Part One of this post explores how to determine if a study qualifies as a clinical trial under NIH's definition.…
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One of the primary tasks of the IRB is the evaluation of the informed consent process to make sure it…
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At PRIM&R’s 2017 SBER conference, I had the opportunity to sit in on the excellent didactic session, “Certificates of Confidentiality…
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For all the years I’ve been in this industry, I’ve wondered why we haven’t learned from the horrific events scattered…
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One of my favorite parts of attending PRIM&R's annual Advancing Ethical Research Conference is that it refocuses my efforts on…
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