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A WHO study of fetal growth led to controversy.

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Review finds misconduct in events surrounding WHO fetal growth study

For the first time in its 68-year history, the World Health Organization (WHO) has concluded that researchers are guilty of research misconduct. An independent review commissioned by WHO has found that “research ethics misconduct occurred” in a multimillion-dollar global study on fetal growth led by researchers at the University of Oxford in the United Kingdom. WHO has referred the finding, which it did not explain in detail, to the U.K. General Medical Council (GMC), it announced Thursday.

It is unclear whether GMC has opened an investigation. The body is legally obliged to look at any concerns that are referred to it, a spokesperson told ScienceInsider, but she could not comment on the specific case.

The allegations—first reported by Science last month—date back to late 2006. Then, researchers at WHO’s Department of Reproductive Health and Research in Geneva, Switzerland, were working on developing a study to determine global standards to assess whether a fetus is on a healthy growth trajectory. Oxford researchers José Villar and Stephen Kennedy participated as external experts. In 2007, Kennedy signed a contract for Villar to develop a key protocol for the study. But in March 2008, the two Oxford researchers secured a $29 million grant from the Bill & Melinda Gates Foundation for a similar study. Members of the WHO group say that the Oxford duo used ideas developed in the WHO project in their competing grant proposal; some accuse them of deliberately delaying their WHO work while they were courting the Gates Foundation.

An Oxford spokesperson said those allegations were unfounded. “The WHO’s review has not considered any material which has not already been thoroughly investigated by the University,” the spokesperson wrote in an email. “Three separate investigations over an eight year period have concluded there was no misconduct."

The university refused to collaborate with WHO on an independent investigation, and in 2011 WHO dropped the matter. But some of the experts on the WHO study—including Lawrence Platt, a gynecologist at the University of California in Los Angeles who heads the executive committee for the WHO study, and Torvid Kiserud of the University of Bergen in Norway, a member of the executive committee and the study's steering committee—kept pressuring WHO to investigate the claims. In 2014, WHO asked Frank Wells, an independent consultant on research ethics based in Ipswich, U.K, to look into the matter. Wells concluded that an independent investigation was warranted, and WHO moved ahead.

Now, Platt believes the results of the investigation should “prompt the academic community to carefully review Oxford‘s failure to conduct an independent review“ and lead to sanctions, he wrote in an email. Oxford should consider returning the $29 million Gates grant, he believes.

Paul Chamberlain, an Oxford expert in scanning fetuses who was also involved in the WHO project and is now retired, welcomed WHO’s move. “If the integrity of multicentered international research is to be protected and maintained, it is important that the circumstances of the awarding of the Gates grant to Oxford University should be examined independently by a professional organization such as the GMC,” he wrote in an email. “This apparently will now happen.”

The controversy has focused attention on the fact that WHO has no formal policy to deal with research misconduct by organization staff or external experts. “In light of this incident and the fact that several departments across WHO are involved in research in different capacities, WHO is developing its own policy on dealing with suspected research misconduct,” the WHO statement notes. The new policy is to be published later this year.