Recherche en réanimation: consentement et information. Partie I : rappels historiques et considérations éthiques

With severely ill patients and use of high-tech methods, intensive care medicine highlights the need and limitations of the informed consent. Following Nuremberg trial of Nazi medical crimes, the Nuremberg code made patients?? consent mandatory for medical research. Such a decision showed the ambiguity of the patient??s status, considered as sample of a biological species but also as a single and unique person. Several philosophical and ideological currents disagree, emphasizing either science advancement for the good of humanity to the detriment of the person, or the inalienable humanity of each single person. The temptation to increase the scientific knowledge at any price has led to the ongoing need to produce new texts to protect patients?? rights. New technologies make patients?? consent increasingly complex, questioning the actual definition of humanity.     

Medical research in paediatrics: ethical issues

Since 1947 (the Nuremberg Code), the ethics of experimentation on human beings is based on the principle of the informed consent of the subjects participating in the research. In this context, research in paediatrics raised particular and difficult problems. International regulations have evolved in a way that has permitted paediatric research, within strict limits. However, recent studies have shown that the level of clinical paediatric research remains weak. There are economic reasons for this. But it also reveals the persistence of an ethical conflict: some people fear that a relativisation of the principle of consent (proxy consent) will lead to weakened protection for the most vulnerable subjects, including children. The ethics of responsibility requires a balance between the protection of the child as an individual (who should never become a medical guinea-pig) and the protection of children as a group (who should never be deprived of the benefits of the medical research).     

Understanding informed consent.

Understanding and facilitating the informed consent process is our duty as perioperative nurses. Acting as patient advocates, we must determine if our patients have given "informed consent" prior to surgical treatment. When we witness our patients signing consent forms, we must be sure they are competent to sign; that they have spoken with the physician and have discussed the proposed procedure (including the risks, benefits and alternative treatments) and have had their questions answered; and have read the consent form they are being asked to sign. As nurses, we must become aware of our responsibilities related to informed consent. By understanding the concept of informed consent and its legal implications, we will be able not only to the facilitate informed consent process but also to fulfill our legal responsibilities.     

《护理学基础》教材中增加尊重患者同意权内容建议

知情同意权是由“知情权”和“同意权”两部分构成的一个整体。尊重患者的知情同意权是医务人员必须遵守的临床伦理法则,体现了对患者生命价值和人格尊严的尊重,也是防范医疗纠纷的重要内容。为了让护生在专业课程的学习过程逐渐培养尊重患者知情同意权的意识,在《护理学基础》教材的相关内容中,不仅要体现对患者“知情权”的尊重,也应强调尊重患者的“同意权”。     

Informed consent: Protection or obstacle? Some emerging issues

There is widespread consensus on the need for informed consent procedures in medical research. Nevertheless, aspects of the informed consent process remain controversial, and innovative approaches to research may raise new issues and concerns. The randomized consent design for clinical trials, proposed by Zelen (N Engl J Med 1979; 300:1242–1245), permitted physicians to randomize patients without consent, then obtain informed consent from only those patients randomized to the experimental (as opposed to the standard treatment) arm. More recently, the proposal has been made to allow waiver of informed consent for study of patients in emergency circumstances who may be temporarily incapable of providing such consent, and for whom no family member is immediately available to give a “proxy” consent (Biros M.H. et al. JAMA 1995; 273:1283–1287). The medical community and federal regulatory policy have responded differently to these proposals.     

Doing research on the ethics of doing research

In the previous issue of Critical Care Chenaud and colleagues found that most intensive care unit patients who had given informed consent for their participation in a clinical trial could not recall either the purpose of the trial or its related risks several days later. These findings should remind us that informed consent is a process, not an event, but they should not be interpreted to mean that recall is, of itself, a useful criterion for evaluating either the validity or the quality of the informed consent process. On an entirely separate note, the decision of the authors not to obtain informed consent for this study itself raises interesting questions about the ethics of doing research on the ethics of doing research.     

