Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women

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.

Study Overview

• Status: Completed
• Conditions: Biospecimen Donation
• Intervention / Treatment: Behavioral: Study-specific consent model; Behavioral: Broad consent model; Behavioral: Notice consent model

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kimberly A Kaphingst, ScD, The University of Utah; Principal Investigator: Bettina Drake, PhD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): July 31, 2014

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: health literacy; informed consent; biobanks
• Other Study ID Numbers: 201208079; 3U54CA153460-03S1 (U.S. NIH Grant/Contract)