Ethics and Governance of Health Research Data in International Organizations: A Framework Analysis
Journal: Journal of Clinical Medicine Research DOI: 10.32629/jcmr.v5i4.3101
Abstract
Taking the relevant policies of health research data issued by international organizations as the research object, using the life cycle theory, this paper constructs an international ethics governance framework for health research data from the perspectives of governance stages and means. It summarizes the connotation, means, and policy focus of international organizations' ethics governance for health research data. This paper aims to provide references for countries worldwide to optimize the ethics governance of health-related research data, improve the governance level of health research data, and foster a robust ecosystem for data opening and sharing.
Keywords
health research data; data sharing; scientific data governance; ethics; protection of privacy
Full Text
PDF - Viewed/Downloaded: 0 TimesReferences
[1] Wu J R. Big life-science: Study of omics from microscopic to mesoscopic scales. Bulletin of Chinese Academy of Sciences, 2024, 39(5): 832-839, doi: 10.16418/j.issn.1000-3045.20240128001. (in Chinese) CSTR: 32128.14.CASbulletin.20240128001.
[2] Jianwei Wang.et.al.Strengthening the construction and application of biomedical big data to promote the implementation of the Healthy China Initiative，Chinese Science Bulletin，2024, 69(9): 1123-1131.
[3] WMA - The World Medical Association-WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks[EB/OL]. [2024-05-16]. https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/.
[4] WMA - The World Medical Association-Declaration of Helsinki[EB/OL]. [2024-09-30]. https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/.
[5] COOK-DEEGAN R, MCGUIRE A L. Moving beyond Bermuda: sharing data to build a medical information commons[J/OL]. Genome Research, 2017, 27(6): 897-901. DOI:10.1101/gr.216911.116.
[6] Universal Declaration on the Human Genome and Human Rights[EB/OL]. [2024-09-30]. https://www.ohchr.org/en/instruments-mechanisms/instruments/universal-declaration-human-genome-and-human-rights.
[7] HUGO Ethics Committee - Statement on Human Genomic Databases[EB/OL]. [2024-09-30]. https://www.eubios.info/HUGOHGD.htm.
[8] WMA declaration on ethical considerations regarding health databases[EB/OL]. [2024-09-30]. https://www.wma.net/wp-content/uploads/2016/10/DoE-Oct2002.pdf.
[9] International Ethical Guidelines for Biomedical Research Involving Human Subjects - CIOMS[EB/OL].[2024-09-30]. https://cioms.ch/publications/product/international-ethical-guidelines-for-biomedical-research-involving-human-subjects-2/.
[10] MATHARU J. Sharing Data from Large-scale Biological Research Projects: A System of Tripartite Responsibility[J]. 2003.
[11] International Declaration on Human Genetic Data | UNESCO[EB/OL]. (2023-01-16)[2024-05-16]. https://www.unesco.org/en/ethics-science-technology/human-genetic-data.
[12] Universal Declaration on Bioethics and Human Rights (chi) - UNESCO [EB/OL]. [2024-09-30]. https://unesdoc.unesco.org/ark:/48223/pf0000146180_chi.
[13] Recommendation of the Council on Health Data Governance[EB/OL]. [2024-09-18]. https://read.oecd-ilibrary.org/science-and-technology/oecd-principles-and-guidelines-for-access-to-research-data-from-public-funding_9789264034020-en-fr.
[14] International Ethical Guidelines for Epidemiological Studies - CIOMS[EB/OL]. [2024-09-30]. https://cioms.ch/publications/product/international-ethical-guidelines-for-epidemiological-studies/.
[15] RODRIGUEZ H, SNYDER M, UHLÉN M, Recommendations from the 2008 International Summit on Proteomics Data Release and Sharing Policy: the Amsterdam principles[J/OL]. Journal of Proteome Research, 2009, 8(7): 3689-3692. DOI:10.1021/pr900023z.
[16] Guidelines for Human Biobanks and Genetic Research Databases (HBGRDs) - OECD[EB/OL]. [2024-05-16]. https://www.oecd.org/health/biotech/guidelines-for-human-biobanks-and-genetic-research-databases.htm.
