Purpose and Applicability
This guidance leads researchers, the IRB, and HSD staff through the significant complexity of conducting research involving prisoners. This includes a multi-faceted definition of “prisoner”, as well as the considerable variability in applicable regulations and requirements across different external research funding sources. In addition, several HSD policies about prisoner research are described. This guidance applies to research involving individuals who are prisoners at the time of enrollment in the research as well as individuals who become prisoners after they are enrolled in research.
Prisoners are one of the federally-protected populations of research participants. This status, accompanied by additional regulatory requirements and ethical considerations, is designed to reduce specific risks that may be experienced by this vulnerable population. This includes confidentiality risks as well as vulnerability to undue influence on the decision about whether to participate in the research.
While this is a regulatorily complex area, researchers are encouraged to include prisoners in their research when appropriate. This is essential for developing evidence-based understanding, services, care, and interventions (psychological, social, educational, biomedical) for this often-overlooked vulnerable population with its unique needs and characteristics.
Prisoners. The UW applies to all research a definition of “prisoner” that includes, but is broader than, the OHRP definition. It is a complex definition that rests on the key concepts described below.
OHRP definition (with italicized UW addition). A prisoner is any individual involuntarily confined or detained by a law enforcement officer and/or in a penal institution. The term includes individuals sentenced to such an institution under a criminal or civil statute, 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.
Key concepts. Criminal and civil state and federal laws allow for diverse scenarios. Understanding the key concepts of the prisoner definition can help in determining whether individuals in specific scenarios are prisoners. These key concepts have been abstracted from OHRP’s FAQ guidance about the definition of “prisoner”.
- Involuntary confinement or detention is the most important defining characteristic of a prisoner. The individual’s ability to leave is restricted.
- Location. The OHRP definition highlights penal institutions (e.g., prison, jail, civil commitment facility, or juvenile offender facility). However, they are not a required element of the UW definition. This is clear from the first sentence of the definition: “…involuntarily confined or detained by a law enforcement officer and/or in a penal institution”. The definition also refers to “other facilities”. In other words, there are a variety of settings in which confinement or detention may occur.
- Legal basis. The legal basis of becoming a prisoner is not restricted to criminal statutes and proceedings. Civil statutes and commitment procedures can also result in someone becoming a prisoner.
- Legal status of the individual. The term “prisoner” is not reserved for individuals who have been convicted of a crime or involuntarily committed to a facility at the conclusion of a civil commitment proceeding. It also includes individuals who are involuntarily detained or confined because they are under some type of control by law enforcement officers or awaiting arraignment or trial or other legal proceeding.
Examples that illustrate the key concepts:
- Arrest or other type of police or law enforcement custody. Individuals are prisoners if they are in handcuffs on the street, detained in a police car, arrested but not yet transported to a facility, awaiting arraignment or trial, or are a patient in a hospital but are in the custody of a law enforcement officer.
- Substance abuse or mental health treatment. Individuals who are detained in a residential facility for court-ordered substance abuse or mental health treatment as a form of sentencing, alternative to incarceration, or as a condition of community supervision or parole, are prisoners. Individuals who are receiving non-residential court-ordered substance abuse treatment and are residing in the community are not prisoners.
- Psychiatric institutionalization. Individuals with a psychiatric illness who have been committed involuntarily to an institution as an alternative to criminal prosecution or incarceration are prisoners. Individuals who have been voluntarily institutionalized are not prisoners.
- Work release. Work release involves partial confinement, in that individuals on work release are allowed to leave the residential facility only for work or other specific activities, such as appointments, treatment, shopping, or outings to visit family. They must continue therapy, treatment, programming, and classes. Therefore, the UW considers these individuals to be prisoners.
- Community supervision. Community supervision is defined as circumstances in which an individual who is on parole, probation, Less Restrictive Alternative to Civil Commitment, or is otherwise under the supervision of a state or federal department of corrections, or similar county, regional, tribal, or other legal entity is being supervised by someone who has the authority to cause the individual to be placed in confinement or a detention facility if the individual violates any conditions of their community placement. Sometimes these individuals may be wearing monitoring devices.Individuals on community supervision are generally not prisoners. However, the particular circumstances of the planned subject population and the monitoring should be analyzed against the key concepts of the prisoner definition. If the individuals are ultimately determined to not be prisoners, they should nonetheless be considered a “vulnerable” population (as distinct from a federally-identified “protected” population). The IRB should carefully consider what specific additional protections might be appropriate.
