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 ...

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 ...

Consent forms that people sign before participating in research are widely considered difficult to understand and sometimes inaccurate. Lack of clarity was implicated in a high-profile legal ...

Department of Health and Human Services (DHHS) regulations for the protection of human participants require that informed consent information be presented in language understandable to the participant ...

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 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, ...

I have a question regarding the safe and ethical care of patients. In my institution it is routine for the nurse to witness the anesthesia consent form prior to surgery. We have the patient read the ...

The way current patient consent forms are written -- as formal, legal documents -- plants a litigious relationship in both the patient's and the surgeon's mind even before treatment has begun.