Waiver of Informed Consent

The following HHS regulations provide a source where a waiver of informed consent may be granted:

• 45 CFR 116(c): This regulation identifies cases when it is appropriate for the IRB to approve or waive an alteration of informed consent. Possible reasons for waiving the consent include research examining state or local public benefit programs.
• 45 CFR 116(d): This regulation identifies an overview of criteria the IRB may use to waive or approve an alteration of informed consent for research that meets four main criteria.
• 45 CFR 408(c): This regulation identifies cases where it is appropriate for the IRB to approve the waiver of parental permission in research involving children.
• 45 CFR 101(i): This regulation outlines the provisions for the Secretary and HHS to waive the general requirements for obtaining informed consent in a limited class of research in emergency settings.

According to DHHS (45 CFR 46.117), an IRB classifies the following situations as appropriate cases to grant a waiver of informed consent:

• The consent would be the only link between the research and subject. If the subject is identified through the means of informed consent, there is a major risk including breach of confidentiality for the subject.
• The study participation presents a minimal risk of harm to the subject and the research does not require any procedures requiring consent outside the context of

The IRB may require the investigator to provide a written summary about the research to the subject if either of the above methods are used.

Waiver of Consent Documentation refers to the IRB requiring a consent process but not a signature reflecting that consent. Subjects will still be required to affirm that they wish to participate in the study; however, they will not be required to sign any documents after the investigator goes over it with them. Examples of cases where the IRB finds it appropriate to grant a waiver of consent documentation include:

• The consent would be the only link between the research and subject. If the subject is identified through the means of informed consent, there is a major risk including breach of confidentiality for the subject.
• The study participation presents a minimal risk of harm to the subject and the research does not require any procedures requiring consent outside the context of

If the IRB approves waiver of consent documentation, the investigator may be required to provide subjects with a written statement regarding the research, but without obtaining a signature. Examples of ways that an approved waiver of consent documentation can be presented include the following:

• Waiver of Documentation of Informed Consent: The IRB may waive the requirement for written documentation of informed consent (45 CFR 46.116) if it finds the document contains either one of the two categories:
  • The consent would be the only link between the research and subject. If the subject is identified through the means of informed consent, there is a major risk including breach of confidentiality for the subject.
  • The study participation presents a minimal risk of harm to the subject and the research does not require any procedures requiring consent outside the context of
• Waiver of some or all the elements of informed consent be waived:
  • The IRB may waive consent if there is a consent procedure which alters some of the elements of informed consent or completely waives the right to obtain informed consent.
  • The research or demonstration project is conducted or subject to the approval of state or local government officials and aims at examining: public benefit service programs, procedures for obtaining benefits or services under those programs, possible in or alternatives to those programs/procedures, and possible changes in methods of payment for benefits or services under those programs.
  • The research does not involve more than minimal risk to subjects. The waiver should not affect rights and welfare of subjects and subjects will be provided with additional pertinent information about the investigation.