The role of the consent document in informed consent for pediatric leukemia trials

PURPOSE: To examine both the use of the consent document during the informed consent process for pediatric leukemia clinical trials, as well as relationships between the use of the document and parental understanding of essential elements of informed consent. METHODS: Participants included 140 parents of children diagnosed with pediatric leukemia. Informed consent conferences in which randomized clinical trials were discussed were observed, audiotaped, and coded for specific behaviors. Parents were also interviewed within 48 h of their participation in informed consent conferences. RESULTS: Observations revealed that 74% of cases included explanation of consent documents during consent conferences. Parents who reported that they read the consent document were more likely to understand differences between the clinical trial and off study therapy and were more likely to understand the right to withdraw. Reading of the consent document was not associated with understanding of voluntariness. In comparison to racial/ethnic majority parents, racial/ethnic minority parents were less likely to report that they read the consent document, understand voluntariness or the right to withdraw, and were less likely to be able to distinguish between the clinical trial and off study therapy. Low SES was associated with a lower probability of reading the consent document and being able to distinguish between clinical trials and off study therapy. CONCLUSIONS: Attention to the importance of reading the consent document and improving communication during consent conferences is likely to enhance understanding of essential elements of informed consent.     

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.     

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.     

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 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.     

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.     

护士对知情同意及与之相对角色理解力的质性研究

知情同意是指病人对于自身疾病的一种自主性地了解以及自动地决定其健康状况的一种认知过程,包括拒绝和接受相应治疗的一种心理状态。在西方国家,知情同意属于个人自主性的范畴,并且表示个人能够根据自己的意愿决定自身行为的一种人生态度,在亚洲很多国家包括中国,受传统思想的影响,即便是一个成年人,家庭决定力更多的时候已经超过了病人本身的判断,家长式的作风在病人知情同意方面发挥了巨大的作用。     

Using principles of health literacy to enhance the informed consent process

THE LANGUAGE COMMONLY used in procedural/surgical consent forms often exceeds the average reading level of US patients, and many do not read the document before signing it.INCORPORATING READER-FRIENDLY language and formatting makes it more likely that patients will read the document, understand it, and therefore give informed consent. Adding “teach back” into the document provides a means of evaluating patient understanding.USING READER-FRIENDLY procedural/surgical consent documents merges the objectives of both health literacy and informed consent. AORN J 88 (July 2008) 23-29. © AORN, Inc, 2008.     

护士对知情同意及与之相对角色理解力的质性研究

知情同意是指病人对于自身疾病的一种自主性地了解以及自动地决定其健康状况的一种认知过程,包括拒绝和接受相应治疗的一种心理状态。在西方国家,知情同意属于个人自主性的范畴,并且表示个人能够根据自己的意愿决定自身行为的一种人生态度,在亚洲很多国家包括中国,受传统思想的影响,即便是一个成年人,家庭决定力更多的时候已经超过了病人本身的判断,家长式的作风在病人知情同意方面发挥了巨大的作用。     

Understanding informed consent

The failure of a physician to disclose all of the risks associated with an operative procedure is considered a breach of professional duty and, therefore, a negligent act. Consent for a procedure does not necessarily have to be written; however, signed forms provide written evidence of the patient's agreement. Documentation is essential, especially in cases where the consent form is incomplete or incorrectly filled out. Any concerns about a patient's consent or lack of consent should be discussed with the surgeon.     

Effectiveness of a writing improvement intervention program on the readability of the research informed consent document.

BACKGROUND: Problems with the comprehensibility of human research informed consent have been documented since the 1970s, and efforts aimed at rewriting consents have not been successful in consistently producing more readable consents. This study employed researched principles of reading comprehension research to create writing intervention program designed to help the research writer produce more comprehensible informed consent documents. The purpose of this study was to determine if this intervention program was effective. METHOD: The key component of the writing improvement intervention packet was a newly formatted consent form that contained annotated instructions for researchers on how to write each section for optimum comprehension. The resulting consent forms were evaluated using a Readability and Processability Form (RPF). The RPF is based on reading research and includes the Fry Scale, which yields an approximate grade reading level. The RPF assigned points to each of the 20 areas of comprehension analysis according to strict scoring criteria, and target scores were established by the authors in consultation with the hospital institutional review board. RESULTS: We evaluated 66 post-intervention informed consents. The mean readability and processability score was 62, resulting in the RPF classification of "good." The established readability and processability target range was good to excellent or 61-100 points; 66% of the forms scored in this range. In our 1995 pre-intervention study, the corresponding score was 12%. The target range for grade reading level was 8th grade: 53% scored in that range as compared with 4% in 1995. A question-by-question analysis of each of the 20 checklist items on the RPF identified important aspects of the consent writing that improved and others that were still weak and needed improvement. CONCLUSIONS: The Hartford Hospital writing improvement intervention program was associated with the production of more comprehensible informed consent documents. Using the intervention materials, investigators from a variety of departments could function independently to produce readable consent forms. This program may help others who wish to assist their research departments in creating consents that are written for optimal reading comprehension.     

Improving informed consent in clinical trials: a duty to experiment

Practitioners of clinical trials have a responsibility to ensure that patients' participation in research be informed and voluntary. This responsibility implies that we should strive continuously to improve the effectiveness of methods for informing prospective research volunteers about experimental studies, thereby enhancing the protection of their interests. We should test innovations in informed consent in realistic contexts (i.e., in clinical trials) and with randomization, when it is appropriate, at the first opportunity. In this study, we develop a preliminary proposal to improve the quality of informed consent, based on experimentation with informed consent in ongoing clinical trials. We discuss the conceptual, ethical, organizational, and technical bases for such an effort.