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

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 ...

Informed consent is a process that’s required for most medical procedures. However, there’s often confusion about what informed consent is, what it means, and when it’s needed. In a healthcare setting ...

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 ...

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 ...