Features of ethical expertise in planning and conducting clinical research in regenerative medicine

Abstract

Nowadays we are dealing with a new level of biomedicalscience, that is «regenerative medicine», which providesopportunities for new treatments and the prolongation ofhuman life. It demands that new evaluative criteria, bothethic and regulatory should be worked out and the society,scientific institutions and local authorities should respond in aquick and adequate way.The authors, who are working in the frame of MegagrantProject of the Russian Government on creating Research,Education and Clinical Center of Regenerative Medicine,consider that one of the major tasks is regenerative medicineapproaches to be governed by precise ethical guidelines,and social and cultural aspects. So, the first target of thiscollaboration is to define regulations and address ethicalissues governing the field of bioengineered organs and tissues(simple or complex), both in the field of research and clinic.They present information about clinical application of tissueengineering in the world together with the summary ofexperience how regulations and authorities in Europe involvingregenerative medicine approaches for Human Subjects.The authors presented the list of ethical rules for scientificresearch and clinical application in the field of regenerativemedicine.

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