Model Data Access Agreement Clauses have been approved as an official GA4GH Product

5 Dec 2024

Following a successful vote by the Global Alliance for Genomics and Health (GA4GH) Product Steering Committee, the Model Data Access Agreement Clauses have been approved as an official GA4GH product to help researchers access data more efficiently and ethically in line with local legislation. 

By Jaclyn Estrin, GA4GH Science Writer

The Global Alliance for Genomics and Health (GA4GH) Model Data Access Agreement (DAA) Clauses have been approved by the Product Steering Committee as an official GA4GH product. The document was developed by members of the Regulatory & Ethics Work Stream (REWS), with leadership from Vasiliki Rahimzadeh (Baylor College of Medicine), Bartha Knoppers (McGill University), Jonathan Lawson (Broad Institute of MIT and Harvard), and Alexander Bernier (McGill University; Doctoral student at the University of Toronto).

Genomic data — health data that arises from the study of an individual’s DNA — carries information that can help doctors, researchers, and healthcare professionals better understand underlying causes of genetic diseases to provide precise medical care to patients. Broad, responsible sharing of this data on a global scale can have the power to unlock widespread advancements in genomics research.

Because this data includes inherently personal information, institutions protect it by establishing data access agreements to govern responsible data sharing with researchers outside of their organisation. However, many institutions have different terms within their data access agreements, some with contradictory requirements.

This lack of harmonisation between existing policies presents a difficulty for researchers as they attempt to navigate varying terms, particularly when they are seeking to request and access data quickly. The administrative burden of negotiating data access and use agreements impedes research progress. 

“The Model DAA Clauses were developed in service of a long term vision we have in REWS of creating a sustainable, mobile record of data sharing choices across the research data lifecycle,” said Rahimzadeh.

Now an official GA4GH product, the Model DAA Clauses are an open access, publicly available policy tool to standardise the way data is accessed and shared. The document includes a template agreement that institutions can adapt and modify to form a comprehensive contractual agreement. 

Organisations — particularly global research centres or universities without readily available legal resources — at the beginning phases of drafting data access agreements can turn to this document as a starting point, adding institution-specific or jurisdiction-specific language. Organisations that have existing DAAs can use this document to understand how their policies align with consensus recommendations and consider incorporating standardised language. While the clauses in the template can serve as foundational guidance, they should be adapted to adhere to local legislation, ethics requirements, and policies.

Guidance documents, such as the Model DAA Clauses, are key outputs of REWS. These tools are designed to preserve, update, and revisit data-related decisions throughout the data lifecycle. REWS emphasises the concept of ethical provenance, which involves respecting the original decisions made about health data when it was first contributed. This includes honouring the permissions for sharing, repurposing, and accessing the data across different research contexts.

The Model DAA Clauses are the second product to be released in the REWS Data Access Committee Review Standards (DACReS) Toolkit, which offers guidance and best practices for Data Access Committees when reviewing data access requests. The first product in the toolkit was the Data Access Committee Guiding Principles and Procedural Standards Policy, which provides best practices and standard operating procedures for Data Access Committees.

To develop the Model DAA Clauses, the team leading this project studied Data Access Agreements from GA4GH Driver Projects — global genomic initiatives that develop and pilot GA4GH products — and from other genomics research organisations that manage genomic data to understand and synthesise the topics and clauses inherent within these agreements. 

Knoppers and Bernier, both of whom have expertise in legal research methodologies, began this process in September 2022 to develop these model clauses around consensus positions within each topic area. Based on similarities found within these documents, the team drafted model clauses to establish similar approaches to topics such as intellectual property, data breaches, data security standards, and terms of use, among eleven other categories.

“Being able to provide model template clauses for data transfer — but more importantly, to have such clauses complete the entire process of data sharing from consent to researcher authentication, to data access approvals, and finally, to actual transfer — is remarkable,” said Knoppers. “Most importantly, they will facilitate the tracking of the ethical provenance of the data from collection to use within responsible governance.”

The REWS team will continue to build off the momentum of the DACReS Toolkit and Model DAA Clauses by turning their attention to the next item in the toolkit — streamlining processes for Data Access Requests and measuring the outcomes of responsible stewardship of genomic data over time. They will begin undertaking a landscape analysis of GA4GH Driver Projects to understand uptake of these policies and ensure GA4GH products are fit for purpose to cultivate real-world impact.