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, ...

Informed consent is an agreement between the investigators and the research participants. A signed informed consent form notifies potential research participants of their obligations and rights, and ...

Although exempt research is exempt from some of the federal regulations, in most cases of interaction with participants, a consent process is indicated. It’s important to understand that even though ...

The consent forms signed by patients who take part in medical studies are written in such complex language that most Americans could not understand them, a study suggests. The study looked at the ...

The European Union’s General Data Protection Regulation requires every organization that collects sensitive personal data from those residing in the EU to ask for clear and specific consent before ...

There are times, particularly in behavioral research, when investigators will find it necessary to use deception or incomplete disclosure about the true purpose of the research. Deception and ...

Most men, other than medical professionals, don’t know what a pelvic exam is. In a nutshell, it’s a procedure that doctors perform on patients to evaluate the patient’s reproductive organs. The exam ...

GINA is a federal law that prohibits discrimination in health coverage and employment based on genetic information. GINA defines genetic information as information about: An individual's genetic tests ...

Can a Physician Delegate the Informed Consent Process? Problem With an Informed Consent Prior to Surgery Lawyers Weigh in on Informed Consent The Right Way to Have These Discussions References The ...