Evidence-Based Ethics and Mental Health Research with Prisoners

This project is funded by the National Institute of Mental Health (Grant #R01MH082872)

For additional information and project updates, please visit our website:
CBHRS Research Ethics Projects

“I think that prisoners that have mental disabilities or mental disorders are probably among the most vulnerable of prisoners and perhaps of human subjects and because mental health care within jails and prisons is often dubious, limited, often times of poor quality, offenders who are mentally ill or who have mental disabilities need to be specially protected as human subjects. And my sense is that mental health research involving these individuals need to take into account the fact that such access to healthcare is poor, that these individuals are vulnerable, that issues of confidentiality and undue influence and coercion are present, not necessarily applicable in every circumstance, but are present, and that researchers and research institutions and IRBs need to do more to address how to protect this particularly vulnerable class of prisoner human subjects. Whether it’s regard to recruitment, confidentiality, protection against risk, and access to care after the research has ended because we have a very desperate class of offenders and I think their vulnerability simply stands in stark contrast to other individuals and other prisoners in particular.” (Ethicist)

The United States has the highest incarceration rate in the world, with approximately 2.2 individuals in jails or prisons, or 1 out of every 100 people behind bars (Bureau of Justice Statistics, 2012). There are disproportionate rates of psychiatric disorders in the correctional population compared to the general population, with more than half of all prison and jail inmates having a mental health problem (Bureau of Justice Statistics, 2006). This is in part due to deinstitutionalization, lack of access to mental health services in the community, and criminalization of individuals with a mental illness. Mental health treatment in correctional settings is often inadequate or unavailable. In addition, 95% of incarcerated people will return to the community, making this an important public health concern. The high prevalence of psychiatric disorders in correctional populations, the lack of adequate treatment available, and the subsequent public health impact highlights the need for research on mental illness and treatment delivery in correctional settings.

Ethics and federal laws about human subject protections have evolved to protect research participants in general and vulnerable groups in particular. Under federal law, vulnerable groups include pregnant women; fetuses, neonates, and children; and prisoners (CFR 45 Part 46). According to ethicists, vulnerable groups also include individuals who suffer from impairment due to mental illness, stigmatized medical illness, and other debilitating disorders. Given these definitions, prisoners with mental illnesses are multiply vulnerable. Research with prisoners, especially those with the added vulnerability of mental illness, poses ethical and logistical challenges and responsibilities, yet there have been no empirical studies of the interpretation and application of ethical principles and regulatory safeguards by researchers and IRBs involved in mental health research with prisoners.

In 2006, the Institute of Medicine (IOM) published a consensus report on “Ethical Considerations for Research involving Prisoners”. The report states that the structure of federal regulations and oversight has improved the ethical oversight of research, but its restrictions have also limited research that is needed to address health-related issues. The IOM acknowledged a need for empirical data about ethical, policy and institutional challenges to research in correctional settings.

This project focuses on 1) how researchers and IRB members interpret and apply ethical principles of autonomy, justice, and beneficence in mental health research with prisoners; 2) how researchers and IRB members interpret and apply regulatory safeguards for mental health research with prisoners; 3) ways in which policies and structural environments of correctional systems (including prisons and jails) create ethical challenges that must be addressed by mental health researchers and IRBs; and 4) ways in which ethical safeguards and oversight affect mental health research with prisoners. This project is using sequential qualitative and quantitative phases to examine ethical challenges, responsibilities, and solutions regarding the conduct and oversight of mental health research with prisoners.

In Phase 1, 94 individuals with experience in mental health research with prisoners were interviewed. The sample included 32 researchers, 17 prison administrators, 15 research ethicists, 15 IRB members or chairs and 15 IRB prisoner representatives. Interviews were audio-recorded, transcribed and are currently being analyzed for themes using NVivo software for qualitative data analysis. In Phase 2, an online and paper survey was developed from the Phase 1 qualitative findings. The survey was further refined through pilot testing. In Phase 3, the online and paper survey was conducted with mental health/psychiatric researchers and IRB members, with 1288 researchers and IRB members completing the survey. Quantitative analysis of the survey data is currently being conducted. In Phase 4, 19 prison administrators and prisoner advocates were interviewed to provide feedback and recommendations on study findings. Interviews are currently being analyzed.


Bergman, A., Johnson, M. E., Mills, M. E., & Eldridge, G. D. (2014, April). The verdict is in: Assessing knowledge of federal regulation for research involving prisoners. Paper presented at the 94th Annual Convention of the Western Psychological Association, Portland, OR.

Corey, S., Romanik, S., Eldridge, G., Brems, C., Hanson, B., Johnson, M. (2012, October). Conducting mental health research with incarcerated individuals in correctional settings: Recommendations for new researchers. Posters presented at the 140th Annual Meeting of the American Public Health Association, San Francisco, CA.

Whitmore, C. & Corey, S. (2010, May). Recommendations for conducting mental health research with vulnerable populations. Paper presented at the 2010 University of Alaska Biomedical Research Conference, Anchorage, AK.

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