paREWS Strategic Roadmap 2025/2027

Preamble

This revised Regulatory and Ethics Work-Stream (REWS) roadmap builds upon the framework set out in 2020-21. The original roadmap outlined REWS' agenda to 'activate' the internationally-recognised human right of everyone to benefit from the progress of science and its applications by addressing genomic data sharing issues through data governance policies that can apply internationally.

Since 2020, REWS has completed proposed deliverables, bringing the Work Stream closer to this goal. Recent outputs include the ‘Policy on Diversity in Datasets’, ‘Definition for Genetic Discrimination’, Model Data Access Agreement Clauses and the updated ‘GA4GH Data Sharing Lexicon’. Other published REWS deliverables can be found here. 

Objectives

REWS recognizes that rapid advances in genomics have made addressing ELSI issues increasingly dependent on multidisciplinary solutions that integrate ethical frameworks with technical standards to ensure fair and responsible genomic data sharing. From diverse populations to advanced sequencing technologies, modern genomic research demands this integration of ethical and technical considerations. Building on REWS' established connections with driver projects and GA4GH's technical workstreams, REWS envisions more robust collaborations with these teams to create innovative and ethically sustainable solutions that drive meaningful change.

2025-2027 Priorities

GA4GH’s Strategic Road Map (2023) positions the Regulatory & Ethics Work Stream as a foundational pillar—providing policies, guidance, and frameworks that cut across the organization and catalyze its Technical Work Streams. REWS also plays a central role in the Product Development and Approval Process, engaging early in Study Group phases via landscape analysis, use case development, and consultations. Recent public outputs—including updated consent policies, briefs, and public-attitude posts—underscore the work stream’s ongoing relevance. The updated REWS roadmap for 2025-2027 will advance its ongoing work on developing evidence-based policy products and tools through Study Groups (see below) that respond to emerging regulatory,ethical and policy issues in human genomics. REWS will specifically focus its efforts on:

  • Discovery ethics and policy research on human genomic data sharing
  • Global outreach and capacity building, including in Low-and-Middle Income Countries
  • Policy and product development
  • Cross Work-Stream collaboration and integration

This road map should be read in conjunction with the REWS Study Group & Product Approval Process (link to be added) and the REWS taxonomy of products.

Below, we outline the aim and status of each Study Group and Forum.

Please feel free to mark your support for a project by adding your name after the +1 at each proposed deliverable.

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Study Groups 

Deliverable Name/Topic: Genetic Discrimination/Group Harms

Start date: May 31, 2022

Lead: Yann Joly

Description: Genetic discrimination (GD) is a multifaceted concern that, without adequate regulation, can infringe upon human rights and deter people from undergoing genetic testing or participating in genomic research. While GD was initially concentrated in the life and health insurance sectors, it has since expanded into education, housing, sports, and other areas. Although countries worldwide have implemented diverse legal frameworks to address the issue, discrimination continues to affect both individuals and groups.

Aim: This group works in collaboration with the Genetic Discrimination Observatory (GDO) to better understand the meaning and implications of genetic discrimination and to develop policy-focused solutions.

Status:  In 2022, the group finalized an informational brief on genetic discrimination. A subset of group members collaborated on a paper on the definition of genetic discrimination, which was published by Nature Genetics in 2024. In collaboration with the GDO, the group also completed a Delphi study that identifies the key elements of an optimal genetic non-discrimination policy (published in JAMA Network Open). The approved definition of Genetic Discrimination (GD) has been incorporated as a policy tool into the GD toolkit. The group has now finalized a position statement, and has been approved at the Feb 2, 2026  Product Steering Committee Meeting. The group  will next explore the relationship between discrimination and group harms, given the dual nature of genetic data.

+1: Andreas Bruns, Rosalyn Ryan, Shu Hui Chen (Sue), Anja Bedeker, Shubha Chandrasekharan, Karyn Onyeneho, Keren Limor-Waisberg, Kaori Muto, Ashwin Budden,

Deliverable Name/Topic: Clinical Data Sharing and Consent 

Start date: Mar 2022

Co-Leads: Yann Joly, Juliann Savatt

Description: In the course of clinical genetics testing, there are often requests to clinical laboratories for patient information to be shared without explicit consent between labs or with expert curation efforts. While the sharing of individual patient data may help with variant classification and improve patient care, there is still uncertainty over the kinds of data and level of detail that can be shared without explicit consent from patients.

