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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

• Researcher has IRB approval from Medical School and approval from research committees of corrections department, jails and prisons to collect, combine, and analyze data directly obtained from Subjects.
• DUA with corrections department to receive data about parole/probation violations, arrests and incarceration.
• Certificate of Confidentiality obtained from HHS.

Post conditions

• Information was collected and combined using a researcher generated unique beneficiary identifier.

Alternatives

• Prisoners under drug court mandate to participate in post-release substance use and HIV treatment.
• Persons under age 21 are included

Data Elements Considered

Clinical data from survey/biometric data from subjects, corrections data about violations and contact with CJ system

Purpose of the Data Collection

Research, CJ

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 CJ data, DUA between CJ and researcher’s medical school

Terms of Transfer to Researchers

IRB approval, research committee approval, DUA

Frequency

CJ data transfer quarterly