抑郁症发作期患者就诊与住院知情同意状况的调查与分析

目的探讨抑郁症发作期患者就诊与住院知情同意状况,寻找既方便患者就诊和住院,又可避免因患者知情同意问题引起医疗纠纷的方法。方法对符合CCMD-3的抑郁发作期患者进行知情同意状况调查。结果患者对就诊知情者87例(52.41%),不知情者79例(47.59%);同意就诊者70例(42.17%),不同意就诊者96例(57.83%)。患者对住院知情者65例(39.16%),不知情者101例(60.84%);同意住院者53例(31.93%),不同意住院者113例(68.07%)。结论保证监护人对患者就诊和住院治疗的知情同意权是减少医疗纠纷的关键。     

Process consent: a model for enhancing informed consent in mental health nursing

Informed consent, essentially a legal doctrine, is designed to protect the rights of patients. However, in an area of practice such as psychiatry, informed consent imposes many problems if one considers it to be a static process. In this paper we propose that process consent, the type of consent considered essential in qualitative research projects, is not only appropriate but necessary for mental health nursing practice. This type of consent is an ongoing consensual process that involves the nurse and patient in mutual decision making and ensures that the patient is kept informed at all stages of the treatment process. We have used neuroleptic medications as an example throughout the paper and have suggested that seeking informed consent should be added to the role of the nurse in the mental health setting.     

Voluntary Informed Consent in Research and Clinical Care: An Update

Informed consent is important: in research, it allows subjects to make an informed and voluntary choice to participate—or refuse to participate—in a project where they will be asked to take risks for the benefit of others. In both research and clinical care, informed consent represents a permission to intervene on a person's private sphere. The elements of informed consent are usually described as disclosure, understanding, decision‐making capacity, and voluntariness. Each poses distinct difficulties, and can be amenable to improvements. However, research on the quality of informed consent and on strategies intended to improve it have only become the object of research relatively recently. In this article, we describe some results of this research, and outline how they can be relevant to informed consent in research and clinical care. Although much of the data suffers from limitations, it does suggest that disclosure has improved, but is still uneven, comprehension is often poor, for both patients and research subjects. Moreover, trust is a motivating factor for research participation, and thus we run risks if we allow false expectations and prove ourselves unworthy of this trust. Although improving consent forms does not have a clear effect on understanding, improving the consent process may help. Finally, better information may decrease anxiety and seems to have at most a small negative effect on research recruitment.     

Understanding Exception from Informed Consent in Planned Emergency Research

Many of the current accepted treatment practices provided to patients in the first critical hour after a traumatic injury, stroke, or cardiac arrest have not been rigorously tested in clinical research trials. The inability to obtain informed consent is often a barrier to research in emergency, time-sensitive situations in which the patient is not able to provide informed consent nor is their family member immediately available to provide consent on behalf of the patient. Planned emergency research, often with exception from informed consent, is a type of research study that involves a patient with a life-threatening medical condition that requires urgent interventions, wherein the current treatments may be unproven or suboptimal, and who, because of their current condition, is unable to provide informed consent. This article summarizes the necessary components for using exception from informed consent in planned emergency research. Understanding the research design, particularly research processes specific to time-critical emergency situations, will ensure that the care provided by stretcher-side emergency nurses will result in optimal patient outcomes and is an integral aspect of emergency nursing practice.     

Ethical challenges of informed consent in prehospital research

Informed consent to participation in research is an important protector of potential subjects' rights and autonomy. Ethical research involving critically ill people is challenging because their medical condition often makes obtaining informed consent impossible. This is especially true in the prehospital setting, where additional barriers to obtaining informed consent exist. A recently published Canadian policy (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) specifies circumstances under which an exception to the requirement for informed consent may be granted so that vulnerable individuals are not denied the potential benefits of participating in research. This article reviews the rationale for the Tri-Council Policy Statement and illustrates some problems with its application in the context of a Canadian prehospital study on continuous positive airway pressure. A new risk analysis model and a national research ethics board are discussed as possible ways to facilitate interpretation and application of the current exception of informed consent policy.     

Informed consent to treatment in clinical trials

Special characteristics of clinical trials place unique demands on the concept and practice of informed consent to treatment. We focus on the practical problem that consent to treatment forms are not typically able to be understood by patients in clinical trials research. Informed consent forms are significantly less comprehensible than popular press written material and may be as difficult to read as medical journals. Several guidelines for improving informed consent to treatment documents such as the use of non-professionals and patients to critique drafts of consent to treatment forms are proposed and discussed. The use of these guidelines can insure that patients have the opportunity to understand more clearly what their treatment will involve within a clinical trial before they give an informed consent.     

