Abstract:
The field of biomedical engineering, especially in the areas of stem cell therapies and
regenerative medicine, has experienced significant advancements, providing transformative
potential for treating a wide range of diseases and injuries. These advanced medical techniques
enhance the body’s natural healing capabilities, thereby greatly improving patients’ quality of
life. However, the increasing reliance on human cells and tissues has led to the development
of a growing market for human biomaterials, which presents substantial ethical and legal
challenges. Sri Lanka, recognized as one of the largest donors of human cells and tissues, faces
unique challenges due to its diverse religious background and economic conditions. Despite
its significant contribution, the legal framework in Sri Lanka concerning the procurement and
use of human biomaterials remains inadequate. The Transplantation of Human Tissues Act
No. 48 of 1987, along with existing regulations, primarily addresses transplantation and fails to
comprehensively cover the broader use of human biomaterials in fields like stem cell therapies
and regenerative medicine. This regulatory gap raises serious ethical and legal issues, as it
does not sufficiently protect donors’ rights. This research aims to clearly articulate the ethical
and legal challenges associated with using human biomaterials in biomedical engineering
research, with a particular emphasis on stem cell therapies and regenerative...
