Conducting ethical clinical trials for L. donovani in the Bihar region of India

Visceral leishmaniasis is a severe disease that disproportionally afflicts the Bihar state in India with 40% of the worldwide disease burden. Drug resistance, poor adherence, extreme poverty, malnutrition and certain living conditions have made control and treatment of the disease difficult. There is a great need for new drugs and control programs to reduce the disease burden of this debilitating and potentially fatal disease. Drug discovery research on leishmaniasis is being conducted in the USA and this raises issues concerning the ethical conduct of international clinical trials. Ethical principles dictate that the Bihari who need these drugs should be included in clinical trials. Additional safeguards for the ethical conduct of clinical trials on developing countries by developed countries have been formulated elsewhere. These include collaborative partnership, social value, scientific validity, fair selection of study population, favorable risk-benefit ratio, independent review, informed consent, and respect for recruited participants and study communities. These principles are applied to the Bihari context, and issues of ancillary care and post-trial access are also addressed. The socio-cultural context of the region is discussed in order to give researchers the tools to obtain meaningful informed consent. A description of the Bihari context and relevant ethical considerations should facilitate the design and conduct of ethical clinical trials for L. donovani.