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 principle of respect for persons demands that participants enter the research voluntarily and with adequate information. When deceptive methodologies are used, participants are given incomplete or ...

A cornerstone of the dental practice, as with most healthcare professions, is the requirement to obtain informed consent before commencing treatment and procedures. The ADA Code of Ethics provides ...

This workshop will cover the 5 W’s of obtaining truly informed consent. We will begin by looking at what should be covered through an examination of the correspondence between the HRP-503 Protocol ...

Additionally, the patient must be informed of feasible alternative therapies. The two legal claims are distinct, and a physician can be sued for malpractice, a type of negligence, for failing to ...

Conversations about clinical trial diversity have finally gone mainstream, but the numbers haven’t quite caught up. Improvement may rely on homing in on one key aspect: informed consent. “Informed ...