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

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 ...

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, ...

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 ...

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 ...