Clinical trial NCT02205749: Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women
Official title: Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biospecimen Donation
Keywords: biobanks
informed consent
health literacy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-07-31
Enrollment: 302
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Intent to Donate
timeFrame: Immediate
Secondary outcomes:
measure: Consent Model Preference
timeFrame: Immediate
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
Study officials:
affiliation: The University of Utah
name: Kimberly A Kaphingst, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Bettina Drake, PhD
role: PRINCIPAL_INVESTIGATOR
References: