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, ...

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.

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 ...

Obtaining informed consent is more than getting a signature on a form. Informed consent is one of the primary ethical considerations underlying research with human subjects. ALL human subject research ...