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Resources :: Guide :: Vulnerable and risk sensitive participants :: Vulnerable participants :: Prisoners in research studies :: 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.

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.

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