Clinical trialObsCompleted
Understanding Genetic Incidental Findings in Your Family (UNIFY Study)
Genomic Incidental Findings Disclosure (GIFD) in a Cancer Biobank: An Ethical, Legal and Social Implications (ELSI) Experiment (Protocol for Aim 3 Intervention)
- Outcome
- Finished, no results posted
- Phase
- Obs
- Status
- Completed
- Study type
- Observational
- Start
- August 2015
- Expected end
- 4 November 2019
- Enrollment
- 12 participants
- Sites
- 1
- Primary outcomes
- Uptake of disclosure invitation
- Sponsor
- Other
- Results posted
- No
- Last update
- 6 June 2023
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Brief summary public domain (ClinicalTrials.gov)
Currently, there is no clear legal or ethical guidance about how researchers and IRBs ought to proceed when the research participant in a biobank is deceased and there is clinically relevant information that could be disclosed to family members. This study is designed to test a procedure offering genetic information to family members of research participants who participated in a pancreatic cancer biobank in a Health Insurance Portability and Accountability Act (HIPAA) -compliant design.
Detailed description public domain (ClinicalTrials.gov)
To develop, prototype, and evaluate a novel procedure for offering probands' genetic results to family members. The intervention is to offer a deceased research participant's actionable germline genetic research finding, and depending upon the choice made by the next of kin, a disclosure of the research finding by a genetic counselor in a family conference call. Using mixed methods (quantitative and qualitative), the investigators will assess decision making, family communication, and actions and responses in individuals from families in which a proband is known to have a deleterious germline mutation in one of several known cancer susceptibility genes.