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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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HUMAN RESEARCH PROTECTIONS - PRISONERS

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Human research protections prisoners

HUMAN RESEARCH PROTECTIONS - PRISONERS

Julia Gorey, JD

Division of Policy and Assurances

Office of Human Research Protections


Objectives

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


History and demographics

History and Demographics


Human research protections prisoners

Malaria experiments at Stateville Penitentiary, Illinois, 1944

Defense Use of Research in U.S. Prisons


The demographics of drug testing in prison circa 1975

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


Human research protections prisoners

"... 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 national commission opines

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


Human research protections prisoners

REGULATORY INTERPRETATION OF “PRISONER” – 1ST DETERMINATION


Prisoner definition 45 cfr 46 303 c

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

45 CFR 46 Subpart C

1st Determination:

Does the study involve “prisoners”, as defined in Subpart C?


Who is not a prisoner

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


Human research protections prisoners

2nd DETERMINATION: DOES THE RESEARCH FALL UNDER ONE OF THE CATEGORES IN SUBPART C?


46 306 a 2 categories

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

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

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 categories1

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 categories2

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

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.


Questions

Questions???


Epidemiologic waiver

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

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

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

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

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.


Certification and requirements

Certification and requirements


Prisoner research certification to ohrp

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

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

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

“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

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


Q a questions comments

Q&A – Questions / Comments

Alternatively, questions can be directed to the presenter by sending an email to [email protected]


Thank you for your participation

Thank you for your participation


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