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.

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 ...

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 ...

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 ...