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January 20, 2009

The Declaration of Helsinki has long been regarded as the leading international standard on human research ethics. Drafted in 1964, the Declaration upholds basic patient rights and governs the business practices of clinical researchers. In spite of the Declaration’s widely accepted ethical authority, the U.S. Food and Drug Administration terminated its reliance on the Declaration for international research in October 2008, and instead adopted the International Conference on Harmonization’s Guideline for Good Clinical Practice (GCP).

Although GCP protocols claim common themes with the Declaration, key ethical requirements contained in the Declaration are absent from the GCP. These requirements include: post-trial access to treatment for the patient; the condition that research, especially research done in developing countries, should benefit and be responsive to the health needs of the populations of that country; that the study design be publicly disclosed; and that investigators reveal their sponsors, funding, and potential conflicts of interest to research ethics committees and study participants.

Key tenets of ethical human research include the right of the patient to informed consent, and protection of those who are vulnerable. Both of these important qualifications may be lost in GCP-guided international research. It would be impossible for a patient to truly exercise informed consent if the researchers are less than honest about the study design, sponsors, and potential conflicts of interest in the study. In addition, historic evidence demonstrates that people with fewer educational opportunities and lower socioeconomic status are often more vulnerable to pressure to join medical research. Many populations in third world countries could be vulnerable to undue pressure to participate in research studies.

Sadly, many developing countries lack the financial and healthcare resources to offer their own citizens the benefits of new treatments, even when their citizens participate in research for the treatment. A long-held concept of research ethics contends that research should be conducted only on populations that would receive benefit from the research. Populations that will receive no benefit, even due to socioeconomic reasons, do not seem to be ethically sound sources for research participants.

Good ethics has a global outlook. What we consider impermissible in U.S. research should not be accepted in international research. The Bible teaches us to love our neighbor as we love ourselves. We must stand up for our neighbors around the globe, and call for more accountability from the FDA in international medical research.

The Lancet Article

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