IRB Manual
      7.5 Research Involving Prisoners*
   


*NOTE: Persons who are involuntarily retained under Sections 9.27 or 9.33 of the Mental Hygiene Law are not "prisoners" for the purpose of applying federal research regulations (45 CFR 46 Subpart C). This includes individuals who are involuntarily retained upon their release from incarceration in a correctional facility or who are converted to a civil status after being held pursuant to a final order of observation issued pursuant to CPL 730.40 or 730.50. IRB's should treat these patients as being a vulnerable population and ensure that appropriate safeguards are employed to ensure protection of their rights and welfare. If an involuntary patient is enrolled in a research protocol, and the patient's hospitalization is extended for research purposes, the patient must be converted to voluntary status.

Federal regulations define a "prisoner" as "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."

This definition includes, but is not limited to, the following:

   
  1. Section 517 of the Executive Law - minors transferred from Division for Youth for treatment (includes Juvenile Offenders Act).

  2. CPL 730.40 and CPL 730.50 - persons who are incapable of assisting in their own defense, except those who have been converted to a civil status after a final order of observation under CPL 730.40 or 730.50 has been issued.

  3. CPL 330.20 - not guilty by reason of insanity. Inpatients only. (Outpatients who are on CPL 330.20 status may be enrolled in research without being subject to the additional requirements for research involving prisoners.)

  4. Section 508 of the Corrections Law - County Jail Prisoners who are in need of inpatient treatment.

  5. Section 402 of the Corrections Law - sentenced persons who are in need of treatment.

  6. Family Court Act Sections 251, 322.1 and 322.2.

    IRBs which review research involving prisoners must fulfill the following requirements:

   
  1. A majority of the IRB (exclusive of prisoner members) must have no association with the prison(s) involved apart from membership on the IRB;

  2. At least one member of the IRB must be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity, except that where a particular research project is reviewed by more than one IRB, only one IRB need satisfy this requirement.

    The IRB must ensure that:

   
  1. The research involves:
    1. 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; or

    2. A 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 subjects; or

    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) provided that the study may proceed only after the Secretary (DHHS) has 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. In cases in which those studies require the assignment of prisoners to control groups which may not benefit from the research, the study may proceed only after the Secretary (DHHS) has published notice of his intent to approve such research in the Federal Register.


  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, 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-prison volunteers.

  4. Procedures for the selection of subjects within the prison are fair to all prisoners and are immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides justification (in writing) to the IRB 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.

  5. The information is presented in 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. 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.

   
IIn addition, IRBs should ensure that the investigator has obtained the approval of the appropriate prison officials before the study commences.
     
   


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