Get answers to your ethical and legal questions surrounding the return of research test results of potential clinical significance obtained in non-CLIA-certified labs. Recent amendments to both the Clinical Laboratory Improvement Amendsments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule have created more uncertainty for investigators and IRBs regarding their obligations. And the uncertainties are likely to multiply as the fields of translational genomics and personalized medicine grow. Join us to gain clarity on the ethical and legal requirements. Leave this session with a set of best practices to help you navigate these issues.
Describe the ethical considerations and regulatory requirements related to returning research test results
Distinguish how the CLIA and HIPAA regulations conflict regarding when an individual may receive research test reports
Develop approaches for investigators and IRBs handling requests to return test results that were generated in a non-CLIA-certified laboratory