MARYLEBONE DIAGNOSTIC CENTRE

    GENETIC TESTING CONSENT FORM

    1. Patient Information

    I confirm that:

    • I am providing my sample voluntarily
    • I understand the purpose of the test
    • I have had the opportunity to ask questions

    2. Role of Marylebone Diagnostic Centre

    I understand that:

    • Marylebone Diagnostic Centre (MDC) facilitates access to genetic testing services
    • MDC is responsible for sample collection, handling, and coordination
    • Genetic analysis is performed by independent accredited partner laboratories
    • MDC does not perform the primary genetic sequencing or laboratory analysis

    3. Independent Laboratory Responsibility

    I acknowledge that:

    • All genetic testing is conducted by third-party laboratories
    • These laboratories are solely responsible for:
      • Test performance
      • Accuracy of results
      • Scientific analysis and reporting
    • MDC is not responsible for laboratory processes or technical outcomes

    4. Nature of Genetic Testing

    I understand that:

    • Genetic testing analyses DNA to identify inherited conditions or risks
    • Results may include:
      • Positive findings
      • Negative findings
      • Variants of uncertain significance (VUS)

    5. Limitations of Testing

    I acknowledge that:

    • Not all genetic conditions can be detected
    • A negative result does not eliminate all risk
    • Some findings may be uncertain or inconclusive
    • Scientific understanding may evolve over time

    6. Clinical Interpretation

    I understand that:

    • Test results require interpretation by a qualified healthcare professional
    • Results are not a standalone diagnosis
    • MDC does not provide medical diagnosis unless separately agreed
    • Responsibility for interpretation and clinical decisions rests with the treating clinician

    7. Fertility & Outcome Disclaimer

    I acknowledge that genetic testing does not guarantee:

    • Pregnancy
    • IVF success
    • Absence of miscarriage
    • Healthy offspring

    Results are supportive only and not predictive of outcomes

    8. Use of Results & Follow-Up

    I understand that:

    • My results may be shared with my GP or specialist
    • I am responsible for seeking appropriate medical advice
    • MDC encourages clinical follow-up where appropriate

    9. Optional Referral Support

    I understand that:

    • MDC may facilitate referral to independent clinicians, including genetic specialists
    • These providers are independent
    • MDC is not responsible for advice, treatment, or outcomes from third-party clinicians

    10. Data Protection & Confidentiality

    I understand that:

    • My genetic data is sensitive and will be handled under GDPR
    • My sample may be transferred to partner laboratories
    • Results will be securely stored and shared only with authorised parties

    11. Limitation of Liability

    To the fullest extent permitted by law:

    • MDC shall not be liable for:
      • Third-party laboratory processes
      • Delays outside its control
      • Interpretation or use of results

    12. Genetic Counselling

    I have been offered genetic counselling:

    13. Family Implications

    I understand that:

    • Genetic results may have implications for biological relatives
    • I may wish to share results with family members

    14. Consent

    I confirm that:

    • I have read and understood this document
    • I understand the benefits and limitations
    • I give informed consent voluntarily

    15. Consent for Research Use

    I understand that:

    • My biological sample and/or anonymised data may be valuable for research, quality improvement, and scientific studies
    • Any use for research purposes will be fully anonymised, and I will not be personally identifiable
    • My participation is entirely voluntary and will not affect my care or access to services

    16. Withdrawal of Consent

    I understand that:

    • I may withdraw my research consent at any time by contacting Marylebone Diagnostic Centre
    • Withdrawal will not affect my medical care
    • Any data already anonymised and used in research may not be retrievable

    17. Identity Confirmation

    I confirm that:

    • The personal details provided are accurate
    • The sample provided belongs to me
    • I understand that incorrect information may affect results

    18. Sample Quality & Retesting

    I understand that:

    • In some cases, samples may be insufficient or unsuitable for analysis
    • A repeat sample may be required
    • Additional charges may apply depending on circumstances

    19. Turnaround Times

    I understand that:

    • Turnaround times are estimates only
    • Delays may occur due to laboratory or technical factors
    • MDC is not responsible for delays outside its control

    20. Payments & Refunds

    I understand that:

    • Genetic testing is a personalised service
    • Once processing has begun, refunds may not be possible
    • Refunds are subject to MDC’s terms and conditions

    21. Incidental Findings

    I understand that:

    • Testing may identify findings unrelated to the original reason for testing
    • Such findings may have health implications
    • I may choose whether I wish to be informed of such findings

    22. Sample Storage

    I understand that:

    • My sample may be stored for a limited period for quality control or future testing
    • Storage conditions follow regulatory standards

    23. Communication of Results

    I understand that:

    • Results may be sent via secure email or digital platforms
    • While safeguards are in place, electronic communication carries some risk

    24. Contact for Follow-Up Services

    I agree to be contacted regarding:

    Signature *