Including Prisoners in Including Prisoners in Substance Abuse Clinical TrialsSubstance Abuse Clinical Trials

Aimee Campbell, PhDAssistant 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

Criminal Justice Involvement Incarceration/detention (jail/prison) House arrest/monitoring bracelet Probation/Parole

Diversion program Mandated drug/alcohol treatment

Treatment recommended

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)

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

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

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

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

Required IRB Findings1. Represents 1 of 5 categories of permissible research2. Advantages are not of such a magnitude that ability to weigh

the risks is impaired3. Risks are commensurate to those accepted by non-prisoner

volunteers4. Procedures for subject selection within prison are fair, immune

from arbitrary intervention by prison authorities or prisoners5. Language is understandable to the subject population6. Adequate assurance that parole boards will not take prisoner's

participation into account with regards to parole proceedings7. Adequate provision made for follow up exams/care post

participation as necessary

OHRP, 45 CFR 46.305-306, Subpart C

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

Web-delivery of Evidence-Based, eb-delivery of Evidence-Based, Psychosocial Treatment for Psychosocial Treatment for Substance Use Disorders (WEB-TX)Substance Use Disorders (WEB-TX)

Prisoner follow-up assessment IRB approval

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

Criminal Justice Involvement Significant portion of sample was either

mandated or referred by the CJS Several cases with monitoring bracelets –

none considered prisoners

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?

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

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

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

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

participant

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

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

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