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HRPP Policy - prisoners in research
About This Policy
- Effective date:
- Last updated:
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IU Human Subjects Office
Since prisoners are likely to be vulnerable to coercion or undue influence, additional protections must be applied to protect the rights and welfare of these subjects.
The IRB shall approve research involving prisoners only if it finds all of the following:
- Any possible advantages accruing to the prisoner through his/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
- 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 and immune from arbitrary intervention by prison authorities or prisoners. Unless the Principal Investigator (PI) 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.
- The information is presented in language understandable to the subject population
- 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/her parole
- 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
- Research personnel are appropriately qualified to work and interact with prisoners, based on previous research experience, academic preparation, and/or relevant training and oversight by the PI
- For federally-funded research, the research represents one of the categories of research or waiver permissible under section 2.2 below
Pursuant to 45 CFR 46.306(a)(2), federally-funded biomedical or behavioral research may involve prisoners as subjects only if the IRB determines the research falls under one or more of the following categories:
- 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;
- 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;
- 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 DHHS Secretary has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice in the Federal Register of the intent to approve such research; or
- Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subjects. In cases in which those studies require the assignment of prisoners in a manner consistent with studies approved by the IRB to control groups that may not benefit from the research, the study may proceed only after the DHHS Secretary has consulted with appropriate experts, including experts in penology, medicine, and ethics, and published notice in the Federal Register of the intent to approve such research.
Per notice in the federal register, the requirement that the research represent one of the categories of research listed above may be waived when DHHS conducts or supports certain important and necessary epidemiologic research on prisoners that meet all of the following criteria:
- The sole purposes are (i) to describe the prevalence or incidence of a disease by identifying all cases, or (ii) to study the potential risk factor associations for a disease
- Where the institution responsible for the conduct of research certifies to the Office of Human Research Protections, DHHS, acting on behalf of the DHHS 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
Research involving prisoners cannot be conducted by VA research personnel while on official duty, at VA facilities, or at VA-approved off-site facilities unless a waiver has been granted by the Chief Research and Development Officer. If the waiver is granted, the research must be conducted in accordance with 45 CFR 46, Subpart C.
The use of prisoners for medical, pharmaceutical, or cosmetic experiments is prohibited, per DOC Policy and Administrative Procedure 01-02-101, Section XVI.
Research involving detainees as human subjects is prohibited. Detainees include any individual captured by, or transferred to the custody or control of DoD personnel pursuant to the law of war. This does not include persons being held solely for law enforcement purposes, except where the US is the occupying power.
In addition to allowable categories of research on prisoners in 45 CFR 46, Subpart C, epidemiological research is also allowable when:
- The research describes the prevalence or incidence of a disease by identifying all cases or studies potential risk factor association for a disease;
- The research presents no more than minimal risk;
- The research presents no more than an inconvenience to the subject
- Prisoners are not a particular focus of the research.
For research conducted with the Bureau of Prisons (BOP), the requirements of 28 CFR 512 must be followed.
For studies proposing to enroll prisoners, the study team completes the IRB application and provides protocol-specific information related to research with this population. The IRB considers the information in the IRB application and documents its determinations as appropriate.
When research is conducted in detention or correctional facilities, research personnel must obtain approval or permission to conduct the research from the facilities involved in the research and provide documentation to the IRB.
When a human subject involved in ongoing research becomes a prisoner during the course of the study, and the relevant research study was not previously approved by the IRB for the inclusion of prisoners:
- All research procedures with the now-incarcerated prisoner-subject, including interactions and interventions and collection of identifiable private information, must immediately cease.
- If research personnel wish to have the prisoner-subject continue to participate in the research, the study team must submit an amendment to the IRB requesting inclusion of prisoners and the IRB must approve the inclusion in accordance with this policy. The prisoner-subject may continue to participate in research procedures once the amendment is approved.
- If research personnel believe it is in the best interest of the prisoner-subject to continue to receive research procedures before such an amendment can be reviewed, the IRB Chair may determine that the prisoner-subject may continue to participate in the research until the above requirements are met.
- IRB approval for inclusion of prisoners is not required if research procedures will not occur during the incarceration period.
When a prisoner is also a child (e.g., an adolescent detained in a juvenile detention facility), appropriate additional requirements must be satisfied for the inclusion of children in research as outlined in the IU HRPP Policy on Children in Research.
Individuals found to be in violation of this policy may be subject to sanctions relating to their participation in research with human subjects, up to and including permanent suspension or debarment from engaging in research with human subjects at Indiana University.Back to top
IU HRPP Guidance
Related Guidance Documents
- AAHRPP Standards
- Element II-4
- 28 CFR 512
- 45 CFR 46 Subpart C
- DoD Instruction 3216.02 - Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, Section 7(b)
- Indiana DOC Policy and Administrative Procedure 01-02-101, Section XVI
- OHRP Guidance:
- VHA Directive 1200.05 - Requirements for the Protection of Human Subjects in Research, especially section 20
federally-funded Supported, either directly or indirectly, by funds provided by the federal government. This includes federal pass-through funding (i.e., received as a subrecipient through subcontracts). Use of administrative services funded by a federal grant, alone, is not sufficient to consider research federally-funded.
identifiable private information Private information for which the identity of the subject is or may readily be ascertained by the research personnel or associated with the information.
interaction Includes communication or interpersonal contact between research personnel and the subject.
intervention Includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
principal investigator (see also research personnel, Investigator, IU-affiliated research personnel, key personnel, non-key personnel, non-affiliated research personnel, student, fellow, resident PI, site-specific PI) Responsible leader of a team of research personnel who has the ultimate responsibility for the conduct of the research.
prisoner 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 statute; individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution; and individuals detained pending arraignment, trial, or sentencing. Examples of individuals considered prisoners are available in the OHRP Prisoner Research FAQs.
private information Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., medical records).
research A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (Synonymous with clinical investigation For research subject to FDA regulations, any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under §505(i), §507(d), or §520(g) of the Food, Drug & Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58 regarding nonclinical laboratory studies (21 CFR 50.3(c)).) The following activities are deemed not to be research under this definition: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the individuals about whom the information is collected; Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters); Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for the activities authorized by law or court order solely for criminal justice or criminal investigative purposes; Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
research personnel (See also investigator, IU-affiliated research personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), Student, Fellow, Resident PI, site-specific PI) Individuals engaged in human subjects research; specifically, individuals who interact or intervene with human subjects or access identifiable information for research purposes. May also be called investigators.
written/in writing Writing on a tangible medium (e.g. paper) or in an electronic format.Back to top