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- With respect to authorization of data release to assess eligibility prior to consent, what protections should be afforded to incarcerated populations?
- With respect to consent of data use for research (ROI), what additional protections should be provided to incarcerated populations to prevent coercion?
- What additional privacy protections should be in place for prisoners and former prisoners?
- Do different considerations apply if screening data is collected as part of prison intake vs. research procedures?
- What considerations apply if the study design included plans to continue data collection if a participant is re-incarcerated after release?
- Does there need to be another consent if someone is re-incarcerated?
- What are the implications of using the data that was collected when the patient was not incarcerated?
Title | Response |
Description | The researcher conducts pharmaceutical RCT with prisoners and former prisoners who are HIV-positive and opioid dependent. Study outcomes can only be assessed after prisoners are released. |
Primary actor/participant | Researcher |
Support actor/participant | Jails, corrections department, probation department |
Preconditions |
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Post conditions |
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Alternatives |
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Considerations |
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Data Elements Considered | Clinical data from survey/biometric data from subjects, corrections data about violations and contact with criminal justice system |
Purpose of the Data Collection | Research, criminal justice |
Purpose of Data Use | Analysis under a specific IRB approved research protocol |
Terms of Transfer to the Data Holders | Direct consent from subjects to researcher for survey/biometric data and criminal justice data, DUA between criminal justice and researcher’s medical school |
Terms of Transfer to Researchers | IRB approval, research committee approval, DUA |
Frequency | Criminal justice data transfer quarterly |
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