Araştırma ve Etik
Özet
Teknoloji ve bilimin hızla ilerlemesiyle birlikte biyoteknoloji ve genetik alanlarındaki araştırmalar önemli etik ikilemleri gündeme getirmektedir. Özellikle embriyo araştırmaları ve yardımcı üreme teknolojilerinin yaygınlaşmasıyla ortaya çıkan fazla embriyoların kullanımı, etik tartışmaların merkezinde yer almaktadır. İnsan klonlama ise, genetik kopyalar üretmeyi amaçlayan bir uygulama olarak hem üretim hem de tedavi amacıyla yapılabilmekte, ancak insan hakları ihlali, bireyin metalaşması, klonların psikolojik zarar görme riski ve geleneksel aile yapısının bozulması gibi ciddi etik sorunları beraberinde getirmektedir. Bunun yanı sıra, insan gen düzenlemesi özellikle CRISPR/Cas-9 teknolojisinin kullanımıyla genetik hastalıkların tedavisinde umut vadetmekle birlikte; güvenlik, bireysel özerklik ve sosyal adalet gibi kritik etik sorunları da beraberinde getirmektedir. Üreme çağındaki kadınlar ve gebe kadınların tarihsel olarak araştırmalardan dışlanması, önemli bir bilgi boşluğuna yol açmıştır. Bu nedenle, bu grupların araştırmalara dahil edilmesi hem bilimsel hem de etik açıdan bir ön plana çıkmaktadır. Bu bölümde, biyoteknoloji ve genetik alanlarındaki gelişmelerin etik boyutları ve kadın araştırmaları perspektifiyle ele alınarak, gelecek nesillerin sağlığını koruyacak yasal ve etik düzenlemelerin oluşturulmasının önemi vurgulanmaktadır.
Referanslar
Khorshid A, Alvero R. Consenting and ethical considerations in embryo cryopreservation. Curr Opin Obstet Gynecol. 2020;32(5): 380-384. doi:10.1097/GCO.0000000000000653
Savulescu J, Labude M, Barcellona C, et al. Two kinds of embryo research: four case examples. J Med Ethics. 2022;48(9): 590-596. doi:10.1136/medethics-2021-108038
Niemiec E, Howard HC. Ethical issues related to research on genome editing in human embryos. Comput Struct Biotechnol J. 2020;18: 887-896. doi:10.1016/j.csbj.2020.03.014
Warnock BM. Should the 14-day limit on human embryo research be extended? 2017. (20/07/2023 tarihinde https://www.progress.org.uk/should-the-14-day-limit-on- human-embryo-research-be-extended/ adresinden ulaşılmıştır.
Xue Y, Shang L. Are we ready for the revision of the 14-day rule? Implications from Chinese legislations guiding human embryo and embryoid research. Front Cell Dev Biol. 2022;24;10: 1016988. doi:10.3389/fcell.2022.1016988
Chan S. How to Rethink the Fourteen-Day Rule. Hastings Cent Rep. 2017; 47(3): 5-6. doi:10.1002/hast.698
Hyun I, Wilkerson A, Johnston J. Embryology policy: Revisit the 14-day rule. Nature. 2016;12:533(7602):169-71. doi:10.1038/533169a.
Shahbazi MN, Jedrusik A, Vuoristo S, et al. Self-organization of the human embryo in the absence of maternal tissues. Nat Cell Biol. 2016;18(6): 700-708. doi:10.1038/ncb3347
Deglincerti A, Croft GF, Pietila LN, et al. Self-organization of the in vitro attached human embryo. Nature. 2016;12:533(7602): 251-4. doi:10.1038/nature17948
International Society for Stem Cell Research. Guidelines for stem cell research and clinical translation 2021. (20/07/2023 tarihinde https://www.isscr.org/policy/guidelines-for-stem-cell-research-and-clinical-translation adresinden ulaşılmıştır.
