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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 45 CFR 46.116(d), 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 45 CFR 46.116(c), 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 45 CFR 46.101(i) that permits a waiver of the general requirements for obtaining informed consent in a limited class of research in emergency settings.