7/27/2017: FDA Guidance Document on IRB WAIVER OR ALTERATION OF INFORMED CONSENT

The FDA has issued a new guidance document that permits the IRB to grant a waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects provided certain criteria are met: https://www.fda.gov/RegulatoryInformation/Guidances/ucm566474.htm

All waivers or alterations of informed consent require prior IRB review and approval. Waiver requests must be requested through the Consent Process section of the Investigator Study Plan either as a part of a new study or as a Modification to an existing study.  In the study plan, investigators should explain how the study meets regulatory criteria (1) through (3) below and attest to (4):  

  1. The research is minimal risk.
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects.
  3. The research could not practicably be carried out without the waiver or alteration.
  4. Confirm that in the event it becomes appropriate to provide subjects with additional pertinent information after participation, you will seek the guidance of the IRB.