Abstract
Pathological archival tissue has been used as a source of research material for many years. The advancement in molecular techniques led to an escalated interest in genetic research on archival tissue. Research on archival tissue has been used without obtaining consents from patients, although the ethical justification for such a practice is unlikely to apply for genetic research that involves whole genome sequencing, for instance. Issues of confidentiality and patients’ autonomy are being raised as institutions consider when approval for this type of research should be granted. In addition, patients’ advocate is mandating some of these changes. In the context of the United Arab Emirates, this paper makes clear the current uncertainties arising from the use of archival tissue in genetic research, as it could be highly invasive of privacy interests and also fails to respect autonomous choice. It further explains what needs to change in order to support such research that is directed at promoting public good, but in a way that is not detrimental to the welfare of patients as research participants.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Allen, M.J., M.L. Powers, K.S. Gronowski, and A.M. Gronowski. 2010. Human tissue ownership and use in research: What laboratorians and researchers should know. Clinical Chemistry 56 (11): 1675–1682. https://doi.org/10.1373/clinchem.2010.150672.
Arias, I.M. 2004. A bridge building between medicine and basic science. In Bridging the bed-bench gap: Contributions of the Markey trust. Washington (DC): National Academies Press (US). http://www.ncbi.nlm.nih.gov/books/NBK215898/. Accessed 4 Sept 2018.
Bathe, O.F., and A.L. McGuire. 2009. The ethical use of existing samples for genome research. Genetics in Medicine 11 (10): 712–715. https://doi.org/10.1097/GIM.0b013e3181b2e168.
Benomran, F. 2010. Medical responsibility in the United Arab Emirates. Journal of Forensic and Legal Medicine 17 (4): 188–193. https://doi.org/10.1016/j.jflm.2009.12.009.
Catalogue for Transmission Genetics in Arabs (CTGA). 2017 http://www.cags.org.ae/ctga/graph/. Accessed 4 Sept 2018.
Chalmers, D., D. Nicol, J. Kaye, J. Bell, A.V. Campbell, C.W. Ho, K. Kato, J. Minari, C.H. Ho, C. Mitchell, F. Molnár-Gábor, M. Otlowski, D. Thiel, S.M. Fullerton, and T. Whitton. 2016. Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era. BMC Medical Ethics 17 (1): 39. https://doi.org/10.1186/s12910-016-0124-2.
Clayton, E.W., K.K. Steinberg, M.J. Khoury, E. Thomson, L. Andrews, M.J. Kahn, L.M. Koppelman, and J.O. Weiss. 1995. Informed consent for genetic research on stored tissue samples. Journal of the American Medical Association 274 (22): 1786–1792.
Department of Health. 2017. Healthcare regulator manual (Chapter VII: Human subject research). https://www.haad.ae/haad/tabid/1178/Default.aspx. Accessed 4 Sept 2018.
Department of Health – Abu Dhabi. 2012. HAAD Standard Operating Procedures for Research Ethics Committees (Ref PHP/PHR/R04). 20 February 2012. https://www.haad.ae/haad/tabid/1178/Default.aspx. Accessed 4 Sept 2018.
Dubai Health Authority Code of Ethics and Professional Conduct. 2014. Retrieved from https://www.dha.gov.ae/Documents/HRD/RegulationsandStandards/guidelines/Code%20of%20Ethics%20and%20Professional%20Conduct%20-%20final.latest.pdf. Accessed 4 Sept 2018.
El Obaid, Y., A. Al Hamiz, A. Abdulle, R.B. Hayes, S. Sherman, and R. Ali. 2016. Perceptions and attitudes towards medical research in the United Arab Emirates: Results from the Abu Dhabi Cohort Study (ADCS) focus group discussions. PLoS One 11 (3): e0149609. https://doi.org/10.1371/journal.pone.0149609.
Furness, P.N., and M.L. Nicholson. 2004. Obtaining explicit consent for the use of archival tissue samples: Practical issues. Journal of Medical Ethics 30 (6): 561–564.
Grizzle, W., W.W. Grody, W.W. Noll, M.E. Sobel, S.A. Stass, T. Trainer, H. Travers, V. Weedn, and K. Woodruff. 1999. Recommended policies for uses of human tissue in research, education, and quality control. Ad Hoc Committee on Stored Tissue, College of American Pathologists. Archives of Pathology and Laboratory Medicine 123 (4): 296–300. https://doi.org/10.1043/0003-9985(1999)123<0296:RPFUOH>2.0.CO;2.
Hirota, S., K. Isozaki, Y. Moriyama, K. Hashimoto, T. Nishida, S. Ishiguro, K. Kawano, M. Hanada, A. Kurata, M. Takeda, G. Muhammad Tunio, Y. Matsuzawa, Y. Kanakura, Y. Shinomura, and Y. Kitamura. 1998. Gain-of-function mutations of c-kit in human gastrointestinal stromal tumors. Science 279 (5350): 577–580.
Hull, S.C., R.R. Sharp, J.R. Botkin, M. Brown, M. Hughes, J. Sugarman, D. Schwinn, P. Sankar, D. Bolcic-Jankovic, B.R. Clarridge, B.S. Wilfond, and T. Katz. 2008. Patients’ views on identifiability of samples and informed consent for genetic research. American Journal of Bioethics 8 (10): 62–70. https://doi.org/10.1080/15265160802478404.
