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- Are there special considerations with regard to the risk of re-identification due to the small population size?
- Specifically, what provisions should be in place in the protocol to prevent such a situation?
- Are there any other alternative protections to de-identification?
- What are the implications of the research participation or research findings that might negatively impact/stigmatize the population of interest? How can these risks be mitigated effectively?
- Are AN/AI excluded from research due to the burdens of research study approval? How can these issues be resolved/eased (e.g., better clarity for researchers on what tribal governments may require)?
Title | Response |
Description | Max Researcher is conducting research on the American Indian/Alaska Native subpopulations, where risk for re-identification is high due to the small population size. |
Primary actor/participant | Covered Entity, Researcher |
Support actor/participant | IHS Information System, and Research Information System |
Preconditions |
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Postconditions | The Covered Entity continues to transmit the healthcare records to the researcher in a standardized format consistent with policy and protocol. |
Alternative |
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Considerations | It is ethical to avoid the creation or exacerbation of stigmas among these individuals/populations when publishing study results |
Data Elements Considered | Healthcare records, Study Data |
Purpose of the Data Collection | Clinical care, administrative purposes, research |
Purpose of Data Use | Research |
Terms of Transfer to the Data Holders | DUA |
Terms of Transfer to Researchers | IRB approval |
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