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New FDA Guidance Document: Waiver or Alteration of Informed Consent
COMIRB Aug 28, 2017
The U.S. Food & Drug Administration has released a new guidance document titled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.” This guidance is intended for Sponsors, Investigators, and Institutional Review Boards.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/irb-waiver-or-alteration-informed-consent-clinical-investigations-involving-no-more-minimal-risk
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/irb-waiver-or-alteration-informed-consent-clinical-investigations-involving-no-more-minimal-risk