/Docs/G/GA4GH/Accountability-Policy/Form/0.md
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Appendixes
  1. Appendix 1
    1. Policy Revision History
    2. Policy Number/Version Date Effective Summary of Revisions
  2. Appendix 2
    Accountability Elements in Other GA4GH Specific Policies
    1. Consent Policy
      • The consent process, in any form it takes, should be properly documented.
      • Consent materials and data sharing plans should be available for inspection and discussion with interested parties.
      • Consent materials and data sharing plans should be updated and made available in response to new regulations and policies by responsible individuals within an organization or entity.
      • Procedures should be in place to receive and respond to complaints or inquiries about policies and practices relating to consent to the sharing of genomic and health-related data. The procedures should be easily accessible and simple to use.
    2. Privacy and Security Policy
      • Data Stewards should clearly identify the individuals within their organization or entity who are responsible for data privacy, data management, and reporting procedures (including a contact person or contact point for complaints). Appropriate and regular training for the identified individuals to discharge these duties should be provided.
      • Data Stewards should track new regulations, policies, expectations, and best practices, sharing these with responsible individuals within their organization or entity.
      • Data Stewards and Data Users must comply with applicable privacy regulations and ethical norms at every stage of data sharing, and be in a position to provide assurances that privacy interests are appropriately protected when Data are collected, stored, processed, and shared.
  3. Appendix 3
    Suggested Procedural Guidance
    • Administrative Data Research Network (ADRN), Breaches Policy and Procedures (2015) [link].
    • Article 29 Data Protection Working Party (WP29), Opinion 3/2010 on the Principle of Accountability (2010) [link].
    • The Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC), Draft Tri-Agency Statement of Principles on Digital Data Management (2015) [link].
    • Centre for Information Policy Leadership, Data Protection Accountability: The Essential Elements a Document for Discussion (2009) [link].
    • Council of Canadian Academies (The Expert Panel on Timely Access to Health and Social Data for Health Research and Health System Innovation), Accessing Health and HealthRelated Data in Canada (2015) [link].
    • The Future of Research Communications and e-Scholarship (FORCE11), Guiding Principles for Findable, Accessible, Interoperable and Re-Usable Data (2014) v B1.0 [link].
    • Hrynaszkiewicz I et al, Preparing Raw Clinical Data for Publication: Guidance for Journal Editors, Authors, and Peer Reviewers (2010) BMJ [link].
    • Hrynaszkiewicz I et al, Publishing Descriptions Of Non-Public Clinical Datasets: Guidance For Researchers, Repositories, Editors And Funding Organisations (2015) [link].
    • Mascalzoni D et al, International Charter of Principles for Sharing Bio-specimens and Data, European Journal of Human Genetics (2014) EJHG [link].
    • National Institutes of Health, NIH Guide: Final NIH Statement On Sharing Research Data NOT-OD-03-032 (2003) [link].
    • Nuffield Council on Bioethics, The Collection, Linking And Use Of Data In Biomedical Research And Health Care: Ethical Issues (2015) [link].
    • Piwowar HA et al, Towards a Data Sharing Culture: Recommendations for Leadership from Academic Health Centers (2008) PLoS Medicine [link].
    • Toronto 2009 Data Release Workshop Authors, Benefits and Best Practices of Rapid PrePublication Data Release (2009) [link].
    • Wellcome Trust Expert Advisory Group On Data Access (EAGDA), Establishing Incentives And Changing Cultures To Support Data Access (2014) [link].
    • Wellcome Trust Expert Advisory Group On Data Access (EAGDA), Governance of Data Access (2015) [link].
    • Wellcome Trust Expert Advisory Group On Data Access (EAGDA), Statement for EAGDA Funders on Re-Identification (2013) [link].
    • Wellcome Trust, Medical Research Council, UKCRC, and Cancer Research UK, Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials (2015) [link].
    • United Nations Environment Programme (UNEP), Issues of Compliance: Considerations for the International Regime on Access and Benefit Sharing (2010) [link].