A waiver of the requirement for documentation of informed consent may be granted when:
The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
A waiver of the requirement for documentation of informed consent may be granted when:
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A waiver of the requirement for documentation of informed consent may be granted when the only record linking the subject and the research is the consent document, and the principal risk involves a breach of confidentiality.
This is because if the consent document is the sole record, maintaining anonymity is crucial to minimize risk. Waiving documentation helps protect participants’ identities while still allowing researchers to collect valuable data under ethical guidelines. This typically applies in scenarios involving minimal risk, where participants’ privacy is paramount. Always ensure compliance with ethical standards and regulations in research.