Nine years after the draft version was published, the Food and Drug Administration (FDA) has finalized its guidance on informed consent for sponsors, institutions, IRBs, and investigators. The final ...

Federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representatives) before ...

Failure to obtain informed consent can result in significant consequences Exceptions to informed consent apply only in limited circumstances Elements of valid informed consent include patient capacity ...

If you have a medical practice, it’s easy to think that once you’ve described a treatment route to a patient, they fully understand why it’s appropriate for their healthcare. It’s also easy to think ...

Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers. This requirement is founded on the principle of respect for persons. Potential participants must be ...

There has been an increased focus over the past couple of years on patient rights, resulting in a renewed emphasis on informed consent by healthcare regulators, such as The Joint Commission. This ...

New guidance released by the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) on April 1, 2024, clarified that hospitals will not be eligible for ...

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Joshua Tucker: The following is a guest post by New York University Ph.D. candidate in political science – and Monkey Cage editorial assistant – Renard Sexton. For readers attending the Midwest ...

Brian Green is director of technology ethics and co-author of “Ethics in the Age of Disruptive Technologies: An Operational Roadmap” (The ITEC Handbook). Views are his own. This article, "Should AI ...

Exempt research does not require the informed consent to be documented (it is at the discretion of the researcher), but the Bowdoin IRB does expect that informed consent be provided to the ...