Gedrag tijdens het administreren van informed consent

Baren J, Campbell CF, Schears RM, Shofer FS, Datner EM, Hollander JE. Observed Behaviors of Subjects During Informed Consent for an Emergency Department Study. Ann Emerg Med 2009 Nov 20

Doel: Het bepalen gedrag van patiënten op de spoedeisende hulp tijdens informed consent voor een intieme partner geweld enquête. METHODS: Wij hebben een cross-sectionele studie gedaan tijdens de het administreren van informed consent. Onderzoeksassistenten hebben geregistreerd of informed consent werd gelezen, hoeveel tijd er werd besteed aan het lezen, of vragen werden gesteld, en of de patiënten een kopie meenamen van het formulier dat werd overhandigd.

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

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