The historical, ethical, and legal background of human-subjects research

The current system of human-subject-research oversight and protections has developed over the last 5 decades. The principles of conducting human research were first developed as the Nuremberg code to try Nazi war criminals. The 3 basic elements of the Nuremberg Code (voluntary informed consent, favorable risk/benefit analysis, and right to withdraw without repercussions) became the foundation for subsequent ethical codes and research regulations. In 1964 the World Medical Association released the Declaration of Helsinki, which built on the principles of the Nuremberg Code. Numerous research improprieties between 1950 and 1974 in the United States prompted Congressional deliberations about human-subject-research oversight. Congress's first legislation to protect the rights and welfare of human subjects was the National Research Act of 1974, which created the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research, which issued the Belmont Report. The Belmont Report stated 3 fundamental principles for conducting human-subjects research: respect for persons, beneficence, and justice. The Office of Human Research Protections oversees Title 45, Part 46 of the Code for Federal Regulations, which pertains to human-subjects research. That office indirectly oversees human-subjects research through local institutional review boards (IRB). Since their inception, the principles of conducting human research, IRBs, and the Code for Federal Regulations have all advanced substantially. This paper describes the history and current status of human-subjects-research regulations.     

Informed consent in the intensive care unit: ensuring understanding in a complex environment

PURPOSE OF REVIEW: Informed consent in the intensive care unit continues to receive marked attention. As greater numbers of patients enter into the intensive care unit with devastating illness, patients and families are faced with more complex medical problems and decisions regarding therapy. Furthermore, research investigations of critical illness add a level of complexity to informed consent and decision making that mandates a careful approach. RECENT FINDINGS: Publications in the past year evidence the potential obstacles for appropriate informed consent. Physicians demonstrate variability in interpretation for the need for informed consent and frequently lack formal training in communicating informed consent. Critical care researchers must communicate the goals and benefits of trial participation carefully, avoiding the demonstrably common pitfall of therapeutic misconception. Excellent consensus statements now exist to guide the researcher in pursuing critical care research, creating informed consent documentation, and recognizing the appropriate setting for waiver of consent. As expected, extended discussion is the most effective tool for improving the quality of informed consent. SUMMARY: Quality of informed consent for the critically ill improves as attention is paid to standardizing indications and formalizing training for physicians. In research, conflicts of interest should be recognized and used to guide the investigator's dialogue on research benefits and risks. Patient safety must be maintained as the primary priority; however, waiver of consent may be considered in situations in which the benefit to medical knowledge far exceeds patient risk.     

Research Conditions That Qualify for Emergency Exception from Informed Consent

Medical research involving critically ill and injured subjects unable to provide informed consent can only be conducted under federal regulations that attempt to balance the need to develop lifesaving treatments with protection of research subjects' rights. Regulators, researchers, and medical ethicists have all struggled to define the conditions under which an emergency exception from informed consent is appropriate. Although research has been successfully conducted under the current regulations, confusion remains regarding the meaning of the regulations, the applicable conditions, and the best ways to balance the needs of future patients and the rights of research subjects. In May 2005, at the Academic Emergency Medicine Consensus Conference “Ethical Conduct of Resuscitation Research,” a breakout session was held on the research conditions that qualify for the emergency exception from informed consent process. Several recommendations emerged: 1) The definition of “life‐threatening condition” should be broadly interpreted to include serious disability as well as death. 2) Existing therapies should be considered “unsatisfactory,” even if partially effective, when serious risk of morbidity or mortality remains even with the best available treatment or when the adverse effects of the best available treatment are serious. 3) Research with the emergency exception should be performed only if sufficient evidence exists that the proposed intervention has a reasonable chance of benefit. 4) More evaluation is needed to determine the degree to which the current rules impede research. 5) Application of the current regulatory framework for abbreviated or waived consent in emergency research should be encouraged. 6) Further study should also address variability among institutional review boards, the goals of community involvement, and how best to engage and educate the public in research efforts using emergency exception from informed consent.     

Consent and assessment of capacity to decide or refuse treatment

Consent protects the right of patients to decide what happens to them. Before any medical intervention, adults must give valid consent, which must be voluntary, informed and given free of undue influence. When consent is being obtained, patients must be informed about the intervention, why it is being done and its risks; information they are given must be recorded. Every effort should be made to explain the issues in terms that the patient can understand and by providing support and aids to communicate. Consent can be expressed, where patients say they consent or put it in writing, or implied, where a healthcare professional infers from their behaviour that they consent. While different types of consent are valid, some are evidence of stronger proof in court that valid consent has been given. Competent adults have the right to refuse treatment, regardless of the reasons they give for refusal and even if the refusal will result in death; clinicians must respect their decision. In some circumstances-such as when an unconscious person is admitted as an emergency-healthcare professionals can make decisions on behalf of patients, and must do so in patients' best interests.     

