/Docs/G/GA4GH/Accountability-Policy/Form/0.md
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Context
  1. Context
    The significant public health imperatives for the translation of new genomics knowledge, coupled with rapid technological developments, scientific advancements in genomics, and the increasingly global scale of data sharing, reinforce the need for a framework to ensure accountability, and in turn trust, between stakeholders. Individuals asked to share their data for broad research purposes, together with the ethics bodies responsible for protecting their interests, are asked to trust in a diverse, distributed cast of stakeholders around the world. Data sharing standards continue to emerge from a variety of sources, including consent processes, laws, regulations, and policies established by funding agencies, journals, institutions, large research projects and research consortia. Data stewards impose additional conditions on data use through access agreements. Even in contexts where data sharing standards are clearly established, however, policies and processes for monitoring and responding to non-compliance may be lacking. The community largely relies on employers or guarantors of data users to hold them accountable, but these institutions may lack the necessary resources, incentives, or expertise to do so effectively. Transparency in this and other contexts is crucial for accountability. If data stewards are not open about data availability and access processes, it is difficult to assess if data is fairly and effectively available. If data users do not take steps to demonstrate that use limitations are respected, it is difficult to assess if they are accountable for the data entrusted to them. To ensure accountability between stakeholders and respect for the Framework, there is a need for clear data sharing standards, openness about data handling practices, as well as policies and processes for monitoring and responding to non-compliance with local standards.
  2. Interpretation
    1. For the purposes of this Policy, ‘data sharing’ includes, but is not limited to, the use, viewing, transfer, linkage, or exchange of data between the data donor and another party, or between a data steward and a third party, either openly or under specified access conditions. Data sharing may occur without having the data move from one place to another.
    2. Stakeholders include, but are not limited to, researchers, bioinformaticians, IT experts, research participants and patient communities, journal publishers, research funding agencies, data protection authorities, academic institutions, hospitals, clinicians, research ethics committees, the life sciences and pharmaceutical industry, governments and government agencies, and public health organizations.
    3. This policy addresses compliance with ‘data sharing standards’, by which it means locally applicable data sharing standards derived from laws, regulations, guidelines, policies and agreements. This policy only applies to GA4GH best practices to the extent they are adopted locally.
  3. Definitions
    A number of terms used in this Policy are defined in the GA4GH Data Sharing Lexicon.
  4. Application
    This policy is addressed to individual and organizational members of the GA4GH, as well as the broader community of stakeholders involved in data sharing. Section II outlines best practices for monitoring and responding to non-compliance with data sharing standards, and is primarily directed to stakeholders involved in the oversight of data sharing and data users (in research, the clinical sector, or industry). Section III outlines best practices for transparent and accountable data sharing, addressed to specific stakeholder groups.