Evaluation of informed consent: a pilot study

AIM: This paper is a report of a study to describe and analyse the use of informed consent in clinical research, from the point of view of voluntary adult research participants, in order to develop and test an interview schedule for the evaluation of informed consent. BACKGROUND: Informed consent is one of the central ethical research principles in healthcare research, but empirical research on this topic is still scarce. To evaluate and develop the ethical quality of scientific research, there is a need to explore the meaning and implications of informed consent for research participants. METHOD: The data were collected in 2004 by interviews using an interview schedule created for this study by the first author and discussed in a multidisciplinary group. The response rate was 81%. The sample consisted of 32 patients with a metabolic syndrome who were participants in a project evaluating the effects of betaine on cardiovascular risk factors. FINDINGS: Participants stated that the key elements of informed consent are information, understanding and decision-making, and that competence is an essential factor in the reception and understanding of information and making an independent decision about participation. Our interview schedule was found to be useful in the investigation of informed consent. CONCLUSION: This study strengthened the perception that more extensive research about research participants is needed.     

The effects of local review on informed consent documents from a multicenter clinical trials consortium

There is increasing controversy about the appropriate role of the local institutional review board in the review of multicenter clinical studies. We evaluated the effects of the local review process at 25 study sites on the consent forms from two studies of the Tuberculosis Trials Consortium, a multicenter trials group. Two independent reviewers classified all changes made in the centrally approved consent forms; a third reviewer evaluated those changes if the two initial reviewers disagreed. The median time to initial local approval was 104.5 days (range 31-346). There were no changes in the study protocols as a result of local review. Consent forms became longer and less readable after local review, with a mean increase in grade level of 0.9 (+/-0.9) reading grade levels (p<0.001). A median of 46.5 changes (range 3-160) were made in the centrally approved forms. Most changes (85.2%) involved altering wording without affecting meaning. Errors were commonly introduced (11.2% of changes), and 33 of 50 (66%) locally approved consent forms contained at least one error in protocol presentation or a required consent form element. Local approval of two multicenter clinical trials was time-consuming and resulted in many changes in centrally approved consent forms. These changes frequently decreased readability and introduced errors.     

Research ethics, informed consent, and participant recruitment

PURPOSE/OBJECTIVES: This analysis explores ethical issues and challenges in participant recruitment. BACKGROUND/RATIONALE: The clinical nurse specialist (CNS) as researcher faces many issues and challenges, including ethical issues of informed consent. Balancing participant expectations of care with the research purpose is often challenging. DESCRIPTION OF THE ANALYSIS: This analysis synthesizes literature in key areas related to participant recruitment. Medline, CINAHL, and hand search techniques were used to collect relevant materials for this analysis. OUTCOMES: Key issues related to ethics and informed consent included readability of consent documents, education level, relationships between participants and health care providers, therapeutic misconception, and illness severity. Related issues include compensation of participants, recruitment of special populations, and the role of clinical research associate. INTERPRETATION/CONCLUSIONS: The CNS faces considerable ethical and logistical challenges in any research study. Strategies to support the CNS as researcher are available. IMPLICATIONS FOR NURSING PRACTICE: Increased awareness of ethical issues and challenges in recruitment is important for the CNS to creatively design strategies to enhance recruitment and retention in research studies.     

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。     

Research in critically ill patients: standards of informed consent

Patients in critical care lose their capability to make a judgement, and constitute a 'vulnerable population' needing special and reinforced protection. Even if the standard of informed consent is an essential way of demonstrating respect for the patient's autonomy, the usual informed-consent procedure is not as applicable as required or sufficient to warrant this ethical principle in critical care.     

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.     

Autonomy,privacy and informed consent 2: postnatal perspective

The nursing and healthcare ethics literature over the past 10 years has focused on issues of patient autonomy and patient rights. Despite the growing volume of literature exploring such topics, there is little empirical work investigating what is actually happening in clinical nursing or midwifery practice in relation to patient autonomy, privacy or informed consent, from the perspective of either patients or staff. This four-part series reports the results of a Scottish study that formed part of a multisite comparative research project funded by the European Commission, investigating issues of patient autonomy, privacy and informed consent. This article, the second of four, explores the issues of autonomy, privacy and informed consent in maternity care. The research questions asked were: (1) What is the perception of mothers' autonomy, privacy and informed consent in Scottish NHS hospitals, from the point of view of both mothers and midwives? (2) Are there differences in the perceptions of mothers and midwives on these issues? Data were collected by a self-completion questionnaire for mothers (n = 243) and staff (n = 170) on postnatal units in both district general and university teaching hospital. Results indicated that there are differences between the perceptions of mothers and midwives in relation to mothers' autonomy, privacy and informed consent. Most differences were found in the information-giving and decision-making elements of autonomy.     