Clark AT, Brivanlou A, Fu J, et al. Human embryo research, stem cell-derived embryo models and in vitro gametogenesis: Considerations leading to the revised ISSCR guidelines. Stem Cell Rep. 2021;16(6): 1416–1424. doi:10.1016/j.stemcr.2021.05.008
Czernik M, Anzalone DA, Palazzese L, et al. Somatic cell nuclear transfer: failures, successes and the challenges ahead. The International journal of developmental biology. 2019;63(3-4-5): 123–130. doi:10.1387/ijdb.180324mc
Nasr-Esfahani MH, Ahmad-Khanbeigi KH, Hasannia A. Qur'anic views on human cloning (ı): doctrinal and theological evidences. Int J Fertil Steril. 2021;15(1): 73-79. doi:10.22074/ijfs.2020.134415
Nabavizadeh SL, Mehrabani D, Vahedi Z, et al. Cloning: a review on bioethics, legal, jurisprudence and regenerative ıssues in Iran. World J Plast Surg. 2016;5(3): 213-225.
Egli D, Chen AE, Saphier G, et al. Reprogramming within hours following nuclear transfer into mouse but not human zygotes. Nat Commun. 2011;4(2): 488. doi:10.1038/ncomms1503
Noggle S, Fung HL, Gore A, et al. Human oocytes reprogram somatic cells to a pluripotent state. Nature. 2011;478(7367): 70–75. doi:10.1038/nature10397
Fan Y, Jiang Y, Chen X, et al. Derivation of cloned human blastocysts by histone deacetylase inhibitor treatment after somatic cell nuclear transfer with β-thalassemia fibroblasts. Stem Cells and Development. 2011;20(11): 1951–59. doi:10.1089/scd.2010.0451
Tachibana M, Amato P, Sparman M, et al. 2013. Human embryonic stem cells derived by somatic cell nuclear transfer. Cell. 2013;153(6): 1228–38. doi:10.1016/j.cell.2013.05.006
Yamada M, Johannesson B, Sagi I, et al. Human oocytes reprogram adult somatic nuclei of a type 1 diabetic to diploid pluripotent stem cells. Nature. 2014;510: 533–36. doi:10.1038/nature13287
Ahmadi N, Moavi R, Moavi R, et al. Cloning, an interference or a new science 2nd congress on review of Islamic regulations in medicine. 2nd congress on review of Islamic regulations in medicine 2013: 348–90.
Yerdelen E. Klonlamanın (kopyalama) ceza hukukundaki yeri. Ankara Üniversitesi Hukuk Fakültesi Dergisi. 2014;63 :23-66.
Häyry M. Ethics and cloning. British medical bulletin. 2018;128(1): 15–21. doi:10.1093/bmb/ldy031
Palacios‐González C. Geneticparenthood and causation: An objection to Douglas and Devolder’s modified direct proportionate genetic descent account. Bioethics. 2019;33(9): 1085–1090. doi:10.1111/bioe.12639
Winters-Miner LA, Bolding PS, Hilbe JM, et al. Practical Predictive Analytics and Decisioning Systems for Medicine. Informatics Accuracy and Cost-Effectiveness for Healthcare Administration and Delivery Including Medical Research. 2015:176-204 doi:10.1016/B978-0-12-411643-6.00013-2
Dobner J, Ramachandran H, Rossi A. Genome editing in translational medicine: an ınventory. Front Biosci (Landmark Ed). 2022;12:27(8): 241. doi:10.31083/j.fbl2708241
Akram F, Sahreen S, Aamir F, et al. An ınsight into modern targeted genome-editing technologies with a special focus on CRISPR/Cas9 and its applications. Mol Biotechnol. 2023;65(2): 227-242. doi:10.1007/s12033-022-00501-4
Hsu PD, Lander ES, Zhang F. Development and applications of CRISPR-Cas9 for genome engineering. Cell. 2014;5:157(6):1262-1278. doi:10.1016/j.cell.2014.05.010
Gaj T, Sirk SJ, Shui SL, et al. Genome-Editing technologies: principles and applications. Cold Spring Harb Perspect Biol. 2016; 1:8(12):a023754. doi:10.1101/cshperspect.a023754
Asmamaw M, Zawdie B. Mechanism and applications of CRISPR/Cas-9-Mediated genome editing. Biologics. 2021;21(15):353-361. doi:10.2147/BTT.S326422
Joseph AM, Karas M, Ramadan Y, et al. Ethical perspectives of therapeutic human genome editing from multiple and diverse viewpoints: a scoping review. Cureus. 2022;27;14(11): e31927. doi:10.7759/cureus.31927
Astarăstoae V, Ioan BG, Rogozea LM, et al. Advances in genetic editing of the human embryo. Am J Ther. 2023;01;30(2): e126-e133. doi:10.1097/MJT.0000000000001604
Savulescu J. Five Reasons We Should Embrace Gene-Editing Research on Human Embryos. The Conversation 2015. (06/07/2023 tarihinde https://theconversation.com/five-reasons-we-should-embrace-gene-editing-research-on-human- embryos-51474 adresinden ulaşılmıştır).
