A study was submitted that reported the prevalence of an intestinal infection in a tribal community. The authors did not obtain informed individual consent for stool collection from the study participants; instead they obtained consent from the leaders of each village. The study protocol was approved by the national IRB, but the protocol made no specific mention of stool collection—it referred to a study of a respiratory infection and “interdisciplinary research”, so we are unclear if the IRB knew that such collection would take place. The authors had obtained a permit for research from the country’s “national foundation”.
The handling editors, who work in the country in which this study took place, and who are very familiar with the national laws on conducting health research in tribal communities, state that:
(1) The law makes it clear that while obtaining prior consent from community leaders is very good practice, it should not dispense with efforts to obtain individual consent.
(2) Every individual must give consent; illiterate individuals should give a digital print.
We wrote to the authors to ask why they did not obtain individual consent, and whether the national IRB had approved the stool collection. We asked to see the protocol approved by the IRB.
They explained that they had published nine papers arising from this work, no journal had ever questioned them on ethical oversight (or asked to see the study protocol) and they are the only doctors to have ever offered this tribe any medical treatment. They withdrew their paper in protest.
There was obviously some ethics oversight here—ie, (1) there was national IRB approval of a related study (and perhaps the use of the word “interdisciplinary” gave the researchers license to include stool collection); (2) the village leaders gave consent; (3) the authors had some type of research permit allowing entry to tribal communities. But the editors remain concerned that: (i) national law clearly states that community leaders’ consent should not replace individual consent; (ii) it is not clear whether the IRB specifically approved the stool collection; and (iii) providing a medical service to this community arguably made it even more crucial to obtain individual consent (since provision of care might be coercive in this situation, especially if it was conditional on agreeing to be in the study). On receiving the letter from the authors withdrawing the paper, we wrote to them to share these concerns, but the authors never replied.
Does COPE feel that the editors have any further obligations?
The case caused much debate. Some argued that there was a significant ethical violation and the criteria for consent had not been met, certainly by UK or US standards. This is evident from the authors’ indignant response and their unconvincing explanations. Others argued that the editor has done enough and should not pursue the matter. It is unlikely that the patients came to any harm and the editor has taken the matter as far as he can. However, others argued in favour of contacting the IRB and the authors’ institutions as the paper, although rejected by the editor, could be submitted for publication to another journal. All agreed that this was a difficult case and the ideal solution would be to have constructive dialogue with the authors regarding the issues, but most felt this was unlikely to be achieveable.
Given the lack of consensus of the COPE Forum regarding whether or not we should pursue this case further, the editors handling the paper did not in the end contact the IRB. They have already explained to the authors their concerns about the consent process, and feel that this was probably sufficient. They consider the case now closed.