Communicating With Diverse Patients About Participating in a Biobank: A Randomized Multisite Study Comparing...

Area of Science:

• Bioethics
• Health Disparities
• Informed Consent Research

Background:

• Informed consent (IC) is crucial for ethical research participation.
• Electronic delivery of IC information may enhance understanding for some, while face-to-face (F2F) methods may benefit others.
• Diverse patient populations have varying needs and limitations regarding IC comprehension.

Purpose of the Study:

• To compare patient understanding and confidence in understanding electronic versus F2F informed consent documents.
• To assess the impact of electronic versus F2F IC on research enrollment across diverse populations.
• To identify demographic factors influencing the effectiveness of different IC delivery methods.

Main Methods:

• Randomized, multisite study involving 501 patients at two U.S. biobanks.
• Comparison of understanding, confidence, and enrollment between electronic IC and F2F IC groups.
• Analysis of demographic variables including ethnicity and educational level.

Main Results:

• No significant overall difference in understanding between electronic and F2F IC.
• F2F IC predicted higher confidence in understanding and increased research enrollment.
• Higher educational level and non-Hispanic ethnicity correlated with greater understanding and confidence.
• Hispanic ethnicity and lower socioeconomic status were associated with better outcomes using F2F IC.

Conclusions:

• While electronic IC may benefit some, F2F methods appear more effective for specific populations, including Hispanic and lower socioeconomic status individuals.
• Researchers must consider tailored IC strategies to ensure equitable understanding and participation.
• The choice between electronic and F2F IC processes should be informed by the needs of diverse patient groups to promote inclusivity in research.