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Federal regulations provide for waivers of informed consent or informed consent documentation under specific circumstances only.
- For regulations governing general requirements of informed consent, including waivers, see 45 CFR 46 §116
- For regulations governing the documentation of informed consent, including waivers, see 45 CFR 46 § 117
Waiver of Documentation of Informed Consent
For some research projects, the IRB may approve a waiver of documentation of informed consent. This means that you must provide subjects with the required consent information, but do not obtain a signature on the consent document.
Waivers of documentation are appropriate in two situations:
- Where the signature on the consent document would be the only record linking the subject to the research and the principal risk of harm to the subject would be a breach of confidentiality
- This process is primarily used for research on sensitive topics, such as domestic violence or illegal activities.
- Where the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context
- Much of the minimal risk research reviewed by the IRB-HSBS qualifies for waiver of documentation. This process is used most often for telephone or web-based surveys.
Waiver of Informed Consent
In some circumstances, the IRB may approve a waiver of some or all of the elements of informed consent for research that is no more than minimal risk. This is primarily used for projects involving the secondary analysis of existing data or in projects involving deception.