Implementing a universal informed consent process for the All of Us Research Program

Abstract

The United States’ All of Us Research Program is a longitudinal research initiative with ambitious national recruitment goals, including of populations traditionally underrepresented in biomedical research, many of whom have high geographic mobility. The program has a distributed infrastructure, with key programmatic resources spread across the US. Given its planned duration and geographic reach both in terms of recruitment and programmatic resources, a diversity of state and territory laws might apply to the program over time as well as to the determination of participants’ rights. Here we present a listing and discussion of state and territory guidance and regulation of specific relevance to the program, and our approach to their incorporation within the program’s informed consent processes.

Assessment of theAll of Usresearch program’s informed consent process

“…To create such an informed consent process, the program convened the All of Us Consent Working Group. The Consent Working Group had 55 core members (see Acknowledgments) who met 22 times between August 2016 and March 2017, with additional small-group meetings and expert consultations (e.g., Doerr et al 2019).…”

Formative Evaluation of Participant Experience With Mobile eConsent in the App-Mediated Parkinson mPower Study: A Mixed Methods Study

“…Parkinson mPower is an open study; after download, prospective participants attest to meeting the study’s inclusion criteria (age 18 or older, US residents, and are comfortable with reading and writing in English) and self-administer the study’s eConsent process. The development of Sage’s eConsent, including formatting and use of icons and animations, has been previously described [14]; topics addressed in the mPower eConsent are summarized in Table 1.…”

“…To facilitate the promise of smartphones for research, Sage Bionetworks has developed a scalable, self-guided eConsent process incorporating many of the suggested elements and approaches for improving participant comprehension described previously [14]. Here we present a mixed methods investigation of participant reaction to an implementation of this eConsent within the Parkinson mPower study, an app-based, entirely remote research study focused on tracking within-day fluctuations in certain Parkinson disease symptoms.…”

Medication Adherence: does Patient Participation in Randomized Clinical Trials Affect on it?

“…Кроме того, доступной становится и высококвалифицированная медицинская помощь в научных исследовательских центрах [42]. Как уже отмечалось ранее, в рамках РКИ пациент получает исчерпывающую информацию о состоянии своего здоровья, о необходимости приема и важности соблюдения режима приема ЛП, о предполагаемой пользе от терапии и о возможных побочных эффектах [43,44]. Приверженность пациента строго контролируется как при помощи анкетирования, так и с использованием более сложных и высокотехнологичных методов подсчета исследуемого ЛП (рис.1).…”