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NCT05371327Befejeződött

Community Solutions to Adolescent Research Consent - Minor Consent for Biomedical HIV Research

Use of Public Deliberation in Diverse Communities to Improve Consent Processes for Clinical Research

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. nov. 21.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

Public deliberation is a novel method for engaging the public in collective decision-making. Its goal is to facilitate debate and discussion that: 1) fosters the formation of reasonable and informed opinions, 2) permits participants to revise their perspectives and positions in light of new information and dialogue with others, and 3) encourages participants to consider not only their own preferences but also the greater goal of a policy or resolution that is justifiable for all persons affected by the issue under debate. Public deliberation involves: in-depth education on the topic of interest, presentation of conflicting perspectives from expert witnesses and key stakeholders, facilitated public discussion of core issues, and development of resolutions that are acceptable to participants. Public deliberation requires significant commitment from deliberants who are actively engaged over the course of several sessions. Public deliberation can be successful when more traditional methods of stakeholder engagement fail, as it allows for in-depth discussion and demonstrated awareness of the moral difference in deciding for oneself and others. Minor consent to biomedical HIV prevention research highlights difficulties with consent, particularly for minors, and how key ethical principles may come into conflict. Typically, institutions and investigators rely upon parental permission to protect minors from research-related harm and coercion. However, the parent permission model may be harmful in stigmatizing health research such as HIV. The consent process creates potential for disclosure of the minor's sensitive behaviors and/or identities to their parents who were otherwise unaware of them. This risk is heightened for sexual and gender minority adolescents, who may face physical and social harm when their sexual or gender identities are disclosed. This risk of harm, and the ethical conflict it creates has contributed to delays in clinical trials and clinical use of HIV prevention methods in minors. This project will test public deliberation as a method for improving consent processes for engaging individuals from marginalized communities in clinical research on sensitive or stigmatizing health problems. The investigators use minor consent for biomedical HIV prevention research as an exemplar case. The primary hypothesis is that public deliberation will produce a resolution to ethical conflicts in minor consent that is better or different from the results of more traditional study approaches (e.g. surveys, in depth interviews).

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Megfigyeléses
Résztvevők száma
128 (tényleges)
Első benyújtás
2022. márc. 29.
Kezdés
2021. ápr. 8.
Elsődleges befejezés
2025. aug. 13.
Fő szponzor
Indiana University
Betegségek
HIV-fertőzés
NCT-szám
NCT05371327

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Bevont résztvevők: 128
  • 2021. ápr. 8. és az elsődleges befejezés (2025. aug. 13.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Egyéb

  • Those who are obviously inebriated or high at the time of screening, the deliberation event, or the pre-/post-event interviews;
  • Those who reside in a home with another eligible participant

Kiket keres a vizsgálat

  • Complete the screening survey;
  • Be at least 14 years of age;
  • Speak and understand English; and,
  • Be able to commit to attend all virtual deliberation sessions in their entirety.
  • Be one of the following:
    • 14-21years old
    • Have an adolescent who lives with you
    • Closely involved with an adolescent on a regular basis (e.g. grandparent, adult sibling)
    • Work for an organization or program that is invested in the wellbeing of adolescents in your community (e.g. social worker, high school teacher, nonprofit work)
    • Part of an organization or program that is invested in the wellbeing of adolescents in your community (e.g. mentor, volunteer, church youth group)

Életkor a regiszterben: 14 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Indiana University School of Medicine and School of NursingIndianapolisEgyesült ÁllamokIsmeretlen állapot

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