Collaborative Institutional Training Initiative (CITI) Social and Behavioral Research Practice Exam

The condition under which informed consent requirements can be waived relates to situations where the only record linking the subject to the research is the consent document itself. In such cases, obtaining informed consent can create an unnecessary risk of breaching confidentiality. This scenario allows for the waiver since the primary concern is protecting the subject's privacy and ensuring that their identity remains confidential.

This waiver is particularly applicable in research contexts that involve sensitive data or where the subject's participation could expose them to risks if their involvement were to be disclosed. The focus here is on minimizing risks to participants while still allowing the research to proceed, provided the appropriate ethical considerations are met.

Other conditions may facilitate the waiver of informed consent, but the specific context of the consent document as the only link to the subject is significant for ensuring privacy and confidentiality, making it a valid reason for waiving the informed consent process in certain research settings.