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 ...

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new ...

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 ...

The use of deception or incomplete disclosure limits the subject's ability to make a fully informed decision of whether to participate in the research — one of the essential ethical concerns in human ...

Centers for Medicare & Medicaid Service (CMS) revised hospital interpretive guidance in the State Operations Manual, Appendix A-Hospitals on April 1, 2024 in response to media stories of nation’s ...

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

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 ...

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 ...

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 ...

Achieving informed consent requires a potential contributor to be in possession of sufficient knowledge about our plans for a reasoned decision to take part in our content. The Editorial Guidelines ...