Informed consent represents one of the most important ethical aspects of clinical treatments and scientific research involving humans. This article will discuss the key elements of informed consent ...
Federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representatives) before ...
On March 1, 2024, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services’ (HHS’s) Office for Human Research Protections (OHRP) released a draft guidance ...
A successful consent process presents detailed information which is organized and presented in a way that helps the prospective subject understand why a person might or might not want to participate.
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
How can Canada optimize the impact of human genomic sequencing to increase our understanding of disease? New guidance in CMAJ (Canadian Medical Association Journal) lays out the key elements for ...
The informed consent model involves healthcare professionals providing information to people so they can make informed decisions about their own healthcare. For transgender adults, this model enables ...
The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated ...
Delivering high-quality care starts with understanding what matters most to each patient. Clinicians can’t choose treatments that match patients’ priorities and values until they engage with them. The ...
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