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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

  • All data collection, access procedures, and data uses have been approved by the IRB
  • Consent has been obtained from participants

Postconditions

Ethical best practices are observed for managing and de-identifying genetic data

Alternatives

  • The researcher needs to share identifiable information among the coalition, and must ensure authorization or waiver requirements are met
  • The researcher must collect additional potentially identifiable data (e.g., demographics, environmental data)

Considerations

Resources for contacting and providing indirect benefit to participants

Data Elements Considered

Genetic biomarkers

Purpose of the Data Collection

Research

 

Purpose of Data Use

Disease-specific genetic analysis

 

Terms of Transfer to the Data Holders

IRB approval, informed consent

Terms of Transfer to Researchers

IRB approval

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