Check out our page all about exactly that.
Genomics Medicine Ireland (GMI) are a privately-funded Irish life sciences company researching the human genome to examine the relationship between genetics, health and disease.
GMI are leading multiple research studies across Ireland looking at how changes in our DNA might influence the development, progression and treatment of disease. Working with clinicians, patients, academic researchers and global biotech and pharmaceutical companies, GMI hopes to gain insights that can be used to develop new treatments and diagnostics for a broad range of conditions.
This research would not be possible without you, the volunteer participants! 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 of genomic information that will enable us to compare the genome of those with a particular condition to those without that condition.
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 the genome 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:
- Give 20ml (a tablespoon and a half) of your blood
- Answer a short lifestyle questionnaire
- Sign a consent form once you are provided with all the relevant information to make an informed decision
- Allow your whole genome sequence data to be linked with your health data in a pseudonymised and secure GMI database
- Allow researchers, organisations and companies approved by GMI to look at your data in a way that protects your identity
- If you participate through a clinical centre, you are allowing the clinical team to access your health records and provide relevant information to GMI. (This will not include personally-identifying information such as names, addresses, dates of birth, etc.) that would be used to traditionally identify you.
- You may withdraw your consent at any time 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 pseudonymisation. This process is intended to mask the participant’s identity. Personal identifiers, such as the 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 principal investigator. 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.
The participant’s medical, lifestyle, and biological information will be studied together with that of other participants and analysed by the research team to try and identify factors that contribute to disease.
The participant’s information may also be used:
- for comparison in other health-related and wellness studies undertaken by GMI and
- to help us understand normal biological changes which do not cause health problems.
Once transferred to GMI, access to your data and samples is tightly controlled as follows:
Data in the GMI database
- Your medical, lifestyle and genomic data excluding any information that traditionally would be used to identify you e.g. name or birth date) is stored securely in a GMI database in a secure location with a high level of access control.
- GMI will share your clinical and lifestyle data with your doctor
- GMI will allow approved pharmaceutical/biotechnology companies and research groups to have strictly controlled access to your clinical, lifestyle and genomic data for research into diseases and to increase the chance of important discoveries in this area. This access excludes any personal identifying information like your name or birth date. These approved users may be located outside the EU. All access will be in line with EU data protection laws.
- GMI 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 certified laboratories for analysis, to generate the data required as part of this research study.
Samples will be kept for 10 years, after which they will be destroyed unless the research team applies for and is granted a research study extension by the relevant hospital or institutional ethics board.
Yes, 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 the study participant’s medical, lifestyle and/or genetic information has not yet been included in any analysis, GMI will destroy all of the participant’s samples and delete the participant’s data.
- If the study participant’s medical, lifestyle and/or genetic information has already been included in some analyses, we cannot undo this as this would impair research objectives and validation of key research findings. The data will be kept but we will make sure that the participant’s information, medical, lifestyle and/or genetic information, is not included in any more analyses.
- The information that links the participant’s name with the Study Number is held securely in the participant’s clinic. These documents will be destroyed 20 years after the research study begins. This timeframe may change depending on regulatory or legal obligations, or if our study is extended following approval from the hospital Research Ethics Committee. Once the documents are destroyed the clinical/lifestyle information and data becomes anonymous, i.e. the link between your name and information has been destroyed forever.
- GMI has established Ireland’s first purpose-built genome sequencing laboratory at our headquarters in Dublin and sequencing will be conducted within our own facility, as capacity allows. As needed in order to meet demand, GMI may also use third-party accredited laboratories.
- Any third-party laboratories must be fully accredited and use of these facilities has been approved by the Research Centres’ Ethics Boards.
- Participant data is pseudononymised in the GMI database, meaning GMI do not hold any personally-identifying information (such as name, date of birth, address etc.). Therefore, access to GMI’s database alone will not enable any party to identify a participant in any of our studies.
- GMI do not provide third-party access to our pseudononymised data other than to those with whom we have a collaboration agreement.
- Where a request for data is made pursuant to a court order or applicable law to GMI, this may require the cooperation of the collaborating hospital in order to link the pseudononymised GMI study number to an individual participant’s personal identity.