RACC Certified Research Administrator (CRA) Practice Exam

Are coded data human subjects research if no key access?

No Yes Only if the data include direct identifiers Only if the dataset is linked to a health record

Correct Answer:

Explanation:

The key idea is identifiability. Under federal rules, research involving human subjects hinges on whether the information used can identify the person. If data are coded but the investigator has no access to the key that would link codes to identities, the investigator cannot identify individuals from the data. In that situation, the data are not identifiable to the researcher, so the activity isn’t considered human subjects research. If someone with the key could re-identify, or if the researcher later gains access to the key, the data could become identifiable and would then fall under human subjects research. But with no key access, the defined research activity isn’t about human subjects.

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