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Investigator Resources

Information for Research Participants
Information for Study Teams
Information for Sponsors
Institutional Review Boards
UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
UChart Forms & Guidance
HSRO Forms & Documents
University Fees
Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
HIPAA
Translations
Western IRB (WIRB)
About the HSRO


Basic Folder Information

23.4 Prisoners


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

April 24, 2006



23.4(a) General Principles

23.4(a) General Principles

 

For purposes of these policies [c.f. 45 CFR 46.303(c)], "prisoners" are defined either as:

1)  Individuals involuntarily confined, detained, or incarcerated in a penal institution or other alternative facility (by virtue of criminal or civil statutes or commitment proceedings that provide alternatives to criminal prosecution or incarceration in a penal institution); OR

2)  Individuals detained pending arraignment, trial, or sentencing

Federal, state and local regulations and the policies pertaining to human subjects in research that are included in other sections of this document are applicable also to research involving prisoners. However, federal regulations define increased safeguards that must be provided to biomedical and behavioral research involving prisoners as subjects [c.f. Subpart C at 45 CFR 46.301 through 46.306]. These additional regulations and the ethical standards of the University of Miami include the prison setting and/or subjects who are:

1)  Prisoners at the time of the study

2)  Subjects who become prisoners following their enrollment in the study

3)  Subjects for whom being a prisoner is coincidental with their research involvement (e.g. a prisoner with cancer enrolled in a treatment oriented study that involves no other prisoners)  [NOTE – If an adolescent were to be a prisoner such as through detainment in a juvenile detention facility, Subpart D of the federal regulations and the UM policies that pertain to children (see below) shall apply in addition to Subpart C and the UM policies that pertain to prisoners]

Prisoners are considered a vulnerable population because their incarceration and the constraints imposed on them during their incarceration could affect their ability to make a truly informed, voluntary and uncoerced decision whether or not to participate as subjects in research. The IRB shall understand that prisoners are in a restrictive institutional environment that affords little opportunity for making choices, earning money, communicating with outsiders, or obtaining medical care. Because their autonomy is limited, prisoners may participate only in certain categories of research, and special precautions are needed to assure that their consent to participate in the research is both knowing and voluntary.



23.4(b) IRB Review of Research Involving Prisoners

23.4(b) IRB Review of Research Involving Prisoners

 

In addition to satisfying the general requirements for IRB review of research as defined in federal regulations and in these written policies and procedures, an IRB must meet the following requirements when reviewing studies involving prisoners including initial applications, continuing reports, amendments and unanticipated problems:

1)  A majority of the IRB (exclusive of prisoner members) shall have no association with the prison(s) involved, apart from their membership on the IRB; AND

2)  At least one member of the IRB shall be a prisoner, or a prisoner representative with appropriate background, relevant experience and a close working knowledge, understanding and appreciation of prison conditions from the perspective of the prisoner to serve in that capacity, except that where a particular research project is reviewed by more than one IRB, only one IRB need satisfy this requirement

Convened IRB review shall be a standard for all studies involving prisoners. Regulations do not permit the IRB to categorize and approve prisoner research as exempt [45 CFR46.101 (i, footnote 1)]. Expedited review may be appropriate in limited circumstances such as if the study is restricted to a retrospective review of prisoner records or it constitutes only minor modifications to previously approved prisoner research or if the study would otherwise qualify for exemption (i.e. data registry). If a research study involving prisoners does qualify for expedited review, a prisoner representative should be one of the designated reviewers. In all cases, all required findings must be addressed and documented and a report made to the convened IRB.

Allowable Categories of Prisoner Research: IRB approval of studies involving prisoners may be given if such studies involve solely at least one of the four allowable categories expressed in federal regulations [45 CFR 46.306]. The Principal Investigator shall recommend the applicable category as part of his/her submission to the IRB. The four permissible categories are:

 

1)  The study is of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subject  [NOTE – Minimal risk for prisoner research is defined as 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 health persons.]

This definition is distinct from the definition of minimal risk applied to studies that do not involve prisoners. For the latter studies, federal regulations [45 CR 46.102] define minimal risk as being "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."

2)  The study is of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subject

 

3)  The study is on conditions particularly affecting prisoners as a class (for example, 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) provided that the study may proceed only after the Secretary of Health and Human Services (through OHRP) has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his intent to approve such research

 

4)  The study is on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary OF Health and Human Services (through OHRP) has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his intent to approve such research

 

Another category of research that may be permissible was added by recent federal regulations. This pertains to Epidemiological Research which is defined as ‘public health research that focuses on a particular condition or disease in order to (i) describe its prevalence or incidence by identifying all cases, including prisoner cases, or (ii) study potential risk factor associations, where the human subject may include prisoners in the study population but not exclusively as a target group provided that the study presents no more than minimal risk and no more than inconvenience to the subject (see definition of minimal risk unique to prisoners, above)

