What To Know
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| Introduction | 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. • Research with Prisoners • Under Subpart C • Only allowed if the research is material to the lives of the prisoners Note – the U.S. Department of Justice (which includes the National Institute of Justice and the Federal Bureau of Prisons and other agencies) complies with the pre-2018 Requirements of the Common Rule, but is not a signatory to the 2018 Requirements (the revised Common Rule with a general compliance date of 21 January 2019). Also, additional requirements exist for research conducted with the consent of the Bureau of Prisons (BOP) and each BOP facility may have unique rules and requirements that researchers should be aware of and comply with. These are not addressed in this module. 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 Prisoners | 45 CFR 46.303 (Protection of Human Subjects 2018) 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. |
| Defining Minimal Risk for Prisoners | Minimal risk is also defined differently for prisoners. Non-Prisoner Minimal Risk 46.102(i) (Protection of Human Subjects 2018) defines non-prisoner minimal risk as “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.” Prisoner Minimal Risk 46.303(d) (Protection of Human Subjects 2018) defines prisoner minimal risk 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.” Office for Human Research Protections (OHRP) Clarifications The Subpart C definition (prisoner minimal risk) refers to physical or psychological harm rather than harm or discomfort as in the Subpart A definition (non-prisoner minimal risk). The Subpart C definition compares the probability and magnitude of harm in the research to the probability and magnitude of those harms normally encountered in daily life, or in routine medical, dental, or psychological examinations, rather than in daily life or routine physical or psychological examinations or tests as in Subpart A. The Subpart C definition identifies healthy persons as the comparison group against which the risks of the research should be measured, rather than leaving the comparison group unspecified, as in Subpart A. OHRP interprets the term healthy persons in this definition as referring to healthy persons who are not prisoners. |
| Research allowed under the federal regulations | The regulations at 45 CFR 46.306 (Protection of Human Subjects 2018) allow prisoners to be involved in four categories of research. Most social and behavioral sciences research falls into the first two categories: No more than minimal risk research on the possible causes, effects, and processes of incarceration and of criminal behavior, provided that there is no more than inconvenience to the subjects. No more than minimal risk research that studies prisons as institutional structures or of prisoners as incarcerated persons, provided that there is no more than inconvenience to the subjects. 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). 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 | In designing research that includes prisoners as subjects, it is important to consider issues such as informed consent and confidentiality. Consent Issues Obtaining informed consent from prisoners may be challenging, specific consent issues include: 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. • Strategy to minimize undue influence and promote autonomy • Inform each prisoner 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. 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 2018) 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 IRB should determine that these types of incentives do not compromise a prisoner’s ability to make an informed choice. Here are two examples where incentives may result in undue influence. Example 1: Photograph as an Incentive 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. Example 2: 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. 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 | There may be additional potential risks of harm in research involving prisoners. 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. |
| IRB Review of Prison Research | There are additional requirements under Subpart C for IRBs that review research involving prisoners. 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 (Protection of Human Subject 2018). 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 members that would meet the prisoner or prisoner representative requirement include: Former prisoners Prison chaplains Prison psychologists Prison social workers Other prison service providers Prisoners’ rights advocates 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 OHRP guidance, institutions have the option of stipulating that the prisoner representative will only count toward a quorum when in attendance at a convened meeting 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 (Protection of Human Subject 2018): 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 Exempt research under 45 CR 46.104 (Protection of Human Subjects 2018) may include prisoners if the research is aimed at involving a broader subject population and only incidentally includes prisoners. 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 the IRB member(s) reviewing the research include a prisoner or prisoner representative (OHRP 2018). 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 (OHRP 2018). |
| 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 the subject, or if no interventions will take place while the subject is incarcerated, the research does not need to be re-reviewed because the subject will not be participating in the study as a prisoner. If the research does need to be re-reviewed, the IRB must make the required determinations about the permissibility of the research for prisoners and, where applicable, OHRP must certify that the research may be conducted. |
