Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women

Study Overview
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Brief Summary
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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.

Official Title
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Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women

Conditions
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Biospecimen Donation

Intervention / Treatment
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* Behavioral: Study-specific consent model
* Behavioral: Broad consent model
* Behavioral: Notice consent model


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study-specific consent model<br>• Review plain language brochure describing consent to a biobank based on the study-specific model of consent | Behavioral: Study-specific consent model<br>* • Review plain language brochure describing consent to a biobank based on the study-specific model of consent<br>Behavioral: Broad consent model<br>* • Review plain language brochure describing consent to a biobank based on the broad model of consent<br>Behavioral: Notice consent model<br>* • Review plain language brochure describing consent to a biobank based on the notice model of consent<br>|
| Other: Broad consent model<br>• Review plain language brochure describing consent to a biobank based on the broad model of consent | Behavioral: Study-specific consent model<br>* • Review plain language brochure describing consent to a biobank based on the study-specific model of consent<br>Behavioral: Broad consent model<br>* • Review plain language brochure describing consent to a biobank based on the broad model of consent<br>Behavioral: Notice consent model<br>* • Review plain language brochure describing consent to a biobank based on the notice model of consent<br>|
| Other: Notice consent model<br>• Review plain language brochure describing consent to a biobank based on the notice model of consent | Behavioral: Study-specific consent model<br>* • Review plain language brochure describing consent to a biobank based on the study-specific model of consent<br>Behavioral: Broad consent model<br>* • Review plain language brochure describing consent to a biobank based on the broad model of consent<br>Behavioral: Notice consent model<br>* • Review plain language brochure describing consent to a biobank based on the notice model of consent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intent to Donate | Intention to donate to a biobank. | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consent Model Preference | Preferred type of consent for secondary use of biospecimens. | Immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biobanks, informed consent, health literacy