Observed Behaviors of Subjects During Informed Consent for an Emergency Department Study
Study objective
To determine emergency department patients' behaviors during informed consent for an intimate partner violence survey.
Methods
We conducted a cross-sectional study during administration of informed consent. Research assistants recorded whether informed consent was read, time spent reading it, whether questions were asked, and whether the patients took a copy of the form that was handed to them. Results are reported as percentage of frequency of occurrence.
Results
Of 1,609 patients approached for the intimate partner violence study, 1,312 (82%) patients participated. After verbal description of the study, 53% of patients read the informed consent but only 13% spent more than 2 minutes doing so. Only 20% of patients asked questions and less than half (49%) accepted a copy of the form when it was handed to them.
Conclusion
Patients who participated in an intimate partner violence study did not spend a lot of time reading the consent document, asked few questions, and did not take the copy of the consent form with them. Future studies of the current consent process should determine whether it provides adequate human subjects protections in a manner desired by the patient.
Provide feedback on this article at the journal's Web site, www.annemergmed.com.
Supervising editors: Debra E. Houry, MD, MPH; Michael L. Callaham, MD
Dr. Houry and Dr. Callaham were the supervising editors on this article. Dr. Hollander did not participate in the editorial review or decision to publish this article.
Author contributions: JB was the principal investigator of the substudy. JB, RMS, FSS, EMD, and JEH were responsible for study design. JB, CFC, and JEH collected data. JB, CFC, RMS, FSS, EMD, and JEH analyzed and interpreted the data. JB, CFC, RMS, FSS, and EMD critically reviewed the article. JB supervised the first draft of the article. CFC and FSS wrote the article. FSS was overall statistician for the project. JEH was the overall study principal investigator, prepared the final article, and takes overall responsibility for the data. JEH takes responsibility for the paper as a whole.
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The authors have stated that no such relationships exist. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement.
Publication date: Available online November 20, 2009.
Reprints not available from the authors.
Please see page 10 for the Editor's Capsule Summary of this article.
PII: S0196-0644(09)01561-3
doi:10.1016/j.annemergmed.2009.09.023
© 2009 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.
Refers to article:
- Situated vs Regulatory Rationality
