Teaching the informed consent process to residents

We believe the focus and emphasis of this committee on informed consent is unique, and that the development of an informed consent teaching process for residents will focus on the moral and ethical issues regarding informed consent. Even more important, we believe we will emphasize the patient care aspects of informed consent and also teach residents their responsibilities for long-term patient care with regard to patients' satisfaction and understanding of their disease process.     

National efforts to improve the informed consent process

OBJECTIVES: To inform oncology nurses about several national efforts to improve the informed consent document and process. DATA SOURCES: A federally funded grant program to stimulate research of informed consent, an initiative from the National Cancer Institute to improve informed consent documents in cancer clinical trials, and a model consent document developed by the National Action Plan on Breast Cancer. CONCLUSIONS: These initiatives assist investigators and institutional review boards in presenting relevant and understandable information to potential clinical trial participants. IMPLICATIONS FOR NURSING PRACTICE: These national efforts will raise awareness of providing potential research participants with clear information to assist them in making an educated, informed decision.     

The process of obtaining informed patient consent

Obtaining patients' consent for procedures and operations is not simply a question of getting them to sign a form. It is a process that enables health professionals to explain to patients what is going to be done to them. It should inform them of the risks and benefits of any proposed procedures, and of any alternatives that might be available. It demonstrates respect for patient autonomy and should help to prevent legal action against health professionals.     

The nurse's role in the informed consent process

OBJECTIVES: To review the informed consent process in relation to oncology nursing roles and responsibilities, patient comprehension, cultural sensitivity, and qualitative methodologies. DATA SOURCES: Scientific and review articles, regulatory documents, and texts relating to informed consent. CONCLUSIONS: Nursing is involved in almost every aspect of the informed consent process. To be effective, nurses must be knowledgeable about fundamental concepts associated with informed consent and corresponding responsibilities and willing to address the complexities of the informed consent process. IMPLICATIONS FOR NURSING PRACTICE: Situations related to informed consent provide challenges and opportunities for professional growth. Keeping abreast of the evolving standards and concepts of informed consent enhances the essential roles that nurses play in clinically based research.     

Barriers to informed consent

OBJECTIVES: To provide oncology nurses with a review of barriers that may limit the ability of adults to provide informed consent. DATA SOURCES: Published articles, research studies, and review articles pertaining to informed consent and clinical research. CONCLUSIONS: Patient-centered barriers to informed consent (such as age, education, and illness) and process-centered barriers (such as content and readability of the consent form, timing of discussion, and amount of time allotted to the process) can affect an individual's ability to provide substantial informed consent. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses must be aware and knowledgeable of the various barriers to informed consent to minimize these barriers and to improve and facilitate the informed consent process.     

Approaches to informed consent

Informed consent (IC) is an indicator, or a pivotal point, in broader and more fundamental questions dealing with the way clinical experimentation and, more specifically, randomized controlled trials (RCTs) relate to routine clinical practice; the rules that characterize the doctor-patient relationship; the self-perception of medicine with respect to its capacity, duty, and autonomy in the production of new knowledge; and the role of medicine in society. The asymmetry of knowledge and power that characterizes the usual relationship between care providers and patients does not resolve when something experimental enters the relationship. The real world of clinical investigation is not uniformly distinct from clinical practice. Experimentation is more appropriately considered a continuum with respect to appropriate or recommended care. Fundamental patient rights come first and are more binding than compliance with procedures and regulations. The view that IC is the most important component of the “ethical” aspects of experimentation is highly misleading. The responsibility to foster well-informed decisions shapes the contents, the timing, the validity, and the credibility of IC. Documented, evaluable decisions are the natural substitute for individual IC when the patient is not able to handle information autonomously. Positive examples of IC practices and approaches suggest that IC may be important in improving the way medicine responds to its responsibilities and communicates with society.     

A strategy for learning principles and elements of informed consent

Nurses frequently provide potential study participants with informed consent forms and information regarding involvement in research studies However, there is little information in the nursing literature that emphasizes how to evaluate informed consent documents for appropriateness. The authors present an instructional project for critiquing informed consent documents for content, clarity, readability, and conciseness.     

Improving understanding of the informed consent process and document

OBJECTIVES: To review theoretical perspectives relating to the communication of informed consent and to describe research efforts and strategies to enhance the informed consent process and document. DATA SOURCES: Research studies review articles, education and communication models, and NCI National Working Group on Informed Consent Recommendations. CONCLUSIONS: Information communicated during the informed consent process is difficult to understand, raising ethical concerns about whether informed decision-making has taken place. Empirical research focuses on the nature of patient-provider interactions and the effectiveness of various delivery systems, a need exists to overcome conceptual and methodologic limitations. IMPLICATIONS FOR NURSING PRACTICE: Nurses must ensure that patients understand informed consent information. Several communication strategies are posited.     

