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.

Dr. MedLaw explains the importance of discussing risks, benefits, and alternatives in a manner the patient fully understands ...

The plan for obtaining consent must be included in the Human Subjects Protocol. Investigators may request a waiver or alteration of the informed consent process or waiver of consent documentation, ...

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 ...

Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers. This requirement is founded on the principle of respect for persons. Potential participants must be ...

When the government pulls a public health ad campaign, it usually raises more questions than it answers. And when that ...

Achieving informed consent requires a potential contributor to be in possession of sufficient knowledge about our plans for a reasoned decision to take part in our content. The Editorial ...

The information and sample documents in the compliance form section are provided to help researchers develop consent and assent documents customized to the design of the individual research project.

The informed consent form must be posted on the federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by ...

Warning! Sweeping changes in public health are on the rise. The latest word, according to Stat, is that the Department of Health and Human Services directed the CDC to curtail vaccine advertising and ...