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, ...

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 ...

Under Colorado law, students under the age of 18 who receive medical treatment at Wardenburg Health Center must first have a parent or guardian sign the Parental/Guardian Consent for Treatment of a ...

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 ...

Health data’s potential can be vertigo-inducing, with seemingly limitless insights available to be mined from data sets old and new. The risks, too, can turn the stomach: faulty and biased algorithms; ...

Background: Consent forms have become too long and often do little to help people understand the risk elements of their participation in research, instead focusing on risk reduction for research ...