All laboratory testing performed on humans in the United States, including research testing under the circumstances described here, is subject to the regulations called the Clinical Laboratory Improvement Amendment (CLIA). 

CLIA regulations require laboratories to be certified. This applies to research labs under some circumstances.

CLIA applies to, and requires certification of, all facilities that perform any tests on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings” (see 42 U.S.C. §263(a)).

Lab Certification Requirements

CLIA applies when: “(1) patient-specific results are reported from the laboratory to another entity; AND (2) the results are made available ‘for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings’”. Therefore, any lab that is performing tests that will be used for the above stated purpose must obtain a certificate from the CLIA program.

Applicability to Research Labs

CLIA certification is not required for “research laboratories that test human specimens but do not report patient-specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, individual patients.”

An example of a non patient-specific result is “10 out of 30 participants were positive for gene X.”  The result in this example is a summary of the group data, and is not indicative of an individual’s health. An example of a patient-specific result would be “participant A was positive for gene X” in which the result is specific to participant A.

Examples:

Does CLIA apply?

1)      A study subject is asked to take a urine-pregnancy test during the study visit to determine eligibility. The subject is given the results of the test.

Yes

2)      The laboratory reports patient-specific test results to the study coordinator, who uses the results to assign the patients to the treatment arm of the study.

Yes

3)      A laboratory is conducting research to evaluate a new test method. Specimens are collected and tested in a laboratory. Only summary results are provided by the laboratory to the principal investigator.

No

Patient-specific results of lab tests can only be disclosed to research subjects if the testing facility has a current CLIA certificate. This includes, but is not limited to results from urine pregnancy tests and glucose tests. If results of lab tests will be reported back to the research subjects, a copy of the CLIA certificate for the lab analyzing the test should be provided to the IRB.

For additional information, please see the CLIA Guidance for Research Testing and CLIA.

For questions about CLIA certification in Oregon, please contact:

Oregon Health Authority, Laboratory Compliance
Email: LC.info@state.or.us
Phone: 503-693-4125

Lab Tests outside the United States:

CLIA certification only applies within the United States. For lab tests occurring outside of the United States, the IRB protocol should provide the following additional information:

a)      Testing standard used within the country

b)      Validity of the test being used if not the U.S. standard of care

Sources:  

CMS. (2014). Research Testing and CLIA. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/Research-Testing-and-CLIA.pdf

Oregon Health Authority, Laboratory Compliance. (2014).   https://public.health.oregon.gov/LaboratoryServices/ClinicalLaboratoryRegulation/Pages/index.aspx

Todd, Kathy. (2010). CMS, Division of Laboratory Services. “CLIA and Clinical Trials”. Harvard Cancer Center.  http://www.dfhcc.harvard.edu/fileadmin/DFHCC_Admin/Clinical_Trials/OPRS/Presentations/CMS_Presentation_on_CLIA.ppt

University of Washington: Human Subjects Division. (2014). SOPs Lab Certification (CLIA). washington.edu/research/hsd/docs/1749