Coercion in Same-Day Research Consent

NCT07380035 | Completed

• 2 other identifiers: 2023-0007-E46twc
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

As a result of their unique practice patterns, many specialist physicians typically only meet patients on the date of an intervention such as surgery. However, some of the world's most prestigious academic centers do not allow research participants to be recruited on the same day as surgery. This is because of concerns, shared by researchers and research ethics boards, that patients may be too anxious or rushed to provide informed, voluntary consent immediately before an operation. This is not supported by evidence, and leads to potential inequities by restricting patients' opportunities to contribute to and benefit from research. The investigators undertook a randomized controlled trial incorporating deception to study the voluntariness of research consent provided by patients invited to enroll in a fabricated anesthesia research study at Women's College Hospital in Toronto, Ontario, Canada. Patients undergoing day surgery were randomized to receive research recruitment opportunities either days before surgery in the pre-operative assessment clinic, or on the surgical date. Post-operatively, patient's perceptions of undue influence or coercion in the consent process were examined with questionnaires and compared between these groups. This trial will help to design future perioperative studies, and will answer the important question of whether truly voluntary and informed same-day consent can be provided for participation in perioperative research.

Conditions

Consent of Patients; Coercion to Participate in Research

Keywords

Coercion; Voluntariness; Research consent; Clinical trials; Perioperative research

Outcome Measures

Primary Outcomes (3)

• Average score on combined modified coercion scales

  Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion.

  Measured on postoperative day one.

• Average Score on modified Iowa Coercion Questionnaire

  Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion.

  Measured on postoperative day one.

• Average Score on Modified Coercion Assessment Scale

  Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion.

  Measured on postoperative day one.

Secondary Outcomes (2)

• Rate of enrollment into the fictitious trial

  Measured when patients were approached with an invitation to participate in the trial. For patients in the Advance Consent Group this was, on average, preoperative day seven. For patients in the Day of Surgery Group this was postoperative day zero.

• Responses to individual items on the combined modified coercion scales

  Measured on postoperative day one.

Other Outcomes (15)

• Association between participant sex and average score on combined modified coercion scales

  Measured on postoperative day one.

• Association between participant sex and average score on the modified Iowa Coercion Questionnaire

  Measured on postoperative day one.

• Association between participant sex and average score on the modified Coercion Assessment Scale

  Measured on postoperative day one.

Study Arms (2)

Advance Consent

SHAM COMPARATOR

Patients in this group were presented with the opportunity for trial participation in advance of surgery, during preoperative assessment approximately one week prior in the Pre-Anesthesia Clinic. Recruitment took place via telephone during this pre-operative assessment, and followed all standard procedures for trial recruitment at Women's College Hospital.

Other: Invitation to Consent to Trial Participation

Day of Surgery Consent

EXPERIMENTAL

Patients in this group were presented with the opportunity for trial participation on the day of surgery, immediately before proceeding to their operation at Women's College Hospital. Recruitment took place in person at the bedside, and otherwise followed all standard procedures for trial recruitment at Women's College Hospital.

Other: Invitation to Consent to Trial Participation

Interventions

Invitation to Consent to Trial Participation OTHER

In this trial, the intervention being studied was the timing of an invitation to participate in a fabricated low-risk clinical anesthesia research trial. Patients were recruited into this fictitious trial either several days in advance of surgery, or on the day of surgery, and post-operative evaluations aimed to measure whether these groups experienced different degrees of coercion or voluntariness in their decisions to participate.

Advance Consent; Day of Surgery Consent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient scheduled to undergo ambulatory anterior cruciate ligament repair under general anesthesia with an adductor canal nerve block at Women's Colege Hospital
• Age ≥18

You may not qualify if:

• Inability to provide informed consent

Sponsors & Collaborators

• Women's College Hospital: collaborator
• University of Toronto: lead
• Toronto Metropolitan University: collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (1)

• Brenna CTA, Walton N, Cohn M, Siddiqui U, Huszti E, Brull R. Coerced consent in clinical research: study protocol for a randomized controlled trial. Trials. 2024 Jul 4;25(1):452. doi: 10.1186/s13063-024-08294-4.

  PMID: 38965542 BACKGROUND

Related Links

• Initial trial registration published under embargo

Study Officials

• Richard Brull, MD, FRCPC

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 2, 2026
• Study Start: June 4, 2024
• Primary Completion: June 3, 2025
• Study Completion: June 6, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CA (1)