Good intentions do not replace ethical conduct in research

Abstract

The Dutch Disciplinary Tribunal officially ‘warned’ two Dutch physicians following their study with a Kenyan collaborator on the efficacy of the homeopathic substance Iquilai (‘a potentized mineral supplement’) in 228 HIV/AIDS patients in Kenya.1,2 The case was brought forward by the Dutch Health Inspectorate, who had launched an investigation into the practice of the two involved physicians. The Tribunal deemed the study incompatible with basic medical ethical principles for human subjects’ research, as laid down in the World Medical Association’s Declaration of Helsinki: the study lacked a proper study protocol, informed consent forms, risk assessment, and ethical approval.2,3 This case and its ruling are remarkable for at least two reasons. First, we appreciate the Tribunal’s recognition of previous jurisprudence that their mandate in oversight over Dutch doctors extends beyond the country’s borders. This strengthens the extent to which foreign physicians working in low resource countries can be held accountable for their actions. Second, given the misconduct, the lack of a ‘reprimand’ seems mild. The Tribunal justified it’s ruling with the ‘good intentions’ of the involved researchers, and the assumptions that ‘patients were well informed’ and ‘were not exposed to health risks’. Although we cannot comment on the former, there was no evidence to substantiate the latter two considerations; consent forms were lacking and data collection was inconsistent. We strongly believe that for all research – and especially in low resource settings where institutional ethical safeguards may be limited or easier to circumvent – that the burden to understand and comply with ethical principles is on the researcher, whether foreign or local, all good intentions aside. Finally, research collaborators from low resource settings must also be held accountable and every opportunity seized to collaboratively strengthen institutional ethical protection systems in low resource settings.