Informed consent to the receipt and use of human cellular material: juristic and ethical regulation

Abstract

Further progress in medicine is closely related to the clinical introduction of regenerative technologies, including cell therapy. Presented article covers the ethical and legal status of obtaining an informed consent from donors of cell material. The manuscript defines specific functions of such informed consent related to the features of research object and possibilities of its further use. The recommended content of the informed consent from cell material donors is determined in the context of global trends as well as guidelines for obtaining the consent. Existing difficulties and contradictions while developing an informed consent are presented

Bioethical and Legal Issues in 3D Bioprinting

“…Requirements for obtaining consent from a donor for participation in research, as well as requirements for the processing and transfer of genetic information as a special category of personal data, are not defined in the existing legislation. Additionally, current legislation does not regulate the circulation of biological materials seized from donors for the purpose of conducting scientific research, does not provide guarantees of protection rights of donors, and does not stipulate the mandatory procedure for the preliminary approval of research by ethical committees[ 38 , 39 ].…”

Preimplantation and prenatal genetic diagnostics in Russian Federation: ethical and legal issues

“…Эти, лишь обозначенные мною, общие направления правового обеспечения всех видов генетической диагностики в последние годы получают все более детальное освещение в специальной литературе (Akhtyamova, Alsynbayeva & Khusainova, 2019;Albitskiy, Odinayeva & Mansimova, 2011;Momotov, 2018;Stambolsky, et al, 2018;Altynnik, et al, 2019). В рамках данной статьи основное внимание будет уделено иным аспектам темы, связанным со специфическими проблемами преимплантационного и пренатального генетического тестирования, при решении которых право наиболее тесно соприкасается с биоэтикой.…”