In Part One of this post, I discussed the decision tree used by NIH to determine if a study meets…
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In collaboration with First Clinical Research, each month we share a new question and accompanying anonymous survey, designed to encourage critical thinking about…
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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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With much anticipation, the Office of Human Research Protections (OHRP) released the final version of the 2018 Common Rule on…
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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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