HUMAN RESEARCH PROTECTIONS - PRISONERS

Transcription

1 2014 CTN Web Seminar Series HUMAN RESEARCH PROTECTIONS - PRISONERS Julia Gorey, JD Division of Policy and Assurances Office of Human Research Protections 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.HHSN C."

2 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 , 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

3 HISTORY AND DEMOGRAPHICS 3

4 4

5 Defense Use of Research in U.S. Prisons Malaria experiments at Stateville Penitentiary, Illinois,

6 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,

7 "... 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". 7

8 8

9 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. National Commission s Report on Research Involving Prisoners, p5,

10 10

11 REGULATORY INTERPRETATION OF PRISONER 1 ST DETERMINATION 11

12 Prisoner Definition- 45 CFR (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

13 45 CFR 46 Subpart C 1st Determination: Does the study involve prisoners, as defined in Subpart C? 13

14 14

15 15

16 Who is not a prisoner? Voluntarily entered treatment Released from prison to halfway houses Persons court-adjudicated to attend nonresidential treatment programs as alternative to incarceration while living in community Civilly committed due to danger to self or others 16

17 2 nd DETERMINATION: DOES THE RESEARCH FALL UNDER ONE OF THE CATEGORES IN SUBPART C? 17

18 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

19 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 (d) Note: Point of reference is healthy, un-incarcerated persons. 19

20 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):

21 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

22 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. 22

23 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

24 Questions??? 24

25 Epidemiologic Waiver Functions as a very narrow 5 th 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

26 26

27 IRB Must Include Prisoner Rep! 45 CFR 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

28 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 (a)(2)-(7) 28

29 45 CFR (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

30 (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 (c) Certification requirement The institution shall certify to the Secretary that the duties of the Board under this section have been fulfilled. 30

31 CERTIFICATION AND REQUIREMENTS 31

32 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* 3) OHRP makes determination regarding categories 4) OHRP sends determination letter to institution/irb and grant officer 45 CFR (a)(2) 45 CFR (c) 45 CFR (a)(1) *Note: Required only for HHS conducted or funded studies. 32

33 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

34 What s Different about Subpart C? The exemptions don t apply Must have a Prisoner Representative Study must fit into category Must send subpart C certification to OHRP and wait for response before starting research Prisoner Research Certification et.html Triggered regardless of when a subject becomes a prisoner Emergency waiver of IC not permitted 34

35 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 (a)(2) category determination Grant title and grant number 35

36 On the OHRP Web Site: Julia Gorey, J.D. (240) Prisoner FAQs May 23, 2003 OHRP Prisoner Research Guidance document guidance/prisoner.htm 36

37 Q&A Questions / Comments Alternatively, questions can be directed to the presenter by sending an to CTNtraining@emmes.com. 37

38 THANK YOU FOR YOUR PARTICIPATION 38

39 Survey Reminder 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. Upcoming Webinar 39

40 A copy of this presentation will be available electronically after this session. 40