Description of the types and content of phase 1 clinical trial consent conversations in practice

Clinical Trials : Journal of the Society for Clinical Trials
Louisa WallRebecca D Pentz

Abstract

All agree that informed consent is a process, but past research has focused content analyses on post-consent or on one conversation in the consent series. Our aim was to identify and describe the content of different types of consent conversations. We conducted a secondary analysis of 38 adult oncology phase 1 consent conversations, which were audio-recorded, transcribed, coded, and qualitatively analyzed for type and content. Four types of consent conversations were identified: (1) priming, (2) patient-centered options, (3) trial centered, and (4) decision made. The analysis provided a robust description of the content discussed in each type of conversation. Two themes, supportive care and prognosis, were rarely mentioned. Four themes clustered in the patient-centered (type 2) conversations: affirmation of honesty, comfort, progression, and offer of supportive care. We identified and described four types of consent conversations. Our novel findings include (1) four different types of conversations with one (priming) not mentioned before and (2) a change of focus from describing the content of one phase 1 consent conversation to describing the content of different types. These in-depth descriptions provide the foundation for fu...Continue Reading

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Citations

Jun 30, 2016·Clinical Trials : Journal of the Society for Clinical Trials·Carmen Radecki BreitkopfAminah Jatoi
Mar 2, 2019·Clinical Trials : Journal of the Society for Clinical Trials·Rami TadrosSepehr Shakib
Sep 21, 2018·Therapeutic Innovation & Regulatory Science·Ed KellarBrett Wilson
May 11, 2017·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Sarah B GarrettDaniel Dohan

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