Hooman Noorchashm
Jul 30, 2017 · 1 min read

The reader is correct that the study has misleadingly stated its goal to be “This is a study to determine if there is any leakage from the barrier.” But the serious trouble is that this a misrepresentation of the true purpose of the study, which is to sell a product with a safety rubber stamp when it comes to a deadly oncological danger it fails to admit.

In fact, the central question should be, if there is a possibility of this device spreading cancer, is it ethically justifiable to perform human experimentation to “determine if there is any leakage from the barrier.” The answer is NO. And the impossible ethical constraints are delineated in my critique of the UNC trial.

The University of North Carolina’s IRB is in violation of some fundamental ethical principles in approving this trial- and, very certainly, the risk managers are exposing their institution to an unacceptable burden of legal liability.

    Hooman Noorchashm

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    Hooman Noorchashm MD, PhD is a physician-scientist. He is an advocate for ethics, patient safety and women’s health. He and his 6 children live in Pennsylvania.