NCT01546194

A Survey of Patient's Attitudes Towards Consent For Clinical Research In Anesthesiology

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Informed Consent

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-03-07
• Last updated: 2019-09-16
• Results posted: 2015-09-25

Locations

1 site across 1 country: United States