Incidental prisoners. Subjects may become incarcerated after they have already enrolled in a study. For example, a longitudinal study of non-incarcerated youth at high risk for drug and alcohol abuse is likely to eventually have subjects who become incarcerated during the course of the study.
Prisoner advocate. A prisoner advocate is a voting IRB member who is a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity. The SOP IRB Members provides details about the qualifications for prisoner advocates and how they are listed on the IRB member rosters.
Federal regulations concerning involvement of prisoners in research differ by agency (e.g., unfunded, NIH funded, NIJ funded) and type of research (e.g., interaction with prisoners vs. records review that includes prisoners). A summary of agency requirements are outlined below and additional details can be found in WORKSHEET Prisoners and GUIDANCE Human Subjects Regulations.
45 CFR 46 Subpart C. These regulations apply to all research involving prisoners that is supported by the federal agencies that signed Subpart C of 45 CFR 46: Central Intelligence Agency; Department of Defense (DoD); Department of Energy; Department of Health and Human Services (HHS); Department of Homeland Security; Social Security Administration.45 CFR 46. These regulations apply to research supported by the federal agencies that follow these regulations (often called the Common Rule). The Common Rule prohibits the involvement of prisoners in exempt research except for research aimed at involving a broader subject population that only incidentally includes prisoners. [But see HSD Policy: Research not governed by any specific prisoner regulations and requirements about research not obligated to comply with 45 CFR 46.]
Department of Defense (DoD). In addition to the Subpart C requirements, DOD-supported research cannot involve detainees (prisoners of war).
U.S. Department of Justice (DOJ) and Bureau of Prisons (BOP). These agencies did not sign Subpart C and instead have their own requirements that differ significantly from the Subpart C requirements (GUIDANCE Department of Justice; WORKSHEET Department of Justice).
Food and Drug Administration (FDA). The FDA does not have any regulations specific to prisoner research except for the prohibition against prisoner involvement in research involving the Exception From Informed Consent (EFIC).
Exception From Informed Consent (EFIC) in emergency research. EFIC research that is FDA-regulated or that is supported by federal agencies that signed the Common Rule (Subpart A) cannot enroll prisoners. However, these regulations allow the continued involvement of prisoners who are inadvertently enrolled if the prisoners provide informed consent for their continued participation.
All other research. See HSD Policy: Research not governed by any specific prisoner regulations and requirements.
Expedited Review. The UW allows the use of the expedited IRB process to review prisoner research in some narrow circumstances (WORKSHEET Expedited Review), even though the federal Office of Human Research Protections (OHRP) recommends not doing so.
Prisoner advocate and expedited review. UW policy about the involvement of a prisoner advocate in expedited reviews is described immediately below, which differs from the OHRP recommendation that a prisoner advocate IRB member participate in expedited reviews if an institution chooses to allow expedited review of prisoner research.
- Expedited initial review. The IRB reviewer exercises judgement about whether consultation with a prisoner advocate would be useful and appropriate.
- Expedited continuing review. The IRB reviewer exercises judgement about whether consultation with a prisoner advocate would be useful and appropriate. A consultation may be helpful if the information in the status report indicates that the privacy and confidentiality measures might require changes, or if the reviewer needs assistance assessing any relevant information received since the previous status report as it relates to the prisoner population (e.g., DSMB reports, RNI submissions).
- Expedited review of modifications. The IRB reviewer exercises judgement about whether consultation with a prisoner advocate would be useful and appropriate for the review of modifications to studies that received expedited initial review or that were determined by the convened IRB to be no greater than minimal risk (using the prisoner definition of minimal risk). For modifications to studies that are greater than minimal risk or otherwise require convened IRB review: UW policy requires prisoner advocate consultation only if the modification will affect the prisoner participants.
Expedited research governed by Subpart C must comply with all Subpart C requirements (WORKSHEET Prisoners) including submitting for certification to OHRP but excluding involving a voting prisoner advocate IRB member. However, some Subpart C criteria for approval are irrelevant because of UW policy about the type of prisoner research that is eligible for expedited review.
Multi-institutional research governed by Subpart C. It is a Subpart C requirement that each engaged institution must certify to OHRP unless: a) the institution relied upon the IRB review of another engaged institution; and b) that other institution certified to OHRP on behalf of both institutions. However, Subpart C requires prisoner advocate participation in the review at only one of the institutions.
It is HSD policy that the UW will certify to OHRP on behalf of the other engaged institutions when the UW IRB is reviewing for them as well as the UW.It is HSD policy to assume that the UW IRB will need to satisfy this requirement unless documentation of a prisoner advocate review at another institution is provided to the UW IRB.
Research not governed by any specific prisoner regulations and requirements. As described in the GUIDANCE Authority and Responsibilities of HSD and UW IRB, the UW generally applies the 45 CFR 46 regulations (including Subpart C and its definition of minimal risk for prisoners) to its review of all research, even when the research is not legally obligated to comply with those regulations (unless 45 CFR 46 conflicts with any other regulations that legally govern the research). Listed below are some exceptions, which are collectively called the UW Flexibility Policy.
45 CFR 46 requirements that are not applied:
- Prohibition against exempt status of research that intentionally rather than incidentally includes prisoners. The UW grants exempt status to some prisoner research, as described in the GUIDANCE Exempt Research.
- Prohibition against intentional enrollment of prisoners in EFIC research. The UW IRB has discretionary authority to allow the intentional enrollment of prisoners in research involving the Exception From Informed Consent for emergency research, if the research:
- Is not specifically focused on prison settings, and
- Is not regulated by the FDA (which prohibits prisoners in EFIC research), and
- Otherwise meets all of the Subpart C criteria for IRB approval except the criteria concerning allowable categories of research and informing prisoners in advance that participation will have no effect on their parole or pardon or work release.
Subpart C requirements that are not applied:
- The applicable criteria for approval of prisoner research (WORKSHEET Prisoners) are applied except:
- The IRB is not required to select the permissible category of research for the study. In addition, the IRB may approve research that does not fit into one of the permissible categories of research.
- The IRB may determine whether or not the criterion that each prisoner is clearly informed in advance that participation will have no effect on parole is appropriate for otherwise-approvable EFIC research.
- OHRP certification
Individuals under community supervision (as defined above) are generally not prisoners. It is HSD policy to nonetheless consider them a “vulnerable” population (as distinct from a federally-identified “protected” population). The IRB should carefully consider what specific additional protections might be appropriate. [See the discussion in Definitions.]
IRB Review and Approval
Per HSD policy, certain prisoner studies are eligible for expedited review by a designated reviewer because, either: 1) the convened IRB determined the study is no greater than minimal risk (using the prisoner definition of minimal risk); or 2) the study does not include interaction, intervention, or direct observation of prisoners. It is also HSD policy that all research that includes prisoner populations must undergo continuing review at least once annually.
Coercion and Undue Influence
Information about whether and how prisoners feel coerced or unduly influenced to participate in research is limited. The limited research available indicates that subjects generally report relatively little in the way of significant coercive influences on their capacity to make voluntary decisions about research participation. One study reported that prisoners’ influences for enrolling or not enrolling in research included some influences common to nonincarcerated subjects (e.g., personal benefit, altruism, concern about study risks and inconveniences) and other influences that are unique to prisoners (e.g., perceived lack of treatment options within the prison). If a study involves providing medical or psychological treatment to prisoners in facilities where medical care is poor or treatments of that type are unavailable, the IRB should carefully consider the potential for undue influence. Two of the IRB’s best tools for mitigating the potential for undue influence are ensuring the study has: 1) a reasonable risk/benefit ratio; and 2) a consent process and form that meet the Key Information requirements and that are communicated in appropriate language for the subject population. IRBs should also be careful about heavily weighing societal benefits of the research if the prisoners will not experience individual benefits. See GUIDANCE Consent Protected and Vulnerable Populations for more information about consent and prisoner populations.
Privacy and Confidentiality
- Maintaining subject privacy and confidentiality is complicated in a prison setting. Correctional officers may be required to be present during interview procedures. Communication by mail, telephone, email and social media may be monitored by prison staff. Researchers should contact the institution(s) in which they plan to conduct research so that they clearly understand the extent to which subject privacy and confidentiality can be maintained. See Other Approvals below for additional discussion about communication and coordination with the locations where the research will be conducted.
