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 ...
The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, ...
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 ...
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 ...
A group of UAB researchers developed a web-based decision support tool in their recent publication, “Patient, Nurse, Medical Assistant, and Surgeon Perspectives Inform the Development of a Decision ...
When submitting a project through the eIRB system, researchers can request either a waiver of the need for signatures/documentation, or a waiver to alter or omit the entire consent process. In either ...
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 ...
Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP.
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