Kant, I, (1896). On deontology, cited in EH Loewy, & RS Loewy. (2004). In Textbook of healthcare ethics (2nd ed) (pp. 34–40). Netherlands: Kluwer Academic Publishers.
Krizman, D.B., and J. Burrows. 2013. Use of formalin-fixed, paraffin-embedded tissue for proteomic biomarker discovery. Methods in Molecular Biology 1002: 85–92. https://doi.org/10.1007/978-1-62703-360-2_7.
Laboratory guidelines. 2014. http://www.cps.sk.ca/imis/Documents/Programs%20and%20Services/Laboratory%20Quality%20Assurance/Policies%20and%20Guidelines/2014%20Laboratory%20Guidelines.pdf. Accessed 4 Sept 2018.
Lester, S. 2010. Specimen processing: From gross specimens to tissue cassettes (chapter 2). In Manual of surgical pathology, 11–28. 3rd ed. Philadelphia: Elsevier Saunders.
Loewy, E.H., and R. S. Loewy. 2004. On deontology (chapter 2) and on genetics and ethics (chapter 7). In Textbook of healthcare ethics, 34–40 and 158–159. 2nd ed. Netherlands: Kluwer Academic Publishers.
Matsui, K., A. Abou Zeid, Z. Xinqing, B. Krohmal, V. Muthuswamy, Y. Mo Koo, D. Wendler, J. Chao, Y. Kita, and R. Lie. 2009. Informed consent to future research on stored tissue samples: The views of researchers, ethics review committee members and policy makers in five non-Western countries. Asian Bioethics Review 1 (4): 401–416.
McDonald, S.A., E.R. Mardis, D. Ota, M.A. Watson, J.D. Pfeifer, and J.M. Green. 2012. Comprehensive genomic studies: Emerging regulatory, strategic, and quality assurance challenges for biorepositories. American Journal of Clinical Pathology 138 (1): 31–41. https://doi.org/10.1309/AJCPXBA69LNSCVMH.
Miles, G., J. Rae, S.S. Ramalingam, and J. Pfeifer. 2015. Genetic testing and tissue banking for personalized oncology: Analytical and institutional factors. Seminars in Oncology 42 (5): 713–723. https://doi.org/10.1053/j.seminoncol.2015.07.013.
Ministry of Health Medical Practice Legislations. (2017) http://www.mohap.gov.ae/ar/aboutus/Pages/PublicHealthPolicies.aspx. Accessed 4 Sept 2018.
Moore, P.S., and Y. Chang. 2010. Why do viruses cause cancer? Highlights of the first century of human tumour virology. Nature Reviews Cancer 10 (12): 878–889. https://doi.org/10.1038/nrc2961.
Qualman, S.J., M. France, W.E. Grizzle, V.A. LiVolsi, C.A. Mokaluk, N.C. Ramirez, et al. 2004. Establishing a tumor bank: Banking, informatics and ethics. British Journal of Cancer 90: 1115–1119. https://doi.org/10.1038/sj.bjc.6601678.
UAE National Vision 20121. 2016. Accessed 27th August 2018 from https://www.vision2021.ae/en/publications. Accessed 4 Sept 2018.
Vermeulen, E., M.K. Schmidt, N.K. Aaronson, M. Kuenen, and F.E. van Leeuwen. 2009. Obtaining ‘fresh’ consent for genetic research with biological samples archived 10 years ago. European Journal of Cancer 45 (7): 1168–1174. https://doi.org/10.1016/j.ejca.2008.11.022.
Wendler, D., and E. Emanuel. 2002. The debate over research on stored biological samples: What do sources think? Archives of Internal Medicine 162 (13): 1457–1462.
Wong, E.M., J.E. Joo, C.A. McLean, L. Baglietto, D.R. English, G. Severi, J.L. Hopper, R.L. Milne, L.M. FitzGerald, G.G. Giles, and M.C. Southey. 2015. Tools for translational epigenetic studies involving formalin-fixed paraffin-embedded human tissue: Applying the Infinium HumanMethyation450 Beadchip assay to large population-based studies. BMC Research Notes 8: 543. https://doi.org/10.1186/s13104-015-1487-z.
Zeps, N., and M.J. Bledsoe. 2015. Managing the ethical issues of genomic research using pathology specimens. Clinical Biochemist Reviews 36 (1): 21–27.
Author information
Authors and Affiliations
Contributions
SA drafted the manuscript, revised it, and read and approved final manuscript.
CC revised and approved final manuscript.
Corresponding author
Ethics declarations
Ethics approval and consent to participate
Not applicable.
Consent for publication
Not applicable.
Availability of data and material
Not applicable.
Competing interests
The authors declare that they have no competing interests.
Rights and permissions
About this article
Cite this article
Almarzooqi, S., Campbell, C. Genetic Research Using Archival Tissue: Ethical, Social, and Legal Considerations in the United Arab Emirates. ABR 10, 219–230 (2018). https://doi.org/10.1007/s41649-018-0062-z
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s41649-018-0062-z