Privacy Information

PRECISION ALS PARTICIPANT PRIVACY NOTICE

Introduction

The purpose of this Privacy Notice is to explain to you, as participants of the PRECISION ALS (P-ALS) Research Programme, how we collect, share, and use your personal data, which has been shared with us by you directly or by your hospital or National ALS Registry on your behalf, and with your consent.

This Privacy Notice sets out the steps taken by us, P-ALS to safeguard your rights under data protection law.

This Privacy Notice explains the following:

What is the P-ALS Research Programme?
Who takes part in P-ALS?
What personal data is shared with P-ALS?
How do P-ALS securely store your personal data?
What is the legal basis for the use of your personal data?
Who will access your personal data and samples?
How long will P-ALS retain your personal data and samples?
Your rights in relation to your personal data under data protection law
How can you withdraw from P-ALS.

What is the P-ALS Research Programme?

P-ALS is an ambitious research programme that brings together academic, clinical, health related commercial and data analytic companies and Clinicians, Computer Scientists, Information Engineers, Technologists, and Data Scientists from across Europe to provide new insights into our understanding of Motor Neuron Disease (MND), also known as Amyotrophic Lateral Sclerosis (ALS).

The primary aim of P-ALS is ‘to help find the right drug for the right patient at the right time.

ALS progresses in different ways for individuals and several sub-types of ALS/MND are recognised by clinicians. The number of people in any one country with ALS/MND is small. This makes it difficult to provide in depth knowledge of the causes and patterns of progression of ALS/MND.

P-ALS aims to address this gap by combining clinical data from ALS/MND patients across Europe, into a centralised European registry.

P-ALS combines data collected by European sites which are members of the European ALS/MND Consortium TRICALS (Treatment Initiative to Cure ALS (www.Tricals.org)), with the Irish National ALS Registry. It is a collaboration involving two Irish funded research centres:

ADAPT is the Research Centre for AI-driven Digital Content Technology. ADAPT has expertise in the collection, harmonisation, integration, storage, governance and analysis of data. Data exists in many different forms, for example, text, images, video, speech/audio. ADAPT specialises in converting all these data types into digital information that can be analysed for research purposes. In P-APS, we develop new analytical tools using artificial intelligence, machine learning and natural language processing to look for new patterns and insights into the data to help the P-ALS clinicians find new ways to meet the needs of their patients.

FUTURE NEURO, a Research Centre for Chronic and Rare Neurological Diseases which aims to change the patient journey through research informed by the needs of both patients and neurologists. FUTURE NEURO research aims to develop rapid and accurate tools for diagnosis, therapies to modify brain networks, and technologies to enable patients to monitor their own health and well-being.

The Precision ALS registry is hosted by Trinity College Dublin in Ireland. Trinity College Dublin is a collaborator in both ADAPT and FUTURE NEURO, and the lead Principal Investigator (PI) Professor Orla Hardiman, is an academic and researcher in Trinity College Dublin.

The data within the P- ALS registry, will only be shared for approved research projects.

Research projects may be carried out by academic partners or by industry partners in collaboration with the academic partners, for example health research may develop, trial and manufacture new medicines, tests, treatments, technologies and devices. All research will be by experts on rare neurological disease, to better understand ALS/MND and to develop treatments and drug development targeted to specific forms of ALS/MND.

PRECISION ALS is supported by the Irish Government through a Science Foundation Ireland investment of €5 million, which is matched by an additional €5 million from industry.

Which organisations take part in PRECISION ALS?

PRECISION ALS involves the following research organisations:

Country	Organisation
Belgium	Als Centre, Leuven, UZ Leuven, Belgium
France	Centre de Référence Maladie Rare (CRMR) SLA et les autres maladies du neurone moteur (FILSLAN), Université de Tours, France
Ireland:	National ALS Clinic and Research Group, Beaumont Hospital, Dublin Academic Unit of Neurology, Trinity College Dublin, Dublin 2 ADAPT Centre, O’Reilly Institute, Trinity College Dublin, Dublin 2 Future Neuro, Royal College of Surgeons of Ireland (RCSI), 123 St. Stephen’s Green, Dublin 2
Italy	Torino ALS Centre (CRESLA) University of Torino, Italy
Netherlands	ALS Centre Netherlands, University Medical Centre, Utrecht, Netherlands
Spain	Hospital Universitari de Bellvitge Barcelona, Spain
Sweden	ALS Centre Karolinska, Karolinska Institutet, Sweden
United Kingdom	MND Care and Research Centre, Kings College London, UK
United Kingdom	Care and Research Centre for MND and SITraN, University of Sheffield, UK
Portugal	Associação para Investigação e Desenvolvimento da Faculdade de Medicina

A list of our current collaborating Industry Partners can be found here.

What personal data is shared with P-ALS?

P-ALS fully respects your right to privacy, and we actively seek to preserve your rights. Any personal data provided to P-ALS will be treated with the highest standards of security and confidentiality, in accordance with data protection law.

Only a limited number of essential personnel at your local site, will know your identity.

Your local site replaces your name with a unique code.

All information shared with the P-ALS Registry uses this code instead of your name.

The personal data shared with P-ALS is information you shared with the organisations listed above such as:

demographics (age, sex, location)
clinical information relating to ALS/MND, and your disease progression
cognitive and behavioural, information
information about your psychological health and quality of life
your height and weight
Socioeconomic characteristics (e.g., household income band, occupational status, education)
your family medical history and whether there has been exposure to certain risk factors
the utilization of services by you and your family

For more details you can click on the icon below to view to the full list of variables we are collecting

Where biological samples have been donated (e.g., blood, skin biopsies) these samples will also be labelled with a unique code and will be securely stored according to approved protocols for the storage and use of biological materials by the hospital or national ALS registry within your country.

