When can a waiver of documentation of informed consent be granted?

When can a waiver of documentation of informed consent be granted?

• A. The subject must be over 21.
• B. The consent document must be in multiple languages.
• C. The only record linking subject and research is the consent document and the principal risk is breach of confidentiality.
• D. The document must be signed by a legal guardian.

Answer: (C)

A waiver of documentation of informed consent is allowed when the only record linking the subject to the research would be the consent document and the study involves minimal risk, with other protections in place. This option directly targets confidentiality concerns: if signing the consent creates a potential breach because the consent file is the sole link to the subject, the IRB can allow the study to proceed with consent obtained by other means (for example, oral consent) and without a signed consent form stored as a separate record. The other factors in the scenario aren’t about whether documentation can be waived—age, language, or having a guardian sign don’t address the linkage to the research or the confidentiality risk. So, this condition aligns with the regulatory criteria for a waiver of documentation.

A waiver of documentation of informed consent is allowed when the only record linking the subject to the research would be the consent document and the study involves minimal risk, with other protections in place. This option directly targets confidentiality concerns: if signing the consent creates a potential breach because the consent file is the sole link to the subject, the IRB can allow the study to proceed with consent obtained by other means (for example, oral consent) and without a signed consent form stored as a separate record. The other factors in the scenario aren’t about whether documentation can be waived—age, language, or having a guardian sign don’t address the linkage to the research or the confidentiality risk. So, this condition aligns with the regulatory criteria for a waiver of documentation.