[17] (PDF) 2012 Best practices for repositories: Collection, storage, retrieval, and distribution of biological materials for research[EB/OL]. [2024-09-30]. https://www.researchgate.net/publication/292810644_2012_Best_practices_for_repositories_Collection_storage_retrieval_and_distribution_of_biological_materials_for_research.
[18] OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data[EB/OL]. [2024-09-30]. https://www.oecd-ilibrary.org/science-and-technology/oecd-guidelines-on-the-protection-of-privacy-and-transborder-flows-of-personal-data_9789264196391-en.
[19] Report of the IBC on big data and health - UNESCO Digital Library[EB/OL]. [2024-05-16]. https://unesdoc.unesco.org/ark:/48223/pf0000248724.
[20] Recommendation on The Protection And Use of Health-Related Datahttps://www.ohchr.org/sites/default/files/Documents/Issues/Privacy/SR_Privacy/UNSRPhealthrelateddataRecCLEAN.pdf?__cf_chl_tk=MJ4jbUZEiik3NqpozTNDNaqwjNJNVMK2t849NrzsoH0-1715845008-0.0.1.1-1813[EB/OL]. [2024-05-16]. https://www.ohchr.org/sites/default/files/Documents/Issues/Privacy/SR_Privacy/UNSRPhealthrelateddataRecCLEAN.pdf?__cf_chl_tk=MJ4jbUZEiik3NqpozTNDNaqwjNJNVMK2t849NrzsoH0-1715845008-0.0.1.1-1813.
[21] BIRO T, SHANAHAN H, BEZUIDENHOUT L, World Health Organization Data Principles[J/OL]. 2020. DOI:10.15497/rda00052.
[22] Recommendation-of-the-Council-on-Enhancing-Access-to-and-Sharing-of-Data [EB/OL]. [2024-05-05]. https://www.oecd.org/mcm/2021/Recommendation-of-the-Council-on-Enhancing-Access-to-and-Sharing-of-Data_EN.pdf.
[23] Health Research Performing Organisations (HRPOs) FAIR Guidelines[EB/OL]. [2024-05-16]. https://www.rd-alliance.org/app/uploads/2022/11/HRPO-FAIR_Guidelines.pdf.
[24] Sharing and reuse of health-related data for research purposes: WHO policy and implementation guidance[EB/OL]. [2024-05-16]. https://www.who.int/publications-detail-redirect/9789240044968.
[25] Health Data Governance for the Digital Age[EB/OL]. (2022-05-10)[2024-09-30]. https://www.oecd.org/en/publications/2022/05/health-data-governance-for-the-digital-age_5c42de41.html.
[26] WHO Personal Data Protection Policy[EB/OL]. [2024-05-16]. https://www.who.int/publications/m/item/who-personal-data-protection-policy.
[2] Jianwei Wang.et.al.Strengthening the construction and application of biomedical big data to promote the implementation of the Healthy China Initiative，Chinese Science Bulletin，2024, 69(9): 1123-1131.
[3] WMA - The World Medical Association-WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks[EB/OL]. [2024-05-16]. https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/.
[4] WMA - The World Medical Association-Declaration of Helsinki[EB/OL]. [2024-09-30]. https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/.
[5] COOK-DEEGAN R, MCGUIRE A L. Moving beyond Bermuda: sharing data to build a medical information commons[J/OL]. Genome Research, 2017, 27(6): 897-901. DOI:10.1101/gr.216911.116.
[6] Universal Declaration on the Human Genome and Human Rights[EB/OL]. [2024-09-30]. https://www.ohchr.org/en/instruments-mechanisms/instruments/universal-declaration-human-genome-and-human-rights.
[7] HUGO Ethics Committee - Statement on Human Genomic Databases[EB/OL]. [2024-09-30]. https://www.eubios.info/HUGOHGD.htm.
[8] WMA declaration on ethical considerations regarding health databases[EB/OL]. [2024-09-30]. https://www.wma.net/wp-content/uploads/2016/10/DoE-Oct2002.pdf.
[9] International Ethical Guidelines for Biomedical Research Involving Human Subjects - CIOMS[EB/OL].[2024-09-30]. https://cioms.ch/publications/product/international-ethical-guidelines-for-biomedical-research-involving-human-subjects-2/.
[10] MATHARU J. Sharing Data from Large-scale Biological Research Projects: A System of Tripartite Responsibility[J]. 2003.
