“In and outside his territories and dominions …and with his far off neighbors, Priyadarsi has arranged for the medical treatment of man and beast. He has caused herbs, roots and fruits to be imported, wells to be dug and trees to be planted on the roadside for the enjoyment of men and animals.”
Edits of Asoka – third century BC Inscribed on a rock in Girnar Gujarart

Updated from a presentation and article on the ethics of vaccine research ( See “Clinical Trials of Drugs and Vaccines Among the Desperately Poor in Poor Nations” in reference resources  )

On occasion, an ethical consensus may be reached only to unravel as the questions of “who benefits” and “who pays” becomes a reality. This is precisely the issue facing sponsors of clinical research trials in developing countries. It is also a question that is increasingly relevant in the US as the cost of healthcare skyrockets and the availability of treatment is threatened.

Increasingly, as newer drugs are developed, adequate numbers of research subjects cannot be found in the US.  They are however available in resource poor countries and even among the poor in the US where participating in clinical research studies is a means of obtaining healthcare not available by other means. [1]  This may result in direct exploitation of the vulnerable populations. Link to Caplan PDF on blog

Advances in research have primarily benefited developed countries as evidenced by a marked decline in new HIV infections, a decrease in HIV related deaths, control of hypertension, advances in cancer treatment and significant increases in life expectancy etc.[2]  Two factors emerge as a result of these advances, which directly impact the conduct of clinical research. The first is that the population base required to evaluate new therapeutics has increased significantly because new therapies must now be evaluated in the context of existing therapy and many new treatments are only marginally more effective than existing treatments. Thus a requirement for greater numbers to achieve statistical significance. The second is that the cost of conducting clinical trials in the US has increased dramatically. Consequently, developing countries, with their large populations of untreated or poorly treated individuals who are more likely to agree to participate in research as a means of gaining access to healthcare which would not otherwise be available, are easily exploited and have become attractive targets for recruiting research subjects.

While effective vaccines and treatments for a host of infectious and malignant diseases are desperately needed by both developed and developing countries, the many benefits to developed countries, derived from the efficiency and economy of performing studies in developing countries, may require that developing countries receive compensatory benefits that may not be considered an ethical requirement in developed countries. [3] The principle of distributive justice partially addresses this issue. [4,5]  However, in extremely resource poor countries, proportionately greater benefits need be considered as well (proportionate justice).

Who is ethically and/or legally responsible for assuming the cost for the treatment and monitoring?  The general principle is that the sponsor(s) has ultimate responsibility for clinical research study costs including, direct, indirect and adverse events cost (vaccine breakthroughs might be considered adverse events). These would include the Pharmaceutical or Biotechnology Company, the US government, or the University. Debates among sponsoring parties as to who is obligated, should not deter assignment of responsibility.

  1.  J. Fisher. Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. Rutgers University Press. 2000.
  2.  H. Gayle, “An overview of the global HIV/AIDS epidemic, with a focus on the United States,” Aids, 14 Suppl 2:S8-17, 2000.
  3. M. Barry, “Ethical considerations of human investigation in developing countries: the AIDS dilemma,” N Engl J Med. 319:1083-1086, 1988.
  4. J. Rawls, “Theory of Justice,” The Belknap Press of the Harvard University Press, 1999.
  5. T. Beauchamp, J. Childress, “Principles of Biomedical Ethics,” Fifth ed. Oxford University Press, 2001