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.     

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.     

ICU research: the impact of invasiveness on informed consent

Purpose

Studies into the preferences of patients and relatives regarding informed consent for intensive care unit (ICU) research are ongoing. We investigated the impact of a study’s invasiveness on the choice of who should give consent and on the modalities of informed consent.

Methods

At ICU discharge, randomized pairs of patients and relatives were asked to answer a questionnaire about informed consent for research. One group received a vignette of a noninvasive study; the other, of an invasive study. Each study comprised two scenarios, featuring either a conscious or unconscious patient. Multivariate models assessed independent factors related to their preferences.

Results

A total of 185 patients (40 %) and 125 relatives (68 %) responded. The invasiveness of a study had no impact on which people were chosen to give consent. This increased the desire to get more than one person to give consent and decreased the acceptance of deferred or two-step consent. Up to 31 % of both patients and relatives chose people other than the patient himself to give consent, even when the patient was conscious. A range of 3 to 17 % of the respondents reported that they would accept a waiving of consent. Younger respondents and individuals feeling coerced into study participation wanted to be the decision makers.

Conclusions

Study invasiveness had no impact on patients’ and relatives’ preferences about who should give consent. Many patients and relatives were reluctant to give consent alone. Deferred and two-step consent were less acceptable for the invasive study. Further work should investigate whether sharing the burden of informed consent with a second person facilitates participation in ICU research.     

Assessing readability and comprehension of informed consent materials for medical device research: A survey of informed consents from FDA's Center for Devices and Radiological Health

Legally effective informed consent has been a long-standing requirement for FDA-regulated clinical studies. However, informed consent forms (ICFs) are often thought to be too long, too complex, and too difficult for participants to understand. In this article, investigators from the FDAs Center for Devices and Radiological Health (CDRH) surveyed 399 ICFs from approved investigational device exemption (IDE) applications for fiscal years 2015 and 2016 to evaluate the readability of ICFs.The investigators collected data from the ICFs, using variables related to structure, readability, and comprehension.The investigators found that the mean grade-reading levels of the ICFs ranged from 10th grade to college level (Table 2), higher than the recommended 6th to 8th grade level, when measured by major readability evaluation tools (the SMOG readability grade level formula, the Flesch-Kincaid Index Grade Level Readability Formula, the Flesch Reading Ease test, and the Dale-Chall readability formula).Overall, the ICFs and informed consent (IC) processes, as described in the IDE application, lacked components that enhanced participants' comprehension, such as short sentences (e.g., no more than 8 to 10 to words) and the use of pictures, tables, and diagrams.CDRH investigators believe that information about ICFs' readability, comprehension, and structure will help support current and future efforts to improve the IC process. The intent of the article is to demonstrate that improvements are needed in the IC process and to encourage clinical trial stakeholders to consider implementing those approaches that optimize patient comprehension in the development of their IC processes.     

The concept of informed consent in qualitative research

Informed consent is an essential part of all research endeavors that involve human participants. The human rights of research participants must be protected. It is incumbent upon the qualitative researcher to provide a dynamic informed consent when study outcomes change. The violation of privacy is more apt to occur with in-depth interviews, which has implications for researchers to protect human rights throughout data collection, analysis, and dissemination.     

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.     

Evaluation of informed consent in health research: a questionnaire survey

Scand J Caring Sci; 2010; 24; 56–64
Evaluation of informed consent in health research: a questionnaire survey Objective: Informed consent is ethically and legally required for all biomedical and health research involving human participants. This study analyses the realization of informed consent in health research from the point of view of healthy, voluntary adult participants. Empirical studies from this point of view are still rare. Design: A population‐based questionnaire survey. Participants:  The study population consisted of 1410 men and women aged 57–78 years who are participants in a randomized controlled intervention trial on the effects of physical exercise and diet at Kuopio Research Institute of Exercise Medicine (eastern Finland). Methods:  The data were collected in 2005–2007 using a questionnaire. The questionnaire was given to all able and willing participants (n = 1324) who were still involved in the exercise and diet study at the 3‐month intervention visit. The response rate was 91%. Results: The defined key elements of informed consent were information, understanding, competence, voluntariness and decision‐making. A majority of the participants estimated that these key elements were successfully realized in the exercise and diet intervention study. Conclusions: Despite the general satisfaction with the informed consent process in the exercise and diet intervention study, a minority of the participants were dissatisfied with the information they had received or did not understand this information completely. These findings highlight the essential question: Did all of the participants truly give their genuine informed consent? This carefully executed study reveals objectively the difficulties in distribution of information to healthy adult volunteers.     

The problem of informed consent in emergency medicine research

The CRASH Trial (Corticosteroid Randomisation After Significant Head injury), which started in April 1999 hopes to answer the question of whether or not there is any benefit to giving high dose corticosteroids after significant head injuries. To do this patients are randomised to receive either the standard care for head injuries, as defined by the receiving hospital, or standard care plus a 48 hour infusion of corticosteroids. This is to be started within eight hours of injury, preferably as soon as possible. As all eligible patients will have a reduced level of consciousness informed consent has been deemed unnecessary. In this review the issue of consent in human experimentation is presented with a special emphasis on the problems faced in emergency medicine research, and the way these have been tackled.     

The ethical foundation of informed consent in clinical research

OBJECTIVES: To provide a foundation for understanding the ethical concept of informed consent with particular emphasis on the characteristics and principles that make it a moral imperative. DATA SOURCES: Government reports, published articles, and book chapters from the ethics literature. CONCLUSIONS: Informed consent is central to the conduct of cancer clinical trials and good patient care. It is a thoughtful, collaborative process whereby an individual gives autonomous authorization and the decision of the individual is respected by the health professionals. IMPLICATIONS FOR NURSING PRACTICE: Understanding the theory and practice of informed consent is an essential aspect of the nurses role. There are many challenges to this process in the oncology setting because of the severity of the diseases and the complexity of the research, and nurses must be prepared to assure that informed decision-making takes place.     

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.     

Patient advocacy: witnessing informed consent for research in acute care.

Two views exist about witnessing informed consent for research in acute care settings: nurses witness a signature, and nurses witness the informed consent itself. Nurses are obligated to fulfill legal responsibilities and ethical expectations because of their role in the clinical arena, and to serve as advocates for patients to be informed, willing research participants. This role promotes change in institutional policies to keep up with the changing face of research.