Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 2
- 主要终点
- Intent to Donate
研究概览
简要总结
Research with stored biospecimens can provide substantial societal benefits, including greater understanding of cancer etiology and discovery of new cancer therapies, but one critical social and ethical issue is the use of samples for research unplanned at the time of biospecimen collection. Various models for consent (i.e., no consent, notice, opt-out, broad consent, study-specific consent) have been proposed for secondary research use of biospecimens, but empirical data on individuals' preferences for different consent models are limited, particularly from those with limited health literacy and from racial and ethnic minority groups. It is critically important to understand the consent preferences of diverse individuals, as participation of all population subgroups in biobanks is essential to reach translational cancer research goals. Based on a social ecological conceptual framework, the investigators will examine preferences for consent models for secondary research uses of biospecimens among a racially and socioeconomically diverse sample of women 35 years of age and older. The investigators aim to compare experimentally the effect of consent model on intentions to donate biospecimens for future research use among a diverse sample of women. The investigators hypothesize that women will have stronger intentions to donate based on the broad model of consent and the study-specific model of consent compared with the notice model of consent. These findings from groups underrepresented in research will be critical since the participation of these groups in biobanks is essential to generating findings that will achieve translational research goals of eliminating cancer disparities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •35 years old or older
- •Proficient in English
- •Identifies as Non-Hispanic
- •Identifies as African-American or Black
- •Identifies as Caucasian or White
- •Identifies as Female
排除标准
- •Under 35 years old
- •Not proficient in English
- •Identifies as Hispanic
- •Identifies as a race other than African-American or Black; or Caucasian or White
- •Identifies as more than one race
- •Identifies as Male
研究组 & 干预措施
Study-specific consent model
• Review plain language brochure describing consent to a biobank based on the study-specific model of consent
干预措施: Study-specific consent model (Behavioral)
Study-specific consent model
• Review plain language brochure describing consent to a biobank based on the study-specific model of consent
干预措施: Broad consent model (Behavioral)
Study-specific consent model
• Review plain language brochure describing consent to a biobank based on the study-specific model of consent
干预措施: Notice consent model (Behavioral)
Broad consent model
• Review plain language brochure describing consent to a biobank based on the broad model of consent
干预措施: Study-specific consent model (Behavioral)
Broad consent model
• Review plain language brochure describing consent to a biobank based on the broad model of consent
干预措施: Broad consent model (Behavioral)
Broad consent model
• Review plain language brochure describing consent to a biobank based on the broad model of consent
干预措施: Notice consent model (Behavioral)
Notice consent model
• Review plain language brochure describing consent to a biobank based on the notice model of consent
干预措施: Study-specific consent model (Behavioral)
Notice consent model
• Review plain language brochure describing consent to a biobank based on the notice model of consent
干预措施: Broad consent model (Behavioral)
Notice consent model
• Review plain language brochure describing consent to a biobank based on the notice model of consent
干预措施: Notice consent model (Behavioral)
结局指标
主要结局
Intent to Donate
时间窗: Immediate
Intention to donate to a biobank.
次要结局
- Consent Model Preference(Immediate)
