August 2013

The Organization will comply with Clinical Laboratory Improvement Act (CLIA) requirements and applicable local law to laboratory testing.  Interpretation of the requirements to meet CLIA standards and applicable local law are made by the OHSR in consultation with the General Counsels’ Offices.  Under the current interpretation of these requirements, the Organization will not permit researchers to disclose or report results of research tests when such tests have been performed in laboratories that have not been CLIA-certified and do not have a state laboratory license.  At JHM, an investigator may not disclose or report such research laboratory test results to either subjects, patients, families, or the care givers of subjects or patients. The JHM IRBs may not approve a request from an investigator to disclose research test results obtained from non-certified or non-licensed laboratories to individual participants.  The JHM IRBs may approve a request on a case-by-case basis to allow all participants to receive a form letter indicating that clinical testing is now available and they may wish to have testing conducted at a certified clinical laboratory.