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
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Julia Gorey, JD
Division of Policy and Assurances
Office of Human Research Protections
Malaria experiments at Stateville Penitentiary, Illinois, 1944
Defense Use of Research in U.S. Prisons
National Commission’s Report on Research Involving Prisoners, p.31, 1976
"All I saw before me were acres of skin"... "It was like a farmer seeing a fertile field for the first time".
“There are 2 basic ethical dilemmas concerning the use of prisoners as research subjects:
National Commission’s Report on Research Involving Prisoners, p5, 1976
REGULATORY INTERPRETATION OF “PRISONER” – 1 chimpanzees." ST DETERMINATION
"Prisoner" means any individual involuntarily confined or detained in a penal institution.
Does the study involve “prisoners”, as defined in Subpart C?
2 chimpanzees." nd DETERMINATION: DOES THE RESEARCH FALL UNDER ONE OF THE CATEGORES IN SUBPART C?
Note: Category (i) and (ii) must be no more than minimal risk.
"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.
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
Research on conditions particularly affecting prisoners as a class.
The regulations provide these examples:
Note:Secretarial consultation required forall category (iii) HHS funded research.
“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.
“… 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.
Functions as a very narrow 5th category!
For studies in which the sole purposes are:
Must be minimal risk, prisoners cannot be sole focus, but…IRB must still certify to OHRP!
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)
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.
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.
The institution shall certify to the Secretary…that the duties of the Board under this section have been fulfilled.
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)
The study must be:
At least 50% of certification requests require OHRP follow-up.
Please be sure to include:
Julia Gorey, J.D.
May 23, 2003 OHRP Prisoner Research Guidance document
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