A Survey of Patient's Attitudes Towards Consent For Clinical Research In Anesthesiology
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Purpose
In most current academic anesthesia groups, it appears that consent for research is acquired on the day of surgery. This practice raises concerns because the hospital may be regarded as a coercive environment and there may be the possibility that the immediate preoperative environment prohibits adequate time for understanding the research project and making an informed decision about participation. However, this is often the only opportunity for anesthesiologists to obtain research consent. The aim of the present investigation is to utilize a survey study to determine if patients at Evanston Hospital are comfortable consenting for research on the day of surgery
| Condition | Intervention |
|---|---|
|
Informed Consent |
Other: Phone call explaining the research project |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
- Overall patient satisfaction with the same-day consent process-total number of questions answered with a score of 4 or 5 (on a 5-point scale from 1=strongly disagree to 5=strongly agree). [ Time Frame: Third postoperative day ] [ Designated as safety issue: No ]Subjects will reply using a 5-point scale from 1=strongly disagree to 5=strongly agree.
- Individual scores relating to six areas of informed consent; comprehension, situation (privacy/time), obligation (pressure) motivation, compunction (regrets), and satisfaction [ Time Frame: Third postoperative day ] [ Designated as safety issue: No ]Subjects will reply using a 5-point scale from 1=strongly disagree to 5=strongly agree.
| Enrollment: | 220 |
| Study Start Date: | September 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Morning consent
Consent process consisting of information only provided on the morning of surgery
|
Other: Phone call explaining the research project
A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial
|
|
Phone call and morning consent
Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project
|
Other: Phone call explaining the research project
A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial
|
Detailed Description:
Patients participating in approved, minimal risk clinical research projects will be approached by the study investigators. Consent for clinical research will be obtained on the day of surgery in the ambulatory surgery unit. In addition, some patients will be contacted by telephone on the day prior to surgery to be informed that they will be approached about participation in a research project. If patients agree to participate in the clinical trial, they will be provided with a self-addressed envelope containing the survey and a brief cover letter. The research team member will explain the purpose of the survey (to determine patients' attitudes towards research consent on the day of surgery). Subjects will be requested to complete the survey within a week of the surgical procedure. Two days after surgery, the research team will provide a follow-up call to determine if there are any questions about completing the survey. Although patient names will not be identified on the survey packet, all surveys will be coded with the subjects study number for subsequent analysis.
Questions are designed to investigate six areas of potential concern relating to informed consent; comprehension, situation (privacy/time), obligation (pressure) motivation, compunction (regrets), and satisfaction. Subjects will reply using a 5-point scale from 1=strongly disagree to 5=strongly agree.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients participating in approved, minimal risk clinical research projects in the Department of Anesthesiology at NorthShore University HealthSystem will be approached by the study investigators.
Inclusion Criteria:
- Patients participating in approved, minimal risk clinical research projects will be approached by the study investigators
Exclusion Criteria:
- Inability to speak English
- Refusal to participate in the clinical research projects
Contacts and Locations| United States, Illinois | |
| NorthShore University HealthSystem | |
| Evanston, Illinois, United States, 60201 | |
| Principal Investigator: | Glenn S. Murphy, MD | NorthShore University HealthSystem |
More Information
No publications provided
| Responsible Party: | Glenn S. Murphy, MD, Director, Cardiac Anesthesia and Clinical Research, NorthShore University HealthSystem Research Institute |
| ClinicalTrials.gov Identifier: | NCT01546194 History of Changes |
| Other Study ID Numbers: | EH09-533 |
| Study First Received: | February 28, 2012 |
| Last Updated: | November 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by NorthShore University HealthSystem Research Institute:
|
Informed consent Perioperative period Morning of surgery Anesthesiology |
Additional relevant MeSH terms:
|
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013