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Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women

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The Washington University

Status

Completed

Conditions

Biospecimen Donation

Treatments

Behavioral: Notice consent model
Behavioral: Broad consent model
Behavioral: Study-specific consent model

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02205749
3U54CA153460-03S1 (U.S. NIH Grant/Contract)
201208079

Details and patient eligibility

About

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.

Enrollment

302 patients

Sex

Female

Ages

35+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

302 participants in 3 patient groups

Study-specific consent model
Other group
Description:
• Review plain language brochure describing consent to a biobank based on the study-specific model of consent
Treatment:
Behavioral: Study-specific consent model
Behavioral: Notice consent model
Behavioral: Broad consent model
Broad consent model
Other group
Description:
• Review plain language brochure describing consent to a biobank based on the broad model of consent
Treatment:
Behavioral: Study-specific consent model
Behavioral: Notice consent model
Behavioral: Broad consent model
Notice consent model
Other group
Description:
• Review plain language brochure describing consent to a biobank based on the notice model of consent
Treatment:
Behavioral: Study-specific consent model
Behavioral: Notice consent model
Behavioral: Broad consent model

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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