Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis

1.3 Ethical responsibilities of laboratories providing molecular testing for human genetic disorders

Page last updated: 03 July 2006

    Informed consent

    C1.3.1
    With Level 2 DNA tests, the primary health professional attending the person seeking genetic advice is responsible for ensuring that informed written consent is obtained and for providing or referring to appropriate pre-test and post-test professional genetic counselling.

    Guideline

    G1.3.1
    Clinicians who request genetic testing should be provided with information about which tests need specialised pre-test counselling and informed written consent before collection of samples. In these circumstances the clinician should indicate on the request form that this has been done.

    Confidentiality of reports

    C1.3.2
    Laboratories must comply with Standard 1 of the NPAAC publication Standards for Pathology Laboratories.

    New developments

    C1.3.3
    Because DNA testing in genetic disorders is advancing rapidly, the significance of a result may change with time and experience. Therefore, the DNA laboratory director should be prepared for this and (in consultation with relevant clinical colleagues and, if necessary, the human research ethics committee at the institution) should determine what action will be taken in respect of previous results. Generally, a change in the significance of a test should be reported to the ordering clinician, who will determine what the next step should be.
    C1.3.4
    Further information relating to the ethics of laboratory genetic testing is available in the NHMRC publication Ethical Aspects of Human Genetic Testing: an Information Paper (NHMRC 2000) and in the joint Australian Law Reform Commission – NHMRC publication Essentially Yours — The Protection of Human Genetic Information in Australia (ALRC–NHMRC 2003).