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Ethical and Regulatory Concerns Regarding Potential Research Participants Who Are Justice Involved, But Not Incarcerated: Application of 45 CFR 46 Subpart C in the Healthy Brain and Child Development Study.

The article focuses on the ethical and regulatory challenges of including justice-involved pregnant women, particularly those under court-ordered supervision but not incarcerated, in the HEALthy Brain and Child Development (HBCD) study. It examines the application of US federal regulations under 45...

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Published in:American Journal of Bioethics Vol. 26; no. 4; pp. 87 - 90
Main Authors: Cohen, Abagail D, Dawson, Liza, Johnson, Liza-Marie
Format: Journal Article
Published: Taylor & Francis Ltd Apr2026
Online Access:View this record in EBSCOhost
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      dt: Apr2026
      vid: 26
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      pub: Taylor & Francis Ltd
      place: Philadelphia, Pennsylvania
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        10.1080/15265161.2026.2637083
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        atl: Ethical and Regulatory Concerns Regarding Potential Research Participants Who Are Justice Involved, But Not Incarcerated: Application of 45 CFR 46 Subpart C in the Healthy Brain and Child Development Study.
      aug:
        au:
          Cohen, Abagail D
          Dawson, Liza
          Johnson, Liza-Marie
        affil: St Jude Children's Research Hospital
      sug:
        subj:
          Protection of Human Subjects Legislation and Jurisprudence
          Research Subjects Legislation and Jurisprudence
          Research Ethics
          Prisoners
          United States
          Special Populations
          Child Development
          Substance Use Disorders In Pregnancy
          Pregnancy
          Female
          Research Personnel
          Female
      ab: The article focuses on the ethical and regulatory challenges of including justice-involved pregnant women, particularly those under court-ordered supervision but not incarcerated, in the HEALthy Brain and Child Development (HBCD) study. It examines the application of US federal regulations under 45 CFR 46 Subpart C, which provides additional protections for prisoners and similarly vulnerable populations, to participants who may be classified as "prisoners" despite not being in penal institutions. Commentaries emphasize the importance of including these women to address their and their children’s health needs while balancing protections against coercion and stigma, and recommend nuanced, context-sensitive approaches that respect participants’ perspectives and avoid exclusion. The discussion highlights tensions between protecting vulnerable groups and ensuring their representation in research critical to public health.
      pubtype: Academic Journal
      doctype: Journal Article
      ougenre: Article
    language: English
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