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.

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 ...

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 ...

Substance Use Among Young Adult Survivors of Childhood Cancer With Cognitive Impairment: An Analysis of the Project Forward Cohort Consent processes are critical for clinical care and research and may ...

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 ...

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 ...

This workshop will cover the 5 Ws of obtaining truly informed consent. We begin by looking at What should be covered through an examination of the correspondence between the HRP-503 Protocol Template ...

Informed consent is a fundamental component of modern healthcare and represents a patient's right to understand and agree to a medical procedure, treatment or study. True informed consent empowers ...

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 ...