Abstract
Background Four key challenges have been identified for the informed consent process in pediatric Bone Marrow Transplantation (BMT): 1. The information disclosed is complex, 2. parents are often under significant emotional duress, 3. life or death circumstances are perceived, and 4. there is often significant time pressure. The purposes of this study were A. to survey parental perceptions of the validity of the informed consent provided for their child’s BMT, B. to determine if the quality of the consent influenced hope, guilt, anxiety or stress.
Methods An information package and informed consent document were mailed to 67 English-speaking parents whose children underwent BMT and were prepared for transplant by one physician using a standardized template at the IWK Health Centre (Halifax, Nova Scotia, Canada) between 1998 and 2002. These parents represented the guardians of 36 children who had undergone BMT. Semi-structured interviews were conducted by phone or in person and audiotaped. Transcripts were independently analyzed for common themes by 2 reviewers.
Results Twenty parents (12 mothers and 8 fathers) of 12 children consented to participate in the study. Participants did not differ from eligible non-participants in indication for transplant, donor source, major complications, or death rates.
Elements of consent: (A) Freedom to Choose. All parents reported feeling personally compelled to consent, but denied external pressure to do so. All participants, including those whose children had died (n=5), would consent to BMT again. No parent reported questioning the validity of the informed consent for BMT. (B) Capacity to Understand. A minority of parents (n=5, 25%) reported diminished ability to understand the process, usually related to emotional duress at the time of consent. (C) Adequacy of Information. Most parents (n=15, 75%) stated directly that they felt fully prepared for the potential side effects of BMT. However, there were four reports of unexpected severity of side effects of therapy [excess hair growth (n=1), bleeding (n=1), and fatigue (n=2)] and 1 of an unexpected side effect (pneumonitis).
Emotional impact: 7 parents (35%) reported marked hopelessness during the disclosure process, although all parents expressed that they did not want false hope. 14 parents reported a direct relationship between hope and objective test results (ie daily complete blood count). Parents (n=18) reported peak stress leading up to BMT and the first 6 months post BMT. 18 parents noted ongoing, significant, stress at the time of the study, despite length of time from BMT (median 39 months). One parent reported experiencing guilt. All parents denied experiencing second thoughts with respect to the decision to consent. 8 parents reported heightened health vigilance for their child and increased stress with the appearance of minor health concerns (ie mosquito bites, bruises), or at the time of recheck, despite length of time post BMT. In addition to geographic isolation, all parents reported social isolation, sometimes severe, at the time of, and following BMT.
Conclusions Despite significant barriers to informed consent, no parent reported questioning the validity of the consent for BMT for their child. Hopelessness, social isolation and continuing high levels of stress related to the health of their child are frequently reported. Consent conferences and ongoing follow up should proactively address these issues for parents of children undertaking BMT.
Parental perceptions of the informed consent process in pediatric oncology clinical trials