Bergeron J. Opening Pandora’s Box: Gene Editing and its Consequences. The Conversation 2018. (01/07/2023 tarihinde https://theconversation.com/opening-pandoras-box- gene-editing-and-its-consequences-108003 adresinden ulaşılmıştır).
Smolenski J. CRISPR/Cas9 and germline modification: new difficulties in obtaining ınformed consent. Am J Bioeth. 2015;15(12): 35-7. doi:10.1080/15265161.2015.1103816
Gyngell C, Douglas T, Savulescu J. The ethics of germline gene editing. J Appl Philos. 2017;34(4): 498-513. doi:10.1111/japp.12249
Petraitytė G, Preikšaitienė E, Mikštienė V. Genome editing in medicine: tools and challenges. Acta Med Litu. 2021;28(2): 205-219. doi:10.15388/Amed.2021.28.2.8
Wilson RC, Carroll D. The daunting economics of therapeutic genome editing. CRISPR J. 2019;2(5): 280-284. doi:10.1089/crispr.2019.0052.
Segal DJ. The promise of gene editing: so close and yet so perilously far. Front Genome Ed. 2022;15(4): 974798. doi:10.3389/fgeed.2022.974798
Büken NÖ. Kadınların klinik araştırmalara katılımında devam eden tartışmalar. Sürekli Tıp Eğitimi Dergisi. 2007;16(2): 12-15.
Committee on Ethics of the American College of Obstetricians and Gynecologists (ACOG). Ethical Considerations for Including Women as Research Participants 2015. (07/07/2023 tarihinde https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2015/11/ethical-considerations-for-including-women-as-research-participants adresinden ulaşılmıştır).
Thiele LR, Spong CY. Inclusion of pregnant and lactating people in clinical research: lessons learned and opportunities. Obstet Gynecol Clin North Am. 2023;50(1): 17-25. doi:10.1016/j.ogc.2022.10.001
Referanslar
Khorshid A, Alvero R. Consenting and ethical considerations in embryo cryopreservation. Curr Opin Obstet Gynecol. 2020;32(5): 380-384. doi:10.1097/GCO.0000000000000653
Savulescu J, Labude M, Barcellona C, et al. Two kinds of embryo research: four case examples. J Med Ethics. 2022;48(9): 590-596. doi:10.1136/medethics-2021-108038
Niemiec E, Howard HC. Ethical issues related to research on genome editing in human embryos. Comput Struct Biotechnol J. 2020;18: 887-896. doi:10.1016/j.csbj.2020.03.014
Warnock BM. Should the 14-day limit on human embryo research be extended? 2017. (20/07/2023 tarihinde https://www.progress.org.uk/should-the-14-day-limit-on- human-embryo-research-be-extended/ adresinden ulaşılmıştır.
