Intensive care patients' evaluations of the informed consent process.

This study examines the informed consent process from the perspective of intensive care patients. Using the largest single-method database of patient-derived information in the United States, we systematically outlined and tested several key factors that influence patient evaluations of the intensive care unit (ICU) informed consent process. Measures of information, understanding, and decision-making involvement were found to predict overall patient satisfaction and patient loyalty intentions. Specific actions supportive of ICU informed consent, such as giving patients information on advance directives, patient's rights, and organ donation, resulted in significantly higher patient evaluation scores with large effect sizes. This research suggests that the effectiveness of the informed consent process in the ICU from the patient's perspective can be measured and evaluated and that ICU patients place a high value on the elements of the informed consent process.     

Autonomy and clinical practice. 3: Issues of patient consent

In this, the last in a three-part series considering how the concepts of autonomy, privacy and informed consent are articulated in nursing and the related literature, the authors focus on the notion of consent. Definitions of consent are considered, as are the legal elements of valid consent. Obtaining a patient's consent to treatment has several important functions. This article looks at some of these functions, such as safeguarding patient autonomy and encouraging patient participation in health care. Finally, a number of the difficulties in obtaining an informed consent from patients are considered. Some empirical studies which consider patients' understanding of the information and consent process are also discussed. From a review of the literature it appears that the issue of informed consent is very much tied up with the perceived power struggle between doctors and nurses and doctors and their patients.     

Your role in informed consent. Part 1.

As critical care nurses, we all participate in the informed consent process, whether for a routine procedure or surgery or for a research study or clinical trial. This first article of a 2-part series discusses the critical care nurse's role concerning informed consent for surgery or other invasive procedures, including nursing procedures. Part 2 will discuss the critical care nurse's role concerning informed consent for clinical trials.     

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.     

Informed consent: An overview

Informed consent is a process, not an isolated incident. It therefore requires that health care professionals approach the process with expert knowledge, open communication, and a willingness to participate in shared decision-making. Table 2 identifies the major ethical and legal issues of informed consent. Legal precedents and professional collaboration will be necessary to further define and refine informed consent. The complexity of treatment regimens, potential system toxicities, and the chronicity of the disease process have fostered the development of a multidisciplinary team approach to the care of oncology patients. Therefore, collaboration is essential to meet the demands of the informed consent process and provide an optimal environment for the oncology nurse to intervene actively as a patient advocate.     

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.     

Autonomy,privacy and informed consent 3: elderly care perspective

Despite the growing interest in clinical healthcare ethics, there is a dearth of empirical studies investigating the ethical elements of day-to-day clinical practice from the perspective of either patients or staff. This article, the third in a four-part series, reports the results of a Scottish Study that formed part of a multi-site comparative study funded by the European Commission. It explores patient autonomy, privacy and informed consent in the care of elderly people in long-stay care facilities (i.e. nursing homes and continuing care units). A convenience sample of 101 elderly residents and their nurses (n = 160) participated in the study. Data were collected by means of a self-completion questionnaire for staff and a structured interview schedule for elderly residents. Results indicate marked differences between staff's and residents' responses on three of the four dimensions explored: information-giving, and opportunity to participate in decision-making about care and consent. There was much closer agreement between staff's and residents' responses regarding protection of patient privacy. From the results of this study there is indication of a clear need for further empirical studies exploring issues of patient autonomy, privacy and informed consent in the day-to-day nursing care of older people. Findings to date suggest there is still a significant need to educate staff concerning ethical awareness and sensitivity to the dignity and rights of patients.     

European legislation impedes critical care research and fails to protect patients' rights

The European Clinical Trials Directive requires an informed consent from the patient or a proxy in drug trials. Although informed consent is a valuable tool to protect patients' rights in clinical trials, this requirement largely impedes research in critical care settings, and if pursued in this context, it does not provide the patient with adequate protection. Instead of insisting on informed consent, we suggest that the focus should be shifted towards two other ethically relevant elements in human experimentation: risk assessment and selection of research subjects. When reviewing protocols in which a waiver of consent is deemed necessary, the Ethical Review Board should ensure that non-therapeutic risks are minimal, that the research is specifically designed to benefit critically ill patients, and that it cannot be conducted under circumstances where an informed consent can be obtained. If the European Directive is changed accordingly, this permits clinical trials in critical care settings, while adequate protection from risky non-therapeutic procedures is ensured and exploitation of the patient as an easily accessible research subject is prevented.     

Research on informed consent: investigator-developed versus focus group-developed consent documents, a VA cooperative study

In the Department of Veterans Affairs Cooperative Study (VACSP) #470, A Randomized, Multicenter, Controlled Trial of Multi-Modal Therapy in Veterans with Gulf War Illnesses, a substudy was designed with the primary objective of comparing the utility of an informed consent document developed by a focus group of Gulf War veterans (focus group-developed) to an informed consent document developed by the standard process involving the study investigators (investigator-developed). In December 1998 a focus group of five Gulf War veterans convened at the coordinating center and developed a consent document during three sessions. The focus group used the investigator-developed consent document as a "starting point" and then modified it by consensus agreement. They also reviewed and modified the substudy's assessment questionnaire. Utility will be evaluated in 1092 veterans participating in the parent study, VACSP #470, by directly comparing selected patient-centered outcomes between those receiving the focus group-developed consent document versus those receiving the investigator-developed document. The primary outcomes to be evaluated over a 1-year follow-up period include measures of the informed consent process, such as patient recall, expectations about risks and benefits of participation, and understanding about the voluntariness of consent. Secondary outcomes will assess the impact of the substudy on the parent study with respect to recruitment and adherence. VACSP #470 was initiated in May 1999 in 20 sites that were randomly allocated to use either the focus group-developed or investigator-developed consent document. Sites are unaware of the type of consent document assigned. This article focuses on the rationale and design of the informed consent substudy and also discusses potential ethical issues.     

