Debates on “Standard of Care” in Research

For sometimes now, medical and bioethics communities have been facing some of difficult and divisive issues regarding the ethics of the international research. These issues often get fuel, when the interventional research is conducted on the poor and vulnerable people in the poor developing countries. Normal term “Standard of the Care”, against which some of new interventions and inventions are tested in the medical research has not been adequately defined. This term is often usually taken to mean the “best proved treatment” for any of the condition under investigation in any of the trial. The debate regarding what constitutes a reasonable and fair standard of care for subjects in the developing countries and those who participate in the clinical trials has been aroused by the critics of the studies on transmission of HIV. Those critics also argued that the placebo controlled trials of the new regimens as to prevent the vertical transmission of the HIV were highly unethical because of the reason that they included the placebo arm rather than “best proven treatment” which is available in the developed countries. While some of the commentators considered criticisms to be unbiased and associated with imperialistic attitudes. This debate made it very clear that high standards of the research plans to have not been comprehensively and adequately defined. Although there was some justified concern that the pressure from US food and the drug administration could “dilute” declaration of the Helsinki, and critics were also confident that whether a trial was ethical could be deduced from text of a declaration. But some declarations such as declaration of the Helsinki, that governing international research ethics are accepted like the constitutions and needing interpretation. Also assuming what is ethical, goes beyond merely following all the prescriptions and also requires some moral reasoning (1). In this article, I will discuss and comment on various debates on standard of care in human research in the developing world.Debates on “Standard of Care” in Research