Consent

Dear participant,

 

This document is intended to provide you with important information about the genomic test arcensus is offering. Please read it carefully and contact us if you have problems understanding or any additional questions. You are recommended to read it carefully to understand your testing conditions, as you need to agree with it before sending a sample to arcensus.

  

1.      Definitions

 

GDPR

General Data Protection Regulation is a legal guideline for the collection and processing of personal information from individuals who live in the European Union (EU).

 

Genomic Data

Any data from the genomic analysis of your biological sample.

 

Genome

The entire genetic material that is located in each cell of your body.

 

Whole Genome Sequencing

A method to analyse the complete genome of an individual.

 

Health Data

Any data collected from an individual relating to its health condition.

 

Personal Data

Any data relating to an identified or identifiable person.

 

pseudonymized or to pseudonymize

Pseudonym is translated as ‘false name’ from Greek language.  As per GDPR – “the processing of personal data in such a way that the data can no longer be attributed to a specific data subject without the use of additional information”, meaning your contact information will be replaced with a code and only this code with be shared with third parties. Third party will not be able to connect your sample, family history, clinical info, date of birth, derived from your sample genetic data with your contact details. Your contact detailed are defined as First name, Last name, post address, email address, and phone number.

 

 

2.      What you are agreeing to if you consent

 

By this consent, you agree and accept that you are aware about:

- the operational processes by which arcensus carries out its services;

- the (in)direct potential benefits, limitations, and risks of arcensus’ services.

Further on, you shall acknowledge that due to the provided services, arcensus will have access to your genomic data.

In case you accept this consent as a legal guardian, you agree to be aware that all information provided in this consent applies to your child or a disabled person who you are legal guardian to.

 

3.      Procedures and analysis

 

Step 1:

If you decide to purchase a genomic test of arcensus, you will receive a product box via post. The product box contains all necessary equipment to obtain saliva samples from you. Collecting the saliva samples is a non-invasive and totally painless procedure. By rubbing the head of the swab against your gum regions in combination with proving saliva in a funnel, sufficient cell material for the DNA analysis will be obtained.

 

Step 2:

You need to register in the online account of arcensus and complete all mandatory information. To interpret your DNA information in the correct way, you need to provide your health symptoms and your medical family history as detailed as possible. Only after successful account generation, you shall send back your saliva samples to arcensus.

 

Step 3:

You will send your saliva samples back to arcensus’ headquarter in Rostock, Germany. In arcensus specialized laboratory, we will isolate the DNA from your sample. Independent of the test or product you have purchased, we will always perform Whole Genome Sequencing (WGS) with your DNA sample. This means that we will not sequence some genes but the entire genome. For this, we will send your DNA sample in pseudonymized form to our external WGS partner laboratory, based in UK/Europe. ,This laboratory is responsible for sequencing your DNA only. After sequencing, your resulting genomic data will be sent to arcensus. The laboratory will destroy your remaining DNA sample and derived genomic data in 30 working days after your sample arrival. Arcensus has access to your whole genome data and will focus and analyze only those parts of your genome that are relevant to the product you have purchased. Our bioinformatic and medical experts will connect these genomic results with your provided health symptoms to generate the most accurate medical report.

 

Step 4:

The medical report will be uploaded to your online account. It is arcensus’ vision and aim to be your life long medical partner and update you regularly about new research findings. Therefore, you will receive an updated medical report once per quarter according to the newest findings of genomic medical research. As arcensus has already access to your WGS data, no further sample need to be provided for the regular re-analyses.

 

 

4.      Your saliva samples

 

You guarantee that the provided saliva sample was taken from yourself or belongs to a child (children) or a disabled person who you are legal guardian to. In accordance you assure that you do not act on behalf of a third party, for instance insurance companies, or healthcare-related companies.

 

The DNA that is isolated out of your saliva samples will be shared with an external partner for the sequencing process. This partner will destroy any leftovers of your isolated DNA and derived genomic data in 30 working days after the sample arrival.

 

You transfer ownership of your saliva samples and DNA derived from this samples to arcensus and agree to the storage of any leftovers of its isolated DNA and derived genomic data in arcensus for unlimited time.

 

 

5.      Results/Report

 

With this consent, you give arcensus the permission to send you the medical report of your WGS analysis (as well as to your child (children) or a disabled person who you are legal guardian to). You understand that the result of your genomic analysis can be positive or negative. Hence, you acknowledge that you are fully aware about potential unexpected information that can make you feel uncomfortable and cause emotional stress. You understand that as research in genetics advances, interpretation of your data might change in the future. Arcensus will send you an updated report once per quarter to keep you up to date about interpretation of your genomic results.

