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

A waiver for documentation of informed consent can be granted particularly when the principal risk is a breach of confidentiality. In such cases, the nature of the research might involve sensitive topics where obtaining written consent could lead to undue stress or anxiety for participants, potentially compromising their confidentiality or willingness to participate. Regulatory guidelines allow for this flexibility to protect the participants’ privacy and encourage their participation, especially when the overall study design involves minimal risk.

In scenarios where the waiver is applicable, the research must still uphold the ethical principle of ensuring that participants are informed about the study's nature, risks, and benefits, even if that information is provided without a formal signed consent document. This helps ensure that participants are treated with respect and autonomy, while also facilitating the research process when written documentation might be inappropriate or impractical.