GENETIC DISEASES ASSESSMENT CENTER
GENETIC TEST REQUEST / INFORMED CONSENT FORM
PATIENT INFORMATION
kg / cm
Female
Male
Other
REFERRING PHYSICIAN / INSTITUTION DETAILS
TEST INFORMATION
CLINICAL INFORMATION
Reason for Testing
Diagnosis
Carrier Screening
Family Screening
Other:
No
Yes:
No
Yes:
No
Yes:
No
Yes:
No
Yes:
No
Yes:
FAMILY HISTORY
No
Same Village/Town
Yes, Degree of Relationship:
No
Yes:
No
Yes:
PREGNANCY HISTORY (Prenatal Tests Only)
wk/day
Singleton Twins Triplets+
No Yes
No Yes:
REPORT DELIVERY METHOD
To Me - Email
WhatsApp
To My Physician - Information
To a Relative - Information
INFORMED CONSENT
- Genetic tests are performed for purposes such as diagnosing the condition under investigation, determining carrier status or assessing the risk of developing a disease in the future. The reason for requesting the test will be explained to you by the referring clinician or by the genetics specialists at our center.
- GENAY Genetic Diseases Assessment Center is responsible for performing only the genetic analyses requested and sharing the results with the patient or the treating physician. Interpretation of the results and determination of the appropriate treatment are the responsibility of the clinician overseeing the patient's care.
- Each test is valid only for the disease or indication investigated in the person tested. Because it does not provide information about other conditions, it cannot guarantee that you, your family members and/or your future children will be completely healthy. Even when a test result is interpreted as normal, the possibility that the patient may develop another genetic or non-genetic condition cannot be excluded.
- In some cases, an analysis may reveal findings associated with a condition other than the one being investigated. Such a finding may require lifelong additional follow-up and treatment. Information will not be provided about findings that, at the time of analysis, are of uncertain diagnostic significance, have late onset and have no available treatment. These assessments are made in accordance with current international guidelines in force on the date of analysis.
- You have been informed of the approximate reporting times for the tests. These are business-day estimates based on average turnaround times; your results may be available sooner or later.
- If a specimen does not meet the acceptance criteria, fails quality control at any stage of processing or yields no result in the initial analysis, a new specimen and/or repeat testing may be required. These additional procedures are performed at no extra charge but may extend the reporting time. In such cases, you will be informed by us and/or by the healthcare professional who referred you.
- You may be asked to provide another specimen if an adverse event outside our center's control occurs while a specimen collected elsewhere is being transported. Our center is not responsible for a failure to obtain a result when recollection and/or repeat testing is impossible for reasons not attributable to our center.
- Valuable specimens that are difficult or potentially impossible to recollect are not rejected outright even when they do not meet the acceptance criteria. In such cases, our center may grant conditional acceptance and inform you and/or the referring healthcare professional. If preliminary assessment indicates that the specimen can be tested, it will be accepted and processed. Otherwise, you will be informed, and the remaining specimen and the test fee will be returned after the costs of the preliminary assessment have been deducted. A specimen cannot always be returned if its limited quantity is exhausted during testing.
- Although uncommon, some results may be difficult to interpret, may not yield a definitive diagnosis or may not fully explain the cause of the condition.
- In some cases, technical limitations may prevent a reportable result. This does not mean that no diagnosis exists; it means that no positive or negative result could be obtained for technical reasons.
- The genetic test or tests may indicate a need for additional testing for you and/or your family members. Additional tests provided free of charge may be performed without further consent. If a chargeable additional test is required, you will be informed and new consent, and where necessary a new specimen, will be obtained. Declining additional testing may prevent a diagnosis from being established.
- All test results have an inherent margin of error. Factors affecting test accuracy include the scope of the test, technical limitations of the method, genetic differences among individuals, available genetic-variant databases and the limits of current scientific knowledge. Each report describes the scope of the test, the method used and its limitations.
- Previous organ or bone marrow transplants, blood transfusions or treatments involving exogenous DNA may affect the test result.
