Nine years after the draft version was published, the Food and Drug Administration (FDA) has finalized its guidance on informed consent for sponsors, institutions, IRBs, and investigators. The final ...

Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP.

Increasingly, medical procedures in the United States are being performed in ASCs. According to statistics released earlier this year, the Centers for Disease Control and Prevention’s National Center ...

Informed consent represents a crucial component in modern medical practice, ensuring that patients are fully apprised of the benefits, risks, and alternatives associated with medical procedures. This ...

It can be a rewarding experience to participate in research studies that offer many potential personal, medical, and financial benefits. However, if you are new to or are not entirely familiar with ...

Conversations about clinical trial diversity have finally gone mainstream, but the numbers haven’t quite caught up. Improvement may rely on homing in on one key aspect: informed consent. “Informed ...

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, ...