Coercion in Same-Day Research Consent

University of Toronto

Status: Completed

Conditions: Consent of Patients; Coercion to Participate in Research

Treatments: Other: Invitation to Consent to Trial Participation

Study type: Interventional

Funder types: Other

Identifiers

NCT07380035

2023-0007-E

46twc (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Inability to provide informed consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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114 participants in 2 patient groups

Advance Consent

Sham Comparator group

Description:

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.

Treatment:

Other: Invitation to Consent to Trial Participation

Day of Surgery Consent

Experimental group

Description:

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.

Treatment:

Other: Invitation to Consent to Trial Participation