2014 CTN Web Seminar Series

Produced by: NIDA CTN CCC Training Office "This training has been funded in whole or in part with Federal funds from the National Institute on Drug Abuse,

National Institutes of Health, Department of Health and Human Services, under Contract No.HHSN271201000024C."

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

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HISTORY AND DEMOGRAPHICS

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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

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National Commission’s Report on Research

Involving Prisoners, p.31, 1976

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"All I saw before me were

acres of skin"... "It was like a

farmer seeing a fertile field for

the first time".

"... fine experimental material ...

and much cheaper than

chimpanzees."

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The National Commission Opines….

“There are 2 basic ethical dilemmas concerning

the use of prisoners as research subjects:

1) whether prisoners bear a fair share of the burdens and receive a fair share of the benefits of research; and

2) 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.”

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National Commission’s Report on Research

Involving Prisoners, p5, 1976

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REGULATORY INTERPRETATION OF

“PRISONER” – 1ST DETERMINATION

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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.

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45 CFR 46 Subpart C

1st Determination:

Does the study involve “prisoners”, as defined in

Subpart C?

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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

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2nd DETERMINATION: DOES THE

RESEARCH FALL UNDER ONE OF THE

CATEGORES IN SUBPART C?

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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.

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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.

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Examining addiction treatment

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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 for

all category (iii) HHS funded research.

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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.

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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.

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Questions???

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Epidemiologic Waiver

Functions as a very narrow 5th category!

For studies in which the sole purposes are:

1.To describe the prevalence or incidence of a

disease, OR

2. 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!

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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

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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)

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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.

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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.

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CERTIFICATION AND

REQUIREMENTS

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Prisoner Research Certification to 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)

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3) OHRP makes

determination

regarding categories

4) OHRP sends

determination letter to

institution/IRB and

grant officer

45 CFR 46.306(a)(2)

*Note: Required only for HHS conducted

or funded studies.

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

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What’s Different about Subpart C?

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• 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

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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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Q&A – Questions / Comments

Alternatively, questions can be directed to the presenter by sending

an email to CTNtraining@emmes.com. 37

THANK YOU FOR YOUR

PARTICIPATION

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