On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new ...

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 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.

Conducting a successful clinical trial depends on well-designed patient recruitment procedures and retaining the research participants until the completion of the study. The participants must receive ...

Centers for Medicare & Medicaid Service (CMS) revised hospital interpretive guidance in the State Operations Manual, Appendix A-Hospitals on April 1, 2024 in response to media stories of nation’s ...

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 ...

A group of UAB researchers developed a web-based decision support tool in their recent publication, “Patient, Nurse, Medical Assistant, and Surgeon Perspectives Inform the Development of a Decision ...

While many people indicate “I have read and agree to the terms and conditions”, very few actually take the time to read through everything to truly understand the small print. One journalist estimates ...

Add Yahoo as a preferred source to see more of our stories on Google. What is informed birth consent? Here's why it's vital. (Getty Images) Consent in the medical field is vital to ensuring a ...