The HIV Vaccine: A promising advancement and ethical conundrum
It is a laudable goal to advance innovation in medicine, and the recently released results from the experimental HIV vaccine seem promising yet, with the growing trend of conducting clinical trials abroad and the corresponding increase in research subjects being drawn from developing nations, scientists, physicians, regulators and ethicists must strive to balance beneficence and justice and uphold their professional obligations. Large pharmaceutical companies and investigators based in developed nations are increasingly outsourcing clinical research trials to developing nations. The most commonly cited reasons for this globalization of clinical trials include decreased costs, stream-lined subject recruitment, international harmonization of research guidelines, the development of contract research organizations specializing in global trials and a rapidly expanding global market. While there may be identifiable benefits for the pharmaceutical industry, this trend towards looking to third world nations for research populations raises notable ethical concerns and has public health, economic and regulatory implications for the frequently vulnerable populations living there. Commonly, there is minimal regulatory oversight of clinical trials conducted in developing nations, resulting in a lack of knowledge about research conduct, ethical standards and data quality for many of these studies. Furthermore, there has been much debate over the appropriate content and interpretation of international research guidelines such as the Declaration of Helsinki as applied to international trials. Read the rest of this entry →
