FAQ
The Registry is open to parents or caregivers of an individual with a confirmed diagnosis of Angelman syndrome.
Your experiences with Angelman syndrome add to a collection of information that builds the best comprehensive understanding of Angelman syndrome possible for all stakeholders (researchers, pharma, clinicians and you!). Your participation is 100% voluntary and all your personal information is protected by strict data privacy and security procedures. You can opt into the research project via a series of consents and you can opt-out at any stage.
To meet strict data collection and storage standards and pass a comprehensive ethics (IRB) review there are requirements for participation, how we contact you and how your data can be used. You will see that some consents are mandatory (meaning that you are unable to participate if you have not checked the boxes) and that there are also some that are optional. It is important to consider the optional consents as this is how you may be contacted about involvement in research or clinical trials, if you have not checked consents regarding being contacted we are unable to contact you. You can withdraw any or all of the consents at any stage.
- I confirm that I have read and understand the information sheet (V10.5) dated 25 November 2020, for the above study. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily.
- I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected.
- By entering data into the registry, I understand that I give consent for the storage of data on my child/ adult with Angelman Syndrome in the Global Angelman Syndrome Registry.
- I understand that the storing of data will allow contact to be made with me if a suitable clinical trial/ research study becomes available for my child/ adult with Angelman Syndrome.
- However, I accept that allowing my data to be stored on this database does not mean my child/ adult with Angelman Syndrome will automatically be entered into future clinical trials/ research studies.
- I understand that the data I provide may be used to inform and plan future research.
- I understand that the results from future research may not have any direct implications for me or my family.
- I am happy to consent to be included in this registry.
- I confirm I am happy for the specialist in charge of my medical care to be contacted to verify diagnostic information.
- I confirm that I am happy for my de-identified data to be made available for analysis through third party platforms
- I consent to being contacted to complete additional modules/ for longitudinal follow up.
- I consent to being contacted about clinical trials and research studies that my child/ adult with Angelman Syndrome may be eligible to participate in.
The current modules are:
- Newborn and infancy history
- History of diagnosis and results
- Hospitalisations and surgical procedures
- Epilepsy
- Medications, interventions and therapies
- Clinical trials and studies
- Illnesses or medical problems
- Communication
- Behaviour and development
- Sleep
- Pathology and Diagnostics
The Global Angelman Syndrome Registry is on a cloud based Amazon Web Server hosted in Australia by Queensland University of Technology, who host a number of other patient registries. It has medical-grade security. All information we receive from you will be treated confidentially and will be encrypted and stored on a secure server. The Rare Disease Registry Framework incorporates several levels of security to protect against data loss and unauthorised access to registry information.
Any Registry data disseminated to the public domain will be aggregated and de-identified, as patient names, dates of birth and other information which could potentially lead to the identification of participants will be removed from the analysis and replaced with a unique identification number. Names and other potentially identifiable information will be linked to these unique identification numbers in a separate file stored on a secure computer terminal, on a separate database to any health data at the university. This process ensures that all data is potentially “re-identifiable” should the need occur. Only de-identified data will be made accessible to researchers who are granted permission through the Global Angelman Registry Governance Board.
All requests for data go through the Data Curator to the Global Angelman Syndrome Registry Governance Board. The Governance board consists of a variety of stakeholders including a representative from the Foundation for Angelman Syndrome Therapeutics Australia, a parent representative and a number of other medical professionals from relevant disciplines. Your contact information will not be given to anyone without your consent.
If you consent to be notified of clinical trials, you may be matched with potential clinical trials. If your child/adult with Angelman syndrome matches the eligibility criteria of an upcoming clinical trial, you will be notified of the opportunity and be provided with contact details for the study coordinator. It is your choice whether you wish to follow up with the study coordinator to learn more about what it entails.
