INTERNATIONAL LEGAL FRAMEWORK FOR THE REGULATION OF BIOMEDICAL RESEARCH AND GENETIC DATA SHARING

Abstract

The rapid expansion of biomedical research and the additional use of genetic information have created complex global ethical, legal and regulatory challenges. The age of collaborative research, with data crossing countries in increasing numbers, has never been in greater need of a workable international legal framework. The paper will discuss the evolution of the law in regard to medical research and the use of genetic information, the rights of the participants, information privacy, informed consent and the broader ethical considerations. It also produces anomalies in national law and regulatory gaps, which are huge impediments to efficient and safe data transfers, especially in the new economies. The article underscores one of the ways for the protection of human dignity and development of science, namely transparency, accountability and harmonized legal standards. It also means international cooperation and capacity building for ethical biomedical practice in the context of new technologies. The paper ends with recommendations for a flexible legal policy.