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Including Prisoners in Substance Abuse Clinical Trials

Including Prisoners in Substance Abuse Clinical Trials. Aimee Campbell, PhD Assistant Research Director, Division of Psychiatric Research, St. Luke’s Roosevelt Hospital Center

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Including Prisoners in Substance Abuse Clinical Trials

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  1. Including Prisoners in Substance Abuse Clinical Trials Aimee Campbell, PhD Assistant Research Director, Division of Psychiatric Research,St. Luke’s Roosevelt Hospital Center Assistant Professor of Clinical Psychiatric Social Work, Department of Psychiatry, Columbia University College of Physicians & Surgeons Research Scientist, New York State Psychiatric Institute

  2. Criminal Justice Involvement • Incarceration/detention (jail/prison) • House arrest/monitoring bracelet • Probation/Parole • Diversion program • Mandated drug/alcohol treatment • Treatment recommended

  3. OHRP Prisoner Definition • Specific section of OHRP guidelines for prisoner populations – 45 CFR part 46, subpart C • “Prisoner” means any individual involuntarily confined or detained in a penal institution • Penal institutions include prison, jail, or juvenile offender facility…where the ability to leave the institution is restricted (45 CFR 46.303, Subpart C)

  4. Substance Abuse Treatment • Individuals who are detained in a residential facility for court-ordered substance abuse treatment as a form of sentencing or alternative to incarceration are prisoners; • Individuals who are receiving non-residential court-ordered substance abuse treatment and are residing in the community are not prisoners. OHRP; http://answers.hhs.gov/ohrp/categories/1568

  5. Psychiatric Treatment • Individuals with psychiatric illnesses who have been committed involuntarily to an institution as an alternative to a criminal prosecution or incarceration are prisoners • Individuals who have been voluntarily admitted to an institution for treatment of a psychiatric illness, or who have been civilly committed to non-penal institutions for treatment because their illness makes them a danger to themselves or others, are not prisoners OHRP; http://answers.hhs.gov/ohrp/categories/1568

  6. Parole and Probation • Parolees detained in treatment centers as a condition of parole are prisoners • Persons living in the community and sentenced to community-supervised monitoring, including parolees, are not prisoners • Probationers and individuals wearing monitoring devices are generally not considered to be prisoners OHRP; http://answers.hhs.gov/ohrp/categories/1568

  7. Institutional Review Board Approval • Request prisoner review from IRB • IRB reviews, following OHRP guidelines • IRB sends request for certification to OHRP • OHRP issues prisoner certification to the IRB • All subsequent IRB approvals, including amendments and continuing reviews, must include a prisoner representative

  8. Required IRB Findings • Represents 1 of 5 categories of permissible research • Advantages are not of such a magnitude that ability to weigh the risks is impaired • Risks are commensurate to those accepted by non-prisoner volunteers • Procedures for subject selection within prison are fair, immune from arbitrary intervention by prison authorities or prisoners • Language is understandable to the subject population • Adequate assurance that parole boards will not take prisoner's participation into account with regards to parole proceedings • Adequate provision made for follow up exams/care post participation as necessary OHRP, 45 CFR 46.305-306, Subpart C

  9. Other IRB Regulations • Exemptions do not apply to research involving prisoners • IRB must include a prisoner or prisoner representative • IRB must meet membership requirement concerning the number of IRB members not associated with a prison involved in the research • HHS Secretarial waiver of informed consent in certain emergency research is not applicable to research involving prisoners (61 FR 51531, 1996) OHRP, 45 CFR part 46.304, Subpart C

  10. Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders (WEB-TX) Prisoner follow-up assessment IRB approval

  11. WEB-TX Protocol • Multi-site randomized controlled trial • 2 Arms • Treatment as Usual (TAU) • TAU + Web-based CRA/Contingency Management (replaces 2 hrs of TAU) • 12 weeks of Treatment • Post-treatment, 3- and 6-month follow up

  12. Criminal Justice Involvement • Significant portion of sample was either mandated or referred by the CJS • Several cases with monitoring bracelets – none considered prisoners

  13. Identifying Prisoners in the Community • Building screening questions into recruitment process – determining prisoner status can be challenging • Are you currently under house arrest? • a. If yes, are you free to come and go to the outpatient treatment facility and other pre-determined locations of your own accord, that is, without law enforcement escort?

  14. Timing of Prisoner Certification IRB approval for regular protocol first Submitted modification for prisoner certification to conduct follow-up interviews Approximately 7 months from initial submission to final IRB approval for Lead Team

  15. IRB Protocol-related Issues • Voluntary – no consequences on legal status • Compensation for prisoner participants • Requested no compensation; can’t be held until release nor given to another person in the interim • Confidentiality in prison settings • Assessments will not interfere with visiting hours/legal counsel • Approval from each facility is required

  16. 0044 Prisoner Certification/Approval • 7 of 10 sites sought and received IRB approval to assess prisoner participants at follow up • IRB approval time prohibitive at 2 sites • State did not support research in jails at 1 site • 1 site received approval, but could not set up adequate confidentiality assurances

  17. Access and Process • Variability across states • Access to jails/prisons • Conducting research in jails • Obtaining confidentiality assessment space • Obtaining informed consent with prisoner participant

  18. 0044 Prisoner Assessment (trial in progress) • 54 follow up interviews needed while participants were in jail • 3.6% of all follow up interviews • 13 of 54 completed (24.1%) • 21 not completed, no IRB approval • 21 not completed, with IRB approval

  19. S-CAST: NIDA CTN Protocol 0046 (trial in progress) • 1.8% of active visits missed due to incarceration • 199 visits • 36 participants • 6.9% of follow-up visits missed due to incarceration • 52 visits • 41 participants

  20. Summary • Assess substance abuse treatment seeking clients for CJ status • Important to include individuals that become incarcerated during a study to reduce bias • Seek prisoner certification early (prior to study enrollment) • Determine balance in seeking prisoner certification based on % of lost visits

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