We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation 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, ...

Ethicists have suggested that written consent forms encourage participants in phase 1 cancer trials to expect benefit from the experimental agent and to overlook serious risks. Of 272 forms, 268 ...

A lot has been written about ensuring that the language of informed consent forms is at a level that is easily understandable, and for good reason. The Food and Drug Administration requires all ...

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.

In a cross-sectional study, ChatGPT demonstrated variable effectiveness in generating informed consent forms for treatment with energy-based dermatologic devices, highlighting the need for expert ...

See Corrections & Amplifications item below. Informed consent may be the biggest misnomer in medicine: Studies show that most patients don't read the forms they sign before undergoing surgery or ...