There has been an increased focus over the past couple of years on patient rights, resulting in a renewed emphasis on informed consent by healthcare regulators, such as The Joint Commission. This ...

Nine years after the draft version was published, the Food and Drug Administration (FDA) has finalized its guidance on informed consent for sponsors, institutions, IRBs, and investigators. The final ...

If you have a medical practice, it’s easy to think that once you’ve described a treatment route to a patient, they fully understand why it’s appropriate for their healthcare. It’s also easy to think ...

Federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representatives) before ...

Failure to obtain informed consent can result in significant consequences Exceptions to informed consent apply only in limited circumstances Elements of valid informed consent include patient capacity ...

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 you shop through retailer links on our site, we may earn affiliate commissions. 100% of the fees we collect are used to support our nonprofit mission. Learn more. A fter seeing an ear, nose, and ...

Institutional review boards (IRBs) are charged with safeguarding potential research subjects with limited literacy but may have an inadvertent role in promulgating unreadable consent forms. We ...

I have a question regarding the safe and ethical care of patients. In my institution it is routine for the nurse to witness the anesthesia consent form prior to surgery. We have the patient read the ...

Exempt research does not require the informed consent to be documented (it is at the discretion of the researcher), but the Bowdoin IRB does expect that informed consent be provided to the ...