The IRB determines, for each protocol it reviews, which of the following elements and disclosures must be included in the informed consent process. Investigators can avoid delay in the review process ...

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.

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, ...

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 ...

Conducting a successful clinical trial depends on well-designed patient recruitment procedures and retaining the research participants until the completion of the study. The participants must receive ...

Nine years after the draft version was published, the Food and Drug Administration (FDA) has finalized its guidance on informed consent for sponsors, institutions, IRBs, and investigators. The final ...

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 ...

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Discrepancies in understanding the informed consent ...