January 11, 2019

Why You Should Care About Universal Informed Consent

Why You Should Care About Universal Informed Consent

By John Wilbanks

At the 2019 Pacific Symposium on Biocomputing, Megan Doerr, who’s a Principal Scientist on the Governance team at Sage, presented a poster and paper on the universal informed consent process we designed and implemented for the All of Us Research Program.

Here’s why you should care: First, it explains the structure of the All of Us Research Program consent process. (Most of that work is unfortunately only visible if you create an account and try to enroll, which is something we’re working on fixing.) We built a modular process, with significant investment in user-centered design, to try and communicate the concepts a potential participant would need to know before deciding whether or not to join. There are a series of videos as well as an “evaluation” that serves as a learning reinforcement tool, before enrollees are presented with a consent form to sign. This builds on our work in participant-centered consent that started with Apple and ResearchKit but goes much further, given the scope and duration and scale of the All of Us program.

Next, our mandate was to create the most consistent set of consent experiences possible given that people from all states and territories must be able to enroll and that those people will likely move over the ten years of the study – especially those in populations traditionally underrepresented in medical research. We therefore review a broad range of specific federal and state laws around informed consent, explore choice of law issues, and more. As we were unable to find a resource that collected and cross-referenced all the relevant legislation at the state and territory level, we created one, which we believe on its own represents a significant contribution to the legal commons around informed consent.

Third, we outline our implementation approach, which involves a “parent” consent form covering as many states and territories as possible, plus “child” forms that implement state-specific elements in the minimum possible sets of variations. Despite all the variation we were able to condense down to four consent documents and four HIPAA authorizations. These are in turn available in the public domain for reuse by other studies who would like to inherit and leverage this analysis.

Here’s the link to the paper and you might follow @MegDoerr and @DNAlawyer on Twitter if these topics interest you. Other key work at Sage was done by Shira Grayson, Christine Suver, and Sarah Moore. We are very, very proud of this paper and the resulting implementation.

Our toolkit The Elements of Informed Consent is available to download.

Read the mention in Politico’s Morning eHealth report.