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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 ...

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 ...

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 ...

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 This update follows FDA’s draft guidance, ...

Today’s medical systems move faster, operate at greater scale, and handle a wider volume and variety of ailments than ever before. Doctors have access to vast repositories of medical information and ...

Informed consent has been defined as "an individual's autonomous authorization of a medical intervention or of participation in research". [1] In professional and legal regulations it is widely ...

Informed consent is a necessary part of most medical procedures and yet people are largely unclear about its meaning and significance. It is the process whereby the detail of a medical treatment is ...

The goal of the informed consent process is to ensure that the research participant is treated with respect and human dignity. This is achieved by safeguarding and advocating for the participant's ...

There is a sea change in America’s framework for conducting experiments on humans. The biggest surprise is that you probably know little to nothing about it. It has to do with a provision tucked into ...