HIPAA provides for two exceptions in which approval for research does not require full IRB review. They include _____.

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The correct choice identifies de-identified information and limited data sets as the two exceptions under HIPAA that allow for research to proceed without full Institutional Review Board (IRB) review.

Under HIPAA regulations, de-identified information consists of data from which all personal identifiers have been removed, ensuring that individuals cannot be readily identified. Because this type of information does not pose a risk to individual privacy, it does not require the same level of scrutiny as identifiable data.

Limited data sets, on the other hand, contain some identifiers that are necessary for conducting research but exclude direct identifiers such as names, geographic information, and other personal identifiers. While a limited data set still has some potential for re-identification, it is considered to be less risky than data containing full identifiers and therefore does not require full IRB review.

These provisions facilitate research activities while still maintaining a level of privacy and ethical consideration for the individuals whose information is being used. In this context, options suggesting personal health records, direct observations, anonymized feedback, focus groups, trial evaluations, or quick assessments do not fit the criteria established by HIPAA for exceptions from the full IRB review process.

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