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


CONCLUSIONS
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.
Baren
Jill
J
Department of Emergency Medicine, University of Pennsylvania School of Medicine, Ground floor Ravdin Building, 3400 Spruce Street, Philadelphia, PA 19104-4283, USA. barenj@uphs.upenn.edu
Campbell
Caren F
CF
Schears
Raquel M
RM
Shofer
Frances S
FS
Datner
Elizabeth M
EM
Hollander
Judd E
JE
D000328:Adult; D032882:Comprehension; D003430:Cross-Sectional Studies; D004636:Emergency Service, Hospital; D005260:Female; D006801:Humans; D057226:Information Seeking Behavior; D007258:Informed Consent; D008297:Male; D019370:Observation; D018579:Patient Selection; D035842:Research Subjects / Q000523:psychology*; D013179:Spouse Abuse; D014481:United States