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

https://doi.org/10.1016/j.cct.2006.10.011Get rights and content

Abstract

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.

Introduction

Parental understanding of the key elements of pediatric clinical trials and informed consent is critical for a truly informed decision about participation in a clinical trial. However, previous research suggests limitations in parental understanding of aspects of informed consent [1], [2]. Understanding of information regarding pediatric leukemia trials is expected to be gained through both reading consent documents and discussions with physicians during consent conferences. Thus, it is critical to examine how the consent document is used during consent conferences for pediatric leukemia trials and to what extent the use of the document relates to parental understanding of research.

Reading an informed consent document is an important component of the consent process because it presents essential, but often difficult, elements of clinical trials that parents are expected to understand, such as risks and benefits of participation, voluntariness, confidentiality, and differences between clinical trials and off study therapy. The utility of the consent document is based on the assumption that parents are able to read and comprehend consent documents. However, this assumption has been challenged by the results of a number of studies that have indicated that reading levels of most consent documents for clinical trials are well above the recommended reading level of 8th grade or lower [3], [4]. These findings suggest that many parents may have difficulty reading and understanding the language in consent documents. Consistent with this notion, the literature suggests that many parents have a poor understanding of consent documents [5], [6]. This is particularly noteworthy given the value that institutional review boards (IRBs) place on the consent document. However, it has been suggested that consent documents are more effective at legally protecting institutions than adequately informing research participants about participation in clinical trials [7]. Nonetheless, many previous studies of consent documents have measured general understanding of informed consent but have not assessed the relationship between reading consent documents and parental understanding of the essential elements of informed consent for pediatric cancer trials. Furthermore, most studies have examined consent documents without consideration of the use of the document within the context of informed consent conferences.

One exception is Kodish et al.'s [2] study in which parents who reported reading consent documents had a better understanding of randomization in research on the treatment of pediatric leukemia than those parents who did not. In addition, in an examination of the stability of parental understanding of randomization in this sample, Greenley et al. [8] reported that parents who read the consent document were more likely to show understanding of randomization over time. However, to our knowledge, a number of other essential elements of understanding of informed consent have not been examined as correlates of reading consent documents in pediatric leukemia trials, including the voluntary nature of clinical trials, the right to withdraw, and differences between off study therapy and participation in a clinical trial.

In addition to examining the role of the consent document itself, it is also important to consider the way in which consent documents for pediatric clinical trials are presented. For example, the consent document may be explained or read to research participants. However, to our knowledge, data regarding presentation and explanation of consent documents have not been examined as correlates of parental understanding of informed consent for pediatric leukemia trials.

To address these scientific needs, the purpose of the current study was to expand upon the current research on informed consent for pediatric leukemia trials by examining both the use of the consent document during the informed consent conference and the extent to which parents' reading of consent documents is associated with better understanding of key elements of informed consent. Specifically, it was predicted that reading the consent document and physician explanation of the consent document would be associated with better understanding of voluntariness, the right to withdraw participation, and being able to distinguish clinical trials from off study therapy.

Section snippets

Procedure

A thorough description of the methods used in the current study is described elsewhere by Kodish et al. [2]. This NCI-funded study entitled Informed Consent in the Children's Cancer Group (CCG-S9901) examined the informed consent process for participation in randomized clinical trials (RCTs) for treatment of pediatric leukemia. Participants were recruited from six CCG institutions that routinely treat children with acute leukemia. The study was approved by the Institutional Review Board at each

Observer description of clinician use of the consent document

Table 1 provides descriptive information regarding the management of the consent document by clinicians. Observations during consent conferences revealed that informed consent documents were furnished during 95% of consent conferences. In addition, observer ratings indicated that 74% of clinicians explained the consent document during the consent conference, while 26% did not. However, the meaning of signing the consent document was explained by only 26% of clinicians. Observer reports also

Discussion

The findings of the current study expand upon previous research by utilizing both participant report and researcher observations during consent conferences to examine the use of the consent document and its relation to understanding of key elements of informed consent for pediatric leukemia trials. The use of observational data in the current study provides the critical methodological advantage of reducing bias inherent in participants' report of their behavior during consent conferences.

Acknowledgements

This research was conducted as a limited-institution study in the Children's Cancer Group (CCG-S9901) and funded by the National Cancer Institute RO1 CA83267. We would like to thank Michelle Eder and Stephen Zyzanski for review of earlier drafts of this manuscript (ME and SZ) and assistance with data analyses (SZ).

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