 

Arcensus’ experts will use both your genomic data and provided health and medical info for the proper interpretation and preparation of your medical report. Genetic variants that differ from the currently used human genome reference, can be classified into Class I – V, according to their potential to cause diseases. Arcensus will only report to you clinically relevant variants of Class I (Pathogenic) and Class II (Likely pathogenic).

 

The reports will inform you about variants in genes or regions of your DNA that are linked to the conditions of your purchased product. Additionally, incidental (secondary) findings can be reported if you consent them to be reported. Incidental findings are results that are not related to the indication for ordering the sequencing but are causing diseases with available treatment options. For example, Familial hypercholesterolemia, a genetic disorder of lipoprotein metabolism characterized by elevated serum cholesterol levels. Initially this disease might have no symptoms, however, if untreated, atherosclerosis may take place manifesting as chest pain, heart attacks, or even sudden death. Pathogenic variants in 3 genes lead to this genetic disease. If a person has a pathogenic variant in one of these gene, he/she is diagnosed with this condition. Familial hypercholesterolemia has treatment options aimed to inhibit cholesterol synthesis in the body. Such a treatment delays or even stops cholesterol accumulation and thus prevents atherosclerosis.

Based on the recommendations of the American College of Medical Genetics (ACMG), there is a list of 82 disorders that are considered incidental findings. Arcensus will take this ACMG list as a basis but will take the freedom to update the list and add new genes. Independent of the product you purchased, arcensus can inform you about an incidental finding if you consent it/them to be reported. You can find a current list of arcensus’ reported incidental findings here: https://arcensus-diagnostics.com/#incidentals

 

The report provided by arcensus will inform you of the aspects about your potential diagnosed disease, its typical clinical manifestations, the treatment, and ongoing clinical trials. The report summarizes the genetic results for the tested individual, as well as for a medical expert.

 

 

6.      Genetic counseling

 

Your medical report (accessible via your online account) gives you all information about your WGS results and the according implications. In addition, arcensus offers you a professional genetic counseling service. Whenever you want to receive further clarifications or want to speak to one of our genetic experts, please contact us at the email address [email protected].

 

 

7.      Purpose and limitations of the service

 

As part of the service of arcensus, you will receive a fully validated medical report with your genomic results. The sample analysis is carried out in certified and accredited laboratories and the result interpretation is done and validated by our medical experts. Any diagnosis that can be made according to your genomic results, is a medically profound and acknowledged diagnosis.

 

Arcensus will further give you recommendations regarding the available treatment and currently running clinical trials of the disease you might be diagnosed with. These recommendations are only for your information and do not replace a visit of an expert physician who can support you with starting treatment and prescribing drugs.

 

Also, the optional genetic counseling is a purely informative session with the purpose to provide you more personalized information to your potential disease and the risk to your family members. Additionally, medical counseling can be ordered before the test to support you understanding which product should be ordered by you and to explain potential physiological risks. The medical and the genetic counseling does not replace visiting a healthcare professional for starting your treatment or therapy.

 

The service provided by arcensus for your requested analysis and interpretation is based on the current available scientific evidence. Even though arcensus will update your genetic data interpretation once per quarter according to the newest research findings, every report or its update is a snapshot of the information available at this time point. Arcensus will use only scientifically safe and published research data for interpretation of your genome.

 

Example:

It might happen that your initial report does not include any pathogenic variant and no disease diagnosis. However, in some cases we might update you at a later time point (months or years later) that scientific knowledge changed, and you are now considered as having a genetic disease.

 

 

8.      Risks of participation

 

The medical report about your WGS data can be complex and difficult to understand. Arcensus will give its greatest efforts to explain the results to you in understandable scientifically correct way. In this regard, you should know and accept the potential risks that are associated with arcensus’ services.

 

Unexpected information.

It might happen that your medical report contains information about yourself that you did not expect. This information can make you feel worried, uncomfortable, or cause situations of emotional stress. In extreme cases this information can even alter your life.

 

Minimum analysis errors.

Arcensus follows strict quality assurance protocols during the laboratory analysis processes. Nevertheless, a very small percentage (<0.01%) of the data generated during the offered services (of the external laboratory or arcensus) can be incorrect or unable to be interpreted.

 

Future genomic research.

Genetics is a relatively young scientific discipline and research is still ongoing. New future findings can partially or completely alter the interpretation of your WGS data and disease risks. You will be updated about any interpretation changes via our quarterly report updates.

 

Non-sharing of genetic data.

Genomic data might be used against your own interests when shared with third parties. Arcensus hence strongly recommends to not share your genetic information with any third party (including family members, friends, colleagues, etc). Of course, your medically findings can be shared with a doctor, however when sharing your genetic information with health care professionals, your genetic information can become part of your medical history and become accessible to undesired third parties (for example insurance companies).

You acknowledge that you will take responsibility for the possible consequences of sharing your genetic data with third parties. You will further exonerate arcensus, its employees, managers, directors, contractors, subcontractors, collaborators, successors, and authorized representatives and don’t consider them responsible for (A) the use or sharing of any information that was provided by you; and (B) the utilization of your genetic information and your provided personal data  in case you have shared those with third parties.

 

Data leakage.

Like with any other online service, others may be able to access your account and see your information if you disclose your password. The same applies in case your account password or genomic information is stolen (for instance due to the unlikely event of a security breach). Arcensus has strong data protection policies in place to minimize the possibility of a data breach, including the most recent IT technologies for storing of your data. To report a personal data security breach, please send an email with full details to [email protected]. You will find more detailed information at www.arcensus-diagnostics.com/privacy-policy.

 

Uniqueness of your Genome and pseudonymization.

Arcensus will share your pseudonymized data and samples with third parties for the genomic information interpretation purposes to generate your medical reports.

Additionally, you are able to consent for research. From these shared pseudonymized data, third parties cannot identify you. Nevertheless, there is a theoretic risk of re-identification of a person due to the uniqueness of genomic information. We thus recommend that you carefully handle your genetic and personal information. We advise you to not publish your genomic information in freely accessible databases or in Internet (e.g. for ancestry research), particularly not with any direct information or link to your person.

 

There may be additional risks to participation that are currently unforeseeable.

 

 

9.      Data collection and storage

 

The terms used here have the same meanings as given in the regulation 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (the “Regulation”). Such terms include without limitation controller, processor, personal data, data subject, processing, and personal data breach.

 

Arcensus will collect the following information of you during the registration process:

- First Name

- Last Name

- Date of birth

- Gender

- Race

- Nationality

- Medical information / symptoms

- Family history and relationships

- Specimen

- Email address

- Phone number

- Post address

 

You agree that arcensus stores your genomic and health data for unlimited time on its server.

 

You as the customer are the sole controller of your personal data or you have been instructed and authorized by the relevant controller(s) to agree to the processing of your personal data by arcensus. During the agreed services, you appoint arcensus as the processor to process your personal data under the terms agreed. Arcensus shall process your personal data only to perform its obligations of the services and in accordance with any written instructions by you. The personal data relates to the customer and his/her family members.

 

Arcensus is entitled to use sub-processors for processing personal data if it notifies you in writing not later than 30 days in advance. Arcensus’ obligation to notify you includes the addition, removal, or change of a sub-processor. When using sub-processors for processing your personal data, arcensus agrees that it will implement data protection measurements to protect your personal data in a no less stringent manner as for its own services. Arcensus is fully liable for its sub-processors’ compliance with the data protection requirements. A list of approved sub-processors will be updated from time to time.

 

If you consent on behalf of a minor or a disabled person, you declare that you hold the custody of your child(children) or disabled person and you are acting on its behalf.

Minors can also access their genetic data when reaching the legal age if they request so.

 

 

10.  Data protection and Data privacy

 

All personal data processed by arcensus on behalf of you is considered customer’s confidential information and arcensus shall not disclose these pseudonymized personal data to anyone else or use it for any other purpose. Arcensus ensures that only such people shall have access to the personal data that is necessary to fulfill its agreed services and that these people shall keep the data confidential. The duties of personal data confidentiality will survive the termination or expiration of this consent.

 

Consent for secondary use of data

Customers may give arcensus an informed consent for the secondary use of pseudonymized data for research, commercial, and related purposes (see chapter 13). Such consent must be freely given and will not affect the agreed services in any other way. In such an event, arcensus will act as the controller of the personal data for research and related purposes and assumes the liabilities of a controller. The legal basis for such data processing is Art. 6 para. 1 a) and Art. 9 para. 2 a) GDPR. In this regard, you will be asked for a broad permission to use your pseudonymized saliva sample and data. Your saliva sample and data will be used to speed up the prevention, diagnosis, and treatment of genetic diseases in general. In any research on genetic diseases - particularly due to the latest findings in genetic research - it is usually not possible to accurately predict which research questions will be addressed in the future. Therefore, the specific research purpose cannot be detailed herein, and your sample and data may be used for research projects that cannot be foreseen today.

 

Data transfer

The external partner for WGS sequencing will generate your genomic pseudonymized data. This partner will delete your genomic pseudonymized data in 30 working days after the sample is processed.

Additionally, you have the optional decision to share your data in pseudonymized form with third parties for future research and commercial purposes.

 

In principle, your Personal Data is processed only within Germany, the EU and the European Economic Area, where the GDPR provisions provide reasonable protection. However, if a data sub-processor is based outside the European Economic Area, arcensus may transfer your pseudonymized Data to such so-called third country, where GDPR provisions do not apply. However, such transfer shall only take place, if either (1) the European Commission has decided that such third country already provides an adequate level of data protection or (2) if arcensus establish appropriate safeguards with the data sub-processor; e.g. by concluding GDPR-compliant so-called “standard contractual clauses” for data transfers between EU and non-EU countries with the third country recipient including as the case maybe supplemental clauses containing additional safeguards, which fulfill GDPR requirements. In such case you have a right to request a copy of such “standard contractual clauses” by arcensus.

 

Security

Arcensus shall implement reasonably appropriate technical measures to protect your personal data from accidental or unlawful destruction, loss, alteration, unauthorized disclosure or access. Such measures shall take into account the state of the art, the costs of implementation and the nature, scope, context, and purposes of processing as well as the risk of varying likelihood and severity for natural persons’ rights and freedoms. Such measures include:

a) the pseudonymization and encryption of personal data;

b) the ability to ensure the ongoing confidentiality, integrity, availability and resilience of processing systems and services;

c) the ability to restore the availability and access to personal data in a timely manner in the event of a physical or technical incident;

d) a process for regularly testing, assessing, and evaluating the effectiveness of technical and organizational measures for ensuring the security of the processing.

 

Personal data breaches

Arcensus will notify you without undue delay about personal data breaches it becomes aware of, so that you can comply with the provisions of the regulation regarding personal data breach notifications within the set time limits. In such a case, arcensus must include necessary details about the personal data breach and provide reasonable assistance for you. Arcensus must also take other necessary measures to mitigate or remedy the effects of such a personal data breach and to prevent further breaches.

 

Contact information and data protection officer

For any privacy-related matters, you can contact arcensus’ data protection officer at arcensus GmbH, Goethestrasse 20, 18055 Rostock, Germany with the addition “Attn: Data Protection Officer” or by email at [email protected].

 

Only a unique bar code will permit arcensus to link the genetic information derived from your DNA sample to your account as a client of arcensus.

 

 

11.  Your rights and how to withdraw

 

You can exercise the following legal rights at any time by contacting the arcensus’ data protection officer at arcensus GmbH, Goethestrasse 20, 18055 Rostock, Germany with the addition “Attn: Data Protection Officer” or by email at [email protected].

 

You acknowledge and accept that providing your DNA sample and its subsequent processing of your genomic data does not mean the acquisition of any rights on the scientific research or the services or products that arcensus or organizations or persons associated with arcensus may develop.

 

Right to withdraw your consent and to request destruction of your saliva sample

You have the right (1) to withdraw your consent to receive the initial or the following update medical reports, (2) to withdraw your consent to the analysis of your saliva sample unless the analysis has already been performed (such a decision is not changing the obligation to fully take responsibility of the payment of the price per test as given at the Web page), (3) to withdraw your consent to the processing of your Personal Data at any time, (4) to request destruction of your saliva sample, and (5) to withdraw your consent to share your data for research purposes or with third parties according to chapter 13 (only with effect for the future). In each case, such right can be exercised with effect for the future and without giving a reason and it will not affect your access to your genomic information or to the Genetic counseling options.

Unless the analysis of your saliva sample has already been performed, arcensus will not perform the analysis once you withdraw your consent and/or request destruction of your saliva sample. However, if you withdraw your consent and/or request destruction, you get no medical reports about your genomic data anymore.

 

Right of access

You have the right to know if and which of your personal data is processed and stored.

 

Right to erasure

You have the right to have your personal, health, and genomic data deleted. However, arcensus may be allowed or required by applicable laws to retain certain personal data even after receiving a request to delete those.

 

Right to restriction of processing

You have the right to obtain restriction of the processing of your personal data.

 

Right to lodge a complaint with a supervisory authority

You have the right to file a complaint with a supervisory authority. With regard to pseudonymized data processed at arcensus in Rostock, the responsible supervisory authority is "Der Landesbeauftragte für Datenschutz und Informationsfreiheit Mecklenburg-Vorpommern“, Werderstraße 74a, 19055 Schwerin, Germany, phone: +49 385 59494 0, www.datenschutz-mv.de. However, you are free to file a complaint also with the supervisory authority of your place of residence, place of work or at the place where the alleged infringement occurred.

 

 

12.  Whom to contact if you have questions

 

In case of any questions, please contact [email protected].

 

 

13.  Consent

Optionally 

I consent to the use of my saliva sample, derived genomic and health data by arcensus in pseudonymized form - for statistical analyses, publications, and further scientific (including commercial) research, which focuses on the cause, early detection and/or treatment of genetic diseases in general. For that purposes my pseudonymized data might be shared with external scientific institutions and/or (pharmaceutical) companies that maintain data protection standards comparable to the GDPR for their own scientific (including commercial) research.


I would like my incidental finding(s) to be reported via a medical report.

 

Mandatory:

I herewith agree that I have read and understood this consent form. I agree to and accept all conditions and allow arcensus to use my saliva sample for a WGS analysis and to send me medical reports about my genomic data.