Impact of detailed informed consent on research subjects' participation: a prospective, randomized trial

This study was undertaken to measure potential research subjects' participation in a survey research design, based on level and type of informed consent required before enrollment. In this prospective, randomized trial, 300 eligible Emergency Department participants were randomized to one of three groups: verbal consent (n = 100), limited written consent (n = 100), and detailed written consent with signature (n = 100). The consent was related to a self-administered patient satisfaction survey. The primary outcome was level of participation, where participation was categorized as full, limited, or refusal. Ninety-five percent confidence intervals (CI) constructed about proportions were used to assess differences in participation rates between the three consent groups. Among 300 participants, no demographic differences were found between groups for age or gender. Participants who were randomized to complete the detailed written consent had a significantly lower rate of full participation (72%) when compared to those randomized to verbal consent (85%; mean difference between groups 13%, 95% CI 2% to 24%) and to those with limited written consent (84%; mean difference between groups 12%, 95% CI 1% to 23%). Participants randomized to detailed written consent also had a significantly higher refusal rate (23%) when compared to those in the limited written group (12%; mean difference between groups -11%, 95% CI -21% to -1%). The length and type of informed consent required affected potential research subject participation in a survey research design. Participants who were asked to sign a detailed written informed consent document had a lower rate of participation compared to those with verbal or limited written consent.     

Autonomy,privacy and informed consent 4: surgical perspective

This is the fourth article in a four-part series that considers the issues of patient autonomy, privacy and informed consent. The article discusses these issues in the context of surgical patients and their nurses. There is an abundance of references to issues of autonomy and informed consent within the healthcare literature, although there are few empirical studies investigating these issues within practice. The issue of privacy has been somewhat less explored than that of autonomy or consent, particularly in the UK literature. This article reports the findings of a Scottish study that formed part of a multisite comparative study funded by the European Commission. A convenience sample of surgical patients (n = 282) and their nurses (n = 260) participated in the study. Data were collected by means of a self-completion questionnaire for both patients and nursing staff. Results indicated that there are significant differences in patient and staff perceptions on issues of patient autonomy, privacy and informed consent. However, the most marked difference in perceptions of patients and staff were found on the information-giving element of the autonomy subscale. Implications for nursing practice, education and research are highlighted.     

Heart transplantation without informed consent: discussion of a case

Objective: To discuss informed consent to heart transplantation in the case of an intensive care unit (ICU) patient: relatives' informed consent was refused by the patient himself whose cognitive ability appeared to be reasonable for the purpose. Setting: ICU of a university teaching hospital. Patient: a 62-year-old man who underwent myocardial revascularization had in the immediate post-operative hemodynamic instability, continuous serious arrhythmias, ventilatory support, fentanyl infusion. Heart transplantation could be the only chance for his survival. Intervention: heart transplantation. Results: despite patient's refusal, we decided to hold the relative's consent as valid, and transplantation was accordingly performed, to the subsequent satisfaction of the patient. Conclusions: Our decision was based on two beliefs: (1) the severity of the patient's clinical condition may have impaired his cognitive abilities; (2) the very same conditions may mask impairment and certainly make reliable assessment of cognition and judgment impossible. This being so, the preservation of life assumes priority. Received: 18 February 1997 Accepted: 18 December 1997     

French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase I biomedical research

The content of informed consent documents (ICD) is a crucial element in the process of providing information to participants in biomedical research. Clear comprehension of the information, i.e. the ability to understand its meaning and its consequences, is of utmost importance. The objective of this study was to describe the different steps in the French adaptation and preliminary validation of the Qualité de Compréhension des Formulaires d'information et de consentement (QCFic) questionnaire (http://www.lyon.inserm.fr/cic-grenoble) based on the American Quality of Informed Consent (QuIC) questionnaire. Adaptation and preliminary validation of the QuIC for use in France was composed of five principal steps: translation, scientific validation, lexical validation, edition of gold-standard answers and a pilot study. Each stage was conducted by independent groups of experts, under the coordination of the study board. Thirteen questions were added and one was suppressed. Two steps were required for the scientific validation and for lexical validation, 21 modifications were proposed. Relative to gold-standard answers, the three experts gave the same answer for 24 questions and for nine other questions, two of the three gave identical answers, which were validated by the study board. Results of a pilot study showed a global QCFic score of 88.99 (84.13-90.92) and no specific commentary was made about the content of the questions, so no more modification needed to be made. A preliminary validated French questionnaire, the QCFic, is now available to evaluate the quality of an informed consent document in phase I clinical trials. It is quick and easy to use.     

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.     

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.     

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.     

Autonomy,privacy and informed consent 1: concepts and definitions

This article is the first in a four-part series that explores the concepts of patient autonomy, privacy and informed consent in the context of the provision of nursing care. In this first article an overview of the concepts is provided, and some of the difficulties with definitions of these concepts are considered. The dearth of empirical exploration of the operationalization of the concepts of patient autonomy, privacy and informed consent within nursing practice is highlighted. The second, third and fourth articles report a series of empirical studies carried out with patients and staff in postnatal care, in continuing care of elderly people and in acute surgical care within Scottish NHS settings. These studies are part of a concerted effort to address the lack of empirical investigation of the ethical dimension of nursing care provision and clinical nursing practice.