Xue Y, Shang L. Are we ready for the revision of the 14-day rule? Implications from Chinese legislations guiding human embryo and embryoid research. Front Cell Dev Biol. 2022;24;10: 1016988. doi:10.3389/fcell.2022.1016988
Chan S. How to Rethink the Fourteen-Day Rule. Hastings Cent Rep. 2017; 47(3): 5-6. doi:10.1002/hast.698
Hyun I, Wilkerson A, Johnston J. Embryology policy: Revisit the 14-day rule. Nature. 2016;12:533(7602):169-71. doi:10.1038/533169a.
Shahbazi MN, Jedrusik A, Vuoristo S, et al. Self-organization of the human embryo in the absence of maternal tissues. Nat Cell Biol. 2016;18(6): 700-708. doi:10.1038/ncb3347
Deglincerti A, Croft GF, Pietila LN, et al. Self-organization of the in vitro attached human embryo. Nature. 2016;12:533(7602): 251-4. doi:10.1038/nature17948
International Society for Stem Cell Research. Guidelines for stem cell research and clinical translation 2021. (20/07/2023 tarihinde https://www.isscr.org/policy/guidelines-for-stem-cell-research-and-clinical-translation adresinden ulaşılmıştır.
Clark AT, Brivanlou A, Fu J, et al. Human embryo research, stem cell-derived embryo models and in vitro gametogenesis: Considerations leading to the revised ISSCR guidelines. Stem Cell Rep. 2021;16(6): 1416–1424. doi:10.1016/j.stemcr.2021.05.008
Czernik M, Anzalone DA, Palazzese L, et al. Somatic cell nuclear transfer: failures, successes and the challenges ahead. The International journal of developmental biology. 2019;63(3-4-5): 123–130. doi:10.1387/ijdb.180324mc
Nasr-Esfahani MH, Ahmad-Khanbeigi KH, Hasannia A. Qur'anic views on human cloning (ı): doctrinal and theological evidences. Int J Fertil Steril. 2021;15(1): 73-79. doi:10.22074/ijfs.2020.134415
Nabavizadeh SL, Mehrabani D, Vahedi Z, et al. Cloning: a review on bioethics, legal, jurisprudence and regenerative ıssues in Iran. World J Plast Surg. 2016;5(3): 213-225.
Egli D, Chen AE, Saphier G, et al. Reprogramming within hours following nuclear transfer into mouse but not human zygotes. Nat Commun. 2011;4(2): 488. doi:10.1038/ncomms1503
Noggle S, Fung HL, Gore A, et al. Human oocytes reprogram somatic cells to a pluripotent state. Nature. 2011;478(7367): 70–75. doi:10.1038/nature10397
Fan Y, Jiang Y, Chen X, et al. Derivation of cloned human blastocysts by histone deacetylase inhibitor treatment after somatic cell nuclear transfer with β-thalassemia fibroblasts. Stem Cells and Development. 2011;20(11): 1951–59. doi:10.1089/scd.2010.0451
Tachibana M, Amato P, Sparman M, et al. 2013. Human embryonic stem cells derived by somatic cell nuclear transfer. Cell. 2013;153(6): 1228–38. doi:10.1016/j.cell.2013.05.006
Yamada M, Johannesson B, Sagi I, et al. Human oocytes reprogram adult somatic nuclei of a type 1 diabetic to diploid pluripotent stem cells. Nature. 2014;510: 533–36. doi:10.1038/nature13287
Ahmadi N, Moavi R, Moavi R, et al. Cloning, an interference or a new science 2nd congress on review of Islamic regulations in medicine. 2nd congress on review of Islamic regulations in medicine 2013: 348–90.
Yerdelen E. Klonlamanın (kopyalama) ceza hukukundaki yeri. Ankara Üniversitesi Hukuk Fakültesi Dergisi. 2014;63 :23-66.