Aim: This group aims to understand current institutional practices and opinions of researchers on clinical dating sharing, in order to develop best practice standards that can be c.

Status: The group has drafted a manuscript, examining the policies of 33 institutions globally and will work on developing a standard reference template.

+Evert-Ben van Veen1: T.J. Kasperbauer, Marie-Jo Brion, Shu Hui Chen (Sue), Anja Bedeker, Mollie Minear, Lindsay Smith, Meg Doerr, Subhashini Jagu, Karyn Onyeneho, Keren Limor-Waisberg, Bimal Chaudhari, Marietjie Botes, Eddie Tan + (Aryan Chaudhary ) , Mercury Shitindo

Deliverable Name/Topic: Pathogen genomic data sharing (previously Pandemic Preparedness)

Start date: Jun 2023

Co-leads: Dianne Nicol, Ashwin Budden, Anja Bedeker, Diya Uberoi

Description: Efficient and equitable sharing of pathogen genetic sequence data and pandemic countermeasures is critical in public health emergencies, like the COVID-19 pandemic. Yet significant ethical and regulatory challenges remain, as stakeholders grapple with how to balance the Global North's increasing demand for rapid, open-source pathogen data access with the Global South's concerns about protecting genetic data sovereignty. This persistent tension undermines global pandemic preparedness and response efforts and highlights the urgent need for innovative solutions that can promote equity.

Aim: To bridge this divide, this group is developing recommendations that leverage GA4GH's technical standards, including potential meta-data tagging standards for tracking and tracing provenance, to balance demands for data sovereignty rights and rapid data access.

Status: The group is focusing on refining their approach to articulate the core governance principles that apply across pathogen types, and will work on developing recommendations with concrete examples from both viral and bacterial contexts. A recent submission of a foundational publication to the WHO Bulletin was also completed.

The group will review preliminary findings based on an evaluation of governance frameworks for tracing data provenance across various international pathogen genomic databases, in collaboration with  the GA4GH Infectious Disease Community of Interest and PHA4GE, during the October Connect 2026.  Future work will include manuscript development and governance guidance for pathogen genomic data traceability.

The Pathogen Data Sharing Group is currently taking forward its work on traceability, one of the five institutional strategies developed to support more equitable pathogen genomic data sharing. The group is beginning with a documentary analysis of repository and platform policies and technical documentation, examining what formal governance arrangements specify about what information should remain traceable, for what purposes, where responsibility lies, and the provenance arrangements described. The group will review preliminary findings based on an evaluation of governance frameworks for tracing data provenance across various international pathogen genomic databases, in collaboration with  the GA4GH Infectious Disease Community of Interest and PHA4GE, during the October Connect 2026.  Future work will include manuscript development and governance guidance for pathogen genomic data traceability.

 

+1: Marietjie Botes, Mercury Shitindo

Deliverable Name/Topic: Measuring the uptake of ethics and data governance policies in genomics (Metrics)

Start date: Jul 25, 2023

Co-leads: Yann Joly, Dianne Nicol

Description: Research projects on the ethical, legal, and social implications (ELSI) of genomics and related health policy issues require effective tools to measure their uptake and impact. Identifying the most impactful ELSI and policy research can guide funders in resource distribution and help researchers highlight their work's importance to stakeholders. However, assessing this impact is challenging because potential indicators have not been comprehensively analyzed or unified into one framework. A systematic and efficient tool that can evaluate the uptake of ELSI and health policy research is thus crucial to address these challenges and ensure proper assessment of research influence.

Aim: This group aims to identify impact indicators suitable for evaluating the uptake of REWS’ and other bioethics and health policy documents, and then use these indicators to develop a comprehensive tool for evaluating the impact of ELSI and health policy research within a unified framework.

Status:  The group will develop a prioritized set of core elements, impact categories and indicators to reflect the impact of REWS. Upcoming work at the October Connect 2026 session will inform future draft guidance, and identify which indicators could be integrated into a GA4GH metrics dashboard. The group will also host the “Measuring the impact of REWS work stream through nuanced indicators” session at the October 2026 Connect.

