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 ...
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 ...
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 ...
Federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representatives) before ...
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 ...
Increased scrutiny of informed consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding ...
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 ...
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 ...
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 ...
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