Access and adopt ready-to-use regulatory and ethics guidance for genomic and health-related data sharing.
The GA4GH Framework for Responsible Sharing of Genomic and Health-Related Data provides a principled and practical framework for the responsible sharing of genomic and health-related data. It contains foundational principles and core elements for responsible data sharing and is guided by human rights, including the right to benefit from the progress of science, as well as privacy, non-discrimination, and procedural fairness.
As genome-wide sequencing enters the clinic as part of routine diagnosis, health authorities may require an authorization for such testing in addition to the consent already provided by patients for medical care generally. The Clinical Genomic Consent Clauses provides examples for describing and distinguishing the typology of genomic tests and informing the patient of the core elements of genomic testing in the health care setting.
The Consent Clauses for Large Scale Initiatives is a table of generalized consent clauses from around the world, organized in different categories from biobanking and population studies, including personal genome biobanks. It is available to help researchers when drafting consent forms so they can use language that matches GA4GH international standards. The examples found under the various categories of clauses may need to be adapted to different research and ethico-legal contexts.
Genetic Discrimination: Implications for Data Sharing Projects (GeDI) provides information on key topics in genetic discrimination, such as terminological aspects, available evidence, existing protections, and consent. This accessible information has been developed by a geographically diverse group of experts and can easily be adapted to be part of a good communication strategy by genome data sharing projects across the world.
This document is the Global Alliance for Genomics and Health’s (GA4GH’s) Framework for involving and engaging participants, patients and publics in genomics research and health implementation (hereafter, Engagement Framework). It recognises that the benefits of genomics must be global, yet the practices might impact, benefit and harm people and communities in different ways and builds on the mission of the GA4GH, its Framework for Responsible Sharing of Genomic and Health-Related Data and commitment to Diversity and Inclusion.
The GA4GH Policy on Clinically Actionable Genomic Research Results aims to provide a reference point for managing the return of such results that recognizes the importance of the accountability and transparency of genomic researchers towards participants. It also acknowledges the differing levels of evidence behind the clinical utility of such information, and the complexities involved in returning it to individuals in an ethically and legally appropriate manner. The Policy aims to identify common ground while also allowing for appropriate customization by locale and by research project.
The Data Access Committee Review Standards (DACReS) Policy outlines guiding principles and provides procedural standards for Data Access Committees (DACs). Operationalizing these guiding principles and procedural standards should engender greater trust in the DAC review process across institutions, repositories, and jurisdictions and thereby promote more efficient, more secure, and more consistent procedures for access to data.
Familial Consent Clauses provides researchers with a typology of clauses describing familial consent clauses from studies around the world. Each sample clause can be adapted to fit different research and legal contexts, making this guidance useful to genetics and precision medicine studies around the globe.
The GA4GH Copyright policy ensures that the GA4GH has clear rights under copyright law to adapt and utilize individual and institutional contributions, incorporate them into GA4GH standards, and to distribute those standards widely. The policy encourages open and collaborative participation of institutions and individuals in standards development, and aims to recognize those who contribute.
The GA4GH Consent Clauses for Genomic Research provides researchers with sample phrases addressing various consent elements. Each sample clause can be adapted to fit different research and legal contexts, making this guidance useful to genetics and precision medicine studies around the globe.
The GA4GH Data Privacy and Security Policy aims to guide the sharing of genomic and health-related data in a way that protects and promotes the confidentiality, integrity, and availability of data and services, and the privacy of individuals, families, and communities whose data are shared.
The GA4GH Ethics Review Recognition Policy aims to inspire confidence in the adequacy of an ethics review from another jurisdiction’s ethics review system on the basis of equivalent requirements and the quality of the ethics review performed as part of that system. Recognizing the diversity of legal and ethical approaches and being responsive to emerging issues, this Policy encourages the reduction of duplicative ethics reviews through recognition approaches that enable ethics committees to accept the review of another ethics committee.
The GA4GH Machine Readable Consent Guidance provides instructions for researchers integrate standard data sharing language into consent forms in a way that is able to be translated to a computable language. Machine readable consent language is able to be attached to datasets and stored in their descriptive data using DUO terms. Researchers can then search for datasets that have been consented to for their research purposes.
The GA4GH Pediatric Consent Clauses provide generic consent clauses particular to the pediatric research context for mature minors and for parents consenting on behalf of children. These simple clauses are based on different consent languages currently in use around the world. An accompanying generic Assent Form and Information Sheet (approx. age 7-11) is also provided.
Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, GA4GH and IRDiRC have developed model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants’ overall protection.
The GA4GH GDPR Forum publishes monthly “GDPR Briefs” that answer important questions about the GDPR’s impact on various aspects of international health research and genomic and health-related data sharing, and that further explore the various issues raised in the GDPR Primer.
The Public Attitudes for Genomic Policy subgroup aims to disseminate the findings from the Your DNA Your Say study and other public attitudes studies into a series of blog posts and accompanying infographics. Touching upon a range of themes, these will inform the Global Alliance for Genomics and Health and external audiences on public attitudes towards genomic research and how policy and research should be designed to address these views.
The ‘Your DNA, Your Say’ project is a global online survey gathering public attitudes towards genomic data sharing using nine innovative films that explain the subject in an approachable manner. The survey is available in numerous languages, with more translations to come. English language results will be available in 2018. The findings from the survey will help to ensure GA4GH policies and tools are informed by the people they are ultimately designed to serve. Please see the Your DNA Your Say website for the latest outcomes from the project; the first publication on the between-country analysis of attitudes towards genomic data sharing is published in the American Journal of Human Genetics.