| Accessing prisoners | There may be different rules and requirements researchers must follow in order to gain access to prisoners at different facilities. Jurisdiction The jurisdiction over a correctional facility may exist at the local, state, or federal level. Within a state, policies may vary from county to county. Juvenile correctional systems usually are separate from other state facilities and may have their own rules and policies. Therefore, accessing prisoners might involve an entirely different process depending upon the facility housing the prisoners. There are also various phases of incarceration, from pre-sentencing to work release, with differing restrictions on access to the prisoners. Researchers will need to identify the jurisdiction with authority over access to the prisoners they wish to study and become familiar with its procedures. Gaining Access A few general comments may be made about accessing prison populations: Correctional systems at the state level will have a review process. It may be an administrative process, a permissions board, and/or could include a review comparable to that of an IRB. Researchers who want to do research in a state facility will need approval from their local IRB and the equivalent committee from the state Department of Corrections. The research may also require certification from OHRP. Approval by an IRB is frequently not sufficient to get a researcher inside a state prison. The superintendent has the final authority to allow a researcher access to prisoners. An essential step in preventing problems entails establishing a collaborative relationship with correctional department staff while still in the research design stage. In fact, this step is essential. Staff with whom to establish collaborations include prison social workers, psychologists, and custody staff. Researchers should consider how their proposed studies might help further the mission/goals of a specific department. For instance, if prison staff are worried about or experiencing trouble with gangs, the researcher might consider how the research may lead to information about how to handle or better understand gang activity. As an administrative issue, many penal institutions are willing to provide access provided that the research is not disruptive to the institution. Administrators will be concerned with protecting the safety of researchers, the prison population, and the prison staff. In addition to safety concerns, there are operational concerns. Is there office space? Are there enough officers assigned? Are the prisoners occupied in treatment or work during interview times? If a study disrupts prison operations, it may not be allowed, even if it is ethically sound and might yield useful results. Local and county jails are less likely to have a formal review process for proposed research. In the absence of structural protections for the inmates, the researcher must assume the sole responsibility for ensuring the ethical conduct of research. Access is dependent upon local personnel and could vary significantly. Juvenile correctional systems may or may not have a formal review process. If formal processes do exist, they may reside either at the state level, the local facility level, or both. Research in juvenile facilities is covered by Subpart D of the federal regulations, “Additional Protections for Children as Research Subjects,” in addition to the protections for prisoners as research subjects. |
| Summary | Persons who are confined or detained by court order have lost significant rights, and their ability to freely consent is hampered. When research is conducted with prisoners, researchers and their IRBs have significant responsibilities, as outlined in the regulations, to take steps to ensure that they safeguard the rights of prisoners. Prisoners must be allowed to choose whether to participate in research that is relevant to their lives and their privacy. The confidentiality of their research data must be protected to the extent possible. |
Research With Prisoners Answers
| Question | Answer |
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| Which of the following statements about prison research is true? | Researchers may study the effects of privilege upgrades awarded by the prison. |
| Because studies of the effects of processes of incarceration are allowed under the regulations, researchers may study the effects of privilege upgrades awarded by the prison. The regulations do not prohibit payment of prisoners for their participation. However, the amount of compensation cannot constitute undue influence to participate. Many correctional institutions may prohibit payment. The decision to participate in research may not be considered during parole hearings, as this practice would clearly constitute undue influence to participate. The regulations require that IRBs determine that risks involved in research with prisoners are commensurate with risks that non-prison volunteers would accept. | For prev. line |
| A graduate student wants to examine the effect of print media versus televised media on individuals’ position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student’s IRB should: | Not approve this project because the prisoners are merely a population of convenience for the student. |
| Factors such as the level of risk and proposed facility are irrelevant if the prison population is simply a population of convenience as it is in this case. Research taking place in prisons must be material to the lives of the prisoners. Therefore, according to the regulations, an IRB could not approve this protocol. | For prev. line |
| A researcher’s study uses a dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims, and the IRB chair agrees, that the study is exempt from IRB review. This decision: | Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners. |
