Coercion to Participate in Research, Consent of Patients
Conditions
Keywords
Coercion, Voluntariness, Research consent, Clinical trials, Perioperative research
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.
Interventions
OTHERInvitation to Consent to Trial Participation
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.
Sponsors
University of Toronto
Women's College Hospital
Toronto Metropolitan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average score on combined modified coercion scales | Measured on postoperative day one. | Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion. |
| Average Score on modified Iowa Coercion Questionnaire | Measured on postoperative day one. | Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion. |
| Average Score on Modified Coercion Assessment Scale | Measured on postoperative day one. | Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Each item has a minimum score of 1 and maximum score of 4, with higher scores corresponding to a greater degree of coercion. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORRichard Brull, MD, FRCPC
University of Toronto
Outcome results
None listed