INFORMATION SHEET

Study Title: Online Survey on Recovery from COVID-19

Principal Investigator: Dr. Athena Akrami, PhD; Sainsbury Wellcome Centre, UCL (email: athena.akrami@ucl.ac.uk)

Project Ethics ID: 16159/002


Study Investigators:
Gina Assaf, Hannah Davis, Dr. Athena Akrami (UCL), Hannah Wei, Lisa McCorkell, Dr. Yochai Re’em (NYP-WCMC), Dr. Ryan Low (UCL), Dr. Jared Austin (OHSU), and Dr. Alka Gupta (NYP-WCMC)

Invitation to Participate
You are being invited to participate in this research study because you previously experienced or you are currently experiencing symptoms consistent with COVID-19 as a result of suspected or confirmed SARS-CoV-2 infection.


1. Why is this study being done?
The aim of this research study is to better describe and understand the patient experience and recovery of those with confirmed or suspected COVID-19, with a specific emphasis on the Long COVID experience. The focus of this study includes participants’ backgrounds, testing, symptoms, and psychological wellbeing. A secondary aim of this study is to publish patient-driven data in order to advocate for the Long COVID population within the medical community. The survey was created by a group of patients with COVID-19 symptoms who are members of the Body Politic online COVID-19 support group. 

2. How long will you be in the study?
This survey will be live for at least 2 weeks, but no more than 4 weeks. As new information about COVID-19 infections is discovered, the team may decide to continue their investigation with follow-up surveys (up to 4 more surveys). The data that you enter in this survey may be linked to data you enter in future surveys. 

3. What are the study procedures?
If you agree to participate after reading this message, you will be taken to the survey which is housed on the Qualtrics platform. You will be asked to answer the questions to the best of your ability. In the mental health section and any question marked as optional, you can choose whether or not you would like to respond. The information that you enter will be collected after each page. You can take breaks and return to finish the survey at any time within one week.

4. What type of questions will be asked?
The survey asks different questions on testing, diagnosis, symptoms, treatments, background information, coping methods, as well as health and mental health.
 
5. Who can fill the survey? (inclusion/exclusion criteria)
You are being invited to participate in this research study because you have had a COVID-19, or suspected COVID-19 infection (still suffering or suffered symptoms) for longer than 1 week, and you are 18 years of age or older. Even if your COVID-19 test result was negative, or you were not tested at all, please participate in the survey.

6. How long it will take to fill the survey?
The survey can take between sessions 45-75 minutes to complete. You can take breaks and return to finish the survey at any time within one week.

7. Are there any risks to participating in this study?
There are no known risks associated with this research study. In order to mitigate risks inherent in all online surveys, this survey will be conducted on the Qualtrics platform.

8. What are the benefits for participating in this study?
There are no known direct benefits associated with participating in this research study. Your experiences will help us to better define the recovery from the COVID19 and improve advocacy for Long COVID (long-hauler) population.
 
9. Can participants choose to leave the study?
Participation in this study is voluntary. You may refuse to participate or at any point during the survey, if you decide to opt out from our study, you can fill this form by providing the anonymous ID we generate for you. Once you submit the survey you will be unable to withdraw your data.

10. How will participants’ information be kept confidential? 
There will be no information collected that may in any way identify you based upon your responses. 

Email addresses will only be used to send you a link to the survey, or to notify you of future surveys. A cryptographic algorithm will be used to generate a hash code from each email address. Hash codes will link survey responses to a unique participant without revealing the participant’s email address or identity. Paired email addresses and hash codes will be stored in a GDPR-compliant email database managed by a secure hosting provider. Survey responses will be stored on a separate server in a secure, encrypted format.  Email addresses will not be stored with survey responses and will remain unknown to both the research team and the hosting company. Any data exported will only be used by the above survey investigators, and exported data will be housed solely on secure servers.

Your responses will be housed on a secure server for 10 years, after which they will be destroyed. Anonymized data may be made public or shared with any other researchers.

11. Are participants paid to be in this study?
You will receive no monetary compensation or gifts for participating in this study.

12. Conflict of Interest
The questions in this survey were created by the investigators listed above. All investigators have no conflicts of interests to disclose.

13. Whom do participants contact for questions?
If you have any questions about the study, please contact Athena Akrami. Please note that email is not a secure form of communication. Please contact UCL ethics committee in case of complaint (ethics@ucl.ac.uk, the UCL Data Protection Officer, Alexandra Potts, a.potts@ucl.ac.uk )

14. Local Data Protection Privacy Notice 
Notice: The controller for this project will be University College London (UCL). The UCL Data Protection Officer provides oversight of UCL activities involving the processing of personal data, and can be contacted at data-protection@ucl.ac.uk 

 

This 'local' privacy notice sets out the information that applies to this particular study. Further information on how UCL uses participant information can be found in our 'general' privacy notice: For participants in health and care research studies, click here (https://www.ucl.ac.uk/legal-services/privacy/ucl-general-privacy-notice-participants-and-researchers-health-and-care-research-studies). The information that is required to be provided to participants under data protection legislation (GDPR and DPA 2018) is provided across both the 'local' and 'general' privacy notices. 

The lawful basis that will be used to process your personal data are: 'Public task' for personal data and' Research purposes' for special category data. Your personal data will be processed so long as it is required for the research project. If we are able to anonymise or pseudonymise the personal data you provide we will undertake this, and will endeavour to minimise the processing of personal data wherever possible. If you are concerned about how your personal data is being processed, or if you would like to contact us about your rights, please contact UCL in the first instance at data-protection@ucl.ac.uk.

 

If you have any questions or concerns about the study, or about your rights as a research participant or the conduct of this study, you may contact Athena Akrami. If you feel your concerns have not been handled satisfactorily, you can contact the Chair of the UCL Research Ethics Committee at ethics@ucl.ac.uk. This office oversees the ethical conduct of research studies and is not part of the study team. Everything that you discuss will be kept confidential.

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CONSENT FORM 


This study has been approved by the UCL Research Ethics Committee: Project ID number: 16159/002
 

Thank you for considering taking part in this research.


This survey is voluntary. You may decline to answer any of the questions. By checking the box below you are acknowledging that you are voluntarily participating in this survey, have read and understood the Information Sheet, and consent to the following:
 

  • I understand that my participation is voluntary and that I am free to withdraw at any time without giving a reason.
  • I understand I will need to provide an email address so that I can be sent the future surveys to answer. However, this email address will not be passed to any third parties and will be removed from my answers before any analysis takes place, so the information I provide will be anonymised.
  • I understand that due to this anonymisation it will not be possible to withdraw my answers after they have been submitted, but I can withdraw from future surveys at any point.
  • I understand that the data gathered in this study will be stored securely and it will not be possible to identify me in any outputs from this research.
  • I understand that the data will not be made available to any commercial organisations but is solely the responsibility of the researcher(s) undertaking this study.
  • I understand the direct/indirect benefits of participating.
  • I understand that I will not benefit financially from this study or from any possible outcome it may result in in the future.
  • I agree that my anonymized research data may be used by others for future research. No one will be able to identify me when this data is shared.
  • I understand that the information I have submitted will be published as a report.
  • I hereby confirm that I understand the inclusion criteria as detailed in the Information Sheet
  • I understand the exclusion criteria as detailed in the Information Sheet
  • I do not fall under the exclusion criteria.
  • I am aware of who I should contact if I wish to log a complaint.
  • I voluntarily agree to take part in this study.
  • I would be happy for the data I provide to be securely archived at UCL until project completion
  • I understand that other authenticated researchers working on this study at UCL will have access to my anonymized data