Ethical, Legal, and Social Issues Substudy in Relation to the GTEx Project
ELSI
1 other identifier
interventional
512
1 country
1
Brief Summary
The Ethical, Legal and Social Issues Substudy in relation to the Genotype Tissue Expression Project (GTEx) aims to describe tissue requesters' approach to discussions about donation to GTEx and to assess the determinants of families' and patients' willingness to donate to GTEx. It also explores ethical issues such as privacy, risks, and release of incidental findings and recommend best practices for conducting authorizations and training requesters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 2, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 30, 2021
March 1, 2021
3.4 years
December 17, 2015
March 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of family members who chose to donate to GTEx
Number of family decision makers who choose to donate to GTEx
Up to 8 months after donation request
Secondary Outcomes (1)
Knowledge and Comprehension of Elements of Consent
Up to 8 months after donation request
Study Arms (2)
Intervention Group
EXPERIMENTALTissue requesters from participating OPOs are randomly assigned to complete additional informed consent training through an interactive online training website.
Control Group
EXPERIMENTALThe control group of tissue requesters receive the standard training offered by their OPO and GTEx partners.
Interventions
Eligibility Criteria
You may qualify if:
- Participants must either be a:
- family decision maker approached to donate their loved one's tissues to the GTEx project or
- a staff person at an OPO that approaches family decision makers for the GTEx project.
You may not qualify if:
- \. Persons who neither approached for GTEx or were approached are excluded from participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Temple Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
Related Publications (1)
GTEx Consortium. The Genotype-Tissue Expression (GTEx) project. Nat Genet. 2013 Jun;45(6):580-5. doi: 10.1038/ng.2653.
PMID: 23715323BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Siminoff, PhD
Temple University
- PRINCIPAL INVESTIGATOR
Heather Traino, PhD
Temple University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dean, College of Health Professions and Social Work
Study Record Dates
First Submitted
December 17, 2015
First Posted
September 2, 2016
Study Start
March 1, 2013
Primary Completion
August 1, 2016
Study Completion
December 1, 2017
Last Updated
March 30, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share