The Revised Common Rule requires all clinical trials to post an unsigned consent form on a publicly available website. The Revised Common Rule is in effect for studies approved on or after January 21, ...

The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical ...

Participants' understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organ , 93: 186-198H. Further Reading ...

Written consent: A written informed consent is necessary in case of extensive intervention involving sedation, surgeries, high-risk medications and clinical trials.

The purpose of the informed consent form (ICF) is to outline risks and benefits of an interventional clinical trial to a patient. But most ICFs are written using scientific jargon, are long, and ...

Post-hoc analyses of a large, randomized clinical trial have revealed the potential advantages associated with electronic informed consent (eConsent) in acute ischemic stroke studies, including ...

Trial consent forms have often been noted by prospective trial participants as complex, impersonal, and unclear regarding data privacy, presenting a potential barrier to study recruitment.

Informed consent forms for interventional oncology clinical trials are often lengthy and written at too high of a reading level for some patients, making it hard for them to weigh the decision to ...

Background: High literacy levels are needed to understand oncology clinical trial (CT) informed consent forms (ICF), which represents a barrier to enrollment of older adults and diverse populations.

This trial tested mock consent forms of 2,000, 4,000, and 6,000 words. The first two comprised the two experimental arms and the third the control arm. Phase II was conducted to identify the promising ...

Meeting Coverage > ACEP After-the-Fact Informed Consent for a Clinical Trial? It Can Work in Some Situations — Sometimes it's not practical to perform the study any other way ...