Depolanmış İnsan Örnekleri Üzerinde Yapılan Araştırmalarda Aydınlatılmış Onam Almak Gerekli midir?

Aydınlatılmış onam sağlık merkezlerinde çeşitli araştırmalara katılmak için gerekli olduğu kadar hastaların tedavi edilebilmesi açısından da her zaman önceden yapılması gerekli bir işlemdir. Hastane arşivlerinde biyolojik örneklerin imhaya ayrılması veya saklanması hakkında mevcut kılavuzlar yeterli olmadığı zaman bu gereklilik araştırmacılar için ciddi bir sorun teşkil etmektedir. Mevcut düzenlemelerle talep edilen; araştırma yaparken yararlılığa, adaletli olmaya ve kişisel temel biyoetik prensiplere her zaman saygı duyulmalı ve uyulmalıdır. Biyoteknolojide ilerleme nedeniyle saklanmış biyomateryaller çok değerlidir fakat bu aynı zamanda araştırma için kullanılan materyallerin alındığı donörlerden aydınlatılmış onamın alınıp alınmaması hakkındaki tartışmaların artmasına neden olmaktadır. Bu biyoetik kuralları uygulamak, çoğu kılavuz insan ile doğrudan teması kapsayan araştırmalara odaklanır, vücut parçaları ve biyomateryallerin yıllar içinde araştırma için kullanılabileceğine dikkat edilmemektedir. Bazı hipotezlerde, saklanmış örneklerden araştırma yapılabileceği ve çeşitli testlere tabi tutulabileceği söylenir, özellikle çeşitli üniversite hastanelerine, araştırma merkezleri ve laboratuvarlara bağlı öğrenciler veya araştırmacılar tarafından. Biz bazı senaryolara ve yenilenmiş kılavuzlar ile saklanan veya atılan vücut parçalarının ticari veya araştırma amacıyla kullanılmalarında aydınlatılmış onamın gerekliliğini öne sürenler ile bir uzlaşma sağlamaya katkıda bulunmayı amaçlıyoruz.

ls Informed Consent Necessary for Research on Stored Human Samples?

Informed consent is always required before patients can be treated in health centers as well as participating in any kind of research. This requirement often poses a serious challenge to researchers in situations where existing guidelines are not clear about the ownership of donated or discarded human biological samples in hospital archives. The current regulations demand that when doing research, the major bioethical principles of autonomy, beneficence, nonmaleficence and justice should always be respected and adhered to. There is increased value of stored biomaterials due to advancement in biotechnology which has also contributed to increased debate on whether researchers should seek informed consent from the individual donors before such materials can be used for research. In enforcing these bioethical principles, most guidelines focus on research involving direct contact with human beings, and no much attention is given to stored or discarded body parts and biomaterials that end up being used for research in later years. There are some hypotheses that can be tested by doing research on the stored biological samples, especially by students or scientists attached to various University hospitals, researchcenters and laboratories. We attempt to provide some scenarios and reviewed guidelines that can help provide a consensus as to whether it is strictly necessary to have informed consent for research on stored or discarded human body parts and who should claim ownership of collected human biomaterials for research or potential commercial purposes.

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1. Nilstun T, Hermerén G. Human tissue samples and ethicsattitudes of the general public in Sweden to biobank research. Med Health Care Philos. 2006;9:816.
2. Wendler D, Emanuel E. The debate over research on stored biological samples. Arch Intern Med. 2002;162:145762.
3. Stephenson J. Pathologists enter debate on consent for genetic research on stored tissue. JAMA. 1996;275:5034.
4. NIH. The Nuremberg Code. The Nuremberg Code. 1953:13. http://www.nj.gov/health/irb/documents/nuremburg_code.pdf. Published Last Modified Date. Accessed September 19, 2014.
5. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. Bull World Health Organ. 2001,79:3734.
6. Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical research involving human subjects. Bull Med Ethics. 2002;182:1723.
7. Cameron NM. Humans, rights, and twentyfirst century technologies: the making of the universal declaration on bioethics and human rights. J Leg Med. 2014;35:23572.
8. White MT, Gramm J. Informed consent for research on stored blood and tissue samples: a survey of institutional review board practices. Account Res. 2002;9:116.
9. Genetics TASoH. Statement on informed consent for genetic research. Am J Hum Genet. 1996;59:4714.
10. Chia S, Davies M. Seeking consent in the context of solving the patient's problem. BMJ. 2014;348:2604.
11. George RT, Butcher M, Yentis SM. Pregnant women's views on informed consent for research in labour. Int J Obstet Anesth. 2014;23:2337.
12. Jones JW, McCullough LB, Richman BW. Informed consent: it's not just signing a form. Thorac Surg Clin. 2005;15:45160.
13. Petrini C. Ethical and legal considerations regarding the ownership and commercial use of human biological materials and their derivatives. J Blood Med. 2012;3:8796.
14. Gottesman MM. Guidelines for the conduct of research in the intramural research program at NIH. Biospecimen working group. 2012:118. http://www.cc.nih.gov/ethicconduct/biospecimenworkinggroup%20research%2061113.pdf. (Accessed September 13, 2014).
15. United Nations. The Universal Declaration of Human Rights. 1948. http://www.un.org/en/documents/udhr/. Published Last Modified Date. Accessed September 7,2014.
16. Hakimian R, Korn D. Ownership and use of tissue specimens for research. JAMA. 2004;292:2500 5.
17. Farrugia A, Penrod J, Bult JM. Payment, compensation and replacementthe ethics and motivation of blood and plasma donation. Vox Sang. 2010;99:20211.
18. Muwonge H, Sembajwe LF. Incentive use in research: protecting vulnerable populations from exploitation. Archives Medical Review Journal. 2013;22: 40817.
19. WHO. Global blood safety and availability. Facts and figures from the 2007 Blood Safety Survey. Facts and figures from the 2007 Blood Safety Survey 2009;Fact sheet N 279 http://www.who.int/mediacentre/factsheets/fs279/en/. (Accessed September 3, 2014).
20. de Alba Ulloa J. Difficulties of the negotiation process of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the application of biology and medicine (and a call for its adhesion). Gac Med Mex. 2012;148:30720.
21. Coucil of Europe. Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine (adopted by the Committee of Ministers on 19 November 1996). Council of Europe Convention of Biomedicine. Hum Reprod. 1997;12:207680.
22. Clayton E, Steinberg K, Khoury M, Thomson E, Andrews L, Kahn M et al. Informed consent for genetic research on stored tissue samples. JAMA. 1995;274:178692.
23. Kristin E, Schleiter J. Donors retain no rights to donated tissue. Virtual Mentor.2009;11:6215.
24. Chen DT, Rosenstein DL, Muthappan P, Hilsenbeck SG, Miller FG, Emanuel EJ et al. Research with stored biological samples: What do research participants want? Arch Int Med. 2005;165:6525.
25. World Health Organization. informed consent templates. consent for storage and future use of unused samples. 2014. http://www.who.int/ entity/rpc/esearch_ethics/ informed%20consent% 20for%sample%20storage.doc. (Accessed at August 12, 2014).
26. Rowe LB. You don't own me: recommendations to protect human contributors of biological material after Washington University v. Catalona Symposium: who owns your body? ChicagoKent Law Review. 2009;84:226269.