Research ethics review for the use of anonymized samples and data: A systematic review of normative documents

References

• Canadian Institutes of Health Research. 2005. CIHR best practices for protecting privacy in health research. http://www.cihr-irsc.gc.ca/e/29072.html
   Google Scholar
• Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. 2014. Tri-council policy statement ethical conduct for research involving humans. http://www.pre.ethics.gc.ca/pdf/eng/tcps2-2014/TCPS_2_FINAL_Web.pdf.
   Google Scholar
• Church, G., C. Heeney, N. Hawkins, J. De Vries, P. Boddington, J. Kaye, M. Bobrow, and B. Weir. 2009. Public access to genome-wide data: Five views on balancing research with privacy and protection. PLoS Genetics 5:e1000665. doi:10.1371/journal.pgen.1000665.
   PubMed Web of Science ®Google Scholar
• Council of Europe. 2016. Recommendations of the Committee of Ministers to member states on research on biological materials of human origin. https://search.coe.int/cm/Pages/result_details.aspx?ObjectId=090000168064e8ff.
   Google Scholar
• Council of Europe Steering Committee on Bioethics (CDBI). 2002. Proposal for an instrument on the use of archived human biological materials in biomedical research. http://contenidos.institutoroche.es/pdf/gmbib/proyecto_muestras.pdf.
   Google Scholar
• de Vries, J., S. Nchangwi Munung, A. Matimba, S. McCurdy, O. Ouwe Missi Oukem-Boyer, C. Staunton, A. Yakubu, and P. Tindana; the H3Africa Consortium. 2017. Regulation of genomic and biobanking research in Africa: A content analysis of ethics guidelines, policies and procedures from 22 African countries. BMC Medical Ethics 18:8. doi:10.1186/s12910-016-0165-6.
   PubMed Web of Science ®Google Scholar
• Eriksson, S., and G. Helgesson. 2005. Potential harms, anonymization, and the right to withdraw consent to biobank research. European Journal of Human Genetics 13:1071–76. doi:10.1038/sj.ejhg.5201458.
   PubMed Web of Science ®Google Scholar
• eTRIKS. 2014. Code of practice on secondary use of medical data in scientific research projects. https://www.etriks.org/wp-content/uploads/2014/12/Code-of-Practice-on-Secondary-Use-of-Medical-Data-with-recognition.pdf.
   Google Scholar
• European Council. 2004. 25 Recommendations on the ethical, legal and social implications of genetic testing. http://www.unesco.org.tr/dokumanlar/biyoetik_komitesi/25%20recommendations%20ec.pdf.
   Google Scholar
• European Society of Human Genetics. 2003. Data Storage and DNA Banking for biomedical research: Technical, social and ethical issues. European Journal of Human Genetics 11:906–08. doi:10.1038/sj.ejhg.5201107.
   PubMed Web of Science ®Google Scholar
• FDRE Ministry of Science and Technology. 2014. National research ethics review guideline. http://www.ccghr.ca/wp-content/uploads/2013/11/national-research-ethics-review-guidline.pdf.
   Google Scholar
• Fullerton, S. M., and S. S. Lee. 2011. Secondary uses and the governance of de-identified data: Lessons from the human genome diversity panel. BMC Medical Ethics 12:16. doi:10.1186/1472-6939-12-16.
   PubMed Web of Science ®Google Scholar
• Global Alliance for Genomics and Health. 2015. Privacy and security policy. https://genomicsandhealth.org/privacy-and-security-policy-pdf-26-may-2015.
   Google Scholar
• Goldenberg, A. J., K. J. Maschke, S. Joffe, J. R. Botkin, E. Rothwell, T. H. Murray, R. Anderson, N. Deming, B. F. Rosenthal, and S. M. Rivera. 2015. IRB practices and policies regarding the secondary research use of biospecimens. BMC Medical Ethics 16:32. doi:10.1186/s12910-015-0020-1.
   PubMed Web of Science ®Google Scholar
• Gymrek, M., A. L. McGuire, D. Golan, E. Halperin, and Y. Erlich. 2013. Identifying personal genomes by surname inference. Science 339:321–24. doi:10.1126/science.1229566.
   PubMed Web of Science ®Google Scholar
• Homer, N., S. Szelinger, M. Redman, D. Duggan, W. Tembe, J. Muehling, J. V. Pearson, D. A. Stephan, S. F. Nelson, and D. W. Craig. 2008. Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays. PLoS Genetics 4:e1000167. doi:10.1371/journal.pgen.1000167.
   PubMed Web of Science ®Google Scholar
• Human Tissue Authority. 2017. Code of practice and standards. https://www.hta.gov.uk/hta-codes-practice-and-standards-0
   Google Scholar
• Indian Council of Medical Research. 2006. Ethical guidelines for biomedical research on human research. http://www.nitrd.nic.in/WriteReadData/userfiles/file/Ethical%20Guidelines.pdf.
