Getting the Most out of Consent: Patient-Centered Consent for an Acute Stroke Trial

Neal W. Dickert, Kathleen Metz, S. Iris Deeds, Michael J. Linke, Andrea R. Mitchell, Candace D. Speight, Opeolu M. Adeoye

Research output: Contribution to journalArticlepeer-review

Abstract

Informed consent for clinical trials in acute stroke is characterized by challenges related to urgency, cognitive impairment, and geographical separation. Context-appropriate approaches are needed for this setting. We conducted a mixed-methods project involving focus groups and interviews as well as collaboration with a patient advisory panel and a central institutional review board (CIRB) to design and implement a patient-driven consent process for a multicenter trial incorporating adaptive randomization. Remote consent was recognized as challenging but acceptable. Adaptive randomization was viewed positively, but significant potential for misunderstanding was appreciated. Collaboration between the patient advisory panel and the CIRB resulted in a shortened, more patient-centered consent form that was approved at all sites with few modifications. An information sheet was developed as a resource for patients and surrogates after enrollment. Collaboration between investigators, patient partners, and a CIRB can facilitate innovation and implementation of patient-centered, context-appropriate consent strategies.

Original languageEnglish
Pages (from-to)33-40
Number of pages8
JournalEthics and Human Research
Volume44
Issue number2
DOIs
StatePublished - Mar 1 2022

Keywords

  • human subjects research
  • informed consent
  • institutional review board (IRB)
  • patient advisory panel
  • patient-centered consent process
  • stroke
  • stroke clinical trials
  • surrogate consent

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