| DATA SHARING LEXICON Version 1.0, 15 March 2016 | = | |
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| Note.Original.URL | = | https: www.ga4gh.org/wp-content/uploads/GA4GH_Data_Sharing_Lexicon_Mar15.pdf |
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| Ti | = | Global Alliance for Genomics & Health Data Sharing Lexicon |
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| Preamble.Ti | = | Preamble |
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| Preamble.1.sec | = | The Global Alliance for Genomics and Health (“GA4GH”) is an international, non-profit coalition of individuals and organizations working in healthcare, research, disease advocacy, life science, and information technology dedicated to improving human health by maximizing the potential of genomic medicine through effective and responsible data sharing. The sharing of genomic and health-related data for biomedical research is of key importance in ensuring continued progress in our understanding of human health and wellbeing. The challenges raised by international, collaborative research require a principled but nevertheless practical framework that brings together regulators, funders, patient groups, information technologists, industry, publishers, and research consortia to share principles about data exchange. |
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| Preamble.2.sec | = | GA4GH’s mission is to “accelerate progress in human health by helping to establish a common framework of harmonized approaches to enable effective and responsible sharing of genomic and clinical data, and by catalysing data sharing projects that drive and demonstrate the value of data sharing.” |
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| Preamble.3.sec | = | Sharing of genomic and health data is increasingly international, but must contend with discrepancies in the terms employed by applicable laws, ethics policies and regulatory systems. The purpose of this GA4GH Data Sharing Lexicon is to support international data sharing by promoting common/concordant terms within the GA4GH and across jurisdictions and research contexts with the ultimate aim of improving human health. |
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| Preamble.4.sec | = | This Data Sharing Lexicon is a tool developed to promote data-sharing in general. It is not intended to focus on biobanking or the transfer or processing of tissues or samples. The terms included are predominantly derived from legal/regulatory sources but modified so that they are applicable to many jurisdictions. These terms are not intended to replicate definitions found in particular statutes, or within scientific and technical literatures. Additional resources can be found in the attached bibliography. |
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| Preamble.5.0.sec | = | Where relevant, the Data Sharing Lexicon builds on terminology used in GA4GH documents and policies, the most important of which are: |
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| Preamble.5.1.sec | = | The Framework for Responsible Sharing of Genomic and Health-Related Data |
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| Preamble.5.2.sec | = | Consent Policy |
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| Preamble.5.3.sec | = | Privacy and Security Policy |
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| Preamble.5.4.sec | = | Accountability Policy |
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| Preamble.5.5.sec | = | It also incorporates terms already in use in existing GA4GH glossaries where these are relevant and appropriate. |
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| Preamble.5. | = | [G/Z/ol-bullet/s5] |
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| Preamble. | = | [G/Z/ol/s5] |
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| Acknowledge.Ti | = | Acknowledgements |
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| Acknowledge.sec | = | This Policy is the result of the work of many people and committees. Developed under the auspices of the GA4GH’s Regulatory and Ethics Working Group, the Policy was formulated by an international committee (Data Sharing Lexicon Task Team) representing a wide spectrum of the law, security, bioethics, genomics, and life science industry communities. Collaborative input was provided from individuals as well as biomedical, patient advocacy, and ethical, policy and legal organizations, committees, and projects from all regions of the world (for contributors, see the Data Sharing Lexicon home page). |
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| Acknowledge. | = | [G/Z/ol/s5] |
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| Def. | = | [G/GA4GH/Data-Sharing-Lexicon/Sec/Def/0.md] |
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| _ | = | [G/GA4GH/Data-Sharing-Lexicon/Sec/DefLink/0.md] |
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| Annex.1.Ti | = | Appendix 1: Table of Concordance of Data Privacy and Security Terms (from GA4GH Privacy and Security Policy) |
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| Annex.1.0.sec | = | Spectrum of Identifiability 1 (Most identifiable), 2, 3, (Least identifiable) |
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| Annex.1.1.Ti | = | “Is or can be fully identifiable to everyone” |
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| Annex.1.1.0.sec | = | Category 1: Identified/personal/nominative data are labelled with personal identifiers such as name or identification numbers. Data are directly traceable back to the Data Donor. |
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| Annex.1.1.1.sec | = | identified or identifiable |
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| Annex.1.1.2.sec | = | personal |
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| Annex.1.1.3.sec | = | nominative |
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| Annex.1.1. | = | [G/Z/ol-bullet/s3] |
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| Annex.1.2.Ti | = | “Is unidentifiable to most, but remains re-identifiable to those with access to the key(s)” |
