Case text (Anonymised)
The authors carried out a study. A homeopathic treatment was given to people with HIV/AIDs. The outcome was quality of life, as measured by a questionnaire after 1 month and 18 months of treatment. Participants were selected for inclusion if they had a HIV seropositive status at the time of study and were not taking any other kind of HIV/AIDs treatment.
The participants were stratified into severely ill (including those who could not walk and were cachectic) and not severely ill. The authors said that they had obtained ethics approval for this study from their own institution in their country of origin and that the Ministry of Health in the country where the trial was conducted had “authorised” the study.
We asked the authors whether the participants had been offered antiretroviral treatment at any time and if not why not? The authors confirmed that the study protocol did not include antiretroviral therapy because “There is no obligation of the ARVs use and conventional medicine is expensive. Many patients...were afraid of white people and of the side effects”.
We asked what the participants were told when they gave consent. The participants were given details of the homeopathic treatment but no mention was made of the existence of antiretroviral treatment. We asked to see copies of the protocol submitted to their ethics committee and the actual approval. The document, which was translated by a member of our staff, did not mention antiretroviral treatment. We asked to see documentation of “authorisation” from the Ministry of Health of the country in which the trial was conducted. There was no written documentation. It was verbal.
We asked why they sought approval from their native country and not the country where the study was carried out. The authors told us that once they had approval from their country, the authorities in the country where the trial was conducted did not require local approval.
We asked how the study was funded and what the authors’ relationship was with the funding body. They provided the names of two funding bodies but no documentation (funding came from funding for a Master’s degree of one of the authors). They did not clarify whether they had any relationship with the funding bodies.
We felt that all participants should have received standard care with antiretroviral therapy, that ethics approval should have been sought from a local ethics committee and that the participants should have been informed about antiretroviral therapy when consent was sought. We were also concerned that this protocol apparently was approved by an ethics committee. We rejected the manuscript and wrote to the authors’ institution expressing our concerns and requesting they investigate further and keep us updated on their progress.
Is there further action we should take?
The Forum questioned whether in fact there was a local ethics committee, which may be a reason why the authors obtained approval in their own country. However, the Forum was unanimous in their view that the authors had behaved unethically. All agreed that the editor had done all he could and there is little more action that he can take, although some advised contacting the ethics committee or the licensing body of the authors. If there is no response from the institution, the editor could consider contacting the ministry of health in that country (he should copy in the authors in this communication if he does).
We contacted the authors’ institution, ethics committee and the Ministry of Health but have not received a response from any of them.