Versions Compared

Old Version 12

changes.mady.by.user Gagan Jindal

Saved on

compared with

New Version Current

changes.mady.by.user Gagan Jindal

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

  • 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

  • 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

Considerations

  • Prisoners must not be coerced into participating in the study

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

 

...