- In some cases, genetic testing of family members may reveal that the stated biological relationships do not correspond to the actual biological relationships. Patients acknowledge that such an inference may be drawn from the information in their report even if they applied for a different indication. Accurate interpretation of test results also depends directly on the patient's clinical diagnosis, medical family history and reported family relationships. Family relationships must therefore be stated accurately and completely as biological or non-biological. Our center cannot be held responsible for inaccurate results arising from incorrect information.
- Certain findings obtained from testing may not be reportable for scientific or ethical reasons.
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Patient / Legal Guardian Details
Full Name:
Date: .... / .... / ........
Signature:
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INFORMED CONSENT (Continued)
- Patient information and test results are kept confidential, and all data remain anonymous during analysis. Personal data are stored in a database accessible only to authorized personnel. Unless disclosure is required or permitted by applicable law, patient information and results are shared only with the patient and/or relatives authorized by the patient, the referring physician and other clinicians identified by the patient, and are not disclosed to any other third party.
- Because of their complexity, test results must be interpreted by healthcare professionals; the patient should therefore consult the physician overseeing their care. We also recommend obtaining genetic counseling from a medical genetics specialist at our center.
- To provide genetic testing services in our laboratory, the personal data listed below are processed in accordance with Turkish Law No. 6698 on the Protection of Personal Data and other applicable legislation. For purposes including compliance with legal obligations, the conduct of medical and financial activities, management of patient relations, identity verification, and statutory retention and archiving, the following general and sensitive personal data may be recorded, processed, stored and classified in accordance with the law: your first and last name; national identity details/passport number; date of birth; telephone number; email address; personal clinical information such as weight, height and family history; genetic data, including test results and examination data obtained in the course of medical diagnostic services; CCTV footage recorded during visits to our laboratory; financial data relating to payment and invoicing; and any other personal data you provide when contacting our laboratory by email, call center, website contact form or other channels.
- Interpreting genetic tests and establishing a diagnosis may require health and genetic information about your family. Such data are processed as described above in accordance with the Law on the Protection of Personal Data. By sharing data concerning family members, you confirm that you have obtained their permission beforehand.
- Your specimen and the information provided on the request and consent forms, including your name, surname, address, date of birth and clinical information, may where necessary be sent to contracted laboratories in Turkey or abroad. Any transfer of personal data to another laboratory will be carried out in accordance with Turkish Law No. 6698 on the Protection of Personal Data.
- For the analysis of certain test results, anonymized genetic data may need to be analyzed and evaluated on national or international software platforms and stored in national or international databases.
- Specimens remaining after testing are retained for the periods specified in the Regulation on Genetic Diseases Assessment Centers. Remaining specimens may be anonymized in accordance with patient confidentiality and used in validation and/or educational studies conducted by the laboratory. Results from such studies are not reported to the patient.
- In accordance with good laboratory practice, your anonymized specimens, genetic data obtained from your tests and other information may be used for scientific purposes, technological development and/or clinical research. All personally identifiable information will be removed before any report or publication. All written uses will comply with applicable law. If you do not consent, remaining specimens will be destroyed in accordance with international clinical laboratory standards.
- You may withdraw all or part of your consent to testing at any time without giving a reason. You have the right not to be informed of test results, to stop testing at any time before receiving the results, and to request destruction of all test materials and results collected up to that point. If you withdraw from testing, the test fee will be refunded after deduction of the costs of work already performed. No refund is made if the test is close to completion.
- GENAY Genetic Diseases Assessment Center reserves the right to cancel testing at any stage.
- GENAY Genetic Diseases Assessment Center is not responsible for the legal or psychological consequences of testing.
PATIENT CONSENT AND AUTHORIZATION
I CONSENT
I DO NOT CONSENT
Please write the following statement in your own handwriting: “I have read, understood and accept the information above. I confirm that the information I have provided is complete, accurate and belongs to me, and I request that my test results be sent to the email address and telephone number stated above.”
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Patient / Legal Guardian Details
Full Name:
Date: .... / .... / ........
Signature:
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