The ethics of informed consent in pediatric cancer research are unique. First, unlike medical care for most other diseases of childhood, the majority of children with cancer receive treatment through participation in pediatric oncology research or in hospital settings in which such research is actively conducted (Ablett & Pinkerton, 2003; Aleksa & Koren, 2002; Bleyer, 2002; Ross, Severson, Pollock, & Robison, 1996). Second, for children with newly diagnosed cancers, decisions regarding entry into a clinical protocol typically occur soon after the family is informed about the initial diagnosis. Thus, in many instances consent to research participation occurs during one of the most stressful periods in a family’s life. Third, because treatment decisions must be made very quickly after the initial diagnosis, there may be little opportunity for patients or parents to understand or accept the nature of the disease at the time their consent to research participation is sought. Like other diseases of childhood for which treatments found efficacious for adults may be ineffective or toxic, the absence of pediatric research can deprive pediatric cancer patients of empirically valid therapies. Patient advocates and pediatric oncologists view the imperative of conducting pediatric cancer research with particular urgency because of the life-threatening nature of the disease and the adverse, and sometimes permanent, side effects of many current treatments. Thus, because the cancer patient’s immediate treatment needs are so entwined with the research imperative, a fourth unique aspect of informed consent to pediatric oncology research is that treatment and research goals may be blurred not only by patients and parents but also by investigators, clinicians, and other care providers (Kodish et al., 1998). Interpreting broadly worded federal regulations governing research involving children also provides challenges for developing patient- and family-appropriate consent procedures for pediatric oncology research. In most instances, federal regulations require that adequate provisions be made for soliciting the permission of parents/guardians and the child’s assent (the child’s affirmative agreement to participate in research) prior to conducting research involving children (Department of Health and Human Services, 2001, 45 CFR 46.408; Food and Drug Administration [FDA] 2001, 21 CFR 50.55).
Learning From Vulnerable Populations: Methodological Implications of Interviewing Individuals With Fetal Alcohol Spectrum Disorder
