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

A waiver for documentation of informed consent can be granted under specific circumstances that align with ethical guidelines and regulatory requirements. One of these conditions is when the consent document is the only link to the subject, meaning that the study can proceed without maintaining a physical record of consent that could potentially identify participants. This situation typically arises in studies where anonymity is crucial or where the sensitivity of the information requires additional protections.

In this context, it ensures that participants can provide informed consent without compromising their privacy. If the consent document were the only means of identifying an individual, its existence could pose a risk to confidentiality; therefore, waiving the requirement for a signed consent form would be appropriate.

While minimal risk studies (another condition) might also lead to a waiver, the specific wording of the choice focuses on the linkage provided by the consent document, which is a more direct justification for granting such a waiver. Therefore, the scenario described highlights a primary reason for waiving documented consent, prioritizing participant confidentiality and ethical research practices.