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- What types of laws, policies or governance structures could be established to address re-identification issues?
- Should consent forms include information about reidentification risk? Is it feasible to include this type of information in consent forms given the technical complexity of the subject?
- How do you allow individuals the opportunity to control what types of research is conducted with their data?[vi]
- By what methods should data be deidentified to minimize risk of reidentification?
- Is it feasible to include DUA’s clauses where data subjects are the third-party beneficiaries should patient data be deliberately re-identified by researchers?
- What potential group and individual harms exist even when data is de-identified?[vii]
- Is the possibility of reidentification considered new information since it could lead to an accidental/unauthorized disclosure? If so, should participants be contacted and informed or the potential risk,or even re-consented? Should the DUA even include considerations and subsequent steps for this kind of risk of reidentification?
- What additional data may need to be collected for research that in tandem with genetic biomarker data (clinical, environmental or otherwise) might increase the risk of reidentifiability?
- Should the biospecimen samples be destroyed once researchers collect the data of interest? Is this helpful to protect individuals?
Title | Response |
Description | Researcher collects blood and saliva samples to analyze for particular genetic biomarkers related to disease. |
Primary actor/participant | Researcher (end-user) using in-house repository |
Support actor/participant | Participants, research coalition members |
Preconditions |
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Postconditions | Ethical best practices are observed for managing and de-identifying genetic data |
Alternatives |
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Considerations | Resources for contacting and providing indirect benefit to participants |
Data Elements Considered | Genetic biomarkers |
Purpose of the Data Collection | Research
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Purpose of Data Use | Disease-specific genetic analysis
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Terms of Transfer to the Data Holders | IRB approval, informed consent |
Terms of Transfer to Researchers | IRB approval |
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