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and the U.S. Department of Health and Human Services’ (HHS’s) Office for Human Research Protections (OHRP) released a draft guidance ...
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 ...
Informed consent is an agreement between the investigators and the research participants. A signed informed consent form notifies potential research participants of their obligations and rights, and ...
Anesthesiologists and surgeons are increasingly caught in high‑stakes perioperative situations where the law and the facts ...
The federal regulations for the protection of human subjects (Common Rule) were revised effective January 20, 2019 to reduce administrative burdens for low-risk research while enhancing protections ...
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 ...
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 ...
The Roundtable on Health Literacy convened a one-day workshop to explore the effect of regulatory requirements on the production of written and oral health literate communications. An ad hoc committee ...
Risk of gastrointestinal and hepatic toxicities in patients with hormone receptor-positive HER2-negative breast cancer treated with CDK 4/6 inhibitors: A systematic review and meta-analysis of ...
Informed consent is one of the primary requirements of research involving human participants. It is important to remember that informed consent is an ongoing process, not a document or single event.
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