Seven Required Findings to Approve Prisoner Research: If the IRB determines that a prisoner study is allowable based on the categories defined above, then the IRB may approve the study if it determines and documents that all of the following seven findings are applicable to the study. These seven required additional findings [45 CFR 46.305] are:

1)  The study under review represents one of the four categories of research permissible under 45 CFR 46.306 [see above]; AND

2)  Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired; AND

3)  The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers; AND

4)  Procedures for the selection of subject within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the Principal Investigator provides to the IRB justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project; AND

5)  The information is presented in language which is understandable to the subject population; AND

6)  Adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole; AND

7)  Where the IRB finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact



23.4(c) Subject Becomes a Prisoner During an On-Going Study

23.4(c) Subject Becomes a Prisoner During an On-Going Study

 

If a research project is ongoing, with IRB approval, and one or more of the currently enrolled subjects happens to become incarcerated or otherwise meet the definition of "prisoner", the research with that prisoner/subject (including all research interactions and interventions with, and obtaining identifiable private information about the prisoner) must immediately cease (during the entire time of incarceration) unless the following conditions are met:

1)  The Principal Investigator (in his/her professional opinion) has determined that it is in the best interest of the research subject to continue

2)  The prisoner/subject wishes to continue as a study participant

3)  The IRB Chair has determined that the subject may continue to participate in the study until the convened IRB has re-reviewed the study

4)  The convened IRB approves the study as permitting the involvement of prisoners based on the policy, criteria and findings described above

If the Principal Investigator has determined that it is in the best interest of the research subject to continue his//her participation in the study and the prisoner/subject wishes to continue as a study participant, the Principal Investigator must notify the HSRO in writing of this decision within 5 working days of learning of the change in the subject's status to that of prisoner. Within this time also, the Principal Investigator must attach a justification including the decision of the prisoner/subject, the form necessary to amend the approved study application. This amendment shall include the additional information necessary for IRB re-review of the study for the involvement of prisoners and information and documents pertinent to the re-consent process.

For its review, the convened IRB shall follow the policies on prisoner research detailed above including that its approval shall be contingent upon its determination and documentation that the study falls into one of the four approved categories that define allowable prisoner research and that the study includes all of the seven additional findings required of the IRB.

In the interim between the principal investigator's decision to continue the participation in research of the newly defined prisoner and the review and approval of the convened IRB, the IRB Chair shall decide whether the subject/prisoner may continue to participate in the research. This decision shall be made by the IRB Chair in a timely manner upon his/her receipt of the required documentation from the HSRO.



23.4(d) Adding a Prisoner Component to an On-Going Study

23.4(d) Adding a Prisoner Component to an On-Going Study

If the Principal Investigator identifies a potential need to include prisoners in future recruitment efforts within an on-going study that had not been approved for the involvement of prisoners, the Principal Investigator must submit to the HSRO for forwarding to the IRB an amendment application. This application shall include the additional information necessary for IRB re-review of the study for the inclusion of prisoners. For its review, the convened IRB shall follow the policies on prisoner research detailed above including that its approval shall be contingent upon its determination and documentation that the study falls into one of the four approved categories that define allowable prisoner research and that the study includes all of the seven additional findings required of the IRB.



23.4(e) DHHS-Sponsored Studies Involving Prisoners

23.4(e) DHHS-Sponsored Studies Involving Prisoners

If the IRB approves a study involving prisoners, and if the study is supported by the U.S. Department of Health and Human Services, the study must be submitted to the Secretary of Health and Human Services for approval [c.f. 45 CFR 46.306]. The HSRO shall not issue IRB approval for the study, and the study may not be initiated, until approval is given by the DHHS Secretary.

The HSRO shall be responsible to provide documentation to the DHHS Secretary (through OHRP) necessary to certify that the IRB has appropriately reviewed and approved the research pursuant to regulations and UM policies. This documentation shall address all areas required by the OHRP guidance including the name of the research study, and any relevant HHS grant application or proposal. Also included within this information shall be:

1)  A copy of the grant application including all detailed budgetary pages

2)  A copy of the IRB minutes relevant to the discussion of the study. These should include information on the specific categories of research and the findings pertinent to prisoners

3)  A copy of the IRB approval letter

4)  A copy of all consent forms

5)  The NIH Program Office name and contact information

6)  A copy of any application forms required by the IRB

7)  Any other information requested or required by the IRB to be considered during initial review

8)  A certification affirming that the IRB approved the research and fulfilled its duties under 45 CFR 46.305

The DHHS Secretary (through OHRP) shall determine whether the proposed study falls within the categories of permissible prisoner research. Upon certification by the DHHS Secretary that the research fits into the prisoner category and that the IRB findings have been documented, the DHHS shall issue a certification letter for the IRB. Upon receipt of the certification letter, the HSRO may issue an approval. [NOTE – This certification process only applies to DHHS-sponsored research, unless the Principal Investigator identifies another certification process as required by a sponsor]



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