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临床试验/NCT02205749
NCT02205749已完成不适用

Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2013年1月最近更新:
适应症
干预措施

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

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

Other

• 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

Other

• 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

Other

• 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

Other

• 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

Other

• 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

Other

• 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

Other

• 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

Other

• 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

Other

• 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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