Frequently Asked Questions

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 (Ireland) Limited is a privately-funded life sciences company, headquartered in Ireland, that carries out important research on the human genome to examine the relationship between genetics, health and disease. Genuity Science (Ireland) Limited is owned by HiberCell Inc., a US based biotech 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 (Ireland) Limited is responsible for the management and control of all EU Research Data stored by Genuity Science (Ireland).

We are deeply committed to the ethical and responsible stewardship and use of all Research Data in a safe and secure manner in compliance with all applicable laws, including GDPR, the Irish Data Protection Act 2018 and the Irish Health Research Regulations 2018.

The institution, where you participated in the study, is the data controller of any personal information pertaining to study participants that remains at the study site and the institution continues to be the data controller of all medical files.

Genuity Science collects your data for the purpose of scientific research to improve our understanding of health and disease. This type of research could lead to drug discoveries and better use of existing drug treatments.

We combine your data with data from thousands of other participants (some with similar diseases and some without any particular diseases) in our database to study the similarities and differences in the data and how they relate to health and disease. Researchers then look for patterns that may help understand the causes of health conditions, the reasons why some people develop certain conditions but others do not, why some people have more severe symptoms than others or patterns that might help to find a new way to treat them.

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.

• Keeping your data safe is a priority for Genuity Science. All biological samples and study information are assigned random study ID numbers at the clinic/study site in a process called pseudonymisation. This process is used to mask your identity and code your data.
• We have a robust level of technical and organisational measures in place to protect your data from unlawful or unauthorised destruction, loss, change, disclosure, acquisition or access. We ensure that all personal data controlled by us is stored securely in Europe using high levels of security measures.
• Only your doctor and their research team at your study site has access to 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.
• At Genuity Science, we never receive any directly identifiable personal data such as your name, date of birth or address. All your data in Genuity Science’s database is de-identified and coded.
• Our commercial partners and approved researchers only have restricted access to select de-identified datasets which contain only the information they need for their research study. Furthermore, your data can only be read or analysed by these researchers on the execution of a legal agreement. They run their analyses within our platform. When they log in to our system, all database activity is logged and tracked. These researchers are prohibited from attempting to identify an individual participant from the data in the database. They are also prohibited from downloading your personal data from the Genuity Science database. They are only permitted to download and export summary analysis results.

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.

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. These partners analyse the data through an access-controlled environment. Please click here for the list of current commercial research partners.

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.

Genuity Science has engaged a third party platform provider who has controlled access to your personal data for the purpose of providing services to Genuity Science.

We do not allow access to any data for marketing or insurance purposes.

Genuity Science will retain your biological samples for up to 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.

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.  You should be aware that your data cannot be withdrawn from published results or findings.

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 stored by 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 your consent 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 your consent 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.

All biological samples collected by Genuity Science are securely stored on a coded basis at a certified genomics laboratory at Cherrywood, Co. Dublin, Ireland. Our biobanking partner has no way of identifying any samples that it is storing on behalf of Genuity Science.

• 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.