+1Evert-Ben van Veen: T.J. Kasperbauer, Elena Ghanaim, Vaso Rahimzadeh, Daniela Bodemer, Shakuntala Baichoo, Rosalyn Ryan, Beatrice Amos, Ariana Gonzalez, Ainsley Newson, Shu Hui Chen (Sue), Anja Bedeker, Binay Panda, Keren Limor-Waisberg, Stacey Donnelly, Brad Elphinstone, Sandrine Richard, Ashwin Budden, Emily Boja, Ann Mc Cartney

Deliverable Name/Topic: Newborn Whole Genome Screening (gNBSeq)

Start date: Feb 7, 2022

Co-leads: Anna Lewis, Yvonne Bombard

Description: Whole Genome Sequencing (WGS) for newborns is an emerging practice that is being piloted across many jurisdictions as a part of existing newborn screening programs. While the practice offers the promise to diagnose newborns with detectable diseases and develop personalized treatment plans, the use of WGS for newborns still raises significant legal and ethical concerns.

Aim: This group seeks to respond to the increasing interest in newborn whole genome sequencing by providing a policy tool designed to help implementers of these projects to navigate the ELSI dimensions they will face. It does this primarily via identifying the decision points they will face that have ELSI dimensions, and synthesizing the existing regulatory and ethical standpoints related to each decision point.

Status: The group has finalized its policy tool, and has been approved at the Feb 2, 2026  Product Steering Committee Meeting. Ongoing discussions will help shape future priorities and activities in this area

 +1: Arzoo Ahmed, T.J. Kasperbauer, Mutiat Afolabi, Dimitri Patrinos, Marie-Jo Brion, Ainsley Newson, Claudia Gonzaga-Jauregui, Shu Hui Chen (Sue), Anja Bedeker, Mollie Minear, Emma Tudini, Subhashini Jagu, Keren Limor-Waisberg, Bimal Chaudhari, Ziyi Dai, Stacey Donnelly, Brad Elphinstone, Ashwin Budden, Eddie Tan

Deliverable Name/Topic: Generative AI for Genomic Data Sharing

Start date: Oct 22, 2023

Co-leads:  Ma’n Zawati, Marc Fiume

Description: The rapid rise of chatbots presents promising opportunities to streamline access procedures and enhance data querying. Conversational AI capabilities, powered by generative large language models, have the potential to facilitate large-scale genomic data sharing by integrating multiple open-access datasets available online. However, to ensure the responsible deployment of this technology, clear guidance is needed on how these tools should be developed, implemented, and governed.

Aim: This group seeks to identify key themes and develop guidance points on the responsible use of conversational AI in the context of large-scale open-access genomic databases. As a future step, these guidance points will be pilot-tested using an established AI tool and subsequently refined to inform the development of a resource that can benefit the GA4GH community.

 

Status: Guidance points on the responsible use of AI have been shared with the study group and a manuscript is being drafted for publication. The group will build upon the guidance points to refine the regional adaptive AI risk governance tool and pilot test in collaboration with the AI Workstream. The group will also host the “From guidance to practice: pilot-testing responsible generative AI guidance points for genomic data sharing” working session at the October 2026 Connect.

+1: Emily Boja, Anya Prince, Diya Uberoi, T.J. Kasperbauer, Marie-Jo Brion, Richard Milne, Andreas Brun, Rosalyn Ryan, Ariana Gonzalez, Dianne Nicol, Shu Hui Chen (Sue), Anja Bedeker, Adrian Thorogood, Shakuntala Baichoo, Joe Flores-Toro, Ying Huang, Freddie Pruitt, Nathan Boyd, Emma Kondrup, Binay Panda, Keren Limor-Waisberg, Brad Elphinstone, Ashwin Budden, Vasiliki Rahimzadeh, Marietjie Botes ,+(Aryan Chaudhary), Soichi Ogishima. Dedy Effendi Lingga, Sylvia Gayle

Deliverable Name/Topics: Data Visiting

Start date: May 24, 2024

Co-leads: Donrich Thaldar, Yann Joly

Description: From differences in data privacy regulations to concerns around security, a range of factors can impede the sharing of genomic data across borders. To address these concerns, a number of institutions have championed data visiting, a pivotal innovation in genomics research that promises improved data management, improved data security, and streamlined legal compliance. Yet, despite its benefits, many of the legal intricacies that plague traditional data sharing, remain pertinent with Data visiting.

