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 ...

Increasingly, medical procedures in the United States are being performed in ASCs. According to statistics released earlier this year, the Centers for Disease Control and Prevention’s National Center ...

Informed consent represents a crucial component in modern medical practice, ensuring that patients are fully apprised of the benefits, risks, and alternatives associated with medical procedures. This ...

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 ...

While many people indicate “I have read and agree to the terms and conditions”, very few actually take the time to read through everything to truly understand the small print. One journalist estimates ...

Substance Use Among Young Adult Survivors of Childhood Cancer With Cognitive Impairment: An Analysis of the Project Forward Cohort Consent processes are critical for clinical care and research and may ...

Informed consent is a fundamental component of modern healthcare and represents a patient's right to understand and agree to a medical procedure, treatment or study. True informed consent empowers ...

Informed consent is an important communication process that takes place between patients and their healthcare providers. It is a key part of the healthcare decision-making process. During the informed ...

Informed consent is one of the most important aspects of conducting ethical research with human participants. Respecting the autonomy of research participants, the investigator must provide complete ...

Rapidly expanding support for psychedelic agents in mental health treatment has introduced unique challenges and essential considerations in the design and implementation of informed consent processes ...