GA4GH submits comments on the WHO’s draft principles for human genome access, use, and sharing

28 May 2024

The GA4GH Regulatory and Ethics Work Stream (REWS) compiled and submitted comments to the WHO regarding its draft principles for human genome access, use, and sharing.

By Jaclyn Estrin, GA4GH Science Writer

In April 2024, the World Health Organization (WHO) requested public comment on its draft principles for human genome access, use, and sharing. 

The Global Alliance for Genomics and Health (GA4GH) Regulatory and Ethics Work Stream (REWS) coordinated a collective response to the WHO’s request for comments, conveying the expertise and feedback of the GA4GH contributor community. 

Genomic data holds sensitive information related to people’s identity and health histories. The WHO designed its draft principles to enable responsible genomic data sharing to advance global health research, while simultaneously protecting patients’ personal information. The document intends to offer a blueprint in governing the complete genomic data lifecycle: promoting inclusion, trust, and integrity in genomic data sharing, as well as highlighting its benefits at both individual and communal levels.

GA4GH’s mission is to develop harmonised standards to allow for the safe and responsible sharing and use of genomic data. Within GA4GH, REWS develops guidance on the regulatory, ethical, and social considerations that arise within genomic research and international data sharing. The organisation’s foundational commitments to the protection of human rights, set forth in the Framework for Responsible Sharing of Genomic and Health-related Data (known as the Framework), developed by REWS in 2013, guides the development of all GA4GH products.

GA4GH has a strong interest in ensuring policies align with existing international conventions, regulations, codes, and policies, promoting a globally standardised approach to data sharing that is grounded in the fundamental acknowledgement of human rights. 

The GA4GH Framework emphasises that responsible data and knowledge sharing advances the human right to benefit from science by breaking down scientific and data silos. In its comments submitted to the WHO, GA4GH underscored the importance of embedding explicit mentions of human rights within its principles, including the right to privacy, the right to health security, and the right of all to partake in scientific advancement, along with its associated benefits. 

Vast amounts of genomic data exist across institutions, research centres, universities, and repositories around the world. The sharing of genomic data is imperative to drive collaborative scientific advancements in biomedical research and foster a greater understanding of human health. 

Therefore, GA4GH advised the WHO to recognise human genomic data as a public good with the power to benefit human health and the global research ecosystem. At the same time, data sharing efforts must respect the preferences and prior consents of patients and research participants. GA4GH recommends that consent processes be highly specified about the potential uses of an individual’s data — whether that be in the clinical setting for primary studies or for use in secondary research.

To ensure that the promise of genomics benefits all people globally, GA4GH crucially reminded the WHO to explicitly discuss the importance of sharing datasets that include contributions from donors of diverse ethnicities and backgrounds, particularly those from underrepresented communities. Diverse datasets can better promote equity in genomics and advance the potential of precision medicine. For more perspective on diversity in datasets, please see the GA4GH REWS Diversity in Datasets policy.

A copy of GA4GH’s comments on the WHO’s draft policy was submitted to the open access research platform, SSRN, where it is currently under review. The SSRN link to the PDF document will be made available to the scientific community on the GA4GH REWS webpage once it is published. 

GA4GH’s comments on the WHO’s draft policy demonstrate GA4GH’s commitment to a harmonised approach to the development of global genomic data sharing standards that ensure the ethical and responsible use of genomic and health-related data.

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Amendment 7 June 2024: GA4GH’s submission to the SSRN was accepted and is now available as a preprint. The SSRN link to the PDF document can be found linked here and is available to the scientific community on the GA4GH REWS webpage.