IRB Advisor
RSSArticles
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HIPAA’s effect on clinical trial info causes worry for researchers
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Draft guidance focuses on informed consent
The Food and Drug Administration (FDA) released new draft guidance in July to update its 1998 Informed Consent Information Sheet guidance. -
Study: Clinical trial data not being published
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. -
IRB launches new interactive website
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. -
Firestorm erupts over Facebook study’s social media manipulation
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. -
The Facebook study and the Common Rule
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. -
News briefs: Misconceptions exist in cancer trials; Medical colleges plan to stop research fraud
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Elements for obtaining ART informed consent
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Egg donors may not be fully aware of risks
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Stay one step ahead even after the audit