Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women

Not Applicable

Completed

• Conditions: Biospecimen Donation
• Interventions: Behavioral: Study-specific consent model; Behavioral: Broad consent model; Behavioral: Notice consent model

• Registration Number: NCT02205749
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 302

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study-specific consent model	Broad consent model	• Review plain language brochure describing consent to a biobank based on the study-specific model of consent
Notice consent model	Study-specific consent model	• Review plain language brochure describing consent to a biobank based on the notice model of consent
Broad consent model	Study-specific consent model	• Review plain language brochure describing consent to a biobank based on the broad model of consent
Broad consent model	Notice consent model	• Review plain language brochure describing consent to a biobank based on the broad model of consent
Notice consent model	Broad consent model	• Review plain language brochure describing consent to a biobank based on the notice model of consent
Broad consent model	Broad consent model	• Review plain language brochure describing consent to a biobank based on the broad model of consent
Study-specific consent model	Study-specific consent model	• Review plain language brochure describing consent to a biobank based on the study-specific model of consent
Study-specific consent model	Notice consent model	• Review plain language brochure describing consent to a biobank based on the study-specific model of consent
Notice consent model	Notice consent model	• Review plain language brochure describing consent to a biobank based on the notice model of consent

Primary Outcome Measures

Name	Time	Method
Intent to Donate	Immediate	Intention to donate to a biobank.

Secondary Outcome Measures

Name	Time	Method
Consent Model Preference	Immediate	Preferred type of consent for secondary use of biospecimens.

Trial Locations

Locations (1)

Washington University School of Medicine in St. Louis; 🇺🇸 Saint Louis, Missouri, United States