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Max Researcher has planned an NIH-funded double-blind randomized placebo-controlled trial of a pharmaco-therapeutic agent, studying its impact on reducing high rates of relapse to opioid use upon release from incarceration and its association with poor HIV treatment outcomes. Persons with opioid use disorders with or at risk for HIV infection are concentrated within the criminal justice system.
Institutional Review Boards (IRB) at Max Researcher’s Medical School, and research committees at three correctional institutions review and approve all study procedures. The study is registered at www.clinicaltrials.gov. Additional protections are provided by the Office of Human Research Protections (OHRP) at the Department of Health and Human Services and a Certificate of Confidentiality (CoC) was obtained.
Infectious Disease Nurses will screen prisoners from three participating correctional facilities in a Northeastern state. Initial study inclusion criteria are: 1) HIV-seropositive; 2) incarcerated at one of three participating sites; 3) meets DSM-5 criteria for opioid dependence; 4) able to provide informed consent; 5) speaks English or Spanish; and 6) 18 years or older. Prisoners that meet screening criteria are asked to sign a release of information (ROI) so that research staff can meet them to describe the research study and perform informed consent procedures. After receiving the ROI, Research Staff schedule appointments with each inmate in a confidential setting to review additional eligibility criteria.
If the individual is eligible, the study staff member completes informed consent procedures and assesses the participant’s willingness to enroll in the study. To ensure that there is no real or perceived coercion for enrollment during incarceration, all participants undergo a second written informed consent process upon release from the correctional facility to confirm their interest in study participation.
Post-release research follow-up will be conducted onsite at Max Researcher’s medical school by research nursing staff.
Questions:
- 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?
Title | Response |
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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 |
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Post conditions |
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Alternatives |
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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 |