How do P-ALS securely store your personal data?

Any personal data shared to Precision ALS will be securely transferred to the centralised P-ALS registry hosted in Trinity College Dublin.

The P-ALS Registry complies with the security and technical measures required by the General Data Protection Regulation (GDPR).

What is the legal basis for the use of your personal data?

Your personal data will only be used by PRECISION ALS for approved high impact research projects into the causes, progression, diagnostics and treatment of ALS/MND which we hope will increase our understanding of ALS/MND to inform new treatment and management strategies to improve outcomes for patients.

Our legal basis is GDPR Article 6(1) (e)[1] “processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller” and GDPR Article 9 (2)(j)[2] “Processing is necessary for archiving purposes in the public interest, scientific or historical research purposes.”

Who will access your personal data and samples?

Any use of your personal data will respect the consent you gave your hospital or ALS registry within your country.

The principal investigator and their research team at each organisation listed above may access your personal data and samples (if relevant) for approved research projects.

Other researchers may apply for access to your personal data and samples. P-ALS has strict oversight and governance procedures in place to manage access to your personal data and samples. Oversight is provided by a Scientific Board comprising representatives from each of the participating sites, an external expert in ALS/MND, a data protection officer, an expert in ethics and a patient advocate. This board meets at quarterly intervals or more frequently if needed to review progress of existing projects and to review and approve new projects as they come onstream.

For new project approval, researchers must submit a summary to the Scientific Board. The board will ensure that the project is scientifically worthwhile and ethically sound, for the purposes of developing new and more effective therapies for ALS/MND. No project can commence without appropriate approval from the relevant research ethics committee for each site and an appropriate legal agreement in place.

Researchers may be from your home country, or they may be international. They may work in universities, charities or companies carrying out health research.

Collaboration with researchers in universities or companies is essential to identify and provide new targeted treatments to specific forms of ALS/MND.

Biological samples will only be shared with health-related commercial companies if you consent to this and subject to research ethics approval.

Any sharing of data outside of the EU/EEA will comply with the GDPR.

How long will PRECISION ALS retain your personal data and samples?

As personal data and samples are a very valuable resource in developing our understanding of ALS/MND, and it can take many years for the research to have an impact, your data will be retained indefinitely, and your samples will be kept until used up.

Rights in relation to personal data under data protection law

Under data protection law, you can exercise the following rights in relation to your personal data unless the request would make it impossible or very difficult to conduct an ongoing research project (for example, if research is about to be published)

access to personal data held by PRECISION ALS
the right to restrict the use of the data
the right to correct inaccuracies in the data,
the right to have your personal data deleted from the P- ALS registry,
the right to object to profiling by Precision ALS, though no results will be shared back directly with you

Individuals can exercise the above rights in relation to the data by contacting their local recruitment site. Contact details listed at the bottom of this privacy notice. If you are unsure of who to get in touch with locally, you can contact Precision ALS via the following web page;

How can you withdraw from PRECISION ALS.

If you wish to withdraw from Precision ALS, we will discuss this with you. You can contact us directly or the site where you were recruited.

You can request no further contact, but allow us to continue to use information shared with us for research on ALS, or you can request all data and samples, be deleted.

If you wish to delete personal data held by Precision ALS, we advise you to contact the site where you were originally recruited first, as they have your contact details on file.

If you are unsure of who to get in touch with locally, you can contact Precision ALS via the following web page;

Further Information

For general questions about P-ALS please contact using this webpage [Contact Us – Precision ALS].

For any questions about how your personal data has been used, please contact the data protection officer from your hospital recruitment site, see contact details below on page [insert page number].

If you wish to raise a concern or escalate an issue relating to your data protection rights, you can contact the data protection office at the site where you were originally recruited. The relevant contact details for each site are included in the table below.

If you are not happy with the information we have provided to you in relation to the use of your personal data or if you have any concerns about how P-ALS uses your personal data you can raise this with the Data Protection Commissioner via their online form at: https://forms.dataprotection.ie/contact or contact the Commission at:

Data Protection Commission
21 Fitzwilliam Square South
Dublin 2
D02 RD28

https://www.dataprotection.ie

Date: 04/09/2023

Data Protection Contact Details for P-ALS participating sites

Country	Recruitment site:	DPO contact details
Belgium	AlS Centre, Leuven, UZ Leuven, Belgium	http://www.kuleuven.be/wieiswie/en/person/00000359
France	Centre de Référence Maladie Rare (CRMR) SLA et les autres maladies du neurone moteur (FILSLAN), Université de Tours, France	[email protected]
Ireland	National ALS Clinic and Research Group, Beaumont Hospital Dublin & Academic Unit of Neurology, Trinity College, Dublin, Ireland	[email protected]
Italy	Torino ALS Centre (CRESLA) University of Torino, Italy	[email protected]
Netherlands	ALS Centre Netherlands, University Medical Centre, Utrecht, Netherlands	[email protected]
Spain	Hospital Universitari de Bellvitge Barcelona, Spain	[email protected]
Sweden	ALS Centre Karolinska, Karolinska Institutet, Sweden	[email protected]
United Kingdom	MND Care and Research Centre, Kings College London, UK	[email protected]
United Kingdom	Care and Research Centre for MND and SITraN, University of Sheffield, UK	[email protected]
Portugal	Associação para Investigação e Desenvolvimento da Faculdade de Medicina	[email protected]

Changes to the privacy notice

We regularly review the P-ALS privacy information and, where necessary, update it.

Your data will never be used for a purpose outside of the consent you have given.