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

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

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Key information

Conditions

Informed Consent

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phone call explaining the research project

Other

A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial

Primary outcomes

Overall Patient Satisfaction With the Same-day Consent Process-total Number of Questions Answered With a Score of 0 to 10 (on a 11-point Scale From 0=Strongly Disagree to 10=Strongly Agree).

Time frame: First postoperative day

Subjects will reply using a 11-point scale from 0=strongly disagree to 10=strongly agree.

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Mar 7, 2012
Registry last updated: Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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