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: 

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 enroll prisoners involve the following types of studies: 

• 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. 
• Research involving prisoners is not eligible for exempt review at UVA.

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 Anticipated 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 .

If a prisoner meets the inclusion and exclusion criteria for a study that may fall under 45 CFR 46.305(a)4) the study team must obtain a Letter of Cooperation from the correctional facility/facilities where the prisoner(s) are housed (jail, prison, etc.) allowing the subject to enroll in the study.

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. 
  • This letter is not needed for a modification if no subject is incarcerated after enrollment.
  • The study team should obtain this letter from a specific correctional facility before a specific prisoner is enrolled.
• Request for Modification Form outlining the request to include prisoners  
• Revised Protocol or IRB Application:  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. 

Duties of the IRB for Enrollment of Prisoners

The IRB will review the proposed research, consents or consent addendums, and applicable documents to determine whether the study meets criteria 45 CFR 46.111 and 21 CFR 56.111, if applicable, for approval. For research involving prisoners, this will include review of the protocol appendix entitled: "Appendix: Research with Prisoners". The prisoner representative must be involved in the review the research and will receive all relevant and necessary material for review (same as the Scientific Reviewer)

In order to provide written documentation of these criteria, the Scientific Reviewer or the Prisoner Representative must complete the vulnerable population's checklist for prisoner's entitled "Research with Prisoners" which will detail how each of these criteria are met. If the research is performed within the Bureau of Prisons, the checklist must be completed by the Prisoner Representative. 

If the event is on the Full Board agenda, the full IRB will discuss the additional protections necessary for this population as outlined in the supplemental appendix provided by the Investigator entitled Appendix: "Research with Prisoners". The meeting minutes will note that the prisoner representative was "present" at the meeting and that he/she concurred with the discussion and outcome/permission for prisoners to enroll at subjects in the research. 

In emergent situations, when it is necessary to decide whether or not the incarcerated subject could continue in the protocol, the IRB-HSR chair is empowered to decide, taking into account that this person has suddenly come within the category of a vulnerable subject. In such circumstances, the incarceration of a subject would be treated appropriately as a reportable event in the study, perhaps requiring a protocol change, approved either through expedited or full IRB-HSR review.

The IRB may approve a request for waiver or alteration of consent for research involving prisoners. For a study that involves an interaction/ intervention with the subject, any request for waiver or alteration of consent for research involving prisoners must be reviewed by the full Board. 

The IRB must make, in addition to other requirements under 45 CFR 46, subpart A, seven additional findings under 45 CFR 46.305(a), as follows: 

1. Biomedical or behavioral research conducted or supported by DHHS may involve prisoners as subjects only if the research under review represents one of the four (4) categories of research permissible under 45 CFR 46.306(a)(2); 
   1. Study 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 subjects; [Note that the definition of minimal risk for prisoner research at 45 CFR46.303 (d) differs from the definition of minimal risk for other research contained in 45 CFR 46, subpart A, 45CFR 46.102(i)]
   2. Study 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 subjects; 
   3. Research 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 (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; or 
   4. Research 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 (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.

Note: Research proposals in category (3) or (4) that are not conducted or supported by HHS do not require a Secretarial consultation, nor do they require certification to OHRP.

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;  

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

4. Procedures for the selection of subjects 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;  

5. The information is presented in language, which is understandable to the subject population;  

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 subjects 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 subjects of this fact.