Informed Consent Form Cardiology

Informed Consent Form - Cardiology

Informed consent is required for genetic testing. The patient (or parent or guardian in the case of minors under the age of 18 or adults lacking legal capacity) must sign the attached consent form. If the samples are anonymous, we will accept a statement from the physician responsible for the patient indicating that an appropriate informed consent has been obtained (section “Statement of the existence of informed consent”).

1  Patient

Patient’s full name

2  Genetic study requested

3  Patient’s authorization

I declare that I have been informed of, that I understand, and that I am in agreement with the type of genetic study indicated above and in which I am voluntarily participating.

I understand that I may be affected by or be a carrier of a hereditary genetic disorder, the diagnosis of which may be confirmed by a laboratory study analyzing DNA obtained from my biological samples. I hereby give my consent to have my sample sent to Health in Code S.L., a company with a level of data protection in accordance with European legislation, to carry out the indicated genetic study, as well as to the center or centers designated by it, complying with ethical considerations and current legal regulations:

• Genetic disorders may be inherited by family members and that the results of my test may have implications for my own family.

• In the case of a genetic study of a mutation, the determination of the mutation is diagnostic, while non-determination does not exclude the pathology. A negative test does not exclude the possibility of having the disease (some diseases have multiple causes and it is not possible to test for all of them).

• Occasionally, there may be unusual alterations in the DNA structure of certain individuals that may yield results that are difficult to interpret, making the diagnosis difficult and even making it impossible to obtain conclusive results.

• Although the methods used to perform this diagnostic testing are extremely sensitive and specific, there is always a small chance of failure of the technique or of an interpretation error. For this reason, repeating the test or performing additional ones may be necessary in some cases, which may or may not require obtaining new samples, particularly in those cases where quality of the biological sample is suboptimal.

• Given the complexity of genetic studies based on DNA and the important implications of the results of a genetic study, I will be informed of said results by a physician or genetic expert, always with the highest confidentiality level from both medical and laboratory personnel.

• I may change my mind at any time and withdraw the authorization for the genetic study given by me in this document, thereby revoking my decision to continue with the analysis.

• The only people who will have access to the test results will be members of the Health in Code, S.L. team and health service professionals involved in patient care.

• It is possible to obtain unexpected information during the sample analysis process, and I hereby declare that I want to be informed about it: Yes No

• It is possible that information concerning the relatives of the sample donor will be obtained. We recommend that the latter (or his/her legal representative) should be the person who shares said information. In any event, the approval of each family member will be required.

Current legislation requires Health in Code, S.L. to keep clinical documentation under conditions that ensure its proper maintenance and security for purposes of due patient care for at least five years after the assistance process has ended. I am aware and accept that a DNA aliquot will be kept in the laboratory for subsequent studies and/or confirmation tests: Yes No

In addition, I consent to the biological sample being used by the entity Health in Code, S.L. for research purposes approved by the relevant ethics committee after the termination of the study, always maintaining the patient’s anonymity. Yes No

All personal information provided on this form, as well as subsequent diagnosis, research, and/or statistical information, will be treated in strict confidentiality and under the protection of and in line with specifications set forth in Organic Law 15/1999 of 13 December on the Protection of Personal Data (LOPD), and will be included in the files “CARDIOREGISTER”, “HIC MUTACIONES”, and “LIMS”, duly registered with the Spanish Data Protection Agency and whose purpose is the analysis and diagnosis of genetic diseases. Please note that you are entitled to access the file and to modify and delete your data, and you may exercise said rights by sending a written request to the entity Health in Code at Edificio O Fortín, As Xubias, s/n, Campus de Oza, 15006 A Coruña, Spain, with the reference: “Data Protection”, attaching a copy of your National Identification Card.

4  Statement of the existence of informed consent

I hereby declare that the patient identified on this request is aware of the information on said request and has signed the Informed Consent form to permit this genetic study to be carried out and that this has been included in his/her clinical record.

Name of the patient or legal representative*

*If the patient is a minor or lacks legal capacity

National Identification Number of the patient or legal representative