   Google Scholar
• Irish Council for Bioethics. 2005. Human biological material: recommendations for collection use and storage in research. http://health.gov.ie/wp-content/uploads/2014/07/Human_Biological_Material1.pdf.
   Google Scholar
• Junod, V., and B. Elger. 2010. Retrospective research: What are the ethical and legal requirements? Swiss Medical Weekly 140:w13041.
   PubMed Web of Science ®Google Scholar
• Lynch, H. F., and M. N. Meyer. 2017. Regulating research with biospecimens under the revised common rule. Hastings Center Report 47:3–4. doi:10.1002/hast.2017.47.issue-3.
   PubMed Web of Science ®Google Scholar
• McGuire, A. L., and R. A. Gibbs. 2006. No longer de-identified. Science 312:370–71. doi:10.1126/science.1125339.
   PubMed Web of Science ®Google Scholar
• Medical Research Council. 2014. Human tissue and biological sample for use in research: Operational and ethical guidelines. https://www.mrc.ac.uk/publications/browse/human-tissue-and-biological-samples-for-use-in-research/
   Google Scholar
• Ministry of Health New Zealand. 2007. Guidelines on the use of human tissue for future unspecified research purposes. https://www.health.govt.nz/system/files/documents/publications/guidelines-use-of-human-tissue-may07.pdf.
   Google Scholar
• National Bioethics Advisory Commission. 2000. Research involving human biological materials: Ethical issues and policy guidelines. https://bioethicsarchive.georgetown.edu/nbac/hbm_exec.pdf.
   Google Scholar
• National Health and Medical Research Council. 2015. National statement on ethical conduct in human Research. https://www.nhmrc.gov.au/guidelines-publications/e72.
   Google Scholar
• National Institutes of Health. 2014. Genomic data sharing policy. https://osp.od.nih.gov/wp-content/uploads/NIH_GDS_Policy.pdf.
   Google Scholar
• National Institutes of Health. 2015. Guidance on consent for the future research use and broad sharing of human genomic and phenotypic data subject to the NIH genomic data sharing policy. https://osp.od.nih.gov/wp-content/uploads/NIH_guidance_elements_consent_under_gds_policy.pdf.
   Google Scholar
• Phillips, M., and B. M. Knoppers. 2016. The discombobulation of de-identification. Nature Biotechnology 34:1102–03. doi:10.1038/nbt.3696.
   PubMed Web of Science ®Google Scholar
• Robinson, J. O., M. J. Slashinski, E. Chiao, and A. L. McGuire. 2016. It depends whose data are being shared: Considerations for genomic data sharing policies. Journal of Law and the Biosciences 2:697–704.
   Web of Science ®Google Scholar
• Rodriguez, L. L., L. D. Brooks, J. H. Greenberg, and E. D. Green. 2013. The complexities of genomic identifiability. Science 339:275–76. doi:10.1126/science.1234593.
   PubMed Web of Science ®Google Scholar
• Rothstein, M. A. 2010. Is deidentification sufficient to protect health privacy in research? The American Journal of Bioethics 10:3–11. doi:10.1080/15265161.2010.494215.
   PubMed Web of Science ®Google Scholar
• Sterling, R. 2011. Genetic research among the Havasupai—A cautionary tale. AMA Journal of Ethics 13:113–17.
   Google Scholar
• Tassé, A. M., I. Budin-Ljøsne, B. M. Knoppers, and J. R. Harris. 2010. Retrospective access to data: The ENGAGE consent experience. European Journal of Human Genetics 18:741–45. doi:10.1038/ejhg.2010.30.
   PubMed Web of Science ®Google Scholar
• The Council for International Organizations of Medical Sciences. 2016. International ethical guidelines for health-related research involving humans. https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf.
   Google Scholar
• Tsosie, R. 2007. Cultural challenges to biotechnology: Native American genetic resources and the concept of cultural harm. Journal Law Medicine Ethics 35:396–411. doi:10.1111/j.1748-720X.2007.00163.x.
   PubMed Web of Science ®Google Scholar
• UNESCO. 2004. International declaration on human genetic data. http://unesdoc.unesco.org/images/0013/001361/136112e.pdf
   Google Scholar
• World Health Organization. 2004. Genetic databases: Assessing the benefits and the impact on human and patient rights. http://www.who.int/genomics/publications/en/index5.html
   Google Scholar
• World Medical Association. 2016. WMA declaration of Taipei on ethical considerations regarding health databases and biobanks. https://www.wma.net/policies-post/wma-declarationof-taipei-on-ethical-considerations-regarding-health-databases-andbiobanks/
   Google Scholar