FDA Guidance for IRB Waiver or Alteration of Informed Consent

The United States Food and Drug Administration (FDA) issued a guidance for immediate implementation to Sponsors, Investigators, and Institutional Review Boards for the waiver of alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects.  Read the full guidance on FDA's website here.

Source: https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM566948.pdf