An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine
Elizabeth H. Golembiewski, PhD, MPH, et al
Mayo Clinic, Rochester, Minnesota
Consent forms design influences patient willingness to share personal health information
(Press-News.org) Patients are sometimes asked to share their personal health information for research purposes. Informed consent and trust are critical components in a patient's decision to participate in research. Researchers at the University of Florida conducted a three-arm randomized controlled trial to compare the effects on patient experiences of three electronic consent (e-consent) designs that asked them to share PHI for research purposes. Participants were randomized to a standard e-consent form (standard); an e-consent that contained standard information plus hyperlinks to additional interactive details (interactive); or an e-consent that contained standard information, interactive hyperlinks, and factual messages about data protections and researcher training (trust-enhanced). Researchers found no differences in preferences at one-week follow up. However, after six months, participants expressed the most satisfaction and subjective understanding with the trust-enhanced e-consent. The authors write that research institutions should consider developing and further validating e-consents that deliver information interactively, beyond that which is required by federal regulations, including facts that may enhance patient-informed consent and trust in research.
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