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  4. Trial (or maybe treatment) found on clinicaltrials.gov leads to vision problems for three women

Trial (or maybe treatment) found on clinicaltrials.gov leads to vision problems for three women

A procedure that fell somewhere between “research” and “treatment,” depending on who you ask, involving the injection of stem cells into the eye led to severe vision problems in three women, one of whom went blind as a result, according to a recent report in the New York Times.

The article raises some interesting points. First, was it even research? There is some disagreement about whether this project underwent IRB review. A representative of the company carrying out the project is quoted in the New York Times piece as saying the project had been approved by an independent review board. The review board in question, however, disagrees. (A link to the review board’s statement is available via the Buzzfeed article link below. Try as we might, we can’t get it to work when it’s in the text here.)

The Times piece also notes the women found the company because it had listed a study on clinicaltrials.gov, which is a project of the National Institutes of Health. This affiliation led two of them to believe the project had some sort of government approval, when in fact clinical trials need no such approval to be listed on the website.

Buzzfeed.com also weighs in with a bit more information, including some background on the IRB in question (two Arkansas doctors are mentioned). Please note that we typically think of Buzzfeed in connection with social media posts along the lines of “Answer 8 questions to find out what kind of pizza you are!” But sometimes they seem to dig a little deeper over there.

 

 

Posted by Edith Paal on March 27, 2017

Filed Under: Institutional Review Board Members

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