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Ensuring that our families are truly informed: Considerations for consent in pediatric transplantation

The importance of informed consent when approaching parents in pediatric transplant settings about research, especially when medical stability has yet to be achieved, is at the heart of this issue’s paper by Dreyzin et al. (1). In this study, the authors importantly examined parent perspectives on whether or not to participate in a phase 1 hepatocyte transplant trial. Families were offered this option while waiting for a liver transplant and assured that participation would not affect their standing on the wait-list. Participants in the present study included six families who were approached about the trial (five participated and one declined). Interestingly, 10 other families declined participation and did not agree to complete this interview. Additionally, 10 families who would have been eligible while waiting for, and ultimately did receive, a liver transplant were included to determine their hypothetical considerations. Overall, the results of qualitative analyses suggested consistent areas of confusion that the authors suggest could have “adversely” affected trial participation and if addressed, could improve decision making. Perhaps a critical prerequisite to decision making from both an ethical and patient-centered standpoint is consideration of how to improve informed consent procedures under such difficult circumstances. The field of pediatric oncology contends with this situation frequently and a great deal of research reveals the complexities of this process according to different stakeholders. For example, a population-based survey administered to over 1400 parents in Germany identified from the German Childhood Cancer Registry examined parent recall of and satisfaction with the informed consent process for clinical trials (2). Data were indicative of troubling inadequacies (e.g., 14% of respondents did not recall if they were in a trial and 3% reported incorrect recall of this; only 71% remembered providing written consent). Overall, 79% felt adequately informed. It seems unacceptable that 21% were not. Findings were exacerbated in families with one or more foreign-born parents. Of great concern, this finding has been echoed and amplified in a United States sample with researchers finding that clinicians provide less information to minority and low socioeconomic status families, which in turn leads to less engagement with the informed consent process (3). Additionally, the blur between research and clinical care indicated in this issue’s paper was highlighted here as well, in that over 50% of respondents endorsed that receiving better treatment was their motive for participating. There are a myriad of reasons why the informed consent process may become muddled that are quite relevant to pediatric transplantation. These include parent emotional stress, the clarity of research protocols, and a sense of dependency on the treatment team (4). Parents are striving to make the best decisions for their child. In an incredibly taxing context, it can become extremely difficult to distinguish between choosing to participate in research and making decisions about treatment. Clinicians recognize the anxiety faced by parents in such circumstances (5); however, the informed consent process may not adequately relieve this anxiety and confusion experienced by parents. Physicians are expected to address what Appelbaum et al. (6) coined as “therapeutic misconception,” the incorrect beliefs held by study participants that their individual needs will be considered in the research protocol and that there is a high likelihood of direct benefit from participation. However, clinicians may not sufficiently address patient misconceptions during the