Page 1: Participant information and consent

Epilepsy and COVID 19 – assessing escalation and mitigation of risk 

Ethics Approval Reference: R69353/RE001

 

General Information

The aim of this study is to try and better understand risk in people with epilepsy. We know that there are risks linked to having epilepsy, but by understanding them and putting steps in place to reduce them, people with epilepsy can live well and live safely.

This project aims to better understand what risks people with epilepsy are facing, and what support they have, helping them live well with the condition. Particularly during the current COVID-19 pandemic, we know these things may be changing for people with epilepsy, so we want to better understand the changes and challenges you face. By knowing what problems people with epilepsy and their health professionals face, we will better understand what can be done to help make things better.

We appreciate your interest in participating in this online survey. You have been invited to participate as you are over 18 years old and are either a person with epilepsy, someone who cares for a person with epilepsy (who may be a child or adult with epilepsy), or a healthcare professional who helps in the management of people with epilepsy. Please read through this information before agreeing to participate by ticking the ‘yes’ boxes below.

You may ask any questions before deciding to take part by contacting the research team (details below).

We, Arjune Sen, Nuffield Department of Clinical Neuroscience at the University of Oxford, Jane Hanna OBE & Sammy Ashby (SUDEP Action, Project and PPI leads), in collaboration with other key partners are investigating risk in people with epilepsy.

In the online survey, you will be asked some basic demographic details (for example your age, which town you live in). If you have epilepsy you will be asked about the kind of seizures that you have and how often they occur as well as some other questions about your health. You will then be asked about how you are informed about risk. If you are a health care worker, you will be asked about how you communicate risk to people with epilepsy. We will also be asking questions that directly relate to the COVID 19 pandemic and how the care of people with epilepsy may have been affected by this emergency.

The online survey takes between 10 to 20 minutes to complete. No background knowledge is required and you do not need to do any preparation beforehand

The information we collect is anonymous and we will not be able to identify you personally from your answers. We pool these anonymous answers to better understand epilepsy and the management of risk.

At the end of the survey you will be given the option of contacting the research team if you wish to be informed of other similar research projects by emailing info@sudep.org. There is no obligation for you to do this and should you contact us we will not be able to link you to your responses on the survey

Thank you for your support,

 

 

Arjune Sen, Consultant Neurologist, Head Oxford Epilepsy Research Group

Jane Hanna, CEO, SUDEP Action

Samantha Ashby, Patient and Public Involvment lead, SUDEP Action

Jennifer Thorpe, Researcher, SUDEP Action & University of Oxford

Key collaborators:​

Professor Danielle Andrade, Toronto Western Hospital, Canada
Dr Danny Costello, Cork University Hospital, Ireland
Professor Helen Cross, UCL Great Ormond Street Institute of Child Health, London, UK
Professor Norman Delanty, Beaumont Hospital, Dublin, Ireland
Professor Orrin Devinsky, Langone Medical Centre, New York, USA
Professor Chantal Depondt, Hôpital Erasme – ULB, Bruxelles, Belgium
Dr Patricia Dugan, Langone Medical Centre, New York, USA
Professor Nathalie Jette, The Mount Sinai Hospital, New York, USA
Professor Charles Newton, KEMRI-Wellcome Institute, Kenya and University of Oxford, UK
Professor Terry O’Brien, Monash University, Australia. 
Dr Piero Perucca, Monash University, Melbourne, Australia
Professor Ley Sander, The National Hospital for Neurology and Neurosurgery, University College London, UK

 

Key questions for you to consider:

Do I have to take part?

Please note that your participation is voluntary. If you do decide to take part, you may withdraw at any point during the questionnaire for any reason before submitting your answers by closing the browser. If you close the survey before pressing ‘submit’ at the end of the survey, no responses are sent to us. If you submit your answers to us, these cannot be amended or withdrawn as the data are sent to us anonymously.

 

How will my data be used?

Your answers will be anonymous and we will take all reasonable measures to ensure that they remain confidential.

Your data will be stored in a password-protected file and may be used in academic publications. Your IP address will not be stored. We have included a ‘Prefer not to say’ option for questions should you prefer not to answer a particular question. Research data will be stored for a minimum of three years after publication or public release.

The data that we collect from you may be transferred to, stored and/or processed at a destination outside the UK and the European Economic Area ("EEA"). By submitting your data, you agree to this transfer, storing or processing.

 

Who will have access to my data?

JISC is the data controller with respect to your personal data and, as such, will determine how your personal data is used.  Please see their privacy notice here [https://www.jisc.ac.uk/website/privacy-notice#].  JISC online surveys will share only anonymised data with the University of Oxford, for the purposes of research.

Your information may be shared with other parties that are interested in epilepsy and risk. Only anonymised and aggregated data will be shared. This may include other academic institutions, other charities that work in epilepsy, ministries of health and industry. These organisations may be outside your country of origin.

We would also like your permission to use your anonymised data in future studies, and to share data with other researchers (e.g. in online databases).

Responsible members of the University of Oxford and funders may be given access to data for monitoring and/or audit of the study to ensure we are complying with guidelines, or as otherwise required by law.

The Principal Researcher is Arjune Sen who is attached to the Nuffield Department of Clinical Neurosciences.

This project has been reviewed by, and received ethics clearance through, the University of Oxford Central University Research Ethics Committee [reference number: R69353/RE001].

 

Who do I contact if I have a concern about the study or I wish to complain?

If you have a concern about any aspect of this study, please speak to Arjune Sen; arjune.sen@ndcn.ox.ac.uk  or contact SUDEP Action directly; info@sudep.org

We will acknowledge your concern within 10 working days and give you an indication of how it will be dealt with.  If you remain unhappy or wish to make a formal complaint, please contact the Chair of the Medical Sciences Interdivisional Research Ethics Committee at the University of Oxford who will seek to resolve the matter as soon as possible: ethics@medsci.ox.ac.uk; Address: Research Services, University of Oxford, Wellington Square, Oxford OX1 2JD

The Chair will seek to resolve the matter in a reasonably expeditious manner. 

1.1. Consent: I certify that I am 18 years of age or over Required
2.2. Consent: I certify that I am a healthcare worker who helps in the management of people with epilepsy Required
3.3. Consent: If you have read the information above and agree to participate with the understanding that the data (including any personal data) you submit will be processed accordingly, please check the relevant box below to get started. Required