Community Solutions to Adolescent Research Consent - Minor Consent for Biomedical HIV Research — C-START  

Hiv Clinical Trial

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

Status Enrolling by invitation

Clinical Trial Summary

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 vulnerable populations 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 participation in public deliberation will change participant's acceptability of different models of minor consent.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Hiv
• Informed Consent

• NCT number: NCT05371327
• Study type: Observational
• Source: Indiana University
• Status: Enrolling by invitation
• Start date: April 8, 2021
• Completion date: June 30, 2024