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IRB-HSR > Special Issues > Vulnerable Subjects > Prisoners

 

 

 

 

 

 

Vulnerable Subjects - Prisoners

Prisoner Definition
Background
Categories of Research in Which Prisoners May Participate
Prisoners are Targeted Subjects or Anticipated Subjects : Study Team Responsibilities
Subjects Incarcerated After Enrollment in Research Study: Study Team Responsibilities

Prisoner Definition
Prisoner is defined as an individual involuntarily confined or detained in a penal institution, including persons:

  • sentenced to such an institution under a criminal or civil statute;
  • detained in other facilities (e.g. for the treatment of drug detoxification or alcoholism) by virtue of statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution,
  • detained, pending arraignment, trial, or sentencing (45 CFR 46.303(c).

Individuals are prisoners if they are in any type of penal institution, such as prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons, or may be untried persons who are detained pending judicial action, for example, arraignment or trial. An adolescent detained in a juvenile detention facility is classified as a prisoner according to federal regulations.

Examples of the regulatory definition of prisoner:

  • Individuals who are detained in a residential facility for court-ordered substance abuse treatment as a form of sentencing or alternative to incarceration; however, individuals who are receiving non-residential court-ordered substance abuse treatment and are residing in the community are not prisoners.
  • Individuals with psychiatric illnesses who have been committed involuntarily to an institution as an alternative to a criminal prosecution or incarceration; however, individuals who have been voluntarily admitted to an institution for treatment of a psychiatric illness, or who have been civilly committed to non-penal institutions for treatment because their illness makes them a danger to themselves or others, are not prisoners.
  • Parolees who are detained in a treatment center as a condition of parole are prisoners; however, persons living in the community and sentenced to community-supervised monitoring, half-way house, including parolees, are not prisoners.
  • Probationers and individuals wearing monitoring devices are generally not considered prisoners; however, situations of this kind frequently require an analysis of the particular circumstance of the planned subject population.

Examples of those NOT considered a prisoner:

  • Parolees who are not detained but living in the community and sentenced to community-supervised monitoring, half-way house, including parolees, are not prisoners.
  • Persons who are not “prisoners” when they enroll in the study, however are in jail for short periods of time at a later date if that short period of incarceration does not affect their participation in the study. 

 

Background

Incarceration places prisoners under constraints that may affect their ability to make truly voluntary and un-coerced decisions about whether or not to participate as subjects in research.  Prisoners, therefore, constitute a vulnerable population for which additional protections are warranted. The IRB-HSR shall determine whether proposed studies with prisoners also satisfy the conditions under 45 CFR 46, Subpart C, “Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects.” These provisions of the federal regulations are intended to assure that 1) prisoners provide voluntary consent to participate in research; 2) prisoner’s confidentiality is rigorously protected; 3) and prisoners are not used as subjects in studies for which non-incarcerated subjects are suitable. These provisions apply whether the research involves individuals who are prisoners at the time of enrollment in the research or who become prisoners after they become enrolled in the research.

DHHS also requires that the IRB have among its members one or more individuals knowledgeable about and experienced in working with prisoners when research, involving prisoners, is to be reviewed. Additionally, a majority of the Board, exclusive of the prisoner member(s), can have no association with the prison(s) involved apart from their membership on the IRB.

The current FDA regulations for the protection of human subjects, 21 CFR 50, 56, do not include any specific additional protections for research subjects who are prisoners. However, FDA does consider prisoners to be a vulnerable subject population for which the IRB must include additional safeguards.

If research is conducted within the Bureau of Prisons, the research must comply with Department of Justice regulations 28CFR812.512

The UVa IRB-HSR will also consider applicable state laws in the review of these studies

Categories of Research in Which Prisoners May Participate

To protect this study population, federal regulations stipulate that the only studies that may use prisoners are the following:

  • Studies of the possible causes, effects, and processes of incarceration and criminal behavior, if those studies present no more than minimal risk or inconvenience to the subjects.
  • Studies of prisons as institutions, or of prisoners as incarcerated persons, if those studies present no more than minimal risk or inconvenience to the subjects.
  • Research on conditions affecting prisoners as a class (e.g., research on hepatitis, drug addiction, sexual assaults, and other conditions more prevalent in a prison population than elsewhere), but only after the secretary of the Department of Health and Human Services has consulted with experts in medicine, ethics, and penology and published a notice approving the proposed research in the Federal Register.
  • Research on practices that are intended, and reasonably likely, to enhance the well-being of the subjects; however, if some of the prisoners will be assigned to control groups which will not benefit from the research, then the study must first be approved by the secretary of the Department of Health and Human Services, after consultation with appropriate experts as described above.

The Secretary of DHHS waived the applicability of 45 CFR 46.305(a)(l) and 46.306(a)(2) for certain research conducted or supported by DHHS that involves epidemiologic studies that meet the following criteria:

  • In which the sole purposes are to describe the prevalence or incidence of a disease by identifying all cases, or to study potential risk factor associations for a disease, and
  • Where the institution responsible for the conduct of the research certifies to the Office for Human Research Protections, DHHS, acting on behalf of the Secretary, that the IRB approved the research and fulfilled its duties under 45 CFR 46.305(a)(2)-(7) and determined and documented that the research presents no more than minimal risk and no more than inconvenience to the prisoner-subjects, and prisoners are not a particular focus of the research.

