Observed behaviors of subjects during informed consent for an emergency department study

To determine emergency department patients' behaviors during informed consent for an intimate partner violence survey.

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.

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.

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.