Consent of PatientsNCT07380035
Coercion in Same-Day Research Consent
A study testing Invitation to Consent to Trial Participation in people with Consent of Patients and Coercion to Participate in Research, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Consent of Patients, Coercion to Participate in Research
- What is being tested?
- Invitation to Consent to Trial Participation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jun 2024to 6 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Voluntariness of Same-Day Consent for Participation in Low-Risk Clinical Anesthesia Research Trials: A Prospective, Randomized Trial
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.
- Being tested
- Invitation to Consent to Trial Participation
- Keywords
- Coercion, Voluntariness, Research consent, Clinical trials, Perioperative research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation to Consent to Trial ParticipationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Invitation to Consent to Trial Participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: Measured on postoperative day one.
Secondary outcomes (2)
Rate of enrollment into the fictitious trial
Measured: 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
Each item has a minimum score of 1 and maximum score of 4, with higher scores corresponding to a greater degree of coercion.
Measured: Measured on postoperative day one.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start4 Jun 2024
- Primary completion3 Jun 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Consent of PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Women's College Hospital, Toronto Metropolitan University
- Responsible party
- Principal investigator, Connor Brenna, University of Toronto
- Investigators
- Richard Brull, MD, FRCPC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380035
- Sponsor's protocol ID
- 2023-0007-E
- Other IDs
- 46twc
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified, aggregate trial data supporting the findings of this study will be made available upon reasonable request to the corresponding author after publication.
Publications
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.
PubMed 38965542
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voluntariness of Same-Day Consent for Participation in Low-Risk Clinical Anesthesia Research Trials: A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT07380035
- Acronym / sponsor ID
- 2023-0007-E
- Keywords
- Coercion, Voluntariness, Research consent, Clinical trials, Perioperative research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Women's College Hospital, Toronto Metropolitan University
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advance Consent | Sham comparator | Other: Invitation to Consent to Trial ParticipationPatients 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. |
| Day of Surgery Consent | Experimental | Other: Invitation to Consent to Trial ParticipationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invitation to Consent to Trial ParticipationIn 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. | Other | Advance Consent, Day of Surgery Consent |
Primary outcome
Average score on combined modified coercion scales
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Rate of enrollment into the fictitious trial
Time frame: 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
Time frame: Measured on postoperative day one.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Background: PubMed 38965542Brenna 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.
- Initial trial registration published under embargoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified, aggregate trial data supporting the findings of this study will be made available upon reasonable request to the corresponding author after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Brull, MD, FRCPC principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invitation to Consent to Trial Participation in people with Consent of Patients and Coercion to Participate in Research, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average score on combined modified coercion scales (time frame: Measured on postoperative day one.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07380035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026; AzTrials last refreshed its copy on 28 Oct 2026.