HUMAN RESEARCH PROTECTIONS - PRISONERS
-
Upload
mikayla-washington -
Category
Documents
-
view
54 -
download
4
description
Transcript of HUMAN RESEARCH PROTECTIONS - PRISONERS
![Page 1: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/1.jpg)
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
![Page 2: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/2.jpg)
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
2
![Page 3: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/3.jpg)
HISTORY AND DEMOGRAPHICS
3
![Page 4: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/4.jpg)
4
![Page 5: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/5.jpg)
5
Malaria experiments at Stateville Penitentiary, Illinois, 1944
Defense Use of Research in U.S. Prisons
![Page 6: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/6.jpg)
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
6
National Commission’s Report on Research Involving Prisoners, p.31, 1976
![Page 7: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/7.jpg)
7
"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."
![Page 8: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/8.jpg)
8
![Page 9: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/9.jpg)
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.”
9
National Commission’s Report on Research Involving Prisoners, p5, 1976
![Page 10: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/10.jpg)
10
![Page 11: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/11.jpg)
REGULATORY INTERPRETATION OF “PRISONER” – 1ST DETERMINATION
11
![Page 12: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/12.jpg)
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.
12
![Page 13: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/13.jpg)
45 CFR 46 Subpart C
1st Determination:Does the study involve “prisoners”, as defined in
Subpart C?
13
![Page 15: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/15.jpg)
15
![Page 16: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/16.jpg)
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
16
![Page 17: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/17.jpg)
2nd DETERMINATION: DOES THE RESEARCH FALL UNDER ONE OF THE CATEGORES IN SUBPART C?
17
![Page 18: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/18.jpg)
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.
18
![Page 19: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/19.jpg)
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.
19
![Page 20: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/20.jpg)
Examining addiction treatment
20
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
![Page 21: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/21.jpg)
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
![Page 22: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/22.jpg)
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.
22
![Page 23: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/23.jpg)
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.
23
![Page 24: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/24.jpg)
Questions???
24
![Page 25: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/25.jpg)
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
![Page 26: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/26.jpg)
26
![Page 27: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/27.jpg)
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
27
![Page 28: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/28.jpg)
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)
28
![Page 29: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/29.jpg)
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.
29
![Page 30: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/30.jpg)
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.
30
![Page 31: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/31.jpg)
CERTIFICATION AND REQUIREMENTS
31
![Page 32: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/32.jpg)
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)
32
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.
![Page 33: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/33.jpg)
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
33
![Page 34: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/34.jpg)
What’s Different about Subpart C?
34
• 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
![Page 35: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/35.jpg)
“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
35
![Page 36: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/36.jpg)
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
36
![Page 37: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/37.jpg)
Q&A – Questions / Comments
Alternatively, questions can be directed to the presenter by sending an email to [email protected]. 37
![Page 38: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/38.jpg)
THANK YOU FOR YOUR PARTICIPATION
38
![Page 39: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/39.jpg)
Survey Reminder
Upcoming Webinar
The NIDA CCC encourages all to complete the survey issued to participants directly following this webinar session, as this is the primary collective tool for rating your experience with this and other webinars, and for communicating the interests and needs of CTN members and associates.
Family Involvement in SUD/MH Treatment and Research
WEDNESDAY, NOVEMBER 19, 2014
39
![Page 40: HUMAN RESEARCH PROTECTIONS - PRISONERS](https://reader035.fdocuments.net/reader035/viewer/2022062314/56813223550346895d9885b7/html5/thumbnails/40.jpg)
A copy of this presentation will be available electronically after this session.
http://ctndisseminationlibrary.org
40