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.     

Knowledge and beliefs of nurse researchers about informed consent principles and regulations

We examined differences in the knowledge and beliefs that exist among nurse researchers in the USA (n = 119) regarding informed consent and the use of data from patients' medical records. Using a mail survey, two domains of ethical knowledge and beliefs were assessed: the legal right to privacy and the moral right to privacy. More than half of the participants were very confident in their knowledge of institutional review board procedures, research ethics, informed consent, the legal right to privacy, and the moral right to privacy. In contrast, most rated themselves as uncertain about US federal research regulations and there was wide variation in knowledge about current federal guidelines. Those who were more confident in their knowledge of or had more practical experience with research ethics, were no more likely to answer correctly a question about current federal guidelines regulating the use of patient data from medical records than those who reported less confidence or experience.     

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.     

Bioethics and informed consent in American health care delivery

Bioethics is a multi-dimensional discipline. The traditional aspect being medical ethics, a branch of Western philosophy which, since the time of Hippocrates, has sought to formulate rules of proper conduct for physicians. Ethics and informed consent are interrelated issues. Consent is the central issue on which hangs most of the ethical problems in human experimentation. The informed consent of the human patient is the ultimate protection from the hazards of research and therapy in medicine, the basic premise of this being that every human being has the right to determine what shall be done to his own body. The patient must have full prognosis, complications, sequelae, discomforts, costs, inconveniences, risks and expectations. Medically and ethically what should the patient be told? There appears to be no obvious format, but the patient should be told enough to allow him to make a rational decision. This paper contains an analysis of the reactions of just a few American nurses to this dilemma. The nurse who attempts to use only her scientific training to determine ethical conduct is in a quandary because seldom is there empirical evidence available to support her decision, no matter what it is.     

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.     

Using decision aids may improve informed consent for research

This commentary argues that the existing approach towards obtaining informed consent for clinical research may be improved by using decision aids. Problems with the current approach include i) an emphasis on documentation to the detriment of good quality decision-making; ii) ad hoc rather than theory-based research studying how to improve informed consent; and iii) a lack of clarity around what is meant by ‘comprehension’ and how to measure it. Decision aids, which clearly improve patient treatment decisions but are new to decisions surrounding study participation, have strengths in precisely the areas where the informed consent literature is weak. Decision aids facilitate a process of decision-making, combining clear documentation, exercises to facilitate decision-making, and consultation. They are increasingly informed by theory and clear, empirically-derived standards. Furthermore, decision aid research has clearly defined and operationalized three indicators of good quality decision-making in situations where there is no objectively correct answer: demonstrable knowledge of key aspects of the decision, accurate perceptions of the probabilities of various outcomes, and a match between preferred outcomes and the choice made. We identify outstanding issues and propose a research approach that will determine whether the use of decision aids can improve the informed consent process.     

患者对知情同意权的认知、态度及知情同意权实施现状的调查

目的:了解住院患者对知情同意权的认知、态度及患者知情同意权的实施现状、实施中患者的心理感受。方法:于2006-03/07在石河子大学医学院第一附属医院采用问卷调查的形式对临床内科、外科六大科室新入院患者进行知情同意权的认知、态度调查(简称问卷1)以及知情同意后的实施现状调查(简称问卷2),并将两份问卷的相关内容进行比较。结果:问卷1收回有效问卷250份,问卷2收回有效问卷225份,故实际有效问卷225份,有效率90%。①问卷1调查结果显示,只有22.2%的患者明确认识到自己享有知情同意权,82.7%的患者希望了解自己的疾病情况,如果病情严重,有65.8%患者认为可直接告知自己,而且大部分患者希望由医务人员口头告知,希望非常详细了解疾病信息者有41.3%。②问卷2调查结果显示,在本人参与签署知情同意表格的114人中,仅有34.2%的患者记得表格的相关内容,16.7%的患者在签署之前仔细阅读了表格内容;有84.4%的患者获得了疾病信息,主要通过医务人员口头方式告知,能够较详细地了解疾病信息者占16.8%。③两份问卷相关内容的比较结果显示,在是否知道病情与首先由谁来知道的问题上,患者的态度与实际实施状况是一致的,没有统计学差异(P>0.05),而在家属是否知情、患者如何得知病情、以什么方式知道、知道哪些疾病信息等问题上患者的态度与实际实施状况不一致,差异有显著性(P<0.05)。结论:从患者对知情的期望水平来讲,并不是所有的患者都期望或有能力了解非常详细的疾病信息,应根据患者及家属的需求来提供相应的疾病信息;从知情同意的实施现状来看,其实施现状并不理想,与患者的期望还有一定的差距,仍需医院及医务人员继续努力。