Prisoners are Targeted Subjects or Anticcipated Subjects: Study Team Responsibilities

If the research population includes people who are likely to be jailed during a study, and whose participation the PI would like to continue, the study should be reviewed as prisoner research. This would include studies intending to enroll parolees, street people, addicts, and prostitute as these individuals are more likely to be arrested than the general population.  Prisoners have the fundamental right to decide whether or not to participate in research. Prisoners may not be subjects in research without written informed consent.

For studies where prisoners are targeted or anticipated, the protocol will include the “Appendix: Research with Prisoners”.  This section will be reviewed by the IRB to determine if prisoners may be enrolled.

The study team may not screen, recruit, or enroll any individual involuntarily confined or detained in a penal institution without written IRB approval. If the research is conducted or supported by HHS, it also requires review and written approval by the Secretary (through OHRP) before any research activities may begin, including screening and enrollment.

For research conducted within the Bureau of Prisons the research must comply with all the additional Department of Justice (DOJ) requirements under 28 CFR 812.512

Subjects Incarcerated After Enrollment in Research Study: Study Team Responsibilities

If an enrolled subjects becomes incarcerated (or otherwise meets the definition of prisoner as noted in this document), during the course of conducting the study and the IRB has not previously reviewed the research proposal for prisoner populations, the investigator is responsible for providing written notification to the IRB within 5 days of knowledge of the incarceration.
 
All research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-subject must cease. 

If the subject and the study team would like the subject to remain in the study, the study must be re-reviewed by the IRB under 45CFR46, subpart C.  No additional study procedures may take place until all requirements of subpart C have been satisfied with respect to the relevant protocol.

NOTE: OHRP has allowed one important exception. In special circumstances in which the principal investigator asserts that it is in the best interests of the subject to remain in the research study while incarcerated, the IRB Chairperson may determine that the subject may continue to participate in the research until the requirements of subpart C are satisfied.

In order to conduct any research with a subject in a correctional institution, the PI must seek and receive authority from that institution to continue the research. Questions will need to be asked of the prison or county jail authority or medical authority in regard to the feasibility of the inmates continued participation in the study.

If the prisoner will remain in the study the study team will submit the following documentation to the IRB-HSR to allow for involvement of the prisoner (s) and the continuation of the subject: 

  • Letter of cooperation from the correctional facility/facilities where the prisoner(s) are housed.
  • Request for Modification Form outlining the request to include prisoners 
  • PROTOCOL APPENDIX: Research with Prisoners
  • Consent Addendum- Prisoner Subjects Population

 

The study team must address the following issues in the Consent Addendum- Prisoner Subjects Population:

  • Include the provisions for follow up examination of care following participation in the study
  • State that the subject will not be presented with possible advantages to participation that would be greater in magnitude than the normal limited-choice environment of the prison. For example, you may state that the subject will not receive better living conditions, medical care, quality of food, amenities, or opportunities for earnings than what is normally provided in the prison environment.
  • If participation in the study requires the subjects to travel to a clinic, lab, or other study site outside of the prison, the consent should state how transfer and transportation arrangements will be handled. The researcher must consult with the correctional facility prior to drafting this language to ensure the facility can/will accommodate prisoner transport for the study.
  • Include a statement that participation in the research will have no effect on sentencing, length of sentence or parole.

 

The Request for Modification form and all applicable documents must be submitted via email to the modification pre-review address (irbhsr-mods@virginia.edu) and received by the IRB within 10 business days of having knowledge of the incarceration.

 

Additional Duties of the IRB

When the IRB reviews research that will involve prisoners they are required to first confirm that the proposed study fits within the permissible categories of research. Then, it must determine:

  • Any advantages that prisoners will realize as a result of participation in the research, when compared to general living conditions within the prison, are not so great as to impair the prisoner's ability to weigh the risks and benefits of participation and freely choose.
  • The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers (usually demonstrated by enrolling non-prisoner subjects from the community, as well).
  • Procedures for selecting subjects within the prison are fair, and free from arbitrary manipulation by prison authorities or other prisoners.
  • Control subjects will be selected randomly from among the group of eligible volunteers, unless the principal investigator justifies a different procedure.
  • The information presented during recruitment and consent procedures is in a language, and level of complexity, understandable to the subject population.
  • The IRB is assured that the parole board will not take research participation into account in making decisions about parole, and each prisoner is informed in advance that participation will have no effect on the possibility of parole.
  • If medical follow-up is necessary to protect the health and welfare of the subjects, adequate provision is made for such care, taking into account the varying length of prisoners’ sentences.

Finally, an IRB that reviews research involving prisoners is required to have at least one member who is either a prisoner, or a prisoner representative; and a majority of the IRB members cannot be in any way associated with the prison(s) involved. (This requirement may be waived if two or more IRBs are involved in reviewing the same protocol, and at least one of the IRBs meets this condition.)