Understanding Genetic Incidental Findings in Your Family (UNIFY Study)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/9/2019 |
| Start Date: | August 2015 |
| End Date: | November 2019 |
Genomic Incidental Findings Disclosure (GIFD) in a Cancer Biobank: An Ethical, Legal and Social Implications (ELSI) Experiment (Protocol for Aim 3 Intervention)
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.
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.
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.
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.
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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