For Participants

 

If you have decided to volunteer or you’re considering volunteering for one of Genomic Medicine Ireland’s research studies, we hope the information below will be helpful in answering the questions you may have.

We are grateful for your participation.

Frequently Asked Questions

About GMI and Our Research Studies

  • What is genomics?

    Genomics is the study of genomes. The word “genome” refers to all the DNA contained in the cells of our body. It’s like a very special instruction manual that is unique to you and contains all the information needed to make you, run you and repair you.

  • Who are GMI?

    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.
  • What is GMI's research about?

    GMI are leading multiple research studies across Ireland looking at the human genome for changes in the DNA which influence the development, progression and treatment of disease. Working in partnership with clinicians, patients, academic researchers and global biotech and pharmaceutical sectors, GMI hope to glean new insights that researchers may use to help develop new treatments and diagnostics for a spectrum of incurable conditions.

  • Why take part?

    • 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.
    • It is hoped that this will lead to better individualised treatments and ultimately a cure for their condition.
  • Will this research be of direct benefit to participants?

    Genomics studies, by their nature, take time. The goal of our studies is to facilitate research and not to treat specific participants therefore, 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.

  • What's involved if you elect to take part?

    If you decide to volunteer and consent to one of our studies, in essence, you are agreeing to:

    • Give 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 and organisations approved by GMI to look at your data in a way that protects your identity, including for-profit healthcare companies such as those developing medicines and diagnostic tests
    • 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 any personally-identifying information such as names, addresses, dates of birth, etc.)

    You may withdraw your consent at any time during the course of the study

  • How is your privacy protected?

    • GMI takes responsibility for all personal information that is entrusted to us. Protecting your privacy is of utmost importance to us. All our employees are accountable for personal data privacy.
    • GMI is registered with the Data Protection Commissioner and has a designated Data Protection Officer. Our studies must receive ethical approval from local Research Ethics Committees before any study commences.
    • The company’s activities will also be independently audited.
    • 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.
  • How will participant data be studied?

    • 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.

       

  • Who will have access to the data generated for these research studies?

    Access to the participant’s data and samples is tightly controlled as follows:

    Medical records and research study records

    • Only specified research staff within the clinic can access the participant’s medical records (with his/her consent) and the research study records in the clinic.

    Pseudonymised Data in GMI database

    • The GMI database will be held in a secure place with highly controlled access.
    • This database cannot be accessed by the general public.
    • GMI may approve and grant controlled data access to third-parties including academic research groups, pharmaceutical/biotechnology research group and for-profit companies. Third parties will conduct health-related research to increase the chance of important discoveries. This may include users outside of the European Union.
    • Approved data users must agree to and maintain the strict confidentiality conditions required when working with this data.
    • Approved users will not receive a copy of the participant’s data. GMI will only grant access to view and analyse the data held within the GMI database.
    • GMI does not provide access to our data unless we have a written collaboration agreement or are obliged by applicable law.

    Biological materials

    • GMI may provide a small amount of sample to third-party service providers to generate the data required as part of this research study.
    • GMI does not otherwise provide access to a participant’s biological materials to any third-parties.

    The following groups may also be given access to any data, records and samples to monitor, confirm and maintain the security of the research study: (1) the Ethics Committee and Regulatory Authorities (2) consultants working on behalf of GMI who may need to access these records to monitor and confirm the conduct of the study and the security of the database and (3) any party to whom we are under a duty to disclose any data in order to comply with a legal obligation.

  • How long will blood samples be kept?

    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.

  • Can a participant decide not to take part?

    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; no reason and no permission from a doctor or consultant is required.
  • If a study participant decides to withdraw, what happens to their blood sample and their data?

    • 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.
  • Where will GMI samples be sequenced?

    • GMI are working to establish a world-class clinical laboratory based in Greater Dublin as a priority. Once established, we will conduct all of our sequencing here in Ireland.
    • In the interim, as there is not currently an accredited lab in Ireland capable of conducting whole genome sequencing, we will send pseudononymised samples for sequencing abroad, including to laboratories outside of the European Union (EU). All laboratories are certified by the relevant regulatory authorities.
  • Can a third-party use legal process to gain access to the GMI database?

    • Participant data is pseudononymised in the GMI database and 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.