J Korean Orthop Assoc.  2022 Oct;57(5):371-376. 10.4055/jkoa.2022.57.5.371.

Regulatory Trends and Ethical Issues in Advanced Regenerative Medicine

• Yoon E
• Kim HC

• KMID: 2534390
• DOI: http://doi.org/10.4055/jkoa.2022.57.5.371

Abstract

This paper reviews the ethical issues of advanced regenerative medicine and recent domestic and international regulatory changes. Advanced regenerative medicine is a field where the expectation of solving unmet medical needs and the unknown and unpredictable risks coexist. In advanced regenerative medicine, various ethical issues are being discussed in terms of bioethics. These include the protection of research participants, safety issues, privacy, equal access to advanced regenerative medicine, restrictions on medical advertising and medical tourism, and ELSI (Ethical, Legal, and Social Implications). Many countries, including Korea, seek ways to maximize their potential while stably responding to these ethical issues. Korea recently enacted and implemented the Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biological Products. In accordance with this Act, a system for securing the safety of clinical research in advanced regenerative medicine has been established. In 2021, the International Society for Stem Cell Research and the World Health Organization announced important guidelines for stem cell research and genome editing, respectively. The development of advanced regenerative medicine is impossible without understanding and considering these ethical issues.

Keyword

advanced regenerative medicine; ELSI; protection of research participants; safety and privacy; equal access