Participant Information Sheet – IBEX Innovations Limited

Why are we conducting this research?

IBEX Innovations Limited (IBEX), a high-technology business based locally in Sedgefield, has developed a unique software-based product called Trueview® which significantly improves the quality of mammogram images.

To finalise development and testing of the Trueview® software, we would like to access mammogram images taken of patients in the clinical environment. This research is being conducted by IBEX in collaboration with the Breast Unit at Gateshead Health NHS Foundation Trust.

What does taking part in the research involve? 

We would like your permission to obtain a digital copy of your mammograms taken today. Personal details such as your name, date of birth, and contact details will be removed from the digital images before they are sent to IBEX, so IBEX will never have access to your personal details. Any images you agree to give may be used for the following purposes:

  • Further research, development and testing of IBEX technology, including Trueview® software.
  • Demonstration of Trueview® capabilities to IBEX customers in the future. 
  • Use in promotional material including brochures, product videos and scientific publications. These images will be viewed outside of Gateshead Health NHS Foundation Trust but will remain anonymous at all times.

Your mammograms today will be taken in the normal way using the Breast Unit’s standard mammography machines as part of your standard care. The images will be analysed in the normal way by the Breast Unit team, and the results will be sent to your referring doctors via the usual route. 

Why have I been invited and am I eligible?

We are inviting patients who are attending for mammograms in the Breast Screening Unit of the Gateshead Health NHS Foundation Trust to take part in the research. 

Are there any risks or benefits for me in taking part?

Since you will receive the mammogram you have attended for today in the same manner as normal, there is no additional health risk associated with taking part in this research. Participation will in no way affect your clinical diagnosis or any treatment. 

Participants are asked to give their permission for the use of their images. Images will be provided to IBEX in the form of anonymised raw data with all personal information removed. 

Any personal information collected on the consent form will not be provided to IBEX and will remain the responsibility of the Gateshead Health NHS Foundation Trust. This data will be stored securely in line with the relevant data protection policy.

Although there will be no direct benefit to you in taking part in this project, you will be helping with the development of a technology that has the potential to improve mammograms for patients and doctors in the longer term.

Data and Privacy

Data Controller

Gateshead Health NHS Foundation Trust is the Data Controller for this research based in the United Kingdom. The trust will be providing information from consenting participants for the purposes outlined above. 

The Gateshead Health NHS Foundation Trust will act as a data controller, ensuring that patient data is obtained, handled and stored correctly in line with current data protection legislation. 

Your data and your rights

The EU General Data Protection Regulation (GDPR) defines the rights of individuals with regards to their personal information and regulates the way in which organisations store and use that information. 

The Gateshead Health NHS Foundation Trust will only provide data to IBEX Innovations Limited from patients who have freely consented to the use of their data for the purposes of this project.

All identifiable data obtained by the Gateshead Health NHS Foundation Trust will remain under its control. This data will not be provided to IBEX Innovations Limited, or any other party, for any reason. 

Data Protection

Any personal information is kept confidential.  There may be occasions where your information needs to be shared with other care professionals to ensure you receive the best care possible.

In order to assist us to improve the services available, your information may be used for clinical audit, research, teaching and anonymised for National NHS Reviews and Statistics.  

Further information is available via Gateshead Health NHS Foundation Trust website or by contacting the Data Protection Officer by telephone on 0191 445 8418 or by email [email protected].