Biospecimen DonationNCT02205749
Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women
A study testing Study-specific consent model, Broad consent model and Notice consent model in people with Biospecimen Donation, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Biospecimen Donation
- What is being tested?
- Study-specific consent model, Broad consent model and Notice consent model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
About this study
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
- Being tested
- Study-specific consent model, Broad consent model, Notice consent model
- Keywords
- biobanks, informed consent, health literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study-specific consent modelBehavioural
- Review plain language brochure describing consent to a biobank based on the study-specific model of consent
Broad consent modelBehavioural
- Review plain language brochure describing consent to a biobank based on the broad model of consent
Notice consent modelBehavioural
- Review plain language brochure describing consent to a biobank based on the notice model of consent
| Study group | Role | What they receive |
|---|---|---|
| Study-specific consent model | Other | • Review plain language brochure describing consent to a biobank based on the study-specific model of consent Receives: Behavioral: Study-specific consent model; Behavioral: Broad consent model; Behavioral: Notice consent model |
| Broad consent model | Other | • Review plain language brochure describing consent to a biobank based on the broad model of consent Receives: Behavioral: Study-specific consent model; Behavioral: Broad consent model; Behavioral: Notice consent model |
| Notice consent model | Other | • Review plain language brochure describing consent to a biobank based on the notice model of consent Receives: Behavioral: Study-specific consent model; Behavioral: Broad consent model; Behavioral: Notice consent model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intent to Donate
Intention to donate to a biobank.
Measured: Immediate
Secondary outcomes (1)
Consent Model Preference
Preferred type of consent for secondary use of biospecimens.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biospecimen DonationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kimberly A Kaphingst, ScD, Principal investigator, The University of UtahBettina Drake, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205749
- Sponsor's protocol ID
- 201208079
- Other IDs
- 3U54CA153460-03S1
- Status last verified
- May 2018
- First submitted
- 29 Jul 2014
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women
- ClinicalTrials.gov ID
- NCT02205749
- Acronym / sponsor ID
- 201208079
- Conditions
- Biospecimen Donation
- Keywords
- biobanks, informed consent, health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study-specific consent model | Other | Behavioral: Study-specific consent model, Behavioral: Broad consent model, Behavioral: Notice consent model• Review plain language brochure describing consent to a biobank based on the study-specific model of consent |
| Broad consent model | Other | Behavioral: Study-specific consent model, Behavioral: Broad consent model, Behavioral: Notice consent model• Review plain language brochure describing consent to a biobank based on the broad model of consent |
| Notice consent model | Other | Behavioral: Study-specific consent model, Behavioral: Broad consent model, Behavioral: Notice consent model• Review plain language brochure describing consent to a biobank based on the notice model of consent |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 35 years old or older
- Proficient in English
- Identifies as Non-Hispanic
- Identifies as African-American or Black
- Identifies as Caucasian or White
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study-specific consent model• Review plain language brochure describing consent to a biobank based on the study-specific model of consent | Behavioural | Broad consent model, Notice consent model, Study-specific consent model |
| Broad consent model• Review plain language brochure describing consent to a biobank based on the broad model of consent | Behavioural | Broad consent model, Notice consent model, Study-specific consent model |
| Notice consent model• Review plain language brochure describing consent to a biobank based on the notice model of consent | Behavioural | Broad consent model, Notice consent model, Study-specific consent model |
Primary outcome
Intent to Donate
Time frame: Immediate
Intention to donate to a biobank.
1 secondary outcome
Consent Model Preference
Time frame: Immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
Related trials for Biospecimen Donation
Enrolling by invitationObservational study
Blood Donation Study for ALPCO Syphilis-T and Syphilis-NT Assay Development
Healthy Volunteers, Syphilis Serologic Assay Development
RecruitingObservational study
Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers
Anal Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm
RecruitingObservational study
University of Central Florida BEEAST
Biospecimen Donation, Environmental Impact
RecruitingObservational study
University of Central Florida CereBank
Biospecimen Donation, Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly A Kaphingst, ScD principal investigator
The University of Utah
Bettina Drake, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study-specific consent model, Broad consent model and Notice consent model in people with Biospecimen Donation, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intent to Donate (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.