Genomics is the study of our genes - the DNA contained in the cells of our body that acts as a blueprint for a human being.
Each of us has a slightly different DNA sequence that sets out who we are, how we work… and even how we can be repaired. Studying our DNA can help us understand an amazing range of health-related characteristics, including:
- understanding disease risk
- predicting our response to medications
- pointing the way to new treatments and cures
The famous double-helix structure of our DNA contains a lot of information; there may only be four building blocks in the structure (A, C, G and T) but every strand of our DNA contains 3.2 billion of these letters.
We use techniques such as whole genome sequencing, which reads every letter of your DNA (i.e. your “genomic instructions”), to enable us to read your genomic data from these biological samples.
Genuity Science is a global privately-funded life sciences company, headquartered in the US, which carries out important research on the human genome to examine the relationship between genetics, health and disease. Genuity Science (Ireland) Limited is its Dublin-based company.
Genuity Science conducts research studies by working closely with clinics, universities and commercial partners. To enable this research, Genuity Science is building a database of genomic and health related data that will be used, on a strictly controlled basis, by Genuity Science and appropriately authorised commercial partners and academic research groups.
Genuity Science is undertaking multiple research studies looking at how changes in our DNA might influence the development, progression and treatment of disease. Working with patients, advocacy groups, clinicians, academic researchers and global biotech and pharmaceutical companies, Genuity Science hopes to gain insights that can be used to develop new treatments and diagnostics for a broad range of conditions.
In order to identify the specific genomic factors that contribute to the development, progression and treatment of a condition, we are developing a database (much like a library) of genomic information that will enable us to compare the genome of those with a particular condition to the genome of those without that condition.
Participation in a Genuity Science study will not benefit you directly. You will not receive any financial benefit, results or feedback from the study. This includes results related and unrelated to your condition, either generally or personally. However, information obtained from the study may help us to better understand your condition and to improve diagnosis and treatments in the future.
If you decide to participate and consent to one of our studies, you will be asked to:
- Sign a consent form once you are provided with all the relevant information to make an informed decision.
- Give 20ml (a tablespoon and a half) of your blood.
- Answer a lifestyle questionnaire.
- Allow your pseudonymized (or coded) whole genome sequence data to be linked with your coded health and lifestyle data, which would then be stored in a secure and restricted Genuity Science database.
- Allow researchers, organizations and companies approved by Genuity Science to look at your coded data stored in the Genuity Science database in a way that protects your identity. Genuity Science Participant Data Privacy Statement
- If you participate through a clinical centre, you allow the clinical team to access your health records and provide relevant information to Genuity Science. This will not include directly identifiable personal data such as your name, address, date of birth, etc. that could be used to identify you.
You may withdraw your consent during the course of the study.
- All samples and study information are assigned random study ID numbers at the research study site in a process called pseudonymization. This process is intended to mask each participant’s identity and code your data. Directly identifiable personal data such as a participant’s name or date of birth, are never used to label the participant’s samples or clinical information.
- If required, in very special cases (e.g. withdrawal from the study), this process can be partly reversed using a special ‘decryption key’. This process cannot be fully reversed without the help of the doctor at the study site. He/she is the only person who can convert the participant’s originally assigned random Study Number to the participant’s name. This means that the participant’s identity has been doubly secured.
- Genuity Science Research Study Participant Data Privacy Statement
The participant’s medical, lifestyle, and genomic data will be studied together with that of other participants and analysed to try and identify factors that contribute to disease.
The participant’s information will also be used in other health-related analyses that are undertaken by Genuity Science, as a comparison with other conditions and to help us understand normal biological changes that may be associated with health.
Once transferred to Genuity Science, access to your coded data and samples is tightly controlled as follows:
Secure storage:
We have a robust level of technical and organisational measures in place to protect your data from unlawful or unauthorised destruction, loss, change, disclosure or access. We ensure that all personal data controlled by us is stored securely in the EEA (European Economic Area) using the highest level of security measures.
- Only your doctor, their research team or the Genuity Science study personnel at the research study site have access to your directly identifiable personal data such as your name and date of birth. They keep that information so they can facilitate a request to withdraw from the study. This directly identifiable personal data never leaves the research study site. Genuity Science study monitors liaise with your doctor and the research team at the research study site to check that the study is being carried out correctly, adhering to the research institution’s approved ethics terms and ensuring the appropriate consent is in place.
- At Genuity Science, we do not receive any directly identifiable personal data such as your name, date of birth or address. All your data in the Genuity Science Database is pseudonymised or ‘coded’.
- Our commercial partners and approved researchers only have restricted access to select datasets containing only the de-identified information they need for their specific and approved research study. This restricted access is governed by legal contract with Genuity Science. These researchers are prohibited from attempting to identify an individual participant from the data in the database.
Access:
Genuity Science controls all access to the Genuity Science database where your coded data is stored. Genuity Science’s researchers, Genuity Science’s commercial partners (such as pharmaceutical or biotech companies) and authorised research partners can access your coded data for commercial and academic research projects.
Other than Genuity Science, only our commercial partners and authorized research groups can access the study data as follows:
- Genuity Science may provide your Study Doctor, and the university (s)he is affiliated with, with a copy of your coded health and lifestyle data to use for their own teaching and research.
- You can agree to opt in to permit Genuity Science to also provide a copy of your genomic data to your Study Doctor.
