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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...