent for many years. Recently this dominant understanding has been challenged by ethics of care which, although, also emanates from the West presents a more nuanced concept: relational autonomy, which is more faithful to our human experience. By paying particular attention to relational autonomy, particularity and Process approach to ethical deliberations in ethics of care, this paper seeks to construct a concept of informed consent from the perspective of ethics of care which is here called relational autonomy-in-informed consent (RAIC). Thus, providing a broader theoretical basis for informed consent beyond the usual theoretical perspectives that are particularly Western. Care ethics provides such a broader basis because it appeals to a global perspective that encompasses lessons from other cultures, and this will help to enrich the current ideas of bioethics principles of autonomy and informed consent. This objective will be achieved by exploring the ethics of care emphasis on relationships based on a universal experience of caring; and by contrasting its concept of autonomy as relational with the understanding of autonomy in the approaches of the dominant moral theories that reflect rational, individualistic, and rights-oriented autonomy of the American liberalism.     

Deferred consent for inclusion of patients unable to give their consent in studies in the field of emergency medicine

Respect for individual autonomy, expressed in the concept of informed consent, is a basic principle in research with humans. Many patients in intensive care are unable to give consent because of mental incapacity, and this can be further complicated in emergency research, in which the treatment or experiment needs to be initiated without delay. In those situations consent can be deferred. Randomization is done without prior consent, followed by patients' or relatives' consent at a later stage. Butwhat should one do with the data if the patient dies at an early stage after randomization before consent could be obtained? Should the data be used or not? Should the relatives be asked for consent for using the data? The Dutch Central Committee on Research involving Human Subjects (CCMO) states that asking for consent after the patient has died makes no sense, because with the death of the patient the research has ended. Relatives do not have the authority to give consent for the use of medical data after the patient has died. Data can be used anonymously in the final analysis of the trial. We propose a flowchart for this procedure.     

Futility, autonomy, and informed consent

If clinicians deem a treatment medically futile, is it appropriate to mention such a treatment to patients? Do healthcare professionals violate informed consent if they do not offer patients an opportunity to decline futile treatments? The notion of futility involves an assessment of patient best interest--both short-term and long-term therapeutic benefit for a patient and the community in which he or she intends to survive and flourish. Although survival interests may be construed as long term, a treatment that offers survival without any promise of flourishing is not the goal of medicine and is futile. Flourishing requires some cognitive and affective function. The goal of informed consent practices is to ensure that patients accept the benefits of treatment with cognizance of the burdens and risks. Given the impact of illness on the emotional and psychological states of patients and their families and their resultant vulnerability, the omission of futile options from treatment plans is logical and exemplifies the best of paternalistic behavior. The claim that requests for futile treatment must be honored is based on a perverse understanding of patient autonomy. Rational medicine demands that patients' requests be reasonable from a clinical perspective, as well as from a subjective one. The practice of informed consent can be implemented as a balance between these two interests.     

Informed consent: ideal or reality?

Is it ever possible to give informed consent to treatment or research? Are the standards of consent set by ethicists and lawyers too high for ordinary people to reach? Should these standards be abandoned or modified? These questions are discussed in this paper mainly in relation to the extensive literature on consent in medicine, with examples about consent to children's treatment and research which raise extra dilemmas. Paradoxical meanings are considered: consent as an informed correct choice or a courageous best guess, and autonomy as isolated, uncompromised freedom or reasonably uncoerced self-realisation. Beyond being informed, consent involves evaluating, making and signifying a decision. It is better understood as a process than an event, in which reasoned understandings can be complemented by emotional insights. Ethical and legal standards of voluntary consent, although partly an unrealistic ideal, provide important guidelines for people who request and give consent to research.     

The Role of Community Advisory Boards: Involving Communities in the Informed Consent Process

Ethical research involving human subjects mandates that individual informed consent be obtained from research participants or from surrogates when participants are not able to consent for themselves. The existing requirements for informed consent assume that all study participants have personal autonomy; fully comprehend the purpose, risks, and benefits of the research; and volunteer for projects that disclose all relevant information. Yet contemporary examples of lapses in the individual informed consent process have been reported. The authors propose the use of community advisory boards, which can facilitate research by providing advice about the informed consent process and the design and implementation of research protocols. These activities could help reduce the number of individual informed consent lapses, benefiting study participants and the scientific integrity of the research in question.     

