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NIH’s All of Us Research Issues Initial Research Protocol

August 8, 2017
by Heather Landi
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The National Institute of Health’s All of Us Research Program, previously called the Precision Medicine Initiative, released its initial research protocol, or research plan.

The All of Us Research Program’s 61-page protocol includes information on consent forms, the ethical issues associated with the project and explanations for how participants will be able to provide secure access to their electronic health records (EHRs).

The goal of the All of Us Research Program is to gather health-related information from one million or more diverse participants to detect association between genetic and environmental exposures and a wide variety of health outcomes.

The NIH states that longitudinal tracking of health outcomes through EHRs is an important component of the program. Through a consenting process, participants will be asked to authorize linkage of their EHR information. EHR data may be sent directly by the participant’s health care providers to the DRC or sent by the participant to the program through Sync for Science.

Access to EHR data will be repeated regularly throughout the life of the program. The initial data types to be included are demographics, visits, diagnoses, procedures, medications, laboratory tests, and vital signs, but may be expanded to all parts of the EHR, including health care provider notes. The feed may include mental health data, HIV status, substance abuse and alcohol data, and genomic information stored in the EHR

Participants may need to complete and sign a separate informed consent module to authorize access to their complete EHRs.

“We will create an informatics infrastructure to clean and standardize data from disparate EHR systems across the United States; this broadly applicable system will be a key contribution of the All of Us Research Program to health informatics research efforts nationwide. For participants enrolled by their health care provider organization, the site will extract data from the participant’s EHR, format it according to the DRC’s data model (based on the Observational Medical Outcomes Partnership [OMOP] Common Data Model version 5, and transfer it to the DRC using secure protocols,” NIH stated in a press release.

And, the NIH states that although obtaining EHR data from direct volunteers presents unique challenges, early pilot studies have demonstrated feasibility of such an approach. “For example, the Sync for Science (S4S) project launched by NIH and the Office of the National Coordinator for Health IT is creating a technology that aims to make it easy and safe for people to securely share their EHR data for research. S4S has been adopted by the All of Us Research Program and initially will be enabled in a small pilot for DV participants at S4S-enabled direct volunteer sites,” the NIH states.

All of Us Research Program direct volunteer participants who have enrolled at one of these pilot sites will be able to sign into their healthcare provider’s patient portal using the S4S workflow and authorize sharing their EHR data with the program. Their health care provider’s system will provide a secure application program interface (API), which is used by the research program, rather than the provider sending out data, and transmitted to the Us of All Research program.

And, NIH notes that this is just the first version of its protocol. In future versions, NIH intends to include plans to pilot test wearable devices for real-time data collection.

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