Attorney General Andrew Cuomo Reaches Agreement On Genetic Testing Disclosures With Columbia University And N.y. - Presbyterian Hospitals

"To test or not to test for a predisposition to a disease is an important question with powerful implications for patients and their families. These agreements will empower patients to weigh the benefits and consequences of genetic testing before they consent," said New York State Attorney General Andrew Cuomo. "We commend the hospitals for taking the lead in providing necessary information to help patients make such critical health care decisions."

These agreements are the first to enforce a 1996 New York Civil Rights Law that requires laboratories to obtain written informed consent from patients for genetic testing and maintain the test results confidentially. The law specifically covers only predispositional genetic testing, a type of testing that may be confusing since it cannot accurately predict when or even if a disease will appear.

According to the terms of today's agreements, the laboratories operated by The New York and Presbyterian Hospital and Columbia University Medical Center will ensure that patients are given all the information they need to understand the results of a genetic test, should they choose to undergo one, and give written informed consent before undergoing such tests.

The laboratories will also adopt written genetic testing policies that are in compliance and ensure that all related staff are trained on the requirements of the law. Specifically, before performing a predispositional genetic test, the laboratories will ensure that patients receive an informed consent form that includes:

  • a general description of each specific disease or condition tested for;
  • information about the purpose of the test;
  • a statement that the patient may wish to obtain professional genetic counseling prior to signing the informed consent;
  • a statement that a positive test result is an indication that the individual may be predisposed to, or have the specific disease or condition tested for;
  • the level of certainty that a positive test result for that disease or condition serves as a predictor of such disease;
  • a statement that no tests will be performed without written consent and the patient's biological sample will be destroyed no later than 60 days unless the patient gives consent to sample retention.
  • the name of the person or categories of persons or organizations to whom the test results may be disclosed.
Unlike diagnostic genetic tests that confirm the presence or absence of a disease, predispositional genetic tests can be confusing since they cannot predict with certainty the risk of developing a disease. For example, a predispositional genetic test for breast cancer can help inform an individual about the increased risk of developing breast cancer. But, even with a positive test result, the individual may never develop breast cancer. Likewise, a negative test result cannot rule out the possibility of the individual developing breast cancer at some point in the future.

"The agreements reached by the Attorney General's Office will give patients the opportunity to understand the implications of their test results whether they are positive or negative," said Caroline Lieber, Director of the Joan H. Marks Graduate Program in Human Genetics at Sarah Lawrence College. "When a patient goes to a doctor for genetic testing, it is critical that the patient have genetic counseling. Genetic counselors are uniquely trained in genetic knowledge and the translation of this complex information into language that the patient can easily understand. Lastly, genetic counselors are trained to anticipate and respond to the emotional needs of patients reacting to this information."

Genetic testing, as defined by the New York State Civil Rights Law, is a medical procedure by which human DNA, RNA or proteins are analyzed to determine whether an apparently healthy person is at increased risk for a specific future disease, or to determine whether the child of a healthy individual or couple is at risk of having a recessive disorder. Although genetic tests can be performed to confirm a suspected diagnosis in symptomatic persons, diagnostic genetic tests are not covered by the state law. The Civil Rights Law does not apply to those genetic tests that are performed as part of New York State's mandatory newborn screening program.

This case was handled by Anne Pearson, Director of the Reproductive Rights Unit, Assistant Attorney General Dorothea Caldwell-Brown of the Healthcare Bureau, and Assistant Attorney General Meredith McGowan of the Civil Rights Bureau.

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