CIW Data Analyst Practice Exam

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A study involves a highly sensitive topic. The signed consent form would be the only record linking a participant to the research, and disclosure of participation is the principal foreseeable risk. Which safeguard is most appropriate for the investigator to request from the IRB?

A waiver of documentation of informed consent A waiver of all informed consent requirements solely because the topic is sensitive Public release of the participant list after data collection Retention of signed consent forms with the research data indefinitely

Correct Answer:

A waiver of documentation of informed consent

Explanation:

Under 45 CFR 46.117(c), an IRB may waive the requirement for a signed consent form when the consent document would be the only record linking the subject and the research and the principal risk is harm from a breach of confidentiality. The consent process itself may still be required.

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