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| Annex.1.2.0.sec | = | Category 2: Pseudonymization/coding/key-coding consists of replacing one attribute (typically a unique attribute) in a record by another. Pseudonymized/coded/key-coded data are labelled with at least one specific code and do not carry any personal identifiers, but an individual is still likely to be identified indirectly; accordingly, pseudonymization/coding/key-coding when used alone will not result in an anonymous data. Pseudonymization/coding/key-coding reduces the linkability of a dataset with the original identity of a Data Donor; as such, it is a useful security measure in genomic research, but it is not a method of anonymization. |
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| Annex.1.2.1.sec | = | coded |
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| Annex.1.2.2.sec | = | key-coded pseudonymized |
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| Annex.1.2.3.sec | = | reversibly de-identified |
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| Annex.1.2.4.sec | = | linked anonymized |
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| Annex.1.2.5.sec | = | masked |
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| Annex.1.2.6.sec | = | encrypted |
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| Annex.1.2. | = | [G/Z/ol-bullet/s6] |
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| Annex.1.3.Ti | = | “Is likely no longer identifiable to anyone” |
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| Annex.1.3.0.sec | = | Category 3: Anonymization is intended to prevent re-identification. Data must be processed in such a way that it can no longer be used to identify a Data Donor by using all the means likely reasonably to be used by person or entity. An important factor is that the processing must be irreversible to reasonable degree, i.e., anonymized data must not be traceable back to the Data Donor. |
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| Annex.1.3.1.sec | = | anonymized |
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| Annex.1.3.2.sec | = | de-identified pseudonymized |
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| Annex.1.3.3.sec | = | irreversibly de-identified |
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| Annex.1.3.4.sec | = | non-identifiable |
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| Annex.1.3.5.sec | = | unidentifiable |
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| Annex.1.3.6.sec | = | unlinked anonymized |
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| Annex.1.3. | = | [G/Z/ol-bullet/s6] |
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| Annex.1.4.Ti | = | “Never was identifiable” |
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| Annex.1.4.0.sec | = | Category 4: Anonymous data are never labelled with personal identifiers when originally collected, nor is a coding key generated. Therefore, there is no potential to trace back Data to individual Data Donors. Anonymous data are of extremely limited utility in genomic research. |
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| Annex.1.4.1.sec | = | anonymous |
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| Annex.1.4. | = | [G/Z/ol-bullet/s1] |
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| Annex.1. | = | [G/Z/ol/4] |
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| Note | = | after anonymous is a footnote indicator "6" |
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| Annex.1. | = | [G/Z/ol/s4] |
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| Annex.1.FtNt.1.sec | = | Adapted from William W. Lowrance, Learning from Experience Privacy and the Secondary Use of Data in Health Research (London: Nuffield Trust, 2002) at 34; ICH, Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (April 2008); Article 29 Data Protection Working Party, Opinion 05/2014 on Anonymisation Techniques; Knoppers BM, Saginur M. The Babel of genetic data terminology. Nature Biotechnology 2005; 23(8): 925-927. |
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| Annex.2.Ti | = | Appendix 2: Additional Resources |
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| Annex.2.1.sec | = | GA4GH, Privacy and Security Policy (2015), Appendix 1 “Glossary” and 2 “Table of Concordance of Data Privacy and Security Terms” [link] |
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| Annex.2.2.sec | = | P3G, Biobank Lexicon [link] |
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| Annex.2.3.sec | = | Presidential Commission for the Study of Bioethical Issues, Privacy and Progress in Whole Genome Sequencing (2012) “Appendix I: Glossary of Key Terms” [link] |
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| Annex.2.4.sec | = | World Health Organisation, Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (2011) “Glossary” [link] |
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| Annex.2.5.sec | = | BBMRI, Lexicon [link] |
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| Annex.2.6.sec | = | Nuffield Council of Bioethics, The Collection, Linking and Use of Data in Biomedical Research and Health Care: Ethical Issues (2015) [link] |
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| Annex.2.7.sec | = | OECD, Health Data Governance (2015) [link] |
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| Annex.2.8.sec | = | Administrative Data Research Network (ADRN), Glossary, Definitions of Terms used in the Network (2015) [link] |
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| Annex.2.9.sec | = | OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data (2013) [link] |
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| Annex.2.10.sec | = | Elliot M et al, Glossary on Statistical Disclosure Control (2009) [link] |
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| Annex.2. | = | [G/Z/ol-bullet/s10] |
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| Annex. | = | [G/Z/ol/2] |
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| sec | = | |
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| = | [G/Z/Base] |
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