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, JDDivision 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 NationalCommission 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.21

46.306(a)(2) CategoriesCategory (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!25

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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 requirementThe 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 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)

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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 FAQshttp://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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Family Involvement in SUD/MH Treatment and Research

WEDNESDAY, NOVEMBER 19, 2014

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