Prisoners in Research Studies

A prisoner is defined as any individual involuntarily confined or detained in a penal institution, which includes individuals detained pending arraignment and individuals in alternative locations (i.e. house arrest, parole). Subpart C in the federal regulations provide specific instructions as to how prisoners can be included in research studies.  

Prisoners are in a naturally coercive environment; their ability to make decisions about daily life is severely compromised. They may be more easily persuaded to participate in a study in prison then they would have if otherwise occupied. Thus, it is important that you consider every aspect of the study, particularly the method for obtaining consent. 

Can a Prisoner Participate in My Study?

Prisoners can participate in the following studies:

  1. Study of causes, effects, and processes for incarceration. This can include the study of criminal behavior, but the study cannot be greater than minimal risk and can no more than inconvenience the participants.
  2. Study of the prison institution or the incarcerated person. This study cannot be greater than minimal risk and can no more than inconvenience the participants.
  3. Research on conditions particularly affecting prisoners as a class. This can include research on social and psychological problems that are common among prisoners (i.e. alcoholism, drug addiction, and sexual assaults).
  4. Research on practices that have the intent and probability to improve the health or well-being of the participants. Studies that require control groups (where the control group participants may not benefit from their participation) may be required to provide these benefits to the control group participants after the study is completed. 

Prisoners can only participate in the above studies. If your study does not fit into one of the above categories, the IRB-SBS cannot approve recruiting prisoners to participate in your study.

What Happens if One of My Participants Becomes a Prisoner?

In general, the Prisoners In Research Studies is applicable to researchers recruiting prisoners to participate in a study. However, these regulations also apply to participants who are incarcerated while enrolled in a study. For example, if one of your participants is arrested for driving under the influence and is incarcerated, your study is now considered a prisoner study. In order for you to continue to use that participant in your study, you are required to submit a modification describing the situation. The protocol will need to be reviewed by the prisoner representative and will need the Board’s approval to move forward. If such an incident occurs while you are conducting your study, contact our office immediately and we will help you so that your study can move forward.

Special Rules for Including Prisoners

The federal regulations outline specific rules that both the IRB and the researcher must follow in order to approve prisoner studies.

Rules the IRB must follow:
A majority of the Board cannot have association with the prison involved. In addition, the IRB-SBS is required to have one member of our Board be either a prisoner or a prisoner representative with the appropriate background and experience. Often this person is not a regular member of our board and serves only on a needs basis. It is important to note that you should give the IRB-SBS adequate time to schedule the review of a prisoner study; because of scheduling restrictions, we may not be able to accommodate last-minute reviews.

Rules the Researcher must follow:

  1. Payments and benefits of study will not unduly influence the prisoners to participate. Remember that advances in living conditions, medical care, quality of food, amenities, and opportunities for earning payment in a prison environment can have a much greater effect than identical payments to a non-prison population. Prison policies can help determine an appropriate payment amount.
  2. The risks of the research are comparable to risks that would be acceptable to non-prisoner participants.
  3. Prisoner selection is fair and impartial (unless otherwise justified by the researcher for the design of the study).
  4. Prisoner selection, recruitment, and consent are conducted by the researcher and not the prison staff. The underlying principle for this rule is that the prisoners will not be coerced into participating in the study. As you will be working within the prison system, their rules may require alternative procedures. We recommend that you contact the prison before you submit your protocol and discuss with them any rules or regulations regarding conducting research, particularly any hurdles to the consent process. Please provide a recruitment plan and consent procedure that encourages voluntary participation, making sure that prison leaders do not endorse participation by prisoners. In your protocol, please make the Board aware of any requirements made by the prison system on the implementation of your study, so that the Board can adequately assess this information in their review.
  5. The consent and other study information are presented in language that is understandable to the prison population.
  6. Prisoners are assured that participation will not affect decisions regarding parole. Assurances should also exist that the parole board will not be influenced by the prisoner’s participation. This information should be included in the consent form and explained to the participant. 
  7. Provisions for follow-up care, as needed, will be provided to prisoners. 

In addition to the rules outlined by the federal regulations, please be aware that a prisoner population may have other complicated elements beyond the nature of imprisonment. Incarcerated individuals may be victims of abuse, deal with substance abuse, and or have mental health issues. Obviously this is not the case with all prisoners, but it is important that researchers be prepared to deal with any circumstances that may arise. Information that you collect could relate to on-going investigations and it may be necessary that you obtain a Certificate of Confidentiality in order to protect a participant’s confidentiality.

Consent

A prisoner is defined as any individual involuntarily confined or detained in a penal institution. Because of the involuntary nature of their confinement, prisoners are more vulnerable to coercion regarding their consent to participate in studies. For this reason, the IRB classifies prisoners as vulnerable participants and requires additional safeguards for consent. These include:

  • Recruitment and selection of participants must be both fair and impartial (unless otherwise justified by the researcher for the design of the study).
  • Recruitment and consent of participants will be conducted by the researcher, not by an employee of the prison system. The underlying principle for this rule is that the prisoners will not be coerced into participating in the study. As you will be working within the prison system, their rules may require alternative procedures. We recommend that you contact the prison before you submit your protocol and discuss with them any rules or regulations regarding conducting research, particularly any hurdles to the consent process. Please provide a recruitment plan and consent procedure that encourages voluntary participation, making sure that prison leaders do not endorse participation by prisoners. In your protocol, please make the Board aware of any requirements made by the prison system on the implementation of your study, so that the Board can adequately assess this information in their review. 
  • The consent form and consent session must be presented in language that is understandable to the participants
  • 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 during the consent process that participation in the research will have no effect on his or her parole (please include this information in the “benefits” section and “confidentiality” section).
  • Payment or advantages gained from participation will not be such that it encourages the prisoners to do something that they would not normally do. Remember that payment in a prison environment can have a much greater effect than identical payments to a non-prison population. Prison policies can help determine an appropriate payment amount.

As prisoners are in an involuntary state, it is important to make the consent process as voluntary as possible. For example, prisoners should be recruited and consented by the researcher and not by prison employees. The headers below are template text that can be used in addition to the text provided in the General Consent Template. Please modify this text so that it is appropriate for your study.

Confidentiality
Your information will not be shared with the parole board or with any prison employee.
(Please note that if you are using a Certificate of Confidentiality, there is additional text to be included in this section of the consent; please see the Certificate of Confidentiality section for more information.)

Voluntary Participation
Your information will not be shared with the parole board or the prison staff. Your participation will be kept private and will not affect your parole review. 

Right to Withdraw
If you decide to withdraw from the study, this information will not be shared with the parole board or with the prison staff.