Aim: This group will evaluate the legal challenges associated with cross-border data visiting to develop a model data visiting agreement and guidelines for its national implementation.

Status:  A Data Visiting Lexicon has been developed and a manuscript on the terms has been published with Human Genomics. The group is currently analyzing data visiting models and practices employed by different institutions. Next steps will also involve revising the draft proposed definitions of data layers.

 

+1 Evert-Ben van Veen: Lindsay Smith, Shu Hui Chen (Sue), David Bujold, Subhashini Jagu, Nathan Boyd, Binay Panda, Keren Limor-Waisberg, Anja Bedeker, Stacey Donnelly, Ainsley Newson, Marietjie Botes, Soichi Ogishima

Deliverable Name/Topic: Global ELSI Group: Building Global Capacity for Genomic Research

Start date: Oct 10, 2023

Co-leads: Diya Uberoi, Claudia Gonzaga-Jauregui

Description: Worldwide, governments, funding bodies, institutions, and publishers have developed data infrastructures, policies, and incentives to facilitate the global sharing of genomic research. While these efforts have enabled genomic researchers and health practitioners from low-and middle-income countries (LMICs) to share their data more widely, many existing policies — developed by and for highly competitive economies — have been shown to deter researchers from engaging in data sharing, particularly those from low-resource settings. This creates a paradox where the very systems designed to promote sharing inadvertently exclude those who could benefit most. For the advances of genomic research to benefit everyone equally, it is essential that genomic researchers from LMICs both have access to and contribute to tools that address and navigate the legal and ethical challenges of genomic data sharing.

Aim: This group aims to collaborate with genomic researchers from LMICs to develop contextually relevant resources that can be implemented and used in regions globally. Starting with the example of GA4GH's model consent clauses in genomic research, the group will be developing recommendations for how these clauses could be tailored to better address the research context in Africa.

Status: The group explored the challenges associated with the implementation of REWS’ model consent clauses at the 13th Plenary/Connect meeting. Future work to expand consultations to account for similarities and differences in the African research setting  

+1: Mutiat Afolabi, Shakuntala Baichoo, Andreas Bruns, Rosalyn Ryan, Claudia Gonzaga-Jauregui, Henriette Raventos (jetty), Ariana Gonzalez, Palmira Granados, Dianne Nicol, Shu Hui Chen (Sue), Emily Boja, Anja Bedeker, Matilda Haas, Nathan Boyd, Binay Panda, Keren Limor-Waisberg, Sandrine Richard, Amanda Lim, Ashwin Budden, Ma’n H. Zawati, Mercury Shitindo

Deliverable Name/Topic: Data Sharing in High-Capacity Asian Genomics Jurisdictions 

Start date: Feb 1, 2026

Co-leads: Lingqiao Song, Shih Wee Seow

Description:  Multiple Asian jurisdictions (e.g., China, Japan, Singapore, South Korea, Hong Kong, and Taiwan) have developed robust capacities in genomics and biotechnology. Supported by substantial investment and mature industrial ecosystems, these regions excel in genomics research and biopharmaceutical development, generating large volumes of high-quality genomic and health data within relatively robust ethical and data protection frameworks. Despite these advances, participation in international genomic data-sharing initiatives remains limited. Asian jurisdictions with advanced biotechnology ecosystems remain restrictive toward international genomic data sharing. Shared concerns include lack of trust, privacy risks, data governance, technical interoperability, national security, data sovereignty, geopolitics, normative misalignment, and consent frameworks.

Aim: This group aims to bring together legal and ethical experts, genomic researchers, and bioinformatics scientists from high-capacity Asian jurisdictions and systematically map the underlying legal, ethical, social, and technical factors that impede the integration of Asian genomic data into regional and global scientific research initiatives. Ultimately, the group plans to develop strategies and solutions (e.g., tools, guidelines) to facilitate human genomic data sharing and unlock the potential of genomic innovation in these high-capacity Asian jurisdictions.

