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 ...

Thank you for reminding the research and scholarly community of the fundamental importance of striving to obtain each subject’s true informed consent prior to her or his participation in research ...

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 ...

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 ...

Note: Always use lay language that is appropriate to the population being asked to sign the form. Use short paragraphs, bullets and subheadings to increase readability. See the informed consent form ...

Institutional review boards (IRBs) are charged with safeguarding potential research subjects with limited literacy but may have an inadvertent role in promulgating unreadable consent forms. We ...

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

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 ...

The University IRB applies all Department of Health and Human Services (DHHS) requirements for informed consent to greater than minimal risk research: DHHS general requirements (at 45 CFR 46.116) (see ...

This guide was reviewed by a Business News Daily editor to ensure it provides comprehensive and accurate information to aid your buying decision. If you have a medical practice, it’s easy to think ...