HUMAN RESEARCH PROTECTIONS - PRISONERS Julia Gorey, JD Division of Policy and Assurances Office of Human Research Protections
Objectives: • Briefly describe the history of 45 CFR 46 subpart C • Explain the regulatory interpretation of “prisoner” under subpart C • Explain permissible categories of research at 45 CFR 46.306, and the Epidemiological Waiver • Describe requirement for a prisoner representative and IRB review • Describe the requirement for certification, the process of certification, and the necessary contents of the certification package
Malaria experiments at Stateville Penitentiary, Illinois, 1944 Defense Use of Research in U.S. Prisons
The Demographics of Drug Testing in Prison (Circa 1975) • 16 of 51 pharmaceutical companies used prisoners as subjects • 14 of the 16 companies conducted Phase I drug testing using prisoners • 3600 prisoners were involved in 100 protocols studying 71 substances • 9 of the 14 companies used prisoners only for Phase I testing • 8 state and 6 county or municipal prisons were used as research sites • The Jackson State Prison had the largest research operation National Commission’s Report on Research Involving Prisoners, p.31, 1976
"... fine experimental material ... and much cheaper than chimpanzees." "All I saw before me were acres of skin"... "It was like a farmer seeing a fertile field for the first time".
The NationalCommission Opines…. “There are 2 basic ethical dilemmas concerning the use of prisoners as research subjects: • whether prisoners bear a fair share of the burdens and receive a fair share of the benefits of research; and • whether prisoners are, in the words of the Nuremburg Code, ‘so situated as to be able to exercise free power of choice’- that is, whether prisoners can truly give voluntary informed consent to participate in research.” National Commission’s Report on Research Involving Prisoners, p5, 1976
REGULATORY INTERPRETATION OF “PRISONER” – 1ST DETERMINATION
Prisoner Definition- 45 CFR 46.303(c) "Prisoner" means any individual involuntarily confined or detained in a penal institution. • sentenced under a criminal or civil statute… • individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and, • individuals detained pending arraignment, trial, or sentencing.
45 CFR 46 Subpart C 1st Determination: Does the study involve “prisoners”, as defined in Subpart C?
Who is not a “prisoner”? • Voluntarily entered treatment • Released from prison to halfway houses • Persons court-adjudicated to attend non-residential treatment programs as alternative to incarceration while living in community • Civilly committed due to danger to self or others
2nd DETERMINATION: DOES THE RESEARCH FALL UNDER ONE OF THE CATEGORES IN SUBPART C?
46.306(a)(2) Categories Category (i) • study of possible causes, effects, and processes of incarceration and of criminal behavior Category (ii) • study of prisons as institutional structures or of prisoners as incarcerated persons Note: Category (i) and (ii) must be no more than minimal risk.
Subpart C “Minimal Risk” Differs From Subpart A "Minimal risk" is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. 45 CFR 46.303(d) Note: Point of reference is healthy, un-incarcerated persons.
Examining addiction treatment These images of the dopamine transporter show the brain's remarkable potential to recover, at least partially, after a long abstinence from drugs - in this case, methamphetamine.Source: The Journal of Neuroscience, 21(23):9414-9418. 2001
46.306(a)(2) Categories Category (iii) Research on conditions particularly affecting prisoners as a class. The regulations provide these examples: • Vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and • Research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults Note:Secretarial consultation required forall category (iii) HHS funded research.
46.306(a)(2) Categories Category (iv) “Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject…” Note: Secretarial consultation required for category (iv) HHS funded research where subjects assigned to control groups may not benefit.
Secretarial Consultation With Experts “… the study may proceed only after the Secretary has consulted with appropriate experts, including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of the intent to approve such research” Process usually takes at least 6 months. Note: Not required for non-HHS conducted or funded research. Institutions may convene an equivalent panel.
Epidemiologic Waiver Functions as a very narrow 5th category! For studies in which the sole purposes are: • To describe the prevalence or incidence of a disease, OR • To study potential risk factor associations for a disease Must be minimal risk, prisoners cannot be sole focus, but…IRB must still certify to OHRP!
IRB Must Include Prisoner Rep!45 CFR 46.304 • “At least one member of the Board shall be a prisoner or prisoner representative with appropriate background and experience to serve in that capacity…” • Must be full voting member listed on IRB’s roster • Appropriate qualifications will depending on type of research involved
Other Determinations Required of IRBs as Part of Subpart C Review: In addition to choosing one of the four permissible categories of research involving prisoners, the IRB must make six other specific findings. 45 CFR 46.305(a)(2)-(7)
45 CFR 46.305(a)(2)-(7) 1. Permissible category of research 2. Possible advantages associated with research participation…are not of such a magnitude that his/her ability to weigh the risks…is impaired 3. The risks are commensurate with risks that would be accepted by non prisoners. 4. Selection of subjects within the prison is fair and immune from arbitrary intervention by prison authorities or prisoners. 5. The information is presented in language which is understandable to the subject population.
46.305 (cont.) 6. Assurance exists that parole boards will not consider research participation in parole decisions; prisoners are informed in advance that participation in the research will not affect parole. 7. Adequate provision has been made for follow-up care. 46.305(c)Certification requirement The institution shall certify to the Secretary…that the duties of the Board under this section have been fulfilled.
Prisoner Research Certificationto OHRP 1) IRB reviews, makes Subpart C findings 2) Institution/IRB sends prisoner research certification letter and research proposal to OHRP* 45 CFR 46.305(c) 45 CFR 46.306(a)(1) *Note: Required only for HHS conducted or funded studies. 3) OHRP makes determination regarding categories 4) OHRP sends determination letter to institution/IRB and grant officer 45 CFR 46.306(a)(2)
If a subject becomes a Subpart C “prisoner” after enrollment… The study must be: • reviewed by IRB under Subpart C • certified to OHRP • determined by OHRP to fall into one of the four permissible categories. • IRB Chair can grant temporary approval for the subject to remain on study
What’s Different about Subpart C? • The exemptions don’t apply • Must have a Prisoner Representative • Study must fit into §46.306 category • Must send subpart C certification to OHRP and wait for response before starting research • Prisoner Research Certification http://www.hhs.gov/ohrp/policy/populations/prisoncertlet.html • Triggered regardless of when a subject becomes a prisoner • Emergency waiver of IC not permitted
“WHERE is my approval?” At least 50% of certification requests require OHRP follow-up. Please be sure to include: • Contact information! • FWA#, IRB# • Date of subpart C review • Protocol and consent/assent forms • Name of funding program officer • 46.306(a)(2) category determination • Grant title and grant number
On the OHRP Web Site: Julia Gorey, J.D. (240) 453-8141 Prisoner FAQs http://www.dhhs.gov/ohrp/ May 23, 2003 OHRP Prisoner Research Guidance document http://ohrp.osophs.dhhs.gov/humansubjects/ guidance/prisoner.htm
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