Overview

This trial is active, not recruiting.

Condition biospecimen donation
Treatments study-specific consent model, broad consent model, notice consent model
Sponsor Washington University School of Medicine
Collaborator National Cancer Institute (NCI)
Start date January 2013
End date August 2015
Trial size 454 participants
Trial identifier NCT02205749, 3U54CA153460-03S1, PAS-12-169

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking open label
Arm
(Other)
• Review plain language brochure describing consent to a biobank based on the study-specific model of consent
study-specific consent model
• Review plain language brochure describing consent to a biobank based on the study-specific model of consent
broad consent model
• Review plain language brochure describing consent to a biobank based on the broad model of consent
notice consent model
• Review plain language brochure describing consent to a biobank based on the notice model of consent
(Other)
• Review plain language brochure describing consent to a biobank based on the broad model of consent
study-specific consent model
• Review plain language brochure describing consent to a biobank based on the study-specific model of consent
broad consent model
• Review plain language brochure describing consent to a biobank based on the broad model of consent
notice consent model
• Review plain language brochure describing consent to a biobank based on the notice model of consent
(Other)
• Review plain language brochure describing consent to a biobank based on the notice model of consent
study-specific consent model
• Review plain language brochure describing consent to a biobank based on the study-specific model of consent
broad consent model
• Review plain language brochure describing consent to a biobank based on the broad model of consent
notice consent model
• Review plain language brochure describing consent to a biobank based on the notice model of consent

Primary Outcomes

Measure
Intent to Donate
time frame: Immediate

Secondary Outcomes

Measure
Consent Model Preference
time frame: Immediate

Eligibility Criteria

Female participants at least 35 years old.

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

Additional Information

Official title Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women
Principal investigator Kimberly A Kaphingst, ScD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.