NCT02560896

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Familial Pancreatic Cancer

Timeline

• Start date: 2015-08-01
• Primary completion: 2019-11-04
• Completion: 2019-11-04
• First posted: 2015-09-25
• Last updated: 2023-06-06

Locations

1 site across 1 country: United States