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  • 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 (45 CFR 46.303(c)).
  • OHRP's Prisoner Research FAQs explain that individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons or may be untried persons who are detained pending judicial action, for example, arraignment or trial.
  • OHRP's Prisoner Research FAQs provide common examples of the application of the regulatory definition of prisoner:
    • Individuals who are detained in a residential facility for court-ordered substance abuse treatment as a form of sentencing or alternative to incarceration are prisoners; however, individuals who are receiving non-residential court-ordered substance abuse treatment and are residing in the community are not prisoners.
    • Individuals with psychiatric illnesses who have been committed involuntarily to an institution as an alternative to a criminal prosecution or incarceration are prisoners; however, individuals who have been voluntarily admitted to an institution for treatment of a psychiatric illness, or who have been civilly committed to nonpenal institutions for treatment because their illness makes them a danger to themselves or others, are not prisoners.
    • Parolees who are detained in a treatment center as a condition of parole are prisoners; however, persons living in the community and sentenced to community-supervised monitoring, including parolees, are not prisoners.
    • Probationers and individuals wearing monitoring devices are generally not considered to be prisoners; however, situations of this kind frequently require an analysis of the particular circumstances of the planned subject population. Institutions may consult with OHRP when questions arise about research involving these populations.

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  • If a subject becomes incarcerated and the IRB and OHRP have not previously approved prisoner participation on your research protocol, you must notify IRBO as soon as possible by submitting a Reportable New Information form in the eIRB system.
  • All research interactions, interventions with, and obtaining identifiable private information about the now-incarcerated prisoner-subject, must be halted until IRB and OHRP approval is are obtained.
  • If it is in the best interest of the subject to remain on study while incarcerated, you must promptly notify IRBO and obtain permission from the IRB Chair to continue activities needed to ensure the safety and welfare of the now prisoner-subject until IRB and OHRP approval is are obtained.
    • Submit a modification in the NIH electronic IRB system for review by the convened IRB requesting permission for the prisoner-subject to remain on study and include any additional safeguards and changes to procedures (if any) needed for the now-prisoner-subject to remain on the research.
  • No research activities involving the prisoner-subject may take place prior to IRB approval and receipt of a letter of authorization from OHRP, except for those necessary for the welfare or safety of the prisoner-subject.
  • If the IRB disapproves continued participation of the prisoner-subject, the subject must be taken off study.
  • For additional information, refer toOHRP Guidance–Prisoner Involvement in Research (May 23, 2003).

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  • Research involving children may not begin prior to the IRB approval of your research protocol.
  • Children cannot provide legally effective informed consent for participation in research.
  • No child may be enrolled, screened, or have research procedures initiated, unless parental permission and child assent is obtained unless waived by the IRB.
  • Provide a plan in your protocol for obtaining parental permission as well as assent from the child, or you must provide a justification for requesting a waiver of parental permission and/or assent.
  • For research taking place at an NIH site, when parents share joint legal custody for medical decision-making of a child (e.g., by a custody agreement or court order), both parents must give their permission regardless of the risk level of the research. Exceptions may include if one parent has since died, become incompetent, or is not reasonably available.
  • See NIH Policy 402, Research Involving Children.

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  • The human subjects research regulations define children as persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted (45 CFR 46.402(a)).
  • The OHRP Research with Children FAQs further note that in the United States laws regarding who is legally considered a child may vary from state to state; in a large majority of states eighteen years of age is the legal age of adulthood, but this is not true in every state, locality, or territory. Also, there may be exceptions to who is considered a child and additional laws may be in places place that define emancipated minors.
  • The definition of children also takes into account the particular treatments or procedures involved in the proposed research; for example, in some places individuals who are sixteen years of age may legally consent to certain medical treatments, and so if the involvement of human subjects in a proposed research activity consists of these treatments, then they may be considered as adults for that purpose. If a proposed activity includes something for which the subject has not yet reached the legal age of consent, however, that person must be considered a child.

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  • For research that offers the prospect of direct benefit to the subject (e.g., studies of potential therapeutic intervention for a condition from which the subject suffers), you are not required to obtain IRB approval for enrollment of NIH staff or the immediate family members of the study team.
  • The NIH staff member must still be provided with the FAQs for Staff who are Considering Participation in NIH Research when the research offers no prospect of direct benefit and NIH staff, or immediate family of a study team member wants to participate. In this case, the IRB must approve inclusion of this population prior to enrollment, and the protocol must describe:
    • Whether staff or family members will be included in the research
    • The safeguards for this subject population (e.g., recruitment methods, consent monitoring, eligibility assessment)
    • Recruitment plan, including:
      • Solicitation of subordinates should not be direct, either orally or through individual mailings or email distribution.
      • Recruitment materials may be displayed only where public announcements are permitted.
  • Prior to enrollment the NIH investigator must request NIH staff member to review the Leave Policy for NIH Employees Participating in NIH Medical Research Studies (NIH Policy Manual 2300-630-3). NIH login required
  • If investigators at an NIH site will enroll NIH staff members on a protocol that is being reviewed by an external non-NIH IRB, information about NIH Policy 404, Research Involving NIH Staff as Subjects, will be included as local context information that is provided to that IRB.

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