- These groups can only use your data in a manner that is consistent with the basis on which you agreed to take part in Genuity Science’s study as described in the Patient Information Leaflet and the Informed Consent Form that will be provided to you before you take part in the study. Your separate consent will be required for any other use.
- Before Genuity Science’s commercial partners or authorized research groups can access the select datasets from the study data, Genuity Science enters into legal agreements with these third parties, which strictly control their activities and prohibit them from ever attempting to re-identify a participant. These groups can only access selected datasets containing only the de-identified information they need for their specific and approved research study. They do not have access to your name, date of birth, or other similar identifiers that would allow anyone accessing the dataset to establish your identity. They can never download your personal data from Genuity Science.
Biological materials:
Genuity Science does not provide access to the blood sample you donate or to any biological materials derived (DNA) from that blood samples. Occasionally small amounts of the biological sample may be sent to external, appropriately certified laboratories in the European Economic Area, to process the sample for specialised services or in the event of capacity issues at Genuity’s laboratory in Dublin.
Genuity Science will retain your biological samples for ten (10) years after the study starts at this clinic. If a longer time period is required for the continuation of the study, for example if Genuity Science makes a discovery that requires further investigation, but the approved study period has expired, any request for extension, and the associated period of time, will be subject to approval by the relevant Research Ethics Committee.
Genuity Science periodically reviews the necessity to retain all the data it collects and processes. Genuity Science will keep your coded data for the duration of the scientific research being carried out by Genuity Science and its commercial and other research partners. Any data that is no longer being used for the purposes outlined in the Participant Information Leaflet will be deleted.
Your participation is entirely voluntary. If you elect not to participate, it will not compromise your standard of care in any way. Those who do choose to participate can elect to withdraw from the study later, with no reason and no permission from a doctor being required.
As the information or data that Genuity Science collects for its studies relates to your health, it is known as “personal sensitive data” under Irish Data Protection Laws. In accordance with Irish Data Protection Laws, your explicit consent is the lawful basis on which Genuity Science will process your personal data in the first instance.
In the event that you exercise your right to withdraw your consent from a study, Genuity Science may need to continue to process your data on the basis of the legitimate interests of Genuity Science (and its commercial and academic research partners) in the pursuit of scientific research, as deletion of your data would seriously impair the purpose of the research.
You can withdraw from a Genuity Science study at any time. You will need to contact the clinic where you signed up to the study to exercise your right to withdraw, as Genuity Science does not know your identity and cannot correlate your name with the Coded Data which Genuity Science holds. However, please be aware that the timing of withdrawal from a Genuity Science study, and whether or not your data has been included in a “data freeze”, will affect whether or not Genuity Science needs to continue to process your data.
A “data freeze” means that all the data collected up to a certain point in time is effectively “frozen” to create a fixed point of reference for our research. Each time Genuity Science carries out a new data freeze, the previous one is archived.
In the event of any request by you to withdraw your consent, your Informed Consent Form will be retained at the clinic for legal, regulatory and audit purposes.
Withdrawal before your data has been included in a data freeze:
- If you submit a request to withdraw from this study before your data has been included in a data freeze, Genuity Science will promptly delete any of your data held by Genuity Science and destroy your biological sample so it can no longer be used.
Withdrawal after your data has been included in a data freeze:
- If you submit a request to withdraw from this study after your data has been included in a data freeze, Genuity Science will promptly destroy your biological sample so it can no longer be used but whilst your data cannot be removed from any data freezes in which it has already been included, it will not be included in any future data freezes. Once the next data freeze has been carried out, the previous data freeze is archived.
- Genuity Science will also promptly destroy the link or code connecting your coded data held by Genuity Science to your name, address and date of birth held by your Study Doctor. This means that your coded data held by Genuity Science can no longer be decoded.
- Your data cannot be withdrawn from published results or findings
- Genuity Science established Ireland’s first purpose-built genome sequencing laboratory in Dublin in 2018. Sequencing is conducted within this facility, as capacity allows.
- Our genome sequencing laboratory is accredited by the College of American Pathologists (CAP) which is an internationally recognised accreditation board and widely considered the leader in laboratory quality assurance.
- Genuity Science does not share samples with any third party. In certain circumstances specialised services may be required, or capacity issues may arise, which require small amounts of coded samples to be sent to other certified laboratories located in the European Economic Area or Great Britain. Any data generated by these laboratories from the coded samples will be protected as required by relevant data protection laws in Ireland and the EU, including the General Data Protection Regulation (“GDPR”).
- The research study participant data which Genuity Science holds is pseudonymised or anonymised (‘coded’) meaning Genuity Science does not hold any directly identifiable personal information (such as name, date of birth, address, etc.). Therefore, access to Genuity Science’s data alone will not enable any party to identify a participant in any of our studies.
- Where a request for data is made pursuant to a court order or applicable law to Genuity Science, the cooperation of the source institution is also required in order to link the coded data which Genuity Science holds with an individual. This process can only be successfully completed where the link between the name and the code has not been deleted.
Genuity Science works with commercial partners to carry out health related research, these commercial partners include pharmaceutical and biotech companies who develop new diagnostic tests, identify new risk factors or drug targets, and develop, test and market new drugs. Our collaboration with commercial partners increases the potential of a novel biological finding arising from this research and will be key in accelerating the translation of a novel discovery into the drug development pathway where they may result in a potential new therapy.
For more details on our current commercial partners, please click here.
Genuity Science does not allow access to any personal data for marketing or insurance purposes.
