Understanding Genetic Incidental Findings in Your Family (UNIFY Study)
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Conditions
Details and patient eligibility
About
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.
Full description
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.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Family members and others authorized to receive health information of participants enrolled under Institutional Review Board (IRB) #354-06 and #355-06 who carry one of several known cancer susceptibility genes.
- Mentally competent and able to provide informed consent
- Able to understand and read English
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Data sourced from clinicaltrials.gov
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