Perceptions of informed consent in the care of elderly people in five European countries

The focus of this article is on elderly patients' and nursing staff perceptions of informed consent in the care of elderly patients/residents in five European countries. The results suggest that patients and nurses differ in their views on how informed consent is implemented. Among elderly patients the highest frequency for securing informed consent was reported in Finland; the lowest was in Germany. In contrast, among nurses, the highest frequency was reported in the UK (Scotland) and the lowest in Finland. In a comparison of patients' and nurses' perceptions, nurses had more positive views than patients in all countries except Finland. Patients with less need for nursing interventions in Greece and Spain gave their consent less often. The German and Greek patients were older, and the results also point to an association between this and their lower frequency of giving consent. In Spain, patients who were married or who had a family member or friend to look after their personal affairs were more likely to be included in the group whose consent was sought less often. This is the fourth of a set of five articles published together in this issue of Nursing Ethics in which the results of this comparative research project are presented.     

Informed consent and the elderly. An ethical challenge for critical care nursing

Nursing ethics was long reticent about ethical challenges that elderly patients pose for critical care nursing. One of these, the legal doctrine of informed consent, has important implications for critical care nursing ethics. Deriving from the principle of respect for persons and intended to preserve their autonomy, informed consent represents both a duty and an ideal for care givers to implement in the process of ethical decision making. All too often the ideal is lost, however, and the doctrine reduced to a sterile and bureaucratic procedure. When elderly patients are unable to give an adequately informed consent, advance directives can enable them to express their wishes by prior choosing. If they become cognitively impaired, however, it is much more difficult to determine what, if any, preferences such a patient might express if able to do so. Medical empowerment of the elderly, a laudable social goal, can be as contradictory as informed consent itself and many elderly patients may opt out of their own decision making. The resultant moral distress of such a complex process is still another ethical challenge that faces the critical care nurse. Because nursing holds a position of moral centrality among the health care professions, critical care nurses cannot avoid the prospect that issues like those identified in this article will continue to challenge and confront them in the coming decade. By turning to colleagues in nursing as well as other professions, nurses can best strengthen and consolidate their vital role as mediators of meaning and morality in life-and-death situations.     

Applying the principles of informed consent to patient care. Legal and ethical considerations for physical therapy

This paper presents legal and ethical considerations regarding informed consent for the evaluation and treatment of patients in physical therapy practice. Therapists traditionally think of informed consent in relation to clinical research, but as the trend toward independent practice and private practice increases in physical therapy, the physical therapist must understand the process of informed consent in relation to patient care. Legal concepts of battery, self-determination, and the fiduciary relationship create a legal foundation for informed consent. The patient's moral right to self-determination and the corresponding duty of health professionals to "do no harm" create a strong moral basis for gaining a patient's informed consent. Practical suggestions are offered to physical therapists to help them assess their need for obtaining informed consent.     

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.     

Informed consent: The ultimate right

Understanding the informed consent process permits the nurse to advocate for patient care safety and to promote good ethical and legal practice. This article has identified and highlighted the importance of the informed consent process. It is the ultimate right of all individuals, and the patient with a psychiatric illness is no less deserving of this ultimate right.     

13 Knowledge Translation Shift

Health care providers have demonstrated difficulty in adopting the latest information into their clinical practice patterns. This gap in "Knowledge Translation" (KT) is currently under broad discussion within the medical community and was the focus of SAEM's Consensus Conference in 2007. In an effort to bridge this gap, we implemented a novel "KT shift" for our PGY-2 residents. PGY-2 emergency medicine (EM) residents are required to work a nine hour KT shift during their scheduled EM rotation at one of two large urban training emergency departments (EDs). This shift has reduced patient responsibilities to allow for the development of clinical queries that are answered by searching for the best evidence to be applied to patient care. This process is summarized on a "KT Shift Log" that records the PICO question, databases searched, and level of evidence found to answer clinical questions. KT shift log sheets and search strategies are reviewed by EM faculty with expertise in evidence-based medicine and KT principles. We believe that the implementation of a KT shift will improve residents' ability to obtain high quality evidence to answer real-time clinical questions. This may serve as an important measure in closing the knowledge to practice gap.     

精神障碍患者麻醉知情同意的临床伦理分析

在临床实践中，麻醉技术的知情同意仍是麻醉学科的独特领域，但麻醉科医生轻视精神障碍患者的知情同意成为临床工作的薄弱环节。在人类原始道德本能的加持下，基于对精神障碍患者同情的道德关怀，代理同意被认为有利于患者，但现实中存在多种因素制约患者在麻醉知情同意上享有权利。在医患共同决策医学模式下，应尽可能让轻症精神障碍患者参与知情同意过程，其提供信息的深度和广度取决于患者的自知力。获取精神障碍患者麻醉知情同意的路径尚待优化，可通过多学科合作等多种方式，达到患者真正知情同意，保障精神障碍患者的合法权益。     

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.