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    Forum Posts by
    John Lantos, MD

    • DarkCo Petroceuticals, Angelic Solar Panels, and the SUPPORT Study

      Posted on September 16, 2015

      As the author of the article that claimed “vindication” for the SUPPORT study, I would like to respond to Professor Latham’s insightful interpretation of the issues in the case. Like Professor Latham, I will not discuss whether the researchers exposed patients to risks that the researchers should have known about or adequately disclosed those risks.  And, of course, not… Read more

    • OHRP’s Dangerous Draft Guidance

      Posted on December 21, 2014

      In October, the federal Office for Human Research Protections issued a “Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” It follows the controversy that erupted in 2013 over the SUPPORT study of oxygen therapy for premature babies. The draft guidance attempts to clarify federal regulations regarding the informed consent process. We believe… Read more

    • SUPPORT Update: OHRP’s Compliance Actions on Hold

      Posted on June 5, 2013

      In a thoughtful, nuanced letter to the University of Alabama (the home of the Principal Investigator of the SUPPORT study), the Office for Human Research Protection announced that it has “put on hold all compliance actions against UAB relating to the SUPPORT case.”  Further, OHRP promises not to initiate compliance actions “in studies involving similar designs”… Read more

    • Public Citizen and Misinformed Consent in Neonatal Intensive Care

      Posted on May 16, 2013

      Public Citizen, the so-called “citizen’s advocacy group,” continues to criticize the NIH-sponsored clinical trials of oxygen therapy for premature babies.  They followed up their April 10th letter with another, on May 8th.  The April letter was wrong on a number of counts, as I documented in Bioethics Forum on April 18th.  The latest document is worse. The authors… Read more

    • OHRP and Public Citizen Are Wrong about Neonatal Research on Oxygen Therapy

      Posted on April 18, 2013

      On March 7, 2013, the federal Office of Human Research Protections notified the principal investigator of the Surfactant, Positive Pressure, Oxygenation Randomized Trial (SUPPORT) that “the conduct of this study was in violation of the regulatory requirements for informed consent, stemming from the failure to describe the reasonably foreseeable risks of blindness, neurological damage and… Read more