Part One of this post explores how to determine if a study qualifies as a clinical trial under NIH's definition.…
Read More
When research subjects’ capacity to consent is absent, diminished, or fluctuating, additional consent enhancements, safeguards, and support may be required…
Read MoreIn collaboration with First Clinical Research, each month we share a new question and accompanying anonymous survey, designed to encourage…
Read More
Study teams and regulatory teams have different perspectives when it comes to executing research protocols, due simply to the different…
Read More
As part of PRIM&R’s webinar series on the revised Common Rule, two members of our community were selected to write…
Read More