Last month, PLOS ONE published a paper reporting on a trial to improve the uptake of the measles vaccine in Nigeria. The researchers were affiliated with IDinsight, a San Francisco-based “global advisory, data analytics, and research organization that helps development leaders maximize their social impact.”
San Francisco is about 7,800 miles from Lagos, and the list of authors — Sam Brownstone, Alison Connor and Daniel Stein, a former economist at the World Bank — seemed suspiciously devoid of Nigerian names.
That omission was even more strange given the title of the article: “Improving measles vaccine uptake rates in Nigeria: An RCT evaluating the impact of incentive sizes and reminder calls on vaccine uptake.” Almost immediately after publication, Ejemai Eboreime, a physician and public health worker, pointed out on Twitter the implausibility of the implied claim that no local scientists were involved in a randomized controlled trial covering nine clinics throughout the country — which he alleged also was a violation of local research ethics provisions.
Eboreime called for an investigation into the article:
That call evidently bore fruit, and quickly. According to the retraction notice, posted earlier this week, just two weeks after Eboreime’s tweet:
After this article [1] was published, concerns were raised about the author list, ethics approval, and study locations for the reported study.
Specifically:
— Concerns were raised that this article reports a study for which no collaborators in the local country are included in the author list or acknowledgments. The authors clarified that this was due to an error of omission. There were a number of Nigerian research and operational collaborators whose work was instrumental in conducting the study. The authors apologize for not having acknowledged these key contributors.
Then comes the issue of IRB approval. The notice makes the bizarre claim that the authors did not seek approval because they “did not originally view this work as research” — a preposterous assertion given the title of the paper (and, well, basically everything else). As the notice continues:
Concerns were raised that the ethics approval was granted after the reported intervention dates. According to PLOS ONE’s policy on Human Subjects Research, studies involving human participants must have received approval from an institutional review board or ethics committee before the start of the study. The authors commented that they did not seek approval before the beginning of the trial because they did not originally view this work as research but rather, as a pilot experimentation to inform their partner organization’s operations. The authors argue that this is because the study did not involve primary data collection by the authors, it was based on data collected during the partner organization’s program operations, and in the authors’ view, was not originally intended to contribute to generalizable knowledge. Upon further consideration (specifically driven by the authors’ desire to use the results to contribute to generalizable knowledge), the authors sought ethical approval even though the pilot experimentation had already begun: the pilot study was included in an application to the National Health Research Ethics Committee of Nigeria (NHREC) along with a larger, forthcoming randomized control trial of their implementing partner’s program. The authors received the anonymized data from the partner organization only after the study received ethical approval.
Questions were raised about apparent discrepancies in study location. The Methods section lists study locations of Nasarawa (in the North Central region), Anambra (in South East), and Akwa Ibom (in South South), whereas the study protocol (S1 Data file published with [1]) specifies study locations of the Northern states of Katsina, Zamfara, and Jigawa. The authors clarified that this paper [1] does not report the main clinical trial described in the protocol, but instead reports the pilot study conducted to inform incentive amounts for use in the main trial (see “Evidence to determine incentive amount” in the study protocol). As described in the protocol, the pilot study used data from nine clinics in Nasarawa, Anambra, and Akwa Ibom.
In light of the concerns about attribution and retrospective ethics approval, the authors and PLOS ONE Editors retract this article.
The PLOS ONE Editors apologize that these concerns were not addressed before the article was published.
The authors apologize for omitting acknowledgment of key contributors and for not working more closely with the Nigerian research community to co-produce this study. We also apologize for an error in judgement regarding the timing of the ethical application. At the time of retraction, the authors are working with the National Health Research Ethics Committee of Nigeria to resolve this issue.
In fact, the authors did acknowledge a few people in the paper:
The authors would like to acknowledge the assistance of Ivy Migue, Surilli Seth, and Lulu Tian in the preparation of this manuscript. We would also like to acknowledge the support of the NI-ABAE team. In particular, Svetha Janumpalli and Patrick Stadler for adjusting NI-ABAE’s operations to facilitate the experiment and commenting on the manuscript.
NI-ABAE is part of New Incentives, an NGO. Neither Janumpalli, the group’s founder and CEO, nor Stadler, the co-founder, is Nigerian.
Stein did not immediately respond to our email about the retraction. [See update at end.]
The work was funded by part of a $2.3 million grant from GiveWell, which also did not immediately respond to a request for comment. [See update at end.]
‘Clearly a violation of ethical principles’
Nadia Sam-Agudu, of the Institute of Human Virology in Nigeria and the Institute of Human Virology and Department of Pediatrics at the University of Maryland School of Medicine, in Baltimore, who tweeted about the article, told us:
I have conducted infectious diseases and public health research and implemented health programs in Nigeria for about 10 years now, including spending 3 years as Chair of an institutional IRB. I am well-versed in the required procedures for studies and ethical approvals. This was clearly a violation of ethical principles and an omission of key local researchers who actively contributed to the implementation and data collection (at least) for the study. Not a single local researcher was included in the author byline.
Sam-Agudu added:
To be honest, this phenomenon happens so much that we healthcare workers and scientists/researchers in low and middle income countries are consistently unsurprised when this happens.
Update, 2000 UTC, 7/16/20: A GiveWell spokesperson told us:
We became aware of the concerns that were discussed in the retraction on June 30. We have been looking into the situation since then to better understand what occurred and the lessons for our processes going forward.
Update 0100 UTC, 7/17/20: Stein told us that
the retraction notice was co-produced by the authors and the journal, so this notice reflects our view on the matter. We also released a public statement prior to the retraction being finalized. We are under discussion with various stakeholders on the issues raised, and are also reviewing our internal protocols. Once these discussions are complete, we will release an updated public statement with more information.
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Well done! Keeping watch is noble task.
PLOS One! The Mark of Quality!
Seriously, I’ve never seen so much homework eaten and thoroughly digested by the dog.
Note to the paper’s authors: post-hoc IRB submissions don’t make it.