CAN I TAKE PART IF I AM PREGNANT?
Pregnant people must not take part in this study. All participants for whom it is appropriate will be asked to take a pregnancy test at the beginning of each study visit in order to ensure that they are not pregnant before the study visit commences. Volunteers should use adequate contraception (e.g. "barrier" methods, intrauterine device, and hormonal contraception) or abstinence for the duration of the study. Any participant who finds that they have become pregnant while taking part in the study should immediately tell the research doctor.
WHAT IF NEW INFORMATION BECOMES AVAILABLE?
Sometimes during a research project, new information becomes available about the condition, treatment or biological mechanism that is being studied. If this happens, your research team will tell you about it and discuss with you whether you want to continue in the study. If you decide to continue in the study, you will be asked to sign an updated consent form. Alternatively, on receiving new information your research team might consider it to be in your best interests to withdraw you from the study.
WHAT WOULD HAPPEN IF I LOST THE ABILITY TO CONSENT DURING THE COURSE OF THE STUDY?
In the unlikely event that during the course of the study you were no longer able to give your consent because you had lost the capacity to do so, the research team would withdraw you from the study and not perform any further testing on you. However, they would retain samples and personal data collected previously and would continue to use it for the purposes which you had already consented.
WHAT HAPPENS WHEN THE RESEARCH STUDY STOPS?
Once the study has finished, the results of the study will be made available to you and/or your GP should you wish. If you have any problems immediately following the study, then you should contact one of the research team.
With your consent, any samples collected during the study will be stored for up to 10 years in freezers located in the Section of Investigative Medicine at Imperial College and at Ulster University. We do not know what will happen after the 10 year period but during the 10 years we may use the samples from the sub-studies in future research studies, send them to other organisations including outside of the EEA.
WHAT IF SOMETHING GOES WRONG?
Imperial College London holds insurance policies which apply to this study. If you experience serious and enduring harm or injury as a result of taking part in this study, you may be eligible to claim compensation without having to prove that Imperial College is at fault. This does not affect your legal rights to seek compensation.
If you are harmed due to someone's negligence, then you may have grounds for a legal action. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform the Chief Investigator or the study team (07592589553). The normal National Health Service complaints mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Imperial AHSC Joint Research Compliance Office.
WILL MY TAKING PART IN THIS STUDY BE KEPT CONFIDENTIAL?
Imperial College London is the sponsor for this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Imperial College London will keep your personal data for:
- 10 years after the study has finished in relation to data subject consent forms.
- 10 after the study has completed in relation to primary research data.
We will need to use information from you, your medical records, or GP for this research project. This information will include your:
- Name
- Initials
- NHS Number
- Contact Details
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. We will keep all information about you safe and secure. Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
LEGAL BASIS
As a university we use personally identifiable information to conduct research to improve health, care and services. As a publicly funded organisation, we have to ensure that it is in the public interest when we use personally identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Health and care research should serve the public interest, which means that we must demonstrate that our research serves the interests of society. We do this by following the UK Policy Framework for Health and Social Care Research.
INTERNATIONAL TRANSFERS
There may be a requirement to transfer information to countries outside the European Economic Area (for example, to a research partner). Where this information contains your personal data, Imperial College London will ensure that it is transferred in accordance with data protection legislation. If the data is transferred to a country which is not subject to a European Commission (EC) adequacy decision in respect of its data protection standards, Imperial College London will enter into a data sharing agreement with the recipient organisation that incorporates EC approved standard contractual clauses that safeguard how your personal data is processed.
SHARING YOUR INFORMATION WITH OTHERS
The research team includes researchers from both Imperial College London and Ulster University N. Ireland. Information will therefore pseudonymised data will be shared across these two sites but only within the research team. For the purposes referred to in this privacy notice and relying on the bases for processing as set out above, we will share your personal data with certain third parties:
- Other College employees, agents, contractors and service providers (for example, suppliers of printing and mailing services, email communication services or web services, or suppliers who help us carry out any of the activities described above). Our third party service providers are required to enter into data processing agreements with us. We only permit them to process your personal data for specified purposes and in accordance with our policies.
- The following Research Collaborators/Partners in the study;
o University College Dublin - samples and results will be shared for the purpose of analysis.
o Monash University - samples and results will be shared for the purpose of analysis.
WHAT ARE YOUR CHOICES ABOUT HOW YOUR INFORMATION IS USED?
You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. We need to manage your records in specific ways for the research to be reliable. This means that we won't be able to let you see or change the data we hold about you. If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.
WHERE CAN YOU FIND OUT MORE ABOUT HOW YOUR INFORMATION IS USED
You can find out more about how we use your information
- At www.hra.nhs.uk/information-about-patients/
- By asking one of the research team
- By sending an email to a.miras@nhs.net
- By ringing us on 07592589553.
COMPLAINT
If you wish to raise a complaint on how we have handled your personal data, please contact Imperial College London's Data Protection Officer via email at dpo@imperial.ac.uk, via telephone on +44 7958377674 and/or via post at Imperial College London, Data Protection Officer, Faculty Building Level 4, London SW7 2AZ.
If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner's Office (ICO). The ICO does recommend that you seek to resolve matters with the data controller (us) first before involving the regulator.
WHAT WILL HAPPEN TO THE RESULTS OF THE RESEARCH STUDY?
The results are likely to be published within the 12 months following the study in peer-reviewed journals and websites and presented in medical conferences. Your confidentiality will be ensured at all times and you will not be identified in any publication as these are anonymised. A lay summary of the key results from the study will be written and sent and/or presented to you.
WHO IS ORGANISING AND FUNDING THE RESEARCH?
Imperial College London is the main research Sponsor for this study. The study is funded by the Obesity Research Fund and the Juvenile Diabetes Research Foundation.
WHO HAS REVIEWED THE STUDY?
This study has been peer reviewed by the Imperial College Peer Review Office (Imperial College Healthcare NHS Trust) and reviewed and approved by the London-Fulham Research Ethics Committee.
CONTACT FOR FURTHER INFORMATION
If you experience any problems during the study, you may withdraw at any stage. You will also have direct emergency access, 24 hours a day, to one of the doctors involved in the study through mobile number 07592589553. The doctors may also be contacted through Dr. Alexander Miras' secretary (0207 594 9048) during office hours.
PAYMENT
As a reimbursement for your time and inconvenience, participants in work package 4 of the study will receive £100 upon completion of the study. For participation in work package 5 of the study you will receive £200 upon completion of the study. For participation in work package 6 of the study, you will receive £100 upon completion of the study. Payment for study visits will be processed after a participant completes their study visits. If participants do not complete all study visits they will be paid pro rata.