CONSENT FOR GENETIC TESTING

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PATIENT INFORMED CONSENT - MARYLEBONE DIAGNOSTIC CENTRE

MARYLEBONE LAB (hereinafter referred to as "the Laboratory") is a facility that has verified and determined the accuracy of the genetic testing and reporting methods to meet required regulatory performance standards.

Purpose and Benefits of Testing:

The purpose of a genetic test is to examine your genetic material (DNA) using molecular-genetic methods capable of detecting the presence or suspicion of a disease in you or your family based on genetic changes (mutations).

Understanding Genetic Testing Results:

Positive Test Result: Indicates that one or more mutations in one or more genes were detected. Individuals with a positive test result should be referred for genetic counselling and further evaluation.

Unknown Significance: Some results may reveal DNA variations or mutations with unknown or unclassifiable clinical significance based on current medical and scientific knowledge. Detection of gene variations does not always imply the development of a disease, the severity of related symptoms, or when the disease may manifest.

Negative Test Result: Indicates that no disease-causing mutations were identified in the investigated genes. However, this does not exclude the possibility of mutations in regions of the genome not explored during the analysis.

The test only targets specific genetic diseases or genes and does not detect others. Incidental findings, which are not relevant to the specific analysis, will not be reported.

The Laboratory may contact you for additional information or follow-up clinical history after testing.

Risks and Limitations:

A blood sample or buccal swab will be collected. Risks of blood collection include dizziness, fainting, soreness, pain, bleeding, bruising, and rarely, infection.

Genetic testing should not replace treatment, diagnosis, or health care services provided by a qualified healthcare professional.

The test may not provide informative results due to non-genetic factors, individual genetic variation, insufficient scientific information, technical reasons, or incomplete gene sequence information.

Potential risks include emotional distress, unjustified alarm, false reassurance, impact on life decisions, genetic discrimination, and loss of confidentiality. Results may become part of your permanent medical record and may be accessible to individuals and organisations with legal access to such records.

Informed Consent Acknowledgement:

I understand that this testing is voluntary and freely consent to it. By signing below, I acknowledge that:

I understand written English.

I have read and understood this consent form, all my questions have been answered to my satisfaction, and I agree to the testing. I can receive a copy of this consent by contacting Client Services (see "Questions").

I have discussed the reliability of positive or negative test results with the healthcare provider ordering this test.

I am 18 years of age or older and have the legal authority to provide this consent under all applicable laws.

The Laboratory may use my DNA and clinical information in medical research studies and publications unless I opt-out by initialling below. My personally identifiable information will not be used or linked by the Laboratory to study results.

I can withdraw my consent to the analysis at any time without stating reasons.

I have the right not to be informed about test results, to stop the testing process at any time before receiving the results, and to request the destruction of all test results not already known to me.

❑ (initial to opt-out): I do NOT consent to the use of my extracted DNA sample and clinical information for anonymous medical research purposes.

❑ (initial to opt-in): My DNA and clinical information can be retained for up to five (5) years for anonymised medical research purposes.

Confidentiality and Disclosure:

My personal information and test results are confidential, though absolute privacy cannot be guaranteed. The Laboratory has established safeguards to protect my information, which will be released to the ordering healthcare professional. I can request a copy of my lab results from Client Services.

Information and results may be disclosed if required by law.

If I share this information, I am responsible for any compromise of confidentiality.

If I opt-out of research, my specimen(s) may be stored for sixty (60) days and then destroyed as per regulations. The same applies to any isolated DNA.

Specimens for Medical Research Purposes:

Unless I opt-out, I authorise my DNA to be retained for up to five years for medical research. A unique identifier will protect my identity, and my name will not be available to the research team. I will not receive compensation for any inventions resulting from research using my specimen(s).

Withdrawal of Consent:

Under UK regulations, the Laboratory cannot destroy medical records. However, upon written request, the Laboratory can destroy my DNA specimen(s) at the next scheduled destruction cycle, delete my account, and move all medical information into a secure, offline storage area. This means my account and results will not be searchable, and neither I nor my healthcare professional can obtain copies of my information from the Laboratory. Requests can be made to Client Services.

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