Bio-medical Ethics; A paper on Ethical Issues Surrounding Conduct of Clinical Trials in Developing Countries By
Table of Contents
Bio-medical Ethics; A paper on Ethical Issues Surrounding Conduct of Clinical Trials in Developing Countries1
2.0Scenario of current international guidelines4
3.0The case of HIV Vaccine trials with secondary end-points7
With rapid globalization, there is change in the scenario of every international activity, for example exchange of cultures, business collaborations, international trade and commerce, etc. Such activities have been benefitting both the hosting nation as well as the sponsor of the activities. However, when there is a lot of difference between cultures of nations, the status of their economies, political conditions and in terms of implications such as benefits, there is every chance for dispute. International health research is one such activity that has received many an issue at hand mainly in the scenario of bio-medical ethics involved in collaborative health research. Ethical issues surface mainly when it comes to health research, specifically in clinical trials involving humans as subjects. Ethical issues arise mainly in collaborative health researches. When there is collaboration between two research groups from two or more different nations, on conducting a clinical trial, if any of the nations does not allow such trial then the whole collaboration is thumbed down. Here the question arises whether or not such guidelines be adhered to or are there any allowances given the importance of the research collaboration taken up. Even in the past, there were many such ethical dilemmas and issues, the work of [ (Kiatboonsri P., 1988) ] stands as an example. Likewise there have been numerous instances where people or communities of developing or be it underdeveloped nations have been exploited under the hood of clinical trials and therefore there is a need for a check to be made on the revised international ethics and guidelines to see how far they are feasible as well as beneficial.
Scenario of current international guidelines
The council for international organizations of medical sciences (CIOMS) in its 15th guideline for bio-medical ethics in health research implied that in order to legally conduct collaborative health researches, the existing regulatory bodies and committees of all the nations involved in the research collaboration should approve it and if any of the nations disapprove then the research should not be carried out [ (R.J. Levine & S. Gorovitz, 2000) ]. It was evident in instances of international health research that there are always ethical conflicts when researchers from developed nations collaborate with developing nations in order to host their research in those developing nations. Often there are instances when certain underdeveloped communities within developing or underdeveloped nations are vulnerable to clinical trials or vaccine trials. In view of the above, the 8th CIOMS guideline intends to protect those vulnerable groups, according to which, “Before undertaking research involving subjects in underdeveloped communities, whether in developed or developing countries, the investigator must ensure that persons in underdeveloped communities will not ordinarily be involved in research that could be carried out reasonably in developed communities”. In furtherance to the above, CIOMS specifically mentioned that, “Phase I drug studies and Phase I and II vaccine studies should be conducted only in developed communities of the country of the sponsor. In general, phase III vaccine trials and phase II and III drug trials should be conducted simultaneously in the host community and the sponsoring country; they may be omitted in the sponsoring country on condition only that the drug or vaccine is...