Ultimate consent form - GDPR edition¶
Version: OBC-GDPR-ULT 1.1.0
The current version of the ultimate consent form (GDPR edition) is given below.
This contains GDPR-specific wording that relates to privacy implications due to the intention of processing and sharing the participant’s data.
As such, this is seen as the Privacy Notice form. Informed consent to take part in the study is still recorded for the participant in the main consent form.
The form includes some sentences in square brackets
, which indicates that they may be removed and/or replaced depending on your local legislation and ethics committee.
Some sentences include fields, surrounded by
<> to be entered.
Usage and storage of your data¶
While the collection, use and storage of your data are done for the purpose of conducting the study to which you are currently participating, these data might also be used for other future research projects in the field of medical and cognitive neuroscience. This includes data from your brain and/or other scans, and may also include test results from the study you took part in, family and medical history, and also data such as gender and age.
By agreeing to participate, 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 eventually could lead to the development of new methods for studying the brain, 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.] We ask for your consent to this access to your data.
Confidentiality of your data¶
To the best of our knowledge, the data we release will not contain information that can directly identify you using reasonable means. To protect your privacy, the data will be given a code, so people will not know your name or which data are yours. Your name, but also other information that can directly identify you, will be omitted. [Identifiable facial features on the brain scans will also be removed]. Data can only be traced back to you using information only available to the data processor (i.e. people involved in the study). This information will remain safely stored in the local research institute. The data cannot be traced back to you in reports and publications about the study. However, by using additional data linked to your name (for example brain scans obtained from your medical records) one could potentially associate your imaging or other information in our database back to you. The risks of accessing such data from our servers have however been assessed and are considered to be low (see the university/centre Data Privacy Impact Assessment @<URL>).
Access to your data for verification¶
Some people can access all your data at the research location, including the original data with your name. This is necessary to check whether the study is being conducted in a good and reliable manner and to be able to notify you and your physician in case of any incidental findings resulting from your brain scans. Persons who have access to your data for review are: the local committee that monitors the safety of the study, the data controller <institution> working for the primary investigator of the study, and local, national and international supervisory authorities. They will keep your data confidential.
Retention period of your data¶
There is no plan to delete your data as they can be re-used for legitimate research interest. We will however re-evaluate every <number of years> years if it is worthwhile keeping them.
You can withdraw your consent to the use of your personal data at any time. This applies to this study and also to the sharing for future research. You have however to understand that once shared with other institutions, it is impossible to remove your data from such copies.
Passing on to countries outside the European Union (EU)¶
Your encoded data can also be accessed by and sent to countries outside the EU. This is necessary so that non-EU based scientists can run analyses to verify the scientific results produced from this study or for future unrelated research in the field of medical and cognitive neuroscience. In those countries, the EU rules on the protection of your personal data do not apply. However, your privacy will be protected at an equal level, by means of a Data User Agreement.
More information about your rights regarding processing of the data¶
For general information about your rights regarding the processing of your personal data, you can consult the website of the <Institution> Data Protection Authority.
If you have questions about your rights, please contact the person responsible for the processing of your personal data. For this study, that is:
<contact information> (see Appendix for contact details)
If you have questions or complaints about the processing of your personal data, we advise you to first contact the research location. You can also contact the Data Protection Officer of <Institution> (see the contact details in Appendix ) or the <Institution> Data Protection Authority.
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