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Data sharing template
this template was generated from the Open Brain Consent
Data sharing via the ENBIT repository
Participant Information Sheet
The imaging data that we are collecting are not only useful for you and/or the study you are taking part in, it can also be used for other future research and/or educational projects by including them into the ENBIT repository (European Network for Brain Tumour Imaging - www.enbit.ac.uk). This repository includes data from people all over Europe also suffering from brain cancer. Data are shared through a controlled access to identified researchers from academia and industry worldwide. For [your imaging centre name] research patients, we have opted for sharing without usage restrictions (i.e. industry can access your anonymized data).
Future research projects that will make use of ENBIT data can focus on any topic and might be unrelated to the goals of the imaging you are undertaking today. Our hope by sharing data worldwide is that more researchers will engage in finding new ways to improve diagnostic, treatment and prognosis.
Implications for you
It is important that you understand that consenting or refusing to consent in including your data in the repository does not influence the outcome of the scanning, your treatment, and/or your participation in the current study. You can also change your mind after consenting and withdraw your consent in sharing data (contact Dr XXX email xxx to do this), and we will delete your data. Any data and research results already shared with other investigators cannot however be destroyed, withdrawn or recalled.
By agreeing to share your data, you will be making a free and generous gift for research that might help others. It is possible that some of the research conducted using your information lead to the development of new methods, new diagnostic tests, new drugs or other commercial products. Should this occur, there is no plan to provide you with any part of the profits generated from such products and you will not have any ownership rights in the products.
Which data are collected and shared
All of the imaging data that we are collecting will be shared. We will also collect and share clinical data directly relevant to your condition; some being already collected for the study you are currently involved in. In all cases, only personnel which has been authorized will access these data.
These clinical data includes i) results from neurological and neuropsychological tests you may have or will receive pre-treatment (chemotherapy / radiotherapy / surgery) as part of your treatment and/or as part of the research study you are taking part in, ii) results from neurological and neuropsychological tests you may receive post-treatment as part of your treatment and/or as part of the research study you are taking part in, and up to one year after you received this treatment and iii) results from histopathology (i.e. the lab results telling exactly what kind of tumour you have and possibly what genetic mutation the tumour cells have). This will NOT include medical notes or interviews nor any other medical information not related to your tumour. All these clinical data will be coded and shared in tables as numbers/scores related to the tests you took, and clinical condition will be shared using dedicated dictionary. Personal (e.g. name, address) or sensitive (e.g. DNA) will never be shared in this repository.
Data storage and privacy
ENBIT data are stored in an anonymised format on a secure server at the university of Edinburgh. There is no date limit on how long the data will be stored and shared.
To minimize risks to your privacy, a committee of experts will review every data request from other scientists before allowing them to access the repository. These scientists accessing your data may be at any research centers (academic or commercial) around the world.
To the best of our knowledge, the data we release to other investigators will not contain information that can directly identify you. The data we share with other scientists will not have your name on it, only a code number, so people will not know your name or which data are yours. In addition, the data made available will not include data that we think might help people who know you, to guess which data are yours, such as your facial features or the exact date that you participated. However, a security breach (break in or cyber attack) might lead to someone being able to link you to your data. This risk is very low because your data are stored in a secure server at the university of Edinburgh, and the information about your identity is stored separately from the data themselves, linked only through a code at the unbiversity of [XXX]. We will keep the private portion (name, contact information etc.) of your data in a secure location, remote from the repository itself. This way if one of the researchers that obtained the data from us will find something in your scans that would have a diagnostic value beyond what has already been reported, we will be able to contact you, although this is not expected to be the case. This will also allow us to give you access, request changes or delete your data from ENBIT at a later date, if you wish to do so. You can request access by emailing Dr XXXX or the contact point on the ENBIT website (www.enbit.ac.uk). If you think there is a problem with the way we are handling your data, feel free to contact us at anytime or raise your concern to the UK information commissioner’s office (https://ico.org.uk/).
Consent collected during (where/which occasion):
Name and Signature of Participant:
Name and signature of Person taking consent: