INFORMED CONSENT

DATSME

Before contracting the service provided by OVERGENES, S.L. (from now on, “DATSME”), you must read, agree and expressly accept the terms of this legal agreement and Informed Consent (from now on, the “Consent”). Specifically, by this Consent, you state and agree to: (i) know the process by which DATSME will provide the service; and (ii) be aware of the benefits, limitations and potential risks associated -directly or indirectly- with the service. You need to have a clear understanding of (i) the context of the genetic information to which, through DATSME’s provision of the service, you will have access; and (ii) the possible consequences of making such knowledge available.

PURPOSE OF THE GENETIC ANALYSIS THAT YOU REQUEST FROM DATSME

The analysis and interpretation service provided by DATSME that you request is designed with a purely informative purpose based on the scientific evidence available and used by DATSME. Specifically, through the service provided by DATSME, you will be informed about aspects that promote the prevention and/or treatment of certain conditions, pathologies and/or diseases (genetic predisposition to suffer distinct diseases, medicines metabolism and response to treatments or possibility of being a carrier of hereditary disorders). You expressly acknowledge and accept that the information obtained through the provision of the genetic analysis service you request from DATSME is not intended to diagnose any condition, pathology or disease and, under no circumstances, is it intended to or can it replace the personalised and individualised attention of any health professionals.

SALIVA SAMPLE PROVIDED TO DATSME

You guarantee that the saliva sample provided is yours. For the appropriate purposes, it should be noted that DATSME only provides services to natural persons. In this respect, you guarantee that you are not acting on behalf of any third party including, but not limited to, insurance companies, companies related – directly or indirectly – to the health sector or any other type of company or individual who may have an interest in obtaining information about an insured person, employee, manager or any other person without the required prior authorisation. Additionally, if you reside outside Spain, by accepting this Consent or any other documents necessary for the contracting of the service, you expressly confirm that you are not subject to any legal prohibition or restriction including, but not limited to, prohibitions or restrictions relating to the sending of saliva samples from your country of residence or, in general, any prohibitions or restrictions related – directly or indirectly – to the contracting of genetic services such as the one you are requesting from DATSME. In addition, you acknowledge and agree that the provision of your saliva sample and the processing of your genetic data does not imply the acquisition in your favour of any rights over scientific research or services or products that are developed by DATSME or by organisations or persons associated with DATSME.

SALIVA SAMPLES OF MINORS PROVIDED FOR THE PROVISION OF SERVICES

If you are signing this document on behalf of a minor, you declare that you have parental authority over the minor, that you are acting on his or her behalf and that you have not been deprived of such parental authority by virtue of a court decision. You also declare that the saliva sample corresponds to the minor on whose behalf you are acting. In the absence of parents with parental authority, only the person exercising guardianship of the minor may contract on his or her behalf and submit the saliva samples. Those contracting on behalf of the minor must provide the necessary documents to accredit the minor’s representation and the statements made when formalising the contracting of DATSME’s services, stating that they are authentic, complete, true and up to date. In particular, without limitation, they must provide the Family Book, ID of the parents, testimony of the judicial sentence or certificate of the Civil Registry.

DEOXYRHYRRIBONUCLEIC ACID ANALYSIS (from now on “DNA”)

You give your permission to DATSME, its employees, directors, officers, contractors, subcontractors and collaborators to perform the requested services for DNA analysis of your saliva sample. For all appropriate purposes, you are informed that the data processing centres contracted by DATSME have all the necessary health licenses to perform the analysis.

RESULTS OF THE GENETIC ANALYSIS (REPORT)

You authorise DATSME to transmit, in whole or in part, the results (report) of your DNA analysis to you and to the persons you authorise in advance and in writing. You represent and agree that the information provided by DATSME following your genetic analysis as requested may be positive or negative. Accordingly, you acknowledge and agree that you are aware that such information provided may be unexpected and may cause you emotional stress. However, you also acknowledge and accept that if that your genetic information indicates an above-average risk of developing a particular condition, pathology or disease, it does not mean that you will inevitably develop that condition, pathology or disease. As genetic research advances, you also understand that to more fully assess the meaning and information regarding your DNA in the context of such advances, you may need to call upon these services again.

GENETIC DATA

The laboratory contracted by DATSME to process your saliva sample will analyse your DNA for the sole purpose of determining your genetic information. Neither the laboratory nor DATSME will search your saliva for any agent, marker or biological or chemical component other than your DNA. Furthermore, the laboratory will not have access to any of your personal data (including your first and last name) as the data will be subjected to a dissociation process. A unique barcode will allow DATSME to link the genetic data derived from your saliva sample to your DATSME customer account. In any case, for greater security, two (2) months after completion of the requested analysis, the DNA and saliva remains provided will be destroyed.

