Clinical research consent forms for certain FDA-regulated clinical trials are now required to contain a specific statement advising participants that clinical trial information will be entered into ...

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 ...

Canadian researchers have published new guidelines intended to make consent forms used in clinical research easier for patients to understand. The guidelines describe 75 core elements for consent ...

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 ...

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.

Informed consent involves a subject being given information that a reasonable person would want to have to make an informed decision about whether to participate in research, and the chance to discuss ...

Because audio, video or digital recordings include images or voices of research participants, they pose a greater concern to the IRB than do data that do not have readily available identifying ...

Starting today, March 7, 2012, clinical research consent forms for certain FDA-regulated clinical trials must contain a specific statement advising participants that clinical trial information will be ...