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 ...

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 ...

In her Health Affairs Blog post last fall, Sharon Brownlee lamented how frequently patients agree to treatments that they know little about. In the United States and elsewhere, clinicians have a clear ...

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 ...

The presence of a mental illness does not per se preclude the ability to give an informed consent to medical or surgical treatment. The general requirements are the transfer of relevant information ...

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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 ...

The primary purpose of informed consent is to protect the prospective human subject. Informed consent provides the individual with the pertinent information regarding the research in which s/he is ...

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 ...

Over the past 50 years, the informed consent process has become increasingly regulated and standardized, while the challenges remain persistent and hard to overcome. 8 Consent forms are increasingly ...