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• W2289442594 abstract "Informed consent is fundamental to ethical clinical practice and research. In the context of hematopoietic cell transplantation (HCT), informed consent struggles to meet its ideals of beneficence, justice, and respect for persons(1) given the severity of the disease and complexity of the treatment. As argued by D'Souza and colleagues in Bone Marrow Transplantation,(2) and as shown in other studies, including our own in the setting of pediatric HCT,(3) patient and caregiver expectations of consent are often left unmet in both adult and pediatric contexts. For example, participants enroll in studies with limited knowledge about what they are undertaking and find themselves involved in a rote, passive process that fails to inform and gets bogged down by legalistic language.(4) Consent is often requested under conditions characterized by duress. The medical urgency of HCT or associated treatments that are experimental often blurs the line between treatment and research, even from the clinicians’ perspective. Furthermore, miscommunication or misunderstanding is almost inevitable because the paper forms are overwhelmingly lengthy and complex.(5)Greater simplicity in terms of readability and length is a major goal of recent and forthcoming policy regarding informed consent. For example, the NCI’s Office of Human Research Protection and FDA developed a joint consensus in the “Development of Informed Consent Documents for Cancer Clinical Trials” for less complicated informed consent documents,(6) and the BMT CTN recently published new recommended guidelines for consent forms.(7) The Notice of Proposed Rule Making (NPRM) that would update the Common Rule calls for greater standardization, simplicity, and readability of forms.(8)However, improving patients’ comprehension of what they are consenting to will not be achieved without equal attention to the process of obtaining consent. Universal consent forms will always fall short of meeting the goals of being patient-centered, complete, and fulfilling institutional and regulatory requirements because of the diversity of individual patient needs.(9) Pediatric HCT provides an excellent case example of the need for a more personalized, two-way approach that promotes patient and caregiver activation and utilizes principles of shared decision-making." @default.
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• W2289442594 date "2016-02-29" @default.
• W2289442594 modified "2023-10-06" @default.
• W2289442594 title "Innovating consent for pediatric HCT patients" @default.
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• W2289442594 doi "https://doi.org/10.1038/bmt.2016.10" @default.
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