The federal regulations at 45 CFR 46 Subpart C provide additional protections to biomedical and behavioral research involving prisoners as participants. These safeguards apply to research where any participant is or becomes a prisoner. The ability of prisoners to make a free, voluntarily, and uncoerced decision about whether or not to participate in research is limited because of their status as incarcerated individuals. It is therefore particularly important that the institution and the research community take appropriate measures to ensure that prisoners are safeguarded appropriately when they are included as participants in research.
Who are Prisoners?
The federal regulations define prisoner as "any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statue, individuals detained in other facilities by virtue of statues or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing." This can include individuals that are charged with a crim and being held in a penal institution awaiting trial or sentencing among others. Researchers should contact the IRB if there is uncertainty as to whether the study population may included prisoners.
What if I am enrolling a population at risk for arrest and/or detainment?
If you anticipate that some of the subjects might become prisoners (i.e., be arrested) during the study, you may obtain IRB approval to allow these subjects to continue to participate in the study. Your protocol must still fall under one or more of the allowable categories of research. The regulatory requirements for prisoners in research are incorporated into ETSU IRB Policy 15: Vulnerable Populations. Researchers interested in conducting research with prisoners as subjects should be familiar with the requirements in that policy.
What are the regulatory considerations for prisoner research?
In summary, the major considerations are:
- The exemptions that generally apply to certain types of research do not apply to research involving prisoners, except for research aimed at involving a broader subject population that only incidentally includes prisoners (45 CFR 46.104(b)(2)).
- If the research is conducted or supported by DHHS, the University must certify to OHRP that the IRB has reviewed the protocol and made all the required findings, and then receive OHRP authorization prior to research being initiated (45 CFR 46.305(c).
- In order to approve prisoner research, the IRB must find that the proposed research falls into one of the permissible categories of research and make six other findings.
- IRB review must include a prisoner or prisoner representative (45 CFR 46.304(b) and if the study is reviewed by a full board, the convened meeting must also meet a membership requirement concerning the number of IRB members not associated with a prison/jail involved in the research (45 CFR 46.304(a).
What does the ETSU IRB require for studies that include prisoners?
- Make sure your protocol falls under one or more of the permissible categories of research specified in IRB Policy 15.
- In the IRB New Protocol Submission xform, indicate that you are enrolling prisoners and answer the additional questions in the section related to the inclusion of prisoners.
- If a facility where the recruitment or research is taking place has a research oversight approval process, please attach the approval letter and/or a description of the status. If there is no formal approval process, include a letter of support, indicating knowledge and understanding of the study, from the facility in which the research will take place.
What is the IRB reviewer looking for in a protocol?
The IRB has prisoner research reviewers that have experience with this vulnerable population. They will be looking for the researcher to show that they are experienced and knowledgeable about doing research with a prisoner population, the setting, or are working closely with a mentor with this experience and knowledge. Detention facilities are tightly controlled. Routine research protocols and procedures need to be adjusted when using these settings. If you are not experienced in this area, you will need to involve faculty who are, or work with a co-PI mentor that is. The protocol may need to describe routine research procedures in more detail than normal. In the new protocol submission describe:
- Justification for the inclusion of prisoners in the study. If applicable, delineate the procedures to be conducted in the jail, prison, detention center, or treatment facility from the overall project described.
- If and how detention facility staff are involved in conducting the research.
- How the recruitment and selection of prisoner participants will be done.
- How the project will obtain informed consent, and also state in the consent that“participation will not affect any sentencing, parole decisions or judicial outcomes.”
- Customary treatment or services at these facilities for the condition being studied.
- Where research procedures will be done within the facility, who will be present (e.g., correctional officer, etc.), how data will be collected, and how data will be protected.
- If any materials will be given to the prisoner and if you are seeking institutional approval of distribution.
- What the incentive is, if applicable, and how it will be distributed. Most facilities will not allow direct payment.
- How the study will protect subject confidentiality from staff and other prisoners.
- Plans for ensuring follow-up examination or care of participants after the end of their participation, if necessary.
- How risks specific to these settings are minimized.
- If travel to a clinic, lab, or another study site outside of the facility is needed
for the research. If so, the consent should state how transfer and transportation
arrangements will be handled. Consult with the facility prior to submitting your protocol
to the IRB to
ensure the facility can/will accommodate prisoner transport for the study and who will pay for it.
What is the IRB review process like for research involving prisoners?
The IRB review process depends on the level of risk of the research and whether the research qualifies for any of the exempt or expedited review categories. Research involving prisoners has a modified definition of minimal risk as defined by federal regulation and in ETSU IRB Policy. Minimal risk for research involving prisoners 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 healthy persons."
If the study is minimal risk and only incidentally includes prisoners, meaning prisoners are not specifically targeted for participation, the study may be eligible for exemption as long as the study is not federally funded. If the study is federally funded and involves prisoners, it cannot be exempt. Research using data, samples, or materials that involves prisoners (or that may involve prisoners) that qualifies for an exemption, and the IRB determines that an exemption is appropriate for the prison population being studied, can be granted an exemption by the IRB Chair, who may consult with the prisoner representative as appropriate. An exemption may not be granted if the research involves interaction with prisoners (including obtaining consent).
For research involving interaction with prisoners that is determined minimal risk by the IRB, review can occur via the expedited procedure. The prisoner representative must concur with the determination that the research involves no greater than minimal risk to the prisoner subjects and must serve as one of the expedited reviewers assigned by the IRB Chair. Review of any subsequent modifications or continuing review must use the same procedures for review using this expedited procedure including the responsibility of the prisoner representative.
For minimal risk research that does not involve interaction with prisoners (e.g., existing data, record review) and is determined ineligible for exemption, it can be reviewed by the expedited procedure. Review by a prisoner representative is not required, but the prisoner representative may review the research as a reviewer or consultant if designated by the IRB chair. Review of modifications and continuing review must use the same procedures as initial review.
Research involving prisoners as subjects that is not eligible for exemption or expedited review, or that involves greater than minimal risk to prisoners subjects, must be reviewed by the convened IRB at which a majority of the members are present, including the prisoner representative. The prisoner representative must serve as one of the assigned reviewers, focusing on the regulatory requirements and additional protections for prisoners, and must present his/her review at the convened meeting in which the study is reviewed. Subsequent review of non-minor modification and annual continuing review must use the same procedures as initial review.
What do I do if a subject in my study becomes a prisoner?
If a human subject becomes a prisoner during the course of the study, and the IRB did not approve the study to include prisoners, the investigator must promptly notify the IRB by submitting a Reportable Event xForm in IRBManager as described in IRB Policy 18. All research interactions and interventions with the prisoner-subject must be halted immediately, except as noted below. The collection of identifiable private information about the prisoner-subject must also cease. If the investigator wishes to have the prisoner-subject continue to participate in the research, the IRB must re-review the study for inclusion of prisoners. If the study is conducted or supported by DHHS, the University must also send a certification to OHRP and wait for a letter of authorization in reply. Otherwise, the prisoner subject must stop participating in the research, except as noted below.
OHRP allows one exception to these requirements. In special circumstances in which the investigator asserts that it is in the best interests of the subject to remain in the research study while incarcerated, the subject may continue to participate in the research until the IRB approves the inclusion of prisoners and, if necessary, OHRP authorization is received. In this case, the investigator must promptly submit a study modification so the IRB can re-review the study for compliance with prisoner regulations.
If a participant is incarcerated temporarily while enrolled in a study, and the temporary incarceration has no effect on the study, the researchers must still notify the IRB but may keep the participant enrolled unless the IRB determines otherwise.