Objective: To determine whether patients seen in an urban, primary care setting and recruited for a research study read the written informed consent forms provided to potential study participants. Methods: As part of a women's health study, we observed women as they reviewed and signed the informed consent form. Between October and December 1999, consecutive women with medical appointments at an primary care center who met study eligibility criteria were invited to participate. Research assistants discretely observed the potential study participants as they reviewed and signed the informed consent form, recording the time spent reading and an opinion of the reading behavior (appeared to have read, appeared to have glanced, not read). Verbal informed consent was also provided on important elements (eg, voluntary). Institutional Review Board approval was sought and received. Results: Typically the time spent reading the two page form was short. The form was not read by 22.6% of women and reviewed in 1-15 seconds, 16-30 seconds, 31-60 seconds and 61 or more seconds by 35.8%, 15.1%, 20.8% and 5.7%, respectively. Reading time and reading behavior were strongly correlated. Least likely to read the form included women with education limited to high school, partner violence or child abuse victims, and women who were not depressed. Conclusion: Alterations in the informed consent procedures may be needed for study participants not accustomed to reading technical materials. In this study, most women chose not to read the provided information completely. Potential alternatives to the standard informed consent form will be discussed.
Learning Objectives: At the conclusion of the session the participants will be able to: - identify flaws in the written informed consent process - Describe alternative presentations of information that may to useful in the informed consent process
Keywords: Ethics, Primary Care
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.