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Innovating consent for pediatric HCT patients

Bone Marrow Transplantation volume 51, pages 885–888 (2016)Cite this article

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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 persons1 given the severity of the disease and complexity of the treatment. As argued by D'Souza and colleagues2 in Bone Marrow Transplantation, 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 National Cancer Institute’s Office of Human Research Protection and Food Drug and Administration developed a joint consensus in the ‘Development of Informed Consent Documents for Cancer Clinical Trials’ for less complicated informed consent documents,6 and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) recently published new recommended guidelines for consent forms.7 The Notice of Proposed Rule Making that would update the Common Rule calls for greater standardization, simplicity and readability of forms.8

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Acknowledgements

SWC is an A. Alfred Taubman Institute/Edith Briskin/SKS Foundation Emerging Scholar and she is also supported by a grant from the National Institutes of Health (1K23AI091623). Additional support was provided for JP, DBT and SLRK from the National Institute of Child Health and Human Development, Grant Number 5-R01-HD-067264-02, Linking Community Engagement Research to Public Health Biobank Practice (Kardia, PI).

Author contributions

JP, DBT, SLRK and SWC designed the content, drafted and approved the manuscript.

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Authors and Affiliations

  1. Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI, USA

    J Platt

  2. Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, USA

    D B Thiel

  3. Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, MI, USA

    S L R Kardia

  4. Blood Marrow Transplantation Program, University of Michigan Health System, Ann Arbor, MI, USA

    S W Choi

  5. Department of Pediatrics and Communicable Diseases, University of Michigan Medical School, Ann Arbor, MI, USA

    S W Choi

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  1. J Platt
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Corresponding author

Correspondence to J Platt.

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The authors declare no conflict of interest.

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Platt, J., Thiel, D., Kardia, S. et al. Innovating consent for pediatric HCT patients. Bone Marrow Transplant 51, 885–888 (2016). https://doi.org/10.1038/bmt.2016.10

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