Häyry M. Ethics and cloning. British medical bulletin. 2018;128(1): 15–21. doi:10.1093/bmb/ldy031
Palacios‐González C. Geneticparenthood and causation: An objection to Douglas and Devolder’s modified direct proportionate genetic descent account. Bioethics. 2019;33(9): 1085–1090. doi:10.1111/bioe.12639
Winters-Miner LA, Bolding PS, Hilbe JM, et al. Practical Predictive Analytics and Decisioning Systems for Medicine. Informatics Accuracy and Cost-Effectiveness for Healthcare Administration and Delivery Including Medical Research. 2015:176-204 doi:10.1016/B978-0-12-411643-6.00013-2
Dobner J, Ramachandran H, Rossi A. Genome editing in translational medicine: an ınventory. Front Biosci (Landmark Ed). 2022;12:27(8): 241. doi:10.31083/j.fbl2708241
Akram F, Sahreen S, Aamir F, et al. An ınsight into modern targeted genome-editing technologies with a special focus on CRISPR/Cas9 and its applications. Mol Biotechnol. 2023;65(2): 227-242. doi:10.1007/s12033-022-00501-4
Hsu PD, Lander ES, Zhang F. Development and applications of CRISPR-Cas9 for genome engineering. Cell. 2014;5:157(6):1262-1278. doi:10.1016/j.cell.2014.05.010
Gaj T, Sirk SJ, Shui SL, et al. Genome-Editing technologies: principles and applications. Cold Spring Harb Perspect Biol. 2016; 1:8(12):a023754. doi:10.1101/cshperspect.a023754
Asmamaw M, Zawdie B. Mechanism and applications of CRISPR/Cas-9-Mediated genome editing. Biologics. 2021;21(15):353-361. doi:10.2147/BTT.S326422
Joseph AM, Karas M, Ramadan Y, et al. Ethical perspectives of therapeutic human genome editing from multiple and diverse viewpoints: a scoping review. Cureus. 2022;27;14(11): e31927. doi:10.7759/cureus.31927
Astarăstoae V, Ioan BG, Rogozea LM, et al. Advances in genetic editing of the human embryo. Am J Ther. 2023;01;30(2): e126-e133. doi:10.1097/MJT.0000000000001604
Savulescu J. Five Reasons We Should Embrace Gene-Editing Research on Human Embryos. The Conversation 2015. (06/07/2023 tarihinde https://theconversation.com/five-reasons-we-should-embrace-gene-editing-research-on-human- embryos-51474 adresinden ulaşılmıştır).
Bergeron J. Opening Pandora’s Box: Gene Editing and its Consequences. The Conversation 2018. (01/07/2023 tarihinde https://theconversation.com/opening-pandoras-box- gene-editing-and-its-consequences-108003 adresinden ulaşılmıştır).
Smolenski J. CRISPR/Cas9 and germline modification: new difficulties in obtaining ınformed consent. Am J Bioeth. 2015;15(12): 35-7. doi:10.1080/15265161.2015.1103816
Gyngell C, Douglas T, Savulescu J. The ethics of germline gene editing. J Appl Philos. 2017;34(4): 498-513. doi:10.1111/japp.12249
Petraitytė G, Preikšaitienė E, Mikštienė V. Genome editing in medicine: tools and challenges. Acta Med Litu. 2021;28(2): 205-219. doi:10.15388/Amed.2021.28.2.8
Wilson RC, Carroll D. The daunting economics of therapeutic genome editing. CRISPR J. 2019;2(5): 280-284. doi:10.1089/crispr.2019.0052.
Segal DJ. The promise of gene editing: so close and yet so perilously far. Front Genome Ed. 2022;15(4): 974798. doi:10.3389/fgeed.2022.974798
Büken NÖ. Kadınların klinik araştırmalara katılımında devam eden tartışmalar. Sürekli Tıp Eğitimi Dergisi. 2007;16(2): 12-15.
Committee on Ethics of the American College of Obstetricians and Gynecologists (ACOG). Ethical Considerations for Including Women as Research Participants 2015. (07/07/2023 tarihinde https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2015/11/ethical-considerations-for-including-women-as-research-participants adresinden ulaşılmıştır).
Thiele LR, Spong CY. Inclusion of pregnant and lactating people in clinical research: lessons learned and opportunities. Obstet Gynecol Clin North Am. 2023;50(1): 17-25. doi:10.1016/j.ogc.2022.10.001
