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The Childrens Hospital of Philadelphia (CHOP) IRB launched its massive new website in July, full of information to help investigators and other IRBs in every step of protocol and policy development.
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Almost 30% of completed studies registered at ClinicalTrials.gov fail to achieve published disclosure of result (PDOR) within four years of completion, a new study found.
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The Food and Drug Administration (FDA) released new draft guidance in July to update its 1998 Informed Consent Information Sheet guidance.
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Private companies that are not in the pharmaceutical or device or biologics industries mostly are exempt from following the Common Rule and federal regulations, but there have been debates in the past two decades about whether this exemption should be changed.
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When the Proceedings of the National Academy of Sciences (PNAS) published a study about social contagion on Facebook in June 2014, reaction was fast and furious. By the end of July, one could search online for criticism of Facebooks social contagion study and produce 6.3 million links.
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Investigators and student researchers repeatedly called the IRB at the University of the Incarnate Word, asking the same questions, and IRB reviewers complained of continually seeing the same mistakes. Clearly, it was time to make IRB office system and procedural changes.
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Because of the unusual scope of the National Children's Study (NCS), it raises a significant range of ethical issues for its designers and for the IRBs that have been reviewing it at 105 study centers across the United States.
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The 1960s obedience experiments of Stanley Milgram have become a hallmark of social behavioral research, as well as a cautionary tale for those involved in human subjects protection.
