Consent forms design influences patient willingness to share personal health information

January 12, 2021

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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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
https://www.annfammed.org/content/19/1/16

American Academy of Family Physicians

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