Consent to Psychological Research by People with an Intellectual Disability

This study investigated the ability of people with an intellectual disability to consent to psychological research. The criteria employed were based on the three elements of informed consent: information, competence and voluntariness. Participants were 40 people with an intellectual disability who had agreed to take part in a larger research study investigating their ability to consent to behavioural or medical treatment. A brief questionnaire consisting of six questions was administered to each participant to discover the extent of their ability to consent to take part in the larger study. A scoring protocol was developed to determine whether participants had answered each question satisfactorily. People appeared to understand the nature of the research, but had a limited understanding of the risks and benefits involved or of their right to refuse to participate or to drop out of the study. It is concluded that researchers must carefully assess the ability of people with an intellectual disability to consent before recruiting them to research studies and must be aware of the potential for this client group to agree to participate without fully understanding the implications.     

Medical informed consent: general considerations for physicians

Medical informed consent is essential to the physician's ability to diagnose and treat patients as well as the patient's right to accept or reject clinical evaluation, treatment, or both. Medical informed consent should be an exchange of ideas that buttresses the patient-physician relationship. The consent process should be the foundation of the fiduciary relationship between a patient and a physician. Physicians must recognize that informed medical choice is an educational process and has the potential to affect the patient-physician alliance to their mutual benefit. Physicians must give patients equality in the covenant by educating them to make informed choices. When physicians and patients take medical informed consent seriously, the patient-physician relationship becomes a true partnership with shared decision-making authority and responsibility for outcomes. Physicians need to understand informed medical consent from an ethical foundation, as codified by statutory law in many states, and from a generalized common-law perspective requiring medical practice consistent with the standard of care. It is fundamental to the patient-physician relationship that each partner understands and accepts the degree of autonomy the patient desires in the decision-making process.     

The quality of parental consent for research with children: a prospective repeated measure self-report survey

BACKGROUND: Researchers have ethical and legal responsibilities to ensure that individuals give informed consent to participate in research. The few studies of parental consent for paediatric research suggest there may be inadequate competence, information, understanding, or voluntariness for valid consent to occur. OBJECTIVES: To determine parents' level of understanding of the research study requirements and satisfaction with the informed consent process. PARTICIPANTS: English literate parents of children actively involved in research studies. METHODS: A repeated measures self-report survey was conducted to measure parent understanding (actual and perceived) of the study consented for and satisfaction with the informed consent process. Relationships between parents understanding of the research and their satisfaction with the consent process were explored and changes in parent understanding or satisfaction over time were described. RESULTS: Questionnaires from 109 parents were returned, representing 25 different studies. Parents demonstrated a high level of knowledge of information essential for informed consent, such as the purpose, benefits, and participant rights. Nervousness or inability to concentrate, and reading ease of the information sheet were found to relate to parents' knowledge and their perceptions of the adequacy of the consent. Parents overall reported high satisfaction with the consent process. CONCLUSIONS: These findings support and extend previous research on parental consent for research with children. They suggest areas where further research is indicated, including: the value and use of information and consent documents given to parents, the views and concerns of parents for whom English is not their first language, and further exploration of the concerns of the few dissatisfied parents. Current practices of obtaining informed consent for research lack supporting research evidence and may not be ethically justifiable.     

Adaptive designs, informed consent, and the ethics of research

The ethical tension in research design is often characterized as that between individual and collective ethics. While adaptive clinical trials (ACTs) are generally considered to be more sensitive to individual ethics, the concomitant loss of statistical power associated with them is often used to justify randomized clinical trials (RCTs). This paper challenges this characterization of the central ethical problem in research design. It argues that the key consideration in clinical research hinges on the process of informed consent. When the research context is such that the subject is able to provide informed consent, RCTs can be justified and may be required. However, in desperate medical situations the process of informed consent is often undermined. It is argued that in such situations ACTs are ethically required. We introduce "the principle of interchangeability" and argue that it must be satisfied if research in desperate medical situations is to be justified.