| Research conducted in prisons is not exempt under 46.104 if the subject population only includes prisoners. For research governed by the Common Rule, the exemptions at 46.104 (Protection of Human Subjects 2018) “do not apply to research subject to Subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners.” This means that the research does not include only prisoner subjects or aim to recruit prisoners as subjects. The research questions being answered also do not involve prisoners. It does allow that the research may happen to include a prisoner subject (or a subject who becomes a prisoner) and the prisoner subject’s data may still be used without IRB approval for Subpart C. Although expedited review of prisoner research is permitted, OHRP strongly discourages the use of expedited review procedures as an acknowledgement of the vulnerability of prisoners as a class. The other answers are incorrect because they assume that an IRB can use an exempt status for prisoner research. The study could qualify for expedited review, but OHRP strongly discourages the use of expedited review procedures as an acknowledgement of the vulnerability of prisoners as a class. | For prev. line |
| A researcher is examining the quality of life for prisoners who are HIV-positive using surveys followed by interview. The IRB must ensure that: | Confidentiality of the prisoners’ health status is maintained. |
| One of your subjects is half way through a study of an investigational antidepressant that is injected weekly. The drug requires a taper-down regimen, that is, it should not be stopped abruptly. You learn that the subject will be admitted to prison next week prior to the next scheduled injection. What is the appropriate response for the researcher? | The researcher should contact prison authorities about the medical issue , and report the events to the IRB of record. |
| By participating in the research, it is possible that subjects will become publicly identified as HIV-positive. This breach of confidentiality could lead to negative consequences for the prisoner. One method for the investigator to preserve this confidentiality is to interview a larger sample of offenders, some who are HIV-positive and some who are not. While the survey should be validated and reliable, it does not have to be standardized. Because the research is behavioral only, there is no need for a medical doctor. The prison’s HIV testing procedures are not part of the study. | For prev. line |
| If a human subject who is involved in ongoing research becomes a prisoner during the course of the study, the researcher must notify the IRB promptly and take appropriate steps for the safety of the subject. While the specific details are not known, the subject’s health is of concern here rather than ongoing data collection. However, research activities – including the use of the study drug — may continue but the medical aspects need to be directly addressed. Because it appears that the subject cannot be removed from the study without the possibility of increased risk of harm, additional protections are required. Although the specific details are not known, the researcher should take an active role in ensuring that the subject’s health is protected. The other answers are not sufficient in this case. | For prev. line |
| A sociologist wants to study a culture that occurs in some women’s prisons: “state families,” in which individual prisoners take on certain roles within a group of like-minded prisoners. There is previous evidence that younger prisoners will use older inmates who play the roles of grandparents as a resource before they will turn to staff for help and advice. The lieutenant in charge of a dorm of long-term prisoners offers to gather volunteers to speak to the researcher and also offers to vouch for the integrity of the researcher. The use of this staff is: | For prev. line |
| Because prisoners are vulnerable by their incarceration, it is necessary that research with prisoners does not impose further constraints on voluntariness of their decisions. Researchers must enhance the voluntariness of a prisoner’s consent by minimizing the influence of other people, especially staff or prisoners who may exercise arbitrary authority over these potential subjects. Subject selection needs to be fair within the population that potentially meets the study criteria. Using staff or prisoners to help select subjects leads to undue influence and coercion. This methodology is not “snowball sampling.” There is no waiver for this type of recruitment. | For prev. line |
| Which example of research with prisoners would be allowable under the regulations? | Examining age at first arrest as a predictor of adult criminal history. |
| Examining age at first arrest is the correct answer. This reason for conducting research falls under the first category, ” Study of the possible causes, effects, and processes of incarceration, and of criminal behavior.” Working with de-identified data, this study would be minimal risk – there is no intervention and the confidentiality risk is low. None of the other answers fall within one of the categories of allowable research. While these other studies have possible merit, there is no acceptable rationale for including prisoners. There is no benefit to the prisoners as individuals or as a group. | For prev. line |
| A researcher is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children’s first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are: | Not an excessive incentive. |
| Mothers who may have recently separated from their children may find the prospect of doing something special for their children more important than making a considered decision about becoming a research subject. Thus the toys may be an undue influence to participate. The issue of the toys being educational, of high quality, and age-appropriate are not the focus of the study. The IRB focus needs to be on any undue influence on the women. | For prev. line |
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