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.

Post-hoc analyses of a large, randomized clinical trial have revealed the potential advantages associated with electronic ...

Investigators may request a waiver or alteration of the informed consent process or waiver of consent documentation, provided the conditions described on the waiver form are fulfilled.

Though informed consent often evokes images of thick packets of forms, the process is much broader than that and starts long before it’s time to read the fine print, Agu said. “The FDA ...

You're required to have all participants in your study complete an Informed Consent Form. See an example of an Informed Consent Form (pdf). Below are the Bethel University Institutional Review Board’s ...

Please provide your email address to receive an email when new articles are posted on . Informed consent forms for interventional oncology clinical trials are often lengthy and written at too high ...

as well as its informed consent forms, contain the necessary information to enable a patient, or his or her representative, to make fully-informed decisions about their care, including the right ...

as well as informed consent forms, contain elements and information that allow for a patient, or his or her representative, to make fully informed decisions about the patient’s care. In the ...

It’s something all future doctors learn in medical school: how to communicate informed consent to patients. Yet medical forms are littered with impenetrable jargon, making it hard for lay people ...