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Clinical Trial Design

A qualitative exploration of the informed consent process in hematopoietic cell transplantation clinical research and opportunities for improvement

Bone Marrow Transplantation volume 52, pages 292–298 (2017)Cite this article

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Abstract

Informed consent (IC) struggles to meet the ethical principles it strives to embody in the context of hematopoietic cell transplantation (HCT). Patients often participate in multiple clinical trials making it difficult to effectively inform the participants and fulfill complex regulations. The recent Notice of Proposed Rule Making would make major changes to federal requirements, providing a timely opportunity to evaluate existing practice. Twenty health care professionals within a Midwest Academic Medical Center involved in obtaining IC in the HCT clinic or involved in patient care during or after the IC process were interviewed to understand: (1) how they approached the IC process; (2) how they described a ‘successful’ IC process; and (3) opportunities for innovation. Narrative and discourse analyses of interviews indicate that providers understand IC to be a collaborative process requiring engagement and participation of providers, patients and caregivers. ‘Markers of success’ were identified including cognitive, affective and procedural markers focusing on patient understanding and comfort with the decision to participate. Opportunities for innovating the process included use of decision aids and tablet-based technology, and better use of patient portals. Our findings suggest specific interventions for the IC process that could support the process of consent for providers, patients and caregivers.

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Acknowledgements

This work was supported by grants from the National Institute of Health (5R01HD067264-04 to JP and K23A1091623 to SWC) and the A. Alfred Taubman Medical Research Institute Emerging Scholar/Edith Briskin Shirly K. Schlafer Foundation Award (to SWC).

Author contributions

MR performed all the health care provider interviews. MR, SWC and JP designed the research and analyzed the data. MR wrote the manuscript and produced the figures and tables. JP and SWC also wrote, edited 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

    M Raj & J Platt

  2. Department of Pediatrics, Blood and Marrow Transplantation Program, University of Michigan Medical School, Ann Arbor, MI, USA

    S W Choi

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  1. M Raj
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  2. S W Choi
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  3. J Platt
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Correspondence to S W Choi or J Platt.

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The authors declare no conflict of interest.

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Raj, M., Choi, S. & Platt, J. A qualitative exploration of the informed consent process in hematopoietic cell transplantation clinical research and opportunities for improvement. Bone Marrow Transplant 52, 292–298 (2017). https://doi.org/10.1038/bmt.2016.252

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