Federal regulations identify prisoners as vulnerable subjects in need of additional safeguards.

Prisoners may only be used for research that is material to their lives as prisoners. They may not be used as a convenient population for experimentation. The campus IRB includes an advocate for prisoners as required by federal regulations.

If a research subject becomes a prisoner during the course of a study, all the special protections and review procedures apply.

Required Training for Investigators Using Prisoners As Subjects

An investigator at Duke wishes to study a prison population or who has en enrolled subject become a prisoner, will be asked to complete the on-line tutorial on research with prisoners, available in July of 2003. Instructions for accessing the tutorial will be available at that time.

Background

In the not-to-distant past, prisoners have provided a readily available and easy to manipulate population for researchers. Prisoners have suffered egregious physical and psychological abuses in experiments that held no promise of treatment. For example, prisoners’ testicles were irradiated in experiments conducted by the Atomic Energy Commission. Prisoners have been used in lieu of animals to test cosmetic products.

Defining a Prisoner

"Prisoner" means 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 which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

Review Procedures

Please consult the IRB staff well in advance of the date you hope to begin research so they can guide you through the process. Proposed research in state facilities in North Carolina must be reviewed by the Department of Correction or the Department of Juvenile Justice in addition to the IRB. Research funded by any of the National Institutes of Health must also receive approval from DHHS.

Categories of Permissible Research

The first two categories are those most likely to be used by social and behavioral scientists.

1. 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;
   
2. 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;
   
3. 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). For research funded by NIH, "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
   
4. research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well being of the subject. For NIH funded researcher, "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."

In addition to applying the standard protocol review criteria, if a study is funded by NIH the IRB must also find and certify to OPRR that six additional protections specific to prisoners have been satisfied.

1. any possible advantages accruing to the prisoner through his or 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;
   
2. the risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers;
   
3. 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 Board 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;
   
4. the information is presented in language that is understandable to the subject population;
   
5. 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; and
   
6. where the Board finds there may be a need for follow-up examination or care of participants 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 participants of this fact.

Additional Review by the North Carolina Department of Correction

When potential subjects are inmates in the statewide prison system, the protocol must be reviewed by the IRB for the NC Department of Correction (DOC). This IRB is concerned with both the protection of human subjects and with administrative issues. In the planning stages of developing a protocol for research in a state facility, investigators are advised to have a contact within that facility in order to discuss and resolve administrative problems in advance. The DOC will put investigators in touch with the appropriate contacts.

While members of the DOC IRB will pre-review a protocol, the protocol will not be formally reviewed until the Duke IRB has approved it.

Additional Review by the North Carolina Department of Juvenile Justice

If the potential subjects were adjudicated through the juvenile justice system protocols must be reviewed and approved by the NC Department of Juvenile Justice. The Department does not have an IRB, but does have an internal committee that will review protocols, primarily with regard to administrative issues, e.g., feasibility in the proposed facility.

Research in County Facilities

There are no county IRB’s in place to review research taking place in county jails. Furthermore, there is little consistency from county to county with regard to the difficulty of accessing these facilities. Investigators will have to establish their own contacts through county law enforcement operations.