We recently discovered a relatively old retraction notice — from 2014 — of a study on pregnant women with HIV.
The paper was retracted two years ago when BMC Research Notes discovered the authors falsely claimed they had obtained ethics approval from an institution in Kenya.
The study looked at the effectiveness of an antiretroviral therapy in 50 women who were receiving care at a center in Nairobi, Kenya. But the authors did not have permission from the center to use data from the women, nor the necessary ethics approval from Moi University to carry out the work.
Here’s the retraction note for “Effectiveness of option B highly active antiretroviral therapy (HAART) prevention of mother-to-child transmission (PMTCT) in pregnant HIV women:”
This article has been retracted by the editors of BMC Research Notes because, contrary to the statement in the manuscript, Moi University Institutional Research and Ethics Committee (IREC) has confirmed that ethics approval was not obtained to conduct this study. In addition, the authors did not have permission to use data from the DREAM program.
Here’s what the paper — cited twice, according to Thomson Reuters Web of Science — says about having ethics clearance from the university:
The study obtained ethical clearance from the Moi University Institutional Research and Ethics Committee (IREC), (Formal approval no.: FAN: IREC 000301). Supportive letter was obtained from the district health office before data collection, and written informed consent was obtained from voluntary participants and parents or guardians for children during data collection.
And here’s what the paper says about having clearance from the center where the women were receiving care:
All respective ethical clearance from DREAM centre was adhered to and considerations as pertaining confidentiality, beneficence and justice were followed and all the data collected was treated with anonymity.
In addition, the authors thank the DREAM Center in the acknowledgements:
We also thank the DREAM center grantsmanship office and the director laboratory and logistics affairs for providing logistical support, vital equipment, facilities and enabling environment. The respondents who participated in this study are also thanked for their cooperation.
We’ve reached out to Daughters of Charity of St. Vincent de Paul, which runs the DREAM Center, and to Moi University. We’ll update this post with anything else we learn.
We’ve also reached out to the authors. Though they are not affiliated with Moi University on the paper, they do appear to have ties to the school. First author Erastus K Ngemu is listed at the University of Eldoret, but appears to have been an undergraduate at Moi when the research was carried out, based on his LinkedIn profile. Last author Elijah Oyoo-Okoth is affiliated with Karatina University, and is a lecturer at Moi, according to his profile on ResearchGate. Co-author Christopher Khayeka–Wandabwa‘s affiliation on the paper is Jomo Kenyatta University of Agriculture and Technology; he lists Moi under the education section of his profile on LinkedIn.
This isn’t the first time that authors have lied about having ethics approval — in another, more recent example, a journal pulled a 2009 paper about the relationship between obesity and depression in cultures where fat isn’t stigmatized, after realizing the authors didn’t obtain the approvals they claimed.
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That IREC reference appears to have been a copy/paste from p.3 of this paper:
http://dare.uva.nl/document/2/84700
“During the whole study, the principles of the Ethical Committee for the Protection of Animals in Research of Moi University Institutional Research and Ethics Committee (IREC), (Formal approval no.: FAN: IREC 000301) were strictly followed.”
Compare that to the retracted paper:
“The study obtained ethical clearance from the Moi University Institutional Research and Ethics Committee (IREC), (Formal approval no.: FAN: IREC 000301).”
I realize the importance of the permissions. You haven’t commented on the quality of the study. Did the study contain valid data that would add to the knowledge in AIDS research? If appropriate privacy standards were followed, and the data has value for the field, has DREAM been asked if the results of that data might continue to be part of the knowledge base for that research area?
If the author’s lie about something as important as ethical clearance, how much can we trust any other aspect of their data or methods?
I may be over-reacting, but having just finished reading The censor’s hand : the misregulation of human-subject research by Carl Schneider, I would understand the frustration of trying to move through the permissions process when trying to conduct research I thought would be helpful. I’m not condoning what was done, just interested in why this route was taken.
I have looked at the paper. 50 women, plus their children, with no controls, which may be a reason it has only 3 citations in PMC for a paper published in 2014. PMC lists a large number of similar studies examining exactly the same questions. What treatment alternatives were these women denied in the study? How much choice were they given and what was the informed consent for them and their children? (The authors mention this but clearly no one outside the group cleared this or insured that it happened. )Why was the data not allowed to be used by the DREAM center. This was not no-risk for the patients and their children, and it does not appear that the data has produced anything beyond what other research was already showing.
Thanks, this is very helpful information.
Schneider over-states the problems. There are problems with IRB or ethics committees as they are known outside the US, but one of the points of ethics applications is that people are supposed to think about things before hand. If they do their background to justify the research and put together a well-designed study then it shouldn’t be a problem. Many researchers just want to put together something that is minimal and expect it will just happen.
For this particular research the main problem will be whether they took away the option of better alternative treatments.
Getting approval may be cumbersome, and in some cases even take months to obtain, but ethical approval is an essential part of clinical research. It confirms the integrity of the study design and proposed methods (a peer review of sorts BEFORE the study), while at the same time ensuring the welfare of the study subjects is protected. A win-win.
Add the fact that approval is mandatory, and researchers might as well factor in the lengthy approval process into their workplans.