The authors mention that: *A stool sample was collected from a healthy 49-year-old Brazilian volunteer living in Manaus, Brazil. The patient signed informed consent, and the agreement of the local ethics committee of the IFR48 (Marseille, France) was obtained under agreement 09-022. The patient had not received any antibiotics at the time of sampling. The faecal sample was frozen at −80°C after collection and shipped to Marseille, France. *
The authors also mention that the sample has been obtained in November 2013.
In Brazil, research involving human beings is defined per ResNo466 as "research that, individually or collectively, have as a participant the human being, in its entirety or parts of it, and involve him in adirect or indirect, including the handling of your data, information or biological materials"
As per defined by OrdNo2201, a biological material is defined as : "specimens, samples and aliquots of original material and its fractionated components". And a specimen is defined as : "any human biological material such as organs, tissues, body fluids, obtained from a single subject, at a specific time".
Per ResNo466, research involving human beings must be submitted to the appreciation of the local CEP or to the CONEP when relevant.
The study has prospectively recruited a healthy participant to collect a human biologic material (stool) for research purpose. However, the authors didn't mention any approval from a local brazilian ethics committe, a CEP or the Conep. The exportation of human biologic material from Brazil should also obtain an approval from Brazilian Health Authority (see Manual of Transport of Human Biological Material
The authors only mention an approval from a french local ethics committee affiliated to the institution as some of the authors.
It would be in a great interest if the authors can mention the name of the Brazilian ethics committee which approved this study, the approval number, the date of the ethics approval.
In the case of the authors didn't obtain an approval from a ethics committee in Brazil, can the authors explain the rationale and the reason of this waiver considering the ResNo466 and the OrdNo2201 ?
On april 2nd 2024, this article received an expression of concern for "potential non-compliance with Elsevier’s publishing ethics policies regarding the appropriate conduct of research involving human participants"
This article has been highlighted by researchers Frank et al. in a publication in Research Integrity and Peer Review for the following reason: the article shares its ethics approval number (09-022) with another set of 248 studies. These studies all seem to be about different populations, in different countries, and with different samples taken from people as shown in the article's Figure 1 appended below.
It should also be noted that the findings by Frank et al. have been highlighted by Science in an article by Cathleen O’Grady.
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