Participant Information

IBIS-I: The Interventional Breast Cancer Intervention Studies 1

The IBIS-I trial, which investigated tamoxifen to prevent breast cancer, has shown that the incidence of breast cancer was reduced by 32% in women receiving tamoxifen compared to those taking placebo (dummy medication). Very importantly, these benefits extended beyond the treatment period, whilst most of the side effects did not.

Recruitment to IBIS-I ended in March 2001 and overall 7154 women were recruited from 36 centres in 9 countries. In 2008 IBIS-I was converted to an epidemiological cohort study that aims to collect further information on the effectiveness and safety of tamoxifen via long-term nofollow-up until 2026. The long-term nofollow-up has minimal participant involvement and takes the form of annual questionnaires distributed from the Central Coordinating Office at the Centre for Cancer Prevention, based at Queen Mary University of London, and provision of data by NHS/public bodies (in the UK only). IBIS-I participants have consented to the post-treatment nofollow-up phase of the trial and can withdraw their consent at any time if they change their minds.
Queen Mary University of London will collect information about you for the IBIS-I study from NHS Digital, as well as other devolved public health bodies. This information will include your name, date of birth, NHS number, and post code and health information, which is regarded as a special category of information. We will use these data to help assess the effectiveness of the trials’ interventions.

As Data Controller, Queen Mary University of London (QMUL) is responsible for the collection, storage and processing of these data for the study. These data include the nofollowing identifiable data, categorised under the General Data Protection Regulation (GDPR) as personal and sensitive

  1. Cancer incidence (any diagnosis of cancer and the type of cancer it is);
  2. Mortality data (in the event of death we will receive information confirming the date and cause of death);
  3. Hospital Episode Statistics (HES) which utilises your in-patient, out-patient and A&E data (to look for other significant clinical events of interest to the clinical trial e.g. serious fractures, heart attacks);
  4. Current GP details so that we may request further nofollow up information about an event as identified in points 1-3.

The level of data collected from NHS/public health bodies will only be identifiable to us at QMUL and will not be shared with any third parties. Only authorised staff at the IBIS-I Coordinating Centre are able to access the data and only for specific purposes related to the trial. The data is stored in a secure, restricted-access environment. The data will be retained until destruction at the end of the study archiving period, which will be in 2046. To learn about how Queen Mary University of London is protecting your data and its responsibilities please go here.

The legal bases for processing this data are exemption from Section 251 of the NHS Act 2006, as well as Article 6(1)(e) ‘performance of a task carried out in the public interest’ and Article 9(2)(j) ‘public interest, scientific or historical research purposes or statistical purposes’ pursuant to the GDPR.

You are free to withdraw at any time from the study or long term nofollow up aspects of the trials. This will in no way effect the level of care you receive. However if you decide that we may have no further information from you for the study, it will not be possible to remove your data from analyses that has already been done. Should you have any further questions about the study, please contact the IBIS-I Central Coordinating Office for more detail on how to withdraw from further data collection as part of the IBIS-I trial, by calling 020 7882 5973, e-mailing ibis@qmul.ac.uk or completing this form.


IBIS-II: The Interventional Breast Cancer Intervention Studies 2

IBIS-II is designed to continue the work started in IBIS-I in determining whether a medicine that prevents breast cancer is beneficial. The “post-treatment nofollow-up phase” of the IBIS-II trial (that is after you have stopped taking your tablets) is vitally important in learning more about long-term safety and efficacy of anastrozole and tamoxifen. This includes nofollowing-up with anyone who decided to stop taking their medication before the full five year period. It will help us to find out more about the long-term benefits and side effects, which will provide women in the future with more understanding about choosing the best treatment.

Participants in IBIS-II do not need to attend clinic for nofollow-up visits in the post-treatment phase of the trial as nofollow-up can be done by telephone from local sites or by postal questionnaire. All IBIS-II participants are encouraged to maintain contact with their trial nurse and inform them of any change to contact details as well as any significant health events.
Queen Mary University of London will collect information about you for the IBIS-II study from NHS Digital, as well as other devolved public health bodies. This information will include your name, date of birth, NHS number, and post code and health information, which is regarded as a special category of information. We will use these data to help assess the effectiveness of the trials’ interventions.

As Data Controller, Queen Mary University of London (QMUL) is responsible for the collection, storage and processing of these data for the study. These data include the nofollowing identifiable data, categorised under the General Data Protection Regulation (GDPR) as personal and sensitive:

  1. Cancer incidence (any diagnosis of cancer and the type of cancers);
  2. Mortality Data (in the event of death we will be receiving information confirming the date and cause of death);
  3. Hospital Episode Statistics (HES) which utilises your in-patient, out-patient and A&E data (to look for other significant clinical events of interest to the clinical trial e.g. serious fractures, heart attacks);
  4. Current GP details so that we may request further nofollow up information about an event as identified in points 1-3.

The level of data collected from NHS/public health bodies will only be identifiable to us at QMUL and will not be shared with any third parties. Only authorised staff at the IBIS-II Coordinating Centre are able to access the data and only for specific purposes related to the trial. The data is stored in a secure, restricted-access environment. The data will be retained until destruction at the end of the study archiving period, which will be in 2047. To learn about how Queen Mary University of London is protecting your data and its responsibilities please go here.’

The legal bases for processing this data are exemption from Section 251 of the NHS Act 2006, as well as Article 6(1)(e) ‘performance of a task carried out in the public interest’ and Article 9(2)(j) ‘public interest, scientific or historical research purposes or statistical purposes’ pursuant to the GDPR.

You are free to withdraw at any time from the study or long term nofollow up aspects of the trials. This will in no way effect the level of care you receive. However if you decide that we may have no further information from you for the study, it will not be possible to remove your data from analyses that has already been done. Please contact your local IBIS-II trial nurse for further details on how to withdraw from the IBIS-II trial. Alternatively, you can request to withdraw from post-treatment nofollow-up questionnaires or further data collection by calling the IBIS-II Coordinating Centre on 020 7882 3838, e-mailing ibis@qmul.ac.uk or completing this form.