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Genetic Testing Informed Consent Policy

Policy Statement

New York State Civil Rights Law, Section 79, requires written informed consent for certain genetic tests performed on clinical samples -- blood or other biological samples.  To ensure full compliance with New York State law, CUMC has adopted a policy on genetic testing. 

Responsible University Office and Officer

Office of the General Counsel 

Who is governed by This Policy

The policy applies to all CUMC owned or controlled physician offices and faculty practice plans, and all employed, salaried and non-salaried faculty physicians practicing on CUMC owned or leased space, as well as their clinical support staff, to the extent that they are engaged in the performance of or offering of a genetic test done at CUMC or NYPH laboratories.

Policy Text

Under the policy, it is the responsibility of all CU faculty practitioners to:

-- Obtain signed informed consent for genetic tests using a form that meets the requirements of New York State law;

--  Attest that the signed consent was obtained when you requisition the test from the appropriate CU laboratory;

--  Maintain the signed consent form in the patient's record.

Consent forms are provided internally for genetic tests obtained at CUMC/NYPH laboratories. Only requisition and consent forms approved by the Director of Laboratory Services may be used. 

Note that these consent forms are for clinical genetic testing only.  The samples may not be used for research.  If you are doing genetic testing in a research setting, you must obtain a separate consent form and follow a consent process that meets the requirements of the New York State Law.

As of January 1, 2008, only the new combined requisition and consent form can be used.  These forms are available at: www.pathology.columbia.edu/consents.

The genetic tests covered by the Columbia policy include all of those tests listed at this website.  As new genetic tests are added, the requisition and consent forms will be added to the website.  Please check the website to obtain the latest list of genetic tests.

Currently, genetic tests included in this policy are for:

  • ABCA4 (Stargardt Disease, Fundus Flavimaculatus, Cone-Rod Dystrophy, Retinitis Pigmentosa-19)                                   
  • SOD1 (Amyotropic Lateral Sclerosis)
  • BMPR2 (Pulmonary hypertension)
  • CFTR (Cystic Fibrosis)
  • DYT1 (Dystonia)
  • Fragile X
  • Glycogenoses and Lipid disorders (genetic and biochemical analyses)
  • Mitochondrial disorders
  • Prader Willi/Angelman Syndrome
  • Thrombophilia (Factor V Leiden, Factor II/Prothrombin 20210G>A)

All current and new CU laboratory staff processing requests for genetic tests or performing genetic tests will be trained on the Genetic Testing Informed Consent Policy.  New practitioners will receive the policy and this email within 30 days of hire.

To ensure full compliance with the policy, audits of patient records be conducted to determine if the correct consent forms have been obtained and retained.  Failure of practitioners to comply with this genetic testing policy may result in disciplinary action.

New CU consent and requisition forms are available at: www.pathology.columbia.edu/consents.