Use of Public Deliberation in Diverse Communities to Improve Consent Processes for Clinical Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Acceptability of parental permission in consent for HIV biomedical prevention research.
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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
结局指标
主要结局
Acceptability of parental permission in consent for HIV biomedical prevention research.
时间窗: Duration of public deliberation (2-4 weeks)
One of three items adapted from a previous study (see citation), and are scored separately on a 1-5 scale with 5 being the most acceptable: Imagine a teen wants to join a biomedical HIV prevention study like the one you just read about. The teen asks their parent/guardian to come to the research clinic with them. The parent/guardian is given information about the study, and has the opportunity to ask any questions they want to ask. After the parent's questions are answered, they are asked whether or not they give permission for their teen to join the study. In this approach to consent, the parent/guardian has the final say about whether the teen can join the study. How acceptable is this approach to research consent? 1. Completely unacceptable 2. Somewhat unacceptable 3. Neither unacceptable nor acceptable 4. Somewhat acceptable 5. Completely acceptable
Acceptability of minor self-consent for HIV biomedical prevention research.
时间窗: Duration of public deliberation (2-4 weeks)
One of three items adapted from a previous study (see citation), and scored separately on a 1-5 scale with 5 being the most acceptable: Imagine again that a teen wants to join a biomedical HIV prevention study like the one you just read about. The teen comes to the research clinic on their own. They read the consent form, and have an opportunity to ask questions. Once their questions are answered, the teen is ready to consent to the study. They are allowed to sign the consent form and join the study without speaking to anyone else about the decision. In this approach to consent, the teen is allowed to make the decision about joining the research study on their own. How acceptable is this approach to research consent? 1. Completely unacceptable 2. Somewhat unacceptable 3. Neither unacceptable nor acceptable 4. Somewhat acceptable 5. Completely acceptable
Acceptability of ombudsman for consent for HIV biomedical prevention research.
时间窗: Duration of public deliberation (2-4 weeks)
Third item, scored 1-5, with 5 most acceptable. Imagine a teen wants to join a biomedical HIV prevention study like the one you just read about. The teen comes to the research clinic on their own. They read the consent form, and have an opportunity to ask questions. The teen is required to have an adult's permission to sign up for the study. They can choose to ask either their parent or a neutral adult, called an "ombudsman." The ombudsman is not in charge of the study; the ombudsman's job is to ensure the teen understands the research study, and to help them think about the risks and benefits of joining the study. The teen would need either their parents' permission OR the ombudsman's permission to join the study. In this approach to consent, the teen must have an adult's permission to join the study; the teen would be able to choose whether to seek permission from their parent or the ombudsman. How acceptable is this approach to research consent? (Same 5 responses as above)
次要结局
- Quality of public deliberation(Duration of public deliberation (2-4 weeks))
研究者
Amelia Knopf
Associate Professor
Indiana University