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Waiver of the Requirements to Obtain Informed Consent

There are only two circumstances under which the regulations give IRBs authority to waive the mandate for obtaining legally effective informed consent from subjects.

  • The IRB may approve a consent procedure that doesn’t include or which alters some or all of the consent requirements, or waive the requirement to obtain informed consent provided that:
  • the research involves no more than minimal risk to subjects,
  • the waiver or alteration will not adversely affect the rights and welfare of the subjects,
  • whenever appropriate, the subjects will be provided with additional pertinent information after they have participated in the study, and
  • the research could not be carried out without the waiver or alteration,

OR

  • The research or demonstration project is conducted by, or subject to, the approval of state or local government officials, and is designed to study, evaluate, or otherwise examine:
  • Public benefit or service programs;
  • Procedures for obtaining benefits or services under those programs;
  • Possible changes in or alternatives to those programs or procedures; or
  • Possible changes in methods or levels of payment for benefits or services under those programs; and
  • the research could not practicably be carried out without the waiver or alteration

In each case, all of the points must be evident for a waiver. The IRB will consider whether a waiver is appropriate and may not grant one if they feel it is not in the best interest of the subjects.

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