HIV testing without offering treatment to affected individuals
A team of Western researchers carried out a longitudinal study of pregnant nomadic tribeswomen in Africa between 2002 and 2003. They took blood samples during and after pregnancy to test for a specific disease. Those who tested positive were treated. An attempt was also made to trace contacts, and the women’s status was rechecked after pregnancy to ensure effective treatment.
The researchers also had institutional ethics approval and verbal consent from the women to take anonymous blood samples for antenatal HIV testing. These samples were unnamed and batch tested in a regional laboratory. Those who tested positive were not treated or told the results. Although low cost medications for the prevention of mother-to-child transmission of HIV were being recommended by the WHO and were being used in the region at that time, the research team made no attempt to provide an HIV service. They judged that any HIV testing or treatment should be implemented formally throughout the region and that it was “beyond the scope of their project”.
Did the research team fail in their ethical duty to the trial participants, and should the journal therefore refuse to publish their research?
The editor informed the Forum that although ethics committee approval was obtained for the study from respected institutions, he was not satisfied that the study was ethical. Members of the Forum shared the concerns of the editor and there was overwhelming support for the editor’s position, in that the research team may have failed in their ethical duty to the trial participants. It was also felt that funding to treat the women could have been made available at the time of the study as the costs of a single dose of HAART to avoid vertical transmission were low. Ultimately it is the decision of the editor whether or not to publish the study as ethical committee approval to conduct a research project does not extend to the editor’s duty to publish its results.
The editor wrote to the authors with their concerns and the authors replied that it had been a mistake for their researcher to have access to all of the results before the women delivered; this was not in the protocol approved by the ethics committee of the African country’s authorities). Apparently, there was a hiccup in their organisation of the study which gave this person the knowledge of the women’s test results before delivery. The proposal from the authors was to simply eliminate the section in the paper that mentioned that the researcher had access to all the results before delivery.
The editor thought this was unacceptable as it was obfuscating the truth, and moreover the authors had made matters worse by saying that in reality the study did not have ethics approval (a different one did, but not the one they actually carried out). On this basis, the paper was rejected and the authors’ supervisory bodies are being informed (the WHO said it wasn’t them, and the editor has yet to obtain the addresses of the supervisory bodies in the USA (where the researchers are based) and in Africa (where they had the approval of the governmental authorities)).