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OpenTrials
Completed

NCT Number: NCT02205749

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.

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Key information

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study-specific consent model

Behavioral
  • Review plain language brochure describing consent to a biobank based on the study-specific model of consent

Broad consent model

Behavioral
  • Review plain language brochure describing consent to a biobank based on the broad model of consent

Notice consent model

Behavioral
  • Review plain language brochure describing consent to a biobank based on the notice model of consent

Primary outcomes

  1. Intent to Donate

    Time frame: Immediate

    Intention to donate to a biobank.

Secondary outcomes

  1. Consent Model Preference

    Time frame: Immediate

    Preferred type of consent for secondary use of biospecimens.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 31, 2014
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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