上海市部分公立医院涉及人体医学研究项目知情同意过程分析

建议进一步加强医院伦理委员会的作用,规范知情同意的操作,加强公众宣传、改善医患关系,以改善公立医院涉及人体研究项目的知情同意工作。     

Ethical and legal problems of informed consent

INTRODUCTION: The previously accepted paternalistic relationship between patients and doctors has changed in last century. The expectation for patients to be involved in medical decisions is growing, but this involvement cannot be imagined without informed consent, hence it became one of the most important elements of a physician's responsibilities. Although informed consent is broadly regulated legally in Hungary, experiences show that practical realization is insufficient. This is also represented in the large number of lawsuits in connection with the inadequate or wrong use of informed consent. The aim of this study was to survey for the first time in Hungary the state of informed consent by the analysis of written consents to anaesthesia. METHODS: The authors collected and studied written consents to anesthesia from 36 hospitals and clinics in Budapest. They studied among others the presence of the following formal elements: individual consent forms for anesthesia, signatures on forms etc. They also examined whether the consents contained all of the conventional elements of informed consent. RESULTS: 61% of hospitals had individual forms for consent to anesthesia. Every consent form required a signature by the patient and almost every form (except two) by the doctor as well. 39% of forms describe the medical treatment in detail and only 25% mention its advantages and disadvantages. 28% of them specify definite risks, but only 19% mention their probability. 67% of the documents refer to the possible need to extend intervention. Patients have to declare whether they permit urgent blood transfusion in 25 institutions (69%). In only two hospitals are patients informed of their rights to revoke consent or to resign from being informed of medical treatment. CONCLUSION: Although all institutions have written consent forms that adhere to legal regulations, in terms of their format and matter they leave much to be desired. It is especially conspicuous that possible risks are named in less than a fourth of all forms, thus they have to be mentioned verbally and this obviously is a source of later arguments. The authors believe that all invasive medical procedures require templates for consent forms put together by professional panels. These forms could then be adapted to all specific medical procedures of the hospital in question.     

知情同意--临床医疗服务观念的变革

在临床治疗之前征求患者的意见是医生的职责 ,也是临床医学与有关法律条文所规定的患者权益。在临床治疗之前征求患者的意见是一种社会文化价值的反映 ,它体现了对患者权益的尊重以及个人自治权在道德上的重要性。随着社会文化价值观念的变革和伦理道德的逐步规范 ,知情同意 (Inform ed Consent,IC)在临床医疗服务过程中的作用越来越重要。文章阐述了知情同意在临床运用的发展过程及其在临床治疗过程中出现的一些具体问题 ;分析说明了加强医患关系、向患者提供明确的临床信息以及改善医患交流技巧是知情同意的基本要求。     

契约与侵权——从外国法理上论医师的说明义务

作为医学领域的一个基本伦理原则,医师的说明义务起源于英美法系的"Informed Consent"理论。在我国,对医师的说明义务的研究多集中在伦理学方面,而对说明义务的法理基础,尚无统一的学说。以美国、德国为代表,简要介绍国外有关说明义务的法理基础的学说,希望能够为我国的相关研究提供参考。     

整形美容手术中知情同意的伦理探讨

目的 明确知情同意在整形美容行业中的必要性和重要性,探讨其中隐藏的伦理学意蕴,用知情同意这一重要的伦理原则规范医务人员的行为.方法 使用文献检索法、专家咨询法、抽样调查等方法对整形美容手术中的知情同意情况进行调查,分析实施过程中的规范化情况和遇到的难点和伦理困境.结果 整形美容医师牢牢把握了知情同意这一原则,作为术前常规工作执行,但在实际操作过程中还有些难点.结论 整形美容医生应规范履行知情告知义务,尊重患者的知情权;院方须制定一系列的制度来规范知情同意这一原则.     

Ethical dilemmas in communicating medical information to the public

This paper examines arguments for and against objective communication between health-care experts (HCEs) and the public concerning matters of health and disease. It argues that HCEs should have neither a purely objective approach nor a paternalistic approach to communications with the public. The informed consent model is the best way to promote public health, prevent disease, respect individual autonomy, and safeguard scientific honesty and openness. In following this model, HCEs should provide lay people with the information and advice they need to make sound decisions. They should not manipulate, distort, exaggerate, or conceal relevant information, nor should they use coercive means to induce the 'correct' decisions. Paternalistic communication only makes sense under the extraordinary challenges posed by bona fide public-health emergencies. Of course, informed people may still make unwise choices, but this is a cost that one must accept in a free, open, and democratic society.     

Third-party informed consent in research with adolescents: the good, the bad and the ugly

Third-party informed consent for child and adolescent participation in research is a legal requirement that has been questioned by authors who argue that children over 10 are fully able to make decisions regarding this matter. The extent to which this requirement encumbers survey researches in this age range has not been fully reported. In order to understand the reasons for the inconsistent use of condoms among adolescent students in Rio de Janeiro, we designed a survey based on an anonymous self-reported questionnaire. Two informed consent terms were distributed: one for the adolescent and one for the legal representative signature. Participation was offered to all students aged 12-18 attending class at the day of the consent term distribution. Among 906 distributed legal represents consent terms, 734 (81%) were not returned. The final sample probably presented a bias of selection. Researchers must foresee third-party consent as a major encumbrance. There is a need for the definition of a range of interventions in which the adolescent might have the legal recognition of autonomy for decision about his/her voluntary participation.     

The price of autonomy

The randomized controlled trial produces a clash of ethical principles with the need for informed consent (autonomy) in conflict with the principles of beneficence and justice. Informed consent is one of the major rate‐limiting factors of recruitment and this delays the discovery of life‐saving treatments indirectly. Whilst supporting the concept of non‐exploitation we wish to challenge the prevailing dogma by asking the awkward question ‘what is the price of autonomy?’. Using breast cancer as an example we have developed a decision model with explicit assumptions allowing numerical values to be fed into a mathematical equation, which calculates the cost in lives. With conservative assumptions we estimate that the price of autonomy is 2500 lives over a 10‐year period in the United Kingdom alone. We issue the challenge to health policy makers and ethicists to survey public opinion to determine the value placed on autonomy in the war against cancer.