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Waiver or Alteration of the Requirements for Obtaining Informed Consent

HHS Scenarios for possible waiver

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 IRB may waive or alter the requirement of informed consent under , provided that the IRB finds and documents that all of the following four conditions are met:

  • the research involves no more than minimal risk to the subjects;

  • the waiver or alteration will not adversely affect the rights and welfare of the subjects;

  • the research could not practicably be carried out without the waiver or alteration; and

  • whenever appropriate, the subjects will be provided with additional pertinent information after participation.

2. Public benefit or service programs: an IRB may approve a consent procedure that alters some or all of the elements of informed consent, or waive the requirement to obtain informed consent under HHS regulations at , provided that the IRB finds and documents that both of the following conditions are met:

  • the research could not practicably be carried out without the waiver or alteration; and

  • the research or demonstration project is to be 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.

3. Research in emergency settings: an IRB may also waive the requirement for obtaining informed consent if it finds and documents that the research meets the requirements of the HHS Secretarial waiver under that permits a waiver of the general requirements for obtaining informed consent in a limited class of research in emergency settings.