Deeply committed to
data stewardship

When you volunteer to participate in one of our research studies, with your consent the research team will collect the following data:

• health and lifestyle information from you directly;
• for some studies, study specific assessments such as spirometry; physical
  measurement such as height, weight and blood pressure; and
• if you have a health condition, your medical team, with your permission,
  will provide us with information from your medical records.

Only the information required to address the research question will be taken from your medical records.

The data we collect will never include your name, address, date of birth, social security number or other demographic information which identifies you.

During our research studies we will also collect a biological sample from you such as blood or saliva. In some studies, we may also request access to a small portion of a tissue sample which was previously obtained from you. 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 collects your data in order to try to identify similarities across different diseases in order to maximize discoveries that could lead to drug discoveries and better use of existing drug treatments.

We combine your data with data from thousands of other participants (with similar diseases and without any diseases) in our Clinical Omics Database to study the similarities and differences in the data and how they relate to health. Researchers then look for patterns that may give clues about the causes of health conditions, or patterns that might help us to better understand a condition or find a new way to treat it.

The information or data that Genuity Science collects for this study is known as “personal sensitive data” under Data Protection Laws as it relates to your health. Under Data Protection Laws, your explicit consent is the lawful basis on which Genuity Science can process your personal data in the first instance.

Once your biological sample has been converted into data, combined with your health and lifestyle data and entered into the Clinical Omics Database, the lawful basis after this point is the legitimate interest of the scientific research being undertaken by Genuity Science (and its commercial partners), as deletion of your data after this point would seriously impair the purpose of the research.

In accordance with the European and Irish data protection laws, we shall only process, store and use your data in a manner that is consistent with the basis on which you joined Genuity Science’s research study as described in the information materials and consent form you receive at the research study site.

• Keeping your data safe is a priority for Genuity Science. Personal identifiable data, such as your name or date of birth, are never used to label your samples or clinical information. All samples and study information are assigned random study ID numbers at the clinic in a process called pseudonymization. This process is used to mask your identity and code your data.
• We have a suite of technical and organizational measures in place to protect your data from unlawful or unauthorized destruction, loss, change, disclosure, acquisition or access.  We ensure that all personal data controlled by us is stored securely in Europe 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 shall only have restricted access to select de-identified datasets which contain only the information they need for their specific and approved research study. Furthermore, your data can only be read or analyzed by these researchers on the execution of a legal agreement. These researchers are prohibited from attempting to identify an individual participant from the data in the database.

Genuity Science controls all access to the Clinical Omics Database where your 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 Clinical Omics 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 opt in to Genuity Science also providing 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 Clinical Omics 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 Clinical Omics Database. 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 participants’ personal data from the Clinical Omics Database.

• 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 the Clinical Omics 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 destroy the code that links your Coded Data to your name 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, Genuity Science ensures that high levels of security measures are in place to protect all data in the database.

We also make sure participants are informed about their legal rights as data subjects.

You can find a full copy of our Participant Privacy Statement.  If you have any further questions, our FAQs will hopefully give you the answers you are looking for.  But if you need any more information, please contact us and we will respond to your query.

With the consent of our research study participants, we provide a copy of their genomic, clinical and lifestyle data with the clinical collaborators at the hospital where the data was collected and its associated university. Our clinical collaborators can use the data for their own research purposes (in line with the original consent given by the participant).

As part of our global collaboration studies to uncover new drug therapies and treatments, we allow our commercial collaboration partners to access our Clinical Omics Database (where the genomic, clinical and lifestyle data is stored) to explore the data via an access-controlled environment.  Our commercial partners can only use the data for research in line with the original consent given by the participant.  Our commercial partners can only access our Clinical Omics Database to run their analyses within our platform via Remote Virtual Desktop.  When they log in to our system, all database activity is logged and tracked, and their analyses are monitored by us.  Our collaboration partners can never download genomic data from our Clinical Omics Database.  It is like a “reading library” rather than a “lending library”.  The personal data stored on our Clinical Omics Database does not have any identifiers such as names, dates of birth, addresses, social security numbers or codes that would enable anyone accessing the database to associate the data with the identity of an individual study participant.

We will always ensure that we have the appropriate legal mechanisms in place when we share genomic data, such as EU Standard Contractual Clauses.

All genomic and clinical data that we collect for our research studies is stored and managed using an ISO-certified cloud-based storage provider in the EU. Back-ups are stored on a similarly secure infrastructure within the EU. The data centre facilities in the EU on which this data is stored are Tier 3+ and are operated by the recognised world leader in the field and comply with international standards.

1. Our commercial partners have virtual access only: our commercial partners can only access select coded datasets in our Clinical Omics Database (where the genomic data is stored) to run their analysis within our platform via Remote Virtual Desktop
2. All database activity is logged: when commercial partners or academic collaborators log in to our system, all database activity is logged and tracked, and their analyses are monitored by us
3. No identifiers are stored with the genomic data: the personal data stored on our Clinical Omics Database does not have any identifiers such as names, dates of birth, addresses, social security numbers or codes that would enable anyone accessing the database to associate the data with the identity of an individual study participant
4. Legally binding agreements: before any commercial collaborators can access our Clinical Omics Database, we will put a legally binding agreement in place that imposes strict contractual restrictions around access to and use of the database
5. Law enforcement requests: as we do not know the identity of any participants in our research studies, we cannot disclose genomic data unless a valid court order has been served on the original study site and they request a copy of the data from us under the court order; even then we will only disclose it to the extent specifically required by that court order
6. No access to genomic data is allowed for marketing or insurance purposes:  we never allow access to our Clinical Omics Database for marketing or insurance purposes

• Our Data Management Processes ensure that the clinical and lifestyle data collected for our research studies is of high quality, accurate, complete, standardized and curated
• Stringent Data Quality Control metrics are implemented so that only high-quality data is used in the research study
• All data in our Clinical Omics Database is formatted to maximize usability in research studies and the chance of discovery
• Our Error Detection Program is designed to detect any errors and ensure they are promptly rectified
• All genomic data is generated in accredited genomic laboratories

• Our Deviation Management Processes help ensure all our research studies are performed following the approved Standard Operating Procedures, protocols and work instructions;
• These processes incorporate process optimization, and ensure that corrective and preventative measures are taken promptly when required.

• Our Training Processes help ensure processes and procedures are effectively and consistently carried out
• All personnel within Genuity Science and at our research study sites have necessary training as per their role
• All training is documented, maintained, updated and audited

• Our Review and Approval processes ensure standardization and accuracy of documentation and processes across all research study sites
• These processes ensure that all required stakeholders approve any changes to Study Documentation and processes before they are made
• This minimizes the risk of unintended consequences and optimizes implementation of the change

• Our Site Monitoring Processes monitors compliance with approved Standard Operating Procedures, protocols and work instructions at the research study sites
• Our internal auditing of processes monitors compliance with internal quality system processes and procedures