Obtaining Informed Consent in Genomic and Genetic Studies
https://doi.org/10.17803/1994-1471.2022.134.1.105-115
Abstract
The paper studies the process of obtaining informed consent in genomic and genetic research. The author considers some aspects of obtaining consent in the realm of the emergence of large-scale population studies and genomic databases that have challenged the traditional concepts of informed consent. The author examines foreign experience of obtaining informed consent as well as the concept considering informed consent as two main components, namely a dialogue or a process and form. Today due to the decoding of the genome and the possibility of re-identifying information, the information obtained in the course of scientific research and conducting genomic and genetic research can be disclosed. Therefore, the question is raised about the need for legal protection of such information and mechanisms for its protection. It is concluded that informed consent is no longer a single document tied to a particular study; it is becoming a dynamic process. The paper summarizes the latest theoretical and practical aspects of obtaining informed consent in genomic and genetic studies.
Keywords
informed consent,
genomic research,
human genome,
human rights,
biobank,
confidentiality,
database,
personal data,
genomic registration
Supporting agencies: The reported study was funded by RFBR according to the research project № 18-29-14015
About the Author
A. A. Pestrikova
Togliatti State University
Russian Federation
Russian Federation
Anastasiya A. Pestrikova, Cand. Sci. (Law), Associate Professor, Department of Constitutional and Administrative Law
ul. Belorusskaya, d. 14, Togliatti, 445020
References
1. Berg Dzh. Govorit’ ili ne govorit’: etika i zakon o konfidencial’nosti medicinskoj informacii // Sovremennoe medicinskoe pravo v Rossii i za rubezhom : sb. nauch. tr. / RAN. INION. Centr social. nauch-inform. issled.; otd. pravovedeniya; IGP. Centr ekologo-pravovyh issled. ; Centr adm.-pravovyh issled. ; otv. red.: O. L. Dubovik, Yu. S. Pivovarov. — M. : INION, 2003. — 472 s.
2. Dubovik O. L. Zdorov’e cheloveka — vazhnyj ob«ekt pravotvorchestva i pravorealizacii // Sovremennoe medicinskoe pravo v Rossii i za rubezhom : sb. nauch. tr. / RAN. INION. Centr social. nauch-inform. issled.; otd. pravovedeniya; IGP. Centr ekologo-pravovyh issled.; Centr adm.-pravovyh issled. ; otv. red.: O. L. Dubovik, Yu. S. Pivovarov. — M. : INION, 2003. — S. 6–16.
3. Annas G. J. Rules for research on human genetic variation--lessons from Iceland // № Engl J Med. — 2000. — Jun 15. — 341 (24). — P. 30–33.
4. Barata P. C., Gucciardi E., Ahmad F., Stewart D. E. Cross-cultural perspectives on research participation and informed consent // Social Science & Medicine. — 2006. — 61 (2). — P. 479–490.
5. Bathe O. F., McGuire A. L. The ethical use of existing samples for genome research // Genet Med. — 2009. — 11. — P. 712–715.
6. Beskow L. M., Burke W., Merz J. F., Barr P. A., Terry S., et al. Informed consent for population-based research involving genetics // JAMA. — 2001. — 286. — P. 15–21.
7. Caulfield T. Biobanks and blanket consent: the proper pace of the public good and public perception rationales // Kings Coll Law J. — 2007. — 18. — P. 209–226.
8. Caulfield T., Upshur R. E., Daar A. DNA databanks and consent: a suggested policy option involving an authorization model // BMC Med Ethics. — 2003 Jan 3. — 4.E1.
9. Chen D. T., Rosenstein D. L., Muthappan P., Hilsenbeck S. G., Miller F. G., Emanuel E. J., Wendler D. Research with stored biological samples: what do research participants want? // Arch Intern Med. — 2005 Mar 28. — 161 (6). — P. 652–655.
10. Dara Hallinan. Broad consent under the GDPR: an optimistic perspective on a bright future // Life Sciences, Society and Policy. — Vol. 16. — Article number 1 (2020). — URL: https://link.springer.com/article/10.1186/s40504-019-0096-3.
11. Elger B. S. Consent and anonymization in research involving biobanks: differing terms and norms present serious barriers to an international framework // Caplan ALEMBO Rep. 2006 Jul. — 7(7). — P. 661–666.
12. Gertz R. An analysis of the Icelandic Supreme Court judgment on the Health Sector Database Act. Scripted. — 2004 ;1. — P. 241–258.
13. Greely H. T. The uneasy ethical and legal underpinnings of large-scale genomic biobanks // Annu Rev Genomics Hum Genet. — 2007. — 8. — P. 343–364.
14. Gulcher J. R, Stefánsson K. N. The Icelandic Healthcare Database and informed consent // Engl J Med. — 2000 Jun 15. — 341 (24). — P. 27–30.
15. Malin B. A., Emam K. E., O’Keefe C. M. Biomedical data privacy: problems, perspectives, and recent advances // J Am Med Inform Assoc JAMIA. — 20. — 2013. — P. 2–6.
16. Marsh V. M., Kamuya D. K., Parker M. J., Molyneux C. S., Working with Concepts: The Role of Community in International Collaborative, Biomedical Research // Public Health Ethics. — 2011. — № 1 (1). — P. 26–39.
17. McGuire A. L., Beskow L. M. Informed consent in genomics and genetic research // URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3216676/.
18. Quigley D. Applying Bioethical Principles to Place-Based Communities and Cultural Group Protections: The Case of Biomonitoring Results Communication // Journal of Law, Medicine & Ethics. — 2012. — P. 348–358.
19. Woodward B. Medical record confidentially and data collection current dilemmas // Journal of law, Medicine and Ethics. — 1997. — 25. — P. 88–97.
Review
For citations:
Pestrikova A.A. Obtaining Informed Consent in Genomic and Genetic Studies. Actual Problems of Russian Law. 2022;17(1):105-115. (In Russ.) https://doi.org/10.17803/1994-1471.2022.134.1.105-115
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