The history of conducting research with prisoners has been problematic. As a group, prisoners have been a population of convenience; researchers knew where they were and would be, often for many years. In addition, prisoners lived under controlled conditions conducive to research. It was generally accepted to use prisoners as research subjects for testing medicines, drugs, and medical devices without regard to the risks, benefits, and rights of those individuals.
As documented in Acres of Skin: Human Experiments at Holmesburg Prison (Hornblum 1998), prisoners were used in lieu of laboratory animals to test the toxicity of cosmetics. In other experiments, prisoners were irradiated in research conducted by the Atomic Energy Commission, rendering some sterile and others badly burned. These are only two examples of many experiments using prisoners as subjects.
In 1978, the United States (U.S.) Department of Health, Education, and Welfare, the predecessor to the U.S. Department of Health and Human Services (HHS), issued additional regulations providing safeguards for prisoners as research subjects: Subpart C: "Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects." These regulations address the fact that prisoners are under constraints that could affect their ability to make truly voluntary and un-coerced decisions to participate in research. Subpart C imposes strict limits on the involvement of prisoners as research subjects. The only research that may be conducted with prisoners as subjects is research that is material to the lives of the prisoners.
Learning Objectives
By the end of this module, you should be able to:
• Examine and apply the definition of "prisoner" in the federal regulations.
• List the four categories of permissible research with prisoners allowed by the federal regulations.
• Identify issues to consider when designing research to be conducted with prisoners.
• Identify issues related to accessing prison populations.
• Describe the regulatory obligations of an Institutional Review Board (IRB) reviewing prisoner research.
Defining Prisoner
Part 46.303 of Subpart C (Protection of Human Subjects 2009) defines a prisoner as follows:
Prisoner means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under 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.
Included in this definition are those individuals in hospitals or alcohol and drug treatment facilities, who are under court order. Individuals in work-release and house arrest programs also qualify as prisoners. Individuals on parole are not considered prisoners. The definition applies to both minors and adults.
Research Allowed Under the Federal Regulations
The regulations at 45 CFR 46.306 (Protection of Human Subjects 2009) allow prisoners to be involved in four categories of research. Most social and behavioral sciences research falls into the first two categories:
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.
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 diseases such as hepatitis and HIV which are more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults).
4 Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subjects. Studies that require the assignment of prisoners to control groups in which they may not benefit from the research may need federal-level review.
Examples of social and behavioral sciences research in the categories listed above include:
• Age at first arrest as a predictor of adult criminal history
• Effects of overcrowding on prison populations
• The influence of prison-awarded incentives (such as promotions in custody level) on retention in substance abuse treatment programs
• The use of true crime/detective stories as bibliotherapy
• Social support systems in prisons
• The functioning of pseudo-families in prison
Designing Prison Research
Consent Issues
Free Choice
Informed consent requires the ability to choose freely, without coercion and without undue influence. Because the autonomy of prisoners is necessarily limited, the regulations include provisions designed to reduce any undue influence on prisoners' decisions to participate in research. For example, each prisoner must be clearly informed that the decision to take part in research will have no effect on an inmate's eligibility for parole.
The Use of Incentives
Incentives to take part in research should be appropriate to the research setting and subject population. Prison cultures and prison structures are such that incentives that might seem trivial in the outside world could carry great significance within a prison. For example, a researcher offered women photographs of themselves and their visiting children that would be taken and framed by a professional photographer. In a prison environment, where women are deprived of their children and do not have cameras, this particular form of compensation might create pressure to participate, resulting in undue influence. Another example involves money as an incentive. In many states, the maximum daily wage a prisoner may earn is $1.00. Offering $25.00 for participation in research would be comparable to five weeks pay and might unduly influence prisoners' decisions about participating in the research.
The presence of incentives in research is not always clear within the prison culture. As such, the regulations at 45 CFR 46.305 (Protection of Human Subjects 2009) require the IRB to consider "any possible advantages accruing to the prisoner through…participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunities for earnings" within the prison. The Institutional Review Board (IRB) should determine that these types of incentives do not compromise a prisoner's ability to make an informed choice.
Descriptions of Confidentiality
Consent forms need to be written at a level that is understandable to the subject population. Risks, and measures to minimize these, need to be explicit and detailed. The consent form should clarify the type of information available to correctional staff, such as a final report containing aggregate data but not information that would identify individuals.
Limits to Confidentiality
Researchers need to specify the limits of confidentiality. Consent forms should clearly state what information can never be confidential within a prison, such as prisoners' threats to hurt themselves or others, and professed plans to escape. This kind of information must be reported to the prison authorities. Researchers need to be aware of the circumstance in which even having a copy of the consent form may lead to a breach of confidentiality.
Assessing Risk
Harm in Asking Questions
There is often a limited support system within a prison that prisoners can use to "debrief" following their involvement in research. Prisoners often have limited means and skills to work through their issues and feelings. Strategies used to cope with stress that are available outside prison, such as telephoning a friend or going for a run, may be restricted in the prison setting. Researchers, in conjunction with prison staff, need to develop strategies for managing the risks presented when inmates are asked potentially emotionally charged questions (such as the events leading to their incarceration, their current emotional health, or about relationships).
Breach of Confidentiality
This section includes examples of potential breaches of confidentiality unique to the prison setting and some strategies for managing that risk.