[11] International Declaration on Human Genetic Data | UNESCO[EB/OL]. (2023-01-16)[2024-05-16]. https://www.unesco.org/en/ethics-science-technology/human-genetic-data.
[12] Universal Declaration on Bioethics and Human Rights (chi) - UNESCO [EB/OL]. [2024-09-30]. https://unesdoc.unesco.org/ark:/48223/pf0000146180_chi.
[13] Recommendation of the Council on Health Data Governance[EB/OL]. [2024-09-18]. https://read.oecd-ilibrary.org/science-and-technology/oecd-principles-and-guidelines-for-access-to-research-data-from-public-funding_9789264034020-en-fr.
[14] International Ethical Guidelines for Epidemiological Studies - CIOMS[EB/OL]. [2024-09-30]. https://cioms.ch/publications/product/international-ethical-guidelines-for-epidemiological-studies/.
[15] RODRIGUEZ H, SNYDER M, UHLÉN M, Recommendations from the 2008 International Summit on Proteomics Data Release and Sharing Policy: the Amsterdam principles[J/OL]. Journal of Proteome Research, 2009, 8(7): 3689-3692. DOI:10.1021/pr900023z.
[16] Guidelines for Human Biobanks and Genetic Research Databases (HBGRDs) - OECD[EB/OL]. [2024-05-16]. https://www.oecd.org/health/biotech/guidelines-for-human-biobanks-and-genetic-research-databases.htm.
[17] (PDF) 2012 Best practices for repositories: Collection, storage, retrieval, and distribution of biological materials for research[EB/OL]. [2024-09-30]. https://www.researchgate.net/publication/292810644_2012_Best_practices_for_repositories_Collection_storage_retrieval_and_distribution_of_biological_materials_for_research.
[18] OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data[EB/OL]. [2024-09-30]. https://www.oecd-ilibrary.org/science-and-technology/oecd-guidelines-on-the-protection-of-privacy-and-transborder-flows-of-personal-data_9789264196391-en.
[19] Report of the IBC on big data and health - UNESCO Digital Library[EB/OL]. [2024-05-16]. https://unesdoc.unesco.org/ark:/48223/pf0000248724.
[20] Recommendation on The Protection And Use of Health-Related Datahttps://www.ohchr.org/sites/default/files/Documents/Issues/Privacy/SR_Privacy/UNSRPhealthrelateddataRecCLEAN.pdf?__cf_chl_tk=MJ4jbUZEiik3NqpozTNDNaqwjNJNVMK2t849NrzsoH0-1715845008-0.0.1.1-1813[EB/OL]. [2024-05-16]. https://www.ohchr.org/sites/default/files/Documents/Issues/Privacy/SR_Privacy/UNSRPhealthrelateddataRecCLEAN.pdf?__cf_chl_tk=MJ4jbUZEiik3NqpozTNDNaqwjNJNVMK2t849NrzsoH0-1715845008-0.0.1.1-1813.
[21] BIRO T, SHANAHAN H, BEZUIDENHOUT L, World Health Organization Data Principles[J/OL]. 2020. DOI:10.15497/rda00052.
[22] Recommendation-of-the-Council-on-Enhancing-Access-to-and-Sharing-of-Data [EB/OL]. [2024-05-05]. https://www.oecd.org/mcm/2021/Recommendation-of-the-Council-on-Enhancing-Access-to-and-Sharing-of-Data_EN.pdf.
[23] Health Research Performing Organisations (HRPOs) FAIR Guidelines[EB/OL]. [2024-05-16]. https://www.rd-alliance.org/app/uploads/2022/11/HRPO-FAIR_Guidelines.pdf.
[24] Sharing and reuse of health-related data for research purposes: WHO policy and implementation guidance[EB/OL]. [2024-05-16]. https://www.who.int/publications-detail-redirect/9789240044968.
[25] Health Data Governance for the Digital Age[EB/OL]. (2022-05-10)[2024-09-30]. https://www.oecd.org/en/publications/2022/05/health-data-governance-for-the-digital-age_5c42de41.html.
[26] WHO Personal Data Protection Policy[EB/OL]. [2024-05-16]. https://www.who.int/publications/m/item/who-personal-data-protection-policy.
Copyright © 2024 Qing Cheng
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License