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Data protection rights for participants

If a participant stops taking the study pills and does not wish to have further blood samples to be collected at their study clinic, we would like to keep in touch by phone. However, they can also decline to be contacted again. In this case, we would like to continue to follow how they are getting on by contacting their local doctor or through national registries or other publically available sources of data.

If a participant decides they do not want any new information about them to be collected and used for the study (known as “withdrawal of consent”), we will ask them to sign a form and will not collect any further information from them. All information collected, including analysis results from blood and urine samples that have been already collected, will still be kept and used for the study.

If a participant has previously given consent for us to use leftover blood and urine samples and related information which had been collected in the study, they may also separately withdraw their permission for this optional part of the study at any point in time, without affecting their participation in the main part of the study. Any samples that they no longer wish for us to store or use will be destroyed.

Participants have the right to know what personal data the University of Oxford and Boehringer Ingelheim hold about them and to have a copy of that data. The local study nurse could provide this, however, to ensure the study’s scientific integrity, participants may not be able to review such data until after the study has been completed.

Participants also have the right to correct wrong or outdated personal data and request the deletion of their data. However, the study site and Boehringer Ingelheim (as the study’s sponsor) may be obliged by law to keep data to ensure consistency and reproducibility of the results and we cannot delete data that has already been used in analyses (note that analyses are run regularly throughout the study).

Participants also have the right to restrict or object to what we do with their data, or to request that their data be transferred elsewhere. However, sometimes the data controllers may not be able to (or have grounds not to) follow a request, for example, if we consider that deleting data would seriously harm the research. Any participant wishing to exercise any of these rights can contact us. The data protection officer for the University of Oxford can be contacted by email at: data.protection@admin.ox.ac.uk.

If a participant is not happy with the way we have handled their data, they have the right to lodge a complaint with the Information Commissioner’s Office (telephone 0303 123 1113 or ico.org.uk).