Assessment of the All of Us research program’s informed consent process

AJOB Empirical Bioethics
Volume 12, 2020 Issue 2
https://www.tandfonline.com/toc/uabr21/current

 

Article
Assessment of the All of Us research program’s informed consent process
Megan Doerr, Sarah Moore, Vanessa Barone, Scott Sutherland, Brian M. Bot, Christine Suver & John Wilbankson behalf of the All of Us Consent Working Group* and the Low Health Literacy Consent Study Research Team*
Published online: 04 Dec 2020
Abstract
Informed consent is the gateway to research participation. We report on the results of the formative evaluation that follows the electronic informed consent process for the All of Us Research Program. Of the nearly 250,000 participants included in this analysis, more than 95% could correctly answer questions distinguishing the program from medical care, the voluntary nature of participation, and the right to withdraw; comparatively, participants were less sure of privacy risk of the program. We also report on a small mixed-methods study of the experience of persons of very low health literacy with All of Us informed consent materials. Of note, many of the words commonly employed in the consent process were unfamiliar to or differently defined by informants. In combination, these analyses may inform participant-centered development and highlight areas for refinement of informed consent materials for the All of Us Research Program and similar studies.