How we work

Regulatory & Ethics vision statement

Read the 5-year vision statement of the work stream or read the full GA4GH Connect Strategic Plan.

Motivation and Mandate

Data sharing bridges the genomic-clinical divide, thereby enabling translational medicine. Current frameworks for privacy protections, however, may frustrate the desire of individuals to share such data.

The internationally-recognized human right of everyone to benefit from the progress of science and its applications can serve to break open current barriers. The primary role of the Regulatory and Ethics Work Stream (REWS) is to “activate” this human right—to promote forward-looking data governance through the Framework for Responsible Sharing of Genomic and Health Related Data, harmonized across countries, sectors, and institutions.

Existing Standards

The REWS continues to elaborate on the Framework with policies and tools found in the REWS Toolkit on consent, privacy and security, accountability, and ethics review equivalency. The REWS also plays an important support role within the GA4GH. It regularly assesses the ethical and regulatory implications of GA4GH Work Streams and work products. It liaises with Driver Projects to identify common and emerging issues and to harmonize real-world governance.

Proposed Solution

In the next five years, the REWS aims to address three pressing governance challenges for international data sharing. First, governance must serve and be informed by the individuals providing the data. The REWS is addressing this through a multilingual, international Public Attitudes Survey. Second, processes for handling individual genomic findings of clinical relevance are highly divergent across countries and sectors. A Task Team on return of results will be established to combat this variation. A third challenge is the constantly shifting winds of global data protection regulation. The REWS aims to address this through an international data sharing Code of Conduct. This Code will guide the current push to establish clear and legally binding data sharing rules.