PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Pregnant Women: Scientific and Ethical…
Read More
On April 19, HHS and 16 other federal agencies released a new Notice of Proposed Rulemaking (NPRM) that would delay the general…
Read More
In Part One of this post, I discussed the decision tree used by NIH to determine if a study meets…
Read MoreWhen 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 critical thinking about…
Read More