- If the identifiable information collected during research with prisoners is likely to be subpoenaed or otherwise requested by non-research entities, researchers should consider obtaining a federal Certificate of Confidentiality (CoC). This provides a layer of protection from forced disclosure of confidential, identifiable research information. See GUIDANCE Certificate of Confidentiality for information about which research qualifies for an automatic CoC from the federal government and how to apply for a CoC if it has not been automatically granted.
- Consent materials must clearly and completely disclose the extent to which subject privacy and confidentiality can be maintained, given the constraints of the institutional requirements. The consent materials must also describe any additional protections (e.g., CoC) that the researcher will put in place.
Subject payment. The GUIDANCE Subject Payment describes the constraints and considerations about paying subjects who are prisoners.
OHRP Certification and Authorization. Research that is governed by 45 CFR 46 Subpart C must be certified by the Office for Human Research Protections (OHRP) after IRB approval is obtained and before research with prisoners may begin. After the IRB has approved the inclusion of prisoners, HSD staff submit the required materials to OHRP. If OHRP determines the research meets the Subpart C regulatory requirements, they provide HSD with confirmation in the form of a written Authorization. It usually takes about two weeks from the time HSD submits materials to OHRP to the time the written Authorization is received. HSD will provide the researcher with a copy of the Authorization and inform them that prisoner procedures may begin.
Department of Justice. There are unique requirements for research supported by the DOJ, including the requirement to obtain a Privacy Certificate for research funded by the National Institute of Justice (NIJ) and several other agencies. These requirements are detailed in GUIDANCE Department of Justice and WORKSHEET Department of Justice.
There is wide variation in the policies of federal, state, and local penal institutions and law enforcement entities about research with prisoners – including policies about whether it is even allowed. Researchers are expected to contact institutions in which they plan to conduct research with prisoners prior to submitting external grant applications and IRB application materials to ensure the research will be allowed and to identify institution-specific requirements. For example, any research involving the Washington State Department of Corrections (DOC) requires review by the Washington State IRB (WSIRB) in addition to review by the UW IRB (see the HSD website for more details). It will also likely require approval by the Washington DOC Research Review Committee (see DOC Policy 260.050).
GUIDANCE Authority and Responsibilities of HSD and UW IRB
GUIDANCE Certificate of Confidentiality
GUIDANCE Department of Justice
GUIDANCE Human Subjects Regulations
GUIDANCE Subject Payment
SOP IRB Members
SOP Prisoners – HSD staff access only
WEBPAGE Identify the Correct IRB
WORKSHEET Department of Justice
GUIDANCE Exempt Research
WORKSHEET Expedited Review
45 CFR 46, Subpart C, “Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects”
OHRP Guidance, “Prisoner Research Certification”, July 2020
OHRP Frequently Asked Questions, “Prisoner Research”
Federal Register: volume 68; number 119; Friday June 20, 2003; pages 36929-36931; “Waiver of the applicability of certain provisions of Department of Health and Human Services Regulations for Protection of Human Research Subjects for Department of Health and Human Service Conducted or Supported Epidemiological Research”
FDA Guidance Document, “Exception from Informed Consent Requirements for Emergency Research” April, 2013
28 CFR 512 (Bureau of Prisons)
28 CFR 22 and 28 CFR 46 (National Institute of Justice)
Department of Defense Instruction 3216.02 (April 15, 2020), Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and-Supported Research.
UW email correspondence with OHRP regarding research involving the exception from informed consent; September 30, 2014
Washington Department of Corrections Research Review Committee, DOC Policy 260.050
Christopher et al., “Enrolling in Clinical Research While Incarcerated: What Influences Participants’ Decisions?” Hastings Center Report, 47(2): 21-29 (2017)
Committee On Ethical Considerations for Revisions to DHHS Regulations for Protecting Prisoners in Research, “Ethical Considerations for Research Involving Prisoners” (2006)
Edens et al., “Voluntary Consent in Correction Settings: Do Offenders Feel Coerced to Participate in Research?” Behavioral Sciences and the Law, 29: 771-795 (2011)
Open the accordion below for version changes to this guidance.
|Add guidance re: when to consult with a prisoner advocate for expedited continuing reviews
|Revise to clarify expedited review eligibility and continuing review requirements for studies with prisoner populations
|New Guidance created as part of larger revision to Prisoner document suite
Keywords: EFIC; Prisoners