10 June 2022
For science to advance, researchers need access to the growing troves of data around the world. Robust access procedures can lead to increased transparency and research reproducibility. But for genomic and health data, greater access has the potential for personal health information to be exploited for unintended purposes and carries a greater risk of misuse. Such a risk of data misuse can create distrust between the scientific community and the public and erodes participants’ privacy. To avoid this outcome, data access committees, commonly referred to as DACs, review and manage who can access genomic data.
DACs steward genomic data with two primary considerations: one is determining whether researchers may access data, and another is protecting participant interests. They are the gatekeepers and guardians of data.
“DACs are supervised by their institutions and organisations. However, they also abide by jurisdictional policies and frameworks that are already in place to ensure ethical and responsible data sharing,” said Jonathan Lawson, the Data Use and Researcher Identities (DURI) workstream’s Data Use co-lead, and senior software product manager at the Broad Institute of MIT and Harvard. “They allow researchers to request data that was originally collected for one study to be used in subsequent studies.”
Like research ethics committees (also known as institutional review boards), DACs are comprised of teams of multidisciplinary experts; but they also tend to have different operating procedures and policies that they rely on to make their decisions. This can sometimes lead to inconsistencies in approach and access to genomic data both within a DAC and across different datasets in organisations. This can thwart otherwise important uses of genomic data to drive research discovery and medical breakthroughs. Both under- and over-protecting access to genomic data can undermine participants’ interests, many of whom want their data to be used for public benefit, albeit in a responsible manner and aligned with their initial consent to provide their data in the first place.
In order to ensure that data access requests are met with consistent review criteria, the Global Alliance for Genomics & Health (GA4GH) formed a working group to review and streamline Data Access Committee Review Standards (DACReS) around the world. Intended to unify processes across DACs and data access requests, the group has now published its first product: the GA4GH Data Access Committee Guiding Principles and Procedural Standards.
The genomic data access process can be a tedious one. Normally, researchers request data access by submitting a thoroughly-detailed application to a DAC. The DAC will then meticulously review the request. This includes ensuring that the researcher and the research team are qualified to access and analyse the genomic data; it also includes an assessment of whether the request aligns with the underlying data use terms derived from the participants’ consent. Applicants must respond to issues that arise at each point.
Upon a review by the DAC of an access request, one of three outcomes can arise: the applicant is granted access to the data set, the application is subject to further clarifications from the applicant before it can be approved, or the application is rejected.
The DACReS policy on Data Access Committee Guiding Principles and Procedural Standards lays out specific guidance for DACs, with what are considered “essential” and “desired” criteria for their procedural standards. These principles and standards aim to create an efficient, fair, consistent, and robust review process across DACs globally.
The new policy acts on the GA4GH mission to accelerate genomic research while respecting the interests of participants from whom data are ultimately sourced. The procedural standards offer DACs a roadmap for creating standard operating procedures, committee terms of reference, access request procedures, data leak solutions, progress reporting, and policy implementation.
In addition to being promoted as a much-needed, detailed standard for DACs, the DACReS policy is also anticipated to be seen as a helpful guide for DACs to integrate their work with other GA4GH standards, like the Data Use Ontology, Passports, and Machine-Readable Consent Guidance. These and other deliverables help ensure responsible access to genomic data distributed around the globe.
“Realising that the focus of the DACReS workgroup at this stage ought to be on procedural standards, as this an important first step to achieving greater harmonisation of DACs, we set a series of planned deliverables in due course, similar to how things have been done across other projects within GA4GH,” said Edward Dove, a Lecturer in Health Law and Regulation at the University of Edinburgh, and with Lawson and Vasiliki Rahimzadeh, a co-lead of the DACReS workgroup (a collaboration between members of the DURI WS and the Regulatory and Ethics WS).
“The group’s next steps are to study the uptake of this policy in DACs worldwide, and periodically revisit the guidance as technology and regulation evolve over time. We anticipate that several of our Driver Projects, some of which are involved within the DACReS group, will take up these guiding principles and procedural standards and let us know how it’s impacting the quality and effectiveness of their genomic data access review process,” said Vasiliki Rahimzadeh, an incoming Assistant Professor at Baylor College of Medicine in Houston, Texas.
To help drive the development of future deliverables, the DACReS workgroup is currently surveying DAC members globally about their operations and membership. The joint team invites all members to contribute to their 20-minute research survey.