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Coerced consent in clinical research: study protocol for a randomized controlled trial.

Connor T A Brenna1,2, Nancy Walton3, Melanie Cohn4

  • 1Department of Anesthesiology & Pain Medicine, University of Toronto, Toronto, ON, Canada. connor.brenna@mail.utoronto.ca.

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|July 4, 2024
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Summary

This study investigates same-day versus advance consent for anesthesia research, finding no evidence of coercion. This research aims to improve clinical trial recruitment by addressing ethical concerns in anesthesia and related fields.

Keywords:
Clinical trialsCoercionPerioperative researchResearch consentVoluntariness

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Area of Science:

  • Anesthesiology
  • Clinical Trials
  • Informed Consent

Background:

  • Same-day consent for anesthesia research is often restricted due to ethical concerns about patient vulnerability and decision-making capacity.
  • Anesthesiology and related fields frequently involve brief patient encounters on the day of surgery, limiting opportunities for advance consent.
  • Existing literature does not support concerns of coercion with same-day consent, yet it remains a barrier to research participation.

Purpose of the Study:

  • To examine the voluntariness of patient consent for anesthesia research when solicited either in advance or on the same day as surgery.
  • To address the significant obstacle that same-day consent restrictions pose to clinical researchers and patient participation in studies.

Main Methods:

  • A prospective randomized controlled trial protocol is described.
  • 114 patients undergoing ambulatory anterior cruciate ligament repair will be randomized to consent either pre-operatively or on the day of surgery.
  • Participants will complete a post-operative questionnaire assessing perceptions of undue influence in the informed consent process for a fabricated study.

Conclusions:

  • The study aims to inform trial design and practice guidelines regarding the time needed for patients to make informed decisions about research participation.
  • Findings are expected to impact trial recruitment strategies in settings with limited patient-clinician interaction time.
  • This research will provide evidence to potentially ease restrictions on same-day consent in clinical anesthesia research.