Potential subjects or the parents of children who are subjects are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the ...

For ADULTS and CHILDREN, a waiver or alteration of the requirements for obtaining informed consent can occur under any of the following three provisions set forth by HHS: 1. Research in general: an ...

While the federal regulations state “Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the ...

In addition to understanding informed consent, it is important for researchers to know when to use a waiver and when to use alterations of consent. This UB CTSI Educational Modules video will outline: ...

On Monday, a Florida appeals court upheld a lower court's decision to deny a 16-year-old girl a waiver that she sought in order to obtain a legal abortion at 10 weeks of pregnancy without the consent ...

The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated ...

On April 7, 2025, the FCC’s Consumer and Governmental Affairs Bureau (CGB) released an order announcing a one-year delay of a new implementing rule for the Telephone Consumer Protection Act (TCPA) ...