ABSTRACT
The role of clinical research in health care is signicant. The present world, along with technological advancement, is witnessing a progressive trend in the eld of therapeutic devices and drug inventions. The quest for more safer, affordable, and easily available pharmaceutical products is driving all countries to adopt new legal frameworks to regulate ethical clinical research. At times, the everelastic dynamics and overstretched interpretation of the word ethics make laws more lopsided than for which they were intended to be. The ethical prospects for any law already enacted are reective of subject protection, condentiality of data, informed consent, and right compensation for the victim for adverse events. At the same time, the authors feel that an equal amount of concern should be invested with the rights of the sponsors and investigators to keep the balancing act intact. In this chapter, history and evolution of ethical regulations is examined in a global perspective. Invention of a better cure for a disease is more complex, time consuming, and often entwined with continuous audits and overseeing at different levels of authority than invention of a computer software program. While international covenants guided the ethical principles, the respective governments enacted legislations regulating the clinical trials in their countries in compliance with the broader principles so that a particular drug, therapy, or device invented in a country could well be accepted by other countries. Biomedical research on animals and human subjects are carried on with stricter regulatory monitoring in all countries.
