The Precision Health Initiative is conducted by Genuity Science. Listen to our new podcast here.

Frequently
Asked Questions

For all EU/EEA Personal Data collected by Genuity Science, reference to
“Genuity Science” below means Genuity Science (Ireland) Limited.
Genuity Science (Ireland) Limited is the Data Controller of all Personal Data
collected by Genuity Science and/or its Affiliates in the EU/EEA

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.

Technological advances mean we can now decode a person’s genome in days, compared to the 13 years it took to complete the first ever genomic map. This has made genomic research a viable and revolutionary new front in the pursuit of improved human health.

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 division.

Genuity Science (Ireland) Limited, formerly known as Genomics Medicine Ireland (GMI), was founded in Dublin in 2015 and in 2018 was acquired by WuXi NextCODE, headquartered in Boston.

Following a global corporate re-organisation, the companies began operating under the new and unified Genuity Science brand in Summer 2020, reflecting our efforts to improve offerings and services to customers globally and to grow and scale our operations for the greater benefit of all. Learn more

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 genetic factors that contribute to the development, progression and treatment of a condition, we need to develop 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.

If you have a couple of hours and 20ml (less than two tablespoons) of blood you would be willing to donate, we’d love to hear from you.

Perhaps, but if so, then only indirectly. Genomics studies take time and our goal is to facilitate research rather than treating specific participants, so you should not expect any direct benefit from volunteering to participate. However, your participation will increase our understanding of the relationship between people’s genomic make-up and disease and may lead to improved treatments over a period of years.

If you decide to volunteer 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 data and 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 center, you allow the clinical team to access your health records and provide relevant information to Genuity Science. This will not include personally identifiable information such as your name, address, date of birth, etc. that could be used to traditionally 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. Personal identifiers, 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 biological information will be studied together with that of other participants and analyzed by the research team to try and identify factors that contribute to disease.

The participant’s information may also be used in order to:

  • compare results with other health-related and wellness studies undertaken by Genuity Science
  • help us understand normal biological changes which do not cause health problems.

Once transferred to Genuity Science, access to your coded data and samples is tightly controlled as follows:

Data in the Genuity Science Clinical Omics Database

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, acquisition or access.  We ensure that all personal data controlled by us is stored securely in the European Union 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 traditional identifiable 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 traditional identifiable 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 never receive any personal identifiable data such as your name, date of birth or address. All your data in the Genuity Science Clinical Omics Database is de-identified and coded.
  • Our commercial partners and approved researchers only have restricted access to select de-identified datasets containing only the 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.

Other than Genuity Science, only your doctor and their affiliated institution, and our commercial partners and authorized research groups can access the Genuity Science database 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 joined 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 Genuity Science database to access your coded 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 or from downloading your coded data from the Genuity Science. These groups can only access select coded datasets that are needed for their specific study to read and analyze your coded data. They do not have access to your name, date of birth, or other similar identifiers that would allow anyone accessing the database to establish your identity. They can never download any participant's personal data from the Genuity Science database.

Biological materials:

Genuity Science does not provide access to your biological materials to any third parties except for small amounts of the biological sample that may be sent to external, appropriately certified laboratories for analysis, to generate the data required as part of this research study.

Genuity Science will destroy your biological samples ten (10) years after the study starts at the study site.  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 Ethics Committee.

As science advances, Genuity Science will continue to analyze the coded data in our database for many years to come. For this reason, your medical, lifestyle and biological data generated as part of the study will be retained for the duration of the scientific research, in accordance with EU Data Protection Laws. This data will only be processed for the purposes outlined in the patient information leaflet you receive at the study site. It will not contain any information that traditionally would be used to identify you (such as your name or date of birth).

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 or consultant being required.

If you wish to withdraw from a Genuity Science study and your biological sample has not been converted into data, we will destroy your biological sample and delete your medical and lifestyle data.

If you wish to withdraw from a Genuity Science study and your biological sample has been converted into data and included in Genuity Science’s database, then it will be necessary for Genuity Science to retain your coded data in our database and continue to process and analyze it in order to achieve the scientific purpose of the research. Your data cannot be withdrawn from published results or findings.

Genuity Science will ensure that the code that links your coded data to your name is destroyed, so that it will no longer be possible to link your coded data held by Genuity Science back to your details held at the study site.

Genuity Science will also destroy any remaining biological sample so it can no longer be used.

Where Genuity Science continues to process your coded data, we ensure that high levels of security measures continue to remain in place at all times to protect all data in the Genuity Science database.

  • 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 recognized accreditation board and widely considered the leader in laboratory quality assurance.
  • As needed, in order to meet demand, Genuity Science may also use third-party accredited laboratories.
  • Research study participant data is pseudonymized in the Genuity Science database, meaning Genuity Science does not hold any personally identifying information (such as name, date of birth, address, etc.). Therefore, access to Genuity Science’s database alone will not enable any party to identify a participant in any of our studies.
  • Genuity Science does not provide third-party access to our pseudonymized data other than to those with whom we have a legally binding collaboration agreement.
  • Where a request for data is made pursuant to a court order or applicable law to Genuity Science, this will require the cooperation of the collaborating hospital in order to link the pseudonymized Genuity Science study number to an individual participant’s personal identity.