Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women

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.

Conditions

• Biospecimen Donation

Interventions

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Kimberly A Kaphingst, ScD · The University of Utah

• Bettina Drake, PhD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2015-08-31

Completion

2015-08-31

Countries

• United States

Study Locations