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Obtaining the informed consent of a potential human subject for participation in any research (whether an experiment, survey, interview, or demonstration) is a federally mandated safeguard for ...

Informed consent remains critical in healthcare, and over the last several years, there have been multiple updates from agencies and commissions providing clarifications. Most recently in April 2024, ...

Failure to obtain informed consent can result in significant consequences Exceptions to informed consent apply only in limited circumstances Elements of valid informed consent include patient capacity ...

The FDA issued “Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors” that supersedes its 1998 guidance and finalizes its 2014 guidance. The guidance outlines the primary ...

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.

Relatively simple improvements could increase patient satisfaction and potentially improve the important process of imparting patient information during enrollment of cancer patients into clinical ...

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 ...

An in-depth review of consent forms provided to volunteers for HIV/AIDS research in the United States and abroad about study procedures, risks and benefits has found that the forms were extremely long ...

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 ...

Informed consent may be defined as the process whereby a patient is provided with sufficient and accurate information about the benefits and risks of a proposed course of therapy or procedure, to ...