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 ...

The use of deception or incomplete disclosure limits the subject's ability to make a fully informed decision of whether to participate in the research — one of the essential ethical concerns in human ...

Consent in the medical field is vital to ensuring a patient’s comfort and safety. Some people, however, are sounding the alarm about what they believe to be a major blind spot: the lack of informed ...

The National Human Genome Research Institute announced updates to its online informed consent tool to be more in line with President Barack Obama’s Precision Medicine Initiative. The Precision ...

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 ...

The IRB determines, for each protocol it reviews, which of the following elements and disclosures must be included in the informed consent process. Investigators can avoid delay in the review process ...

Shelby Jennett has a neuroscience major and a philosophy minor and she is the 2023-24 Honzel Fellow with the Markkula Center for Applied Ethics at Santa Clara University. Views are her own. The ...

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 ...

Forbes contributors publish independent expert analyses and insights. Diane Omdahl is a Medicare expert who keeps her readers in the know. Anyone who has had an MRI, a surgical procedure or even a ...

Note: Always use lay language that is appropriate to the population being asked to sign the form. Use short paragraphs, bullets and subheadings to increase readability. See the informed consent form ...

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 ...

When the government pulls a public health ad campaign, it usually raises more questions than it answers. And when the government's official happens to be an attorney with a controversial stance on ...