Status: The first foundational study will be conducted by the group to identify and categorize the regulatory factors that impede international genomic data sharing in high-capacity genomic Asian jurisdictions. The group will assess regulatory barriers across Asian jurisdictions to identify practical pathways for operationalizing legal and ethical requirements, exploring a "compliance by design” approach to help inform a series of recommendations. The group will also host the “Bridging Regulation and Technology: Genomic Data Sharing Across Asia” Connect session in October 2026.

 

+1: Yungui Yang, Minxian (Wallance) Wang, Hongjie Man, Stephen Li Du, Patrick Tan, Shih Wee Seow, Zhangyu Wang, Zhenyu Liu, Fanlin Meng, Shihua Zhang, Xiaojian Shao, Yixue Li, Lingqiao Song, Ma’n Zawati, Ariel Xue, Xiaoli Wang, Ashwin Budden, Hannah Kim, Chih-hsing Ho, Megan Tsao, Mayumi Kusunose,  G. Owen Schaefer, Tazro OHTA, Soichi Ogishima, Jilong Liu, Dedy Effendi Lingga

Forums

Deliverable Name/Topic: Public Attitudes for Genomics and Policy

Start date: Apr 28, 2022

Lead: Dianne Nicol

Description: People have different feelings around how their genomic information is used and shared. This group aims to capture public attitudes towards donation, storage, use and sharing of their genomic data.

Aim: The group invites blog contributions from authors of studies exploring citizens' perspectives and concerns around genomic data storage, use and sharing, with the aim of communicating these findings to policy influencers and to society at large.

Status: Authors are invited to write briefs on specific topics and/or country-specific perspectives. These briefs are expected to relate already published work on public attitudes towards data storage, use and sharing, with particular focus on how these findings can influence genomic policy.  Should you be interested in submitting briefs for the forum please contact: rews-coordinator@ga4gh.org. 

Published briefs can be found here:  

https://www.ga4gh.org/product/public-attitudes-for-genomic-policy-blog-posts/

+1: Arzoo Ahmed, Mutiat Afolabi, Marie-Jo Brion, Daniela Bodemer, Rosalyn Ryan, Henriette Raventos (Jetty), Shu Hui Chen (Sue), Anja Bedeker, Joe Flores-Toro, Karyn Onyeneho, Keren Limor-Waisberg, Brad Elphinstone, Claudia Gonzaga-Jauregui, Kaori Muto, Marietjie Botes, Ashwin Budden, Katherine Bonini, Mercury Shitindo

Deliverable Name/Topic: Health Data Sharing, Privacy and Regulatory Forum (previously GDPR Forum)

Start date: Sep 4, 2018

Co-Leads:  Adrian Thorogood, Fruzsina Molnár-Gábor (Co-editors of the Forum)

Description: Jurisdictions worldwide are establishing or strengthening data protection frameworks that impact the governance of genomic and health-related data. These laws require researchers, research institutions, companies, and health care institutions to protect data subjects' rights to privacy, creating barriers to data sharing and re-use, particularly across borders. International data sharing initiatives also navigate multiple overlapping regulatory frameworks. If the genomic community is to navigate these regulations successfully, greater clarity is needed on how these evolving laws affect data sharing.

Aim: This Forum publishes short and topical blog posts on the GA4GH website for the genomics community, exploring data-related regulations around the world and their impact on data sharing. The Forum consists of an international team of data protection and legal experts who solicit, contribute and review blog posts.  

Status: The group is currently accepting blog submission ideas from members of the GA4GH community and beyond.  To submit ideas for the forum, please contact: rews-coordinator@ga4gh.org and/or health-privacy-forum@ga4gh.org.

+1Evert-Ben van Veen: Emily Boja, Ying Huang, Shu Hui Chen (Sue), Subhashini Jagu, Nathan Boyd, Karyn Onyeneho, Keren Limor-Waisberg, Anja Bedeker, Ainsley Newson, Marietjie Botes, Amanda Lim, Ashwin Budden, Eddie Tan, Mercury Shitindo