Prisoners may not be used to conduct research that only benefits the larger society

1. Policies & Procedures

The University of Pittsburgh IRB adheres to the regulatory requirements for research which involves a prisoner as outlined in 45 CFR 46 Subpart C.

Definitions

Prisoner - A prisoner is defined as “an individual involuntarily confined or detained in a penal institution” and encompasses individuals sentenced to such an institution under criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

Prisoner Representative - An individual who is currently or formerly a prisoner or an individual who has a close working knowledge, understanding and appreciation of prison conditions from the perspective of the prisoner (e.g., prison chaplain, prison social worker, prison health care worker.)

Minimal Risk - For research involving prisoners, the IRB will use the following definition for "minimal risk": "Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons (emphasis added)."

Regulatory Requirements

Research involving prisoners that is federally funded or which is conducted in a federal prison will be reviewed by a convened IRB committee which includes at least one member who is a prisoner or a prisoner representative with appropriate background and experience to serve in that capacity.  All other studies involving prisoners will include a prisoner representative as a consultant. This includes initial review, continuing review, full-board modifications, and reportable unexpected or unanticipated problems.

• Modifications that would otherwise be approvable by expedited review can be expedited (with the exception of DoD funded studies) as long as the prisoner representative receives a copy of the modification and concurs that it does not adversely affect the prisoners.

The IRB will approve the research only if it finds and documents that:

1. the research meets one of the regulatory criteria for approval addressed under 45 CFR 46.306 (a)(2); that is the research is a 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;
   • 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;
   • 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 Secretary has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the FEDERAL REGISTER, of his intent to approve such research; or
   • practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the 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.
      
2. any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, and quality of food, amenities and opportunity for earnings in the prison, are not of such 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;
    
3. the risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers;
    
4. 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 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 research project;
    
5. the information is presented in a language which is understandable to the subject population;
    
6. 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 or her parole;
    
7. 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.

Note: An IRB finding that follow-up examination or care of the prisoner-subjects may be needed after the end of their study participation will necessitate a change in the standard Compensation for Injury section of the informed consent document. The change will need to address the provision of long-term care for this subject population and must be prior approved by legal counsel to the IRB.

If a study utilizing prisoners as research participants is federally funded, the HRP Director or designee will follow the process to submit the electronic certification to the Office for Human Research Protections (OHRP) indicating it has approved a study that will include prisoners, the category the study fits into as well as how the study satisfies the six criteria noted under the regulations. A research study is not permitted to commence for DHHS supported research until written approval is received from OHRP on behalf of the DHHS Secretary under the provisions of 45 CFR 46.306(a)(2).

If a participant becomes a prisoner while enrolled in a research study that was not reviewed according to Subpart C, the IRB will:

1. Confirm that the participant meets the definition of a prisoner.
2. Terminate enrollment or review the research study under Subpart C if it feasible for the participant to remain in the study.
3. Before terminating the enrollment of the incarcerated participant, the risks associated with terminating participation in the study will be considered.
4. If the participant cannot be terminated for health or safety reasons, the participant can either:
   • remain enrolled in the study and a Subpart C review will take place. If some the requirements of Subpart C cannot be met, but it is in the best interests of the participant to remain in the study, keep the participant enrolled and inform OHRP of the decision along with the justification.
   • be removed from the study and kept on the study intervention under an alternate mechanism such as compassionate use, off label use, etc.

Research Conducted in Pennsylvania State Department of Corrections

In Pennsylvania, the Department of Corrections has issued Policy Statement 2.1.2 which effectively bans the use of state prisoners in any medical experiments, cosmetic experiments, or pharmaceutical testing, with the exception for some testing involving treatment for AIDS and HIV infection. If a study utilizes prisoners from a state prison in Pennsylvania, approval from the Research Review Committee of the Commonwealth of Pennsylvania, Department of Corrections is required.

Research Conducted in the Federal Bureau of Prisons

The Federal Bureau of Prisons has adopted extensive regulations for researchers seeking to use federal prisoners as research subjects. Among other things, these regulations prohibit use of prisoners within federal facilities for “medical experimentation, cosmetic research, or pharmaceutical testing.” 28 C.F.R. 512.11(a)(3). In addition, strict limitations are imposed on incentives to prisoner/participants, and researchers may not promise confidentiality to subjects who reveal a future intent to engage in criminal behavior. For additional requirements related to the Department of Justice regulations, see Chapter 26.