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Max Researcher wants to study treatments for heart disease at the population-level for American Indians and Alaska Native sub-populations, who have a high prevalence of this disease. Max will require electronic health record data from the Indian Health Service (IHS), a Covered Entity, to conduct her research.
The research protocol must be approved by the IHS IRB,[1] as well as Max’s own research institution. Additionally, the proposed research study must first obtain the formal, written approval from the appropriate Tribal governments, which Max will submit with the application to the IHS IRB. Max must also provide evidence of support from the IHS facility's Chief Executive Officer (CEO) to document that the project will not use IHS resources in a manner that would adversely impact the health care provided at the facility.
Max will set up a DUA with the IHS in order to get access to their data. She will provide a set of eligibility criteria for inclusion of subjects in the study. Due to the nature of the study (i.e., that Max is studying a very small sub-population) re-identification is a risk. Consequently, IHS will deidentify the data before sending to Max and IHS will abide by the HIPAA minimum necessary standard to disclose data.
Some questions to consider:
- 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?
- Are AN/AI excluded from research due to the burdens of research study approval?
Title | Response |
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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 |
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Alternative |
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Data Elements Considered | Healthcare records, Study Data |
Purpose of the Data Collection | Clinical care, administrative purposes, research
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Purpose of Data Use | Research
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Terms of Transfer to the Data Holders | DUA
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Terms of Transfer to Researchers | IRB approval |