Nature of Conviction
Scenario: A researcher is studying child abuse history of pedophiles in order to develop treatment strategies for use within the prisons. He wants to call 25 pedophiles out of the general prison population for interviews.
Discussion: There is a great deal of offender information that is freely available to the public: an inmate's name, age, race, sex, conviction, court where sentenced, and length of sentence.
However, some of this information, though publicly available in free society, becomes private within the prison. Within prisons some crimes are more "acceptable" than others. Given the culture of a prison, the identification of a research participant as a pedophile may expose that individual to harm. Even though convictions are public information, researchers do not have the right to disclose information about a person's conviction to other prisoners.
A possible strategy for managing this particular risk is to interview 50 people who had committed a variety of crimes so that 25 pedophiles included among the 50 would not be identified to other prisoners.
Health Status
Scenario: A researcher is studying quality-of-life issues in inmates who have a positive HIV status.
Discussion: Prisoners have little privacy and, in many facilities, there is still stigma attached to a positive HIV status. As in the previous scenario, the researcher needs to consider study design strategies to keep the subject matter confidential, perhaps by interviewing prisoners with a range of health conditions that includes a positive HIV status.
It would be easier to maintain confidentiality when conducting this type of research outside the prison setting. A researcher could arrange to conduct the interview in a private setting so that no one but the researcher would know the subject's health status.
Prison Life
Scenario: A researcher proposes to conduct focus groups with women prisoners. The goal is to develop an understanding of the kinds of services incarcerated women will need in order to break the cycle of repeated arrests.
Discussion: Researchers need to be mindful of the inability to guarantee confidentiality within focus groups. One possible consequence in this case, among many, is that a woman might mention something in the focus group that could be used against her by other group members. It is difficult to ensure that group members will not talk outside the group; other inmates or staff may try to persuade members to share information. The researcher needs to ensure that all members understand this risk. In the absence of such assurances, it may be preferable for the researcher to acquire data about needed services through individual interviews.
Institutional Review Board (IRB) Review of Prison Research
Required Composition of the IRB
A majority of the IRB members must have no association with the prison(s) involved, apart from their membership on the IRB.
At least one member of the IRB must be a prisoner or a prisoner representative with appropriate background and experience to serve in that capacity. The prisoner representative must be a voting member of the IRB with a close working knowledge and understanding and appreciation of prison conditions from the prisoner's perspective. If a research project is being reviewed by more than one IRB, only one IRB must satisfy this requirement. Suitable board members would include former prisoners, prison chaplains, prison psychologists, prison social workers, other prison service providers, prisoners' rights advocates, and other individuals who are qualified to represent the rights and welfare of prisoners by virtue of appropriate background and experience with prisons and prisoners.
According to Office for Human Research Protections (OHRP) guidance, institutions have the option of stipulating that the prisoner representative will only count toward a quorum when he or she is in attendance and reviewing studies covered by Subpart C.
Required IRB Findings
For research involving prisoners, the IRB must make additional determinations before approving the research. The IRB must determine that:
• The research under review falls into one of the four categories of permitted research for prisoners.
• Any benefits to the prisoner that may result from being in the research when compared to the general living conditions, medical care, quality of food, amenities, and opportunity for earnings in the prison, do not impair the prisoners' ability to weigh the risks of the research against the benefits in the prison environment.
• The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers.
• Procedures for the selection of subjects within the prison are fair to all prisoners. Control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project.
• The study information is presented in language that is understandable to the subject population.
• Prisoners have been clearly informed in advance that participation in the research will have no effect on their eligibility for parole.
• Adequate provisions have been made for follow-up examination or care, and prisoners are informed that the provisions have been made.
Exempt and Expedited Review of Prisoner Research
Research conducted in prisons may not be exempt under 45 CFR 46.101(b). Although the federal regulations permit expedited review of prisoner research, OHRP strongly discourages the use of expedited review procedures as an acknowledgement of the vulnerability of prisoners as a class. OHRP recommends that all prisoner research be reviewed by the convened IRB with a prisoner representative present for the review.
The Use of Waivers in Prison Research
Research involving prisoners may be approved with a waiver or alteration of informed consent. However, even if documentation of informed consent is waived or altered, Subpart C still requires that the subjects be clearly informed, in advance, that participation in the research will have no effect on their parole.
Federal Review of Prison Research
Prison research funded by the U.S. Department of Health and Human Services (HHS), including the National Institutes of Health (NIH), must be certified by OHRP. In addition, research with prisoners that falls into categories 3 and 4, described earlier in this module, requires federal consultation and approval. If research is not conducted or supported by HHS, these requirements do not apply.
When Enrolled Subjects Become Prisoners
If a human subject involved in ongoing research becomes a prisoner during the course of the study, the researcher must notify the IRB promptly. All research activities with the now incarcerated prisoner/subject must be suspended immediately. The only exception is when it is in the best interests of the subject to remain in the study. This exception is most often used when the subject is receiving an intervention providing direct benefits. In this case, the subject may remain in the study while the IRB makes the determinations required by the regulations. In addition to the potential benefit to the subject, the IRB must also consider issues such as whether the subject can continue to freely consent to participate, whether the subject's confinement will in any way prevent the research from continuing as approved, and whether the subject can continue to meet the requirements of the research. The IRB should specify, in any findings that are made in approval of continued participation, that the allowance is limited to a single subject and cannot be construed as to allow recruitment of prisoners as subjects.
If the subject can be removed from the research without harming