SECURITY

 In compliance with applicable law and DATSME’s own internal policies, rigorous security measures will be employed to prevent unauthorised access to or unauthorised modification, transmission or destruction of your data. This security system includes regular audits of our systems and security measures.

CONFIDENTIALITY

In compliance with the provisions of current data protection regulations (EU Regulation 2016/679 General Data Protection Regulation -RGPD-, and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights -LOPDGDD-), DATSME informs you that the personal data you provide will be used in a completely confidential manner and subject to the technical, legal and organisational measures of compliance and protection, with the aim of adequately providing the contracted service and for the legally required periods of time to DATSME. Likewise, you are informed that you may exercise your rights of access, rectification, opposition, suppression, limitation, portability and not to be subject to automated individual decisions regarding your personal data by email to info@overgenes.com. You may be required to provide documentation proving the identity of the applicant (copy of the front of the National Identity Card, or equivalent). The maximum response period will be 30 days from receipt, which may be extended for a maximum of 2 months if necessary. In any case, you may request the guardianship of the Spanish Data Protection Agency via its website. In the case of minors, their personal data and genetic information will also be used confidentially, with the interests of the minor taking precedence over any other in accordance with the provisions of Organic Law 1/1996, of 15 January, on the Legal Protection of Minors. For complete information on data protection you can consult our Privacy Policy by clicking here.

RESEARCH

DASTME is particularly sensitive to genetic research and has reached agreements to carry out studies and research with prestigious entities in the sector.

 

For this purpose, we request your authorisation to use the data collected by DATSME in a completely anonymous way for its transfer to the entities or persons with whom the entity has reached the aforementioned agreements so that they may have access to your raw genetic data as well as to the interpretation of these, regardless of the country of origin. This data processing will always be based on the provisions of article 9.2 j) of the RGPD.

 

I expressly authorise DATSME to transfer the anonymous data derived from the analysis of my DNA for any studies, research and statistics it deems necessary.

RISK

 DATSME understands that it is in its clients’ best interest to help them access and understand their genetic information. However, this process of accessing and understanding genetic information is complex and is not without risk. In this regard, you acknowledge and accept these potential risks. For illustrative purposes only, below are some considerations that you should be aware of and accept by this Consent given before completing the DATSME service engagement process.

DISCOVERY OF UNEXPECTED INFORMATION

It is very likely that you will learn genetic information about yourself that you do not expect. Such genetic information can be emotionally stressful and, in some cases, life-altering. Specifically, you may discover things about yourself that may worry you. For example, you might have a greater possibility than the average of a particular segment of the population to develop a certain condition, pathology or illness. In this case, you have the right to revoke this Agreement at any time in writing (this right does not exempt you from the economic obligations assumed on contracting DATSME’s services).

MINIMUM ERRORS IN ANALYSIS

Without prejudice to that expressed in the following paragraph, you are informed that DATSME follows rigorous quality protocols in the DNA analysis process. Nevertheless, an extremely small percentage (<0.05%) of the data generated during the process carried out in the external laboratory of DATSME can be incorrect or cannot be interpreted. 

FUTURE GENETIC RESEARCH

Future scientific genetic research may alter – in whole or in part – the interpretation of your DNA, since new genetic markers can be discovered related to the risk of suffering diverse conditions, pathologies or illnesses.

DO NOT SHARE YOUR GENETIC DATA

The genetic data you share with third parties – whether from the service provided by DATSME or from other sources – could be used against your own interests.

You are informed that DATSME strongly discourages you from sharing your genetic information with third parties (including family, friends, co-workers). Even if you decide to share your genetic information with a healthcare professional, you run the risk that such information may become part of your medical record and, because of this, could be in the future accessible to undesired third parties (for example, health care provider service companies or insurance companies).

You acknowledge that even if you share genetic information that is minor or apparently unimportant at the time, it is shared, such information may become relevant in the future when genetic research has advanced and new discoveries have been made (for example, the discovery of new genetic markers related to the risk of suffering diverse conditions, pathologies or illnesses).

In any case, you agree to: (i) assume responsibility for the derived consequences of sharing access to your genetic data with third parties; and (ii) exonerate and hold harmless DATSME, its employees, administrators, directors, officers, contractors, subcontractors, collaborators, successors and assigns from any liability arising from: (A) the use or transmission of any information provided by you and/or obtained as a result of the service requested from DATSME; and (B) the transmission or use of your genetic information or other personal data provided in the event that you share said information with third parties – whether intentional or inadvertent access or third parties for diagnostic or other purposes.

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