We would like to notify all study participants about an important change in how we handle your data as part of the CHIP-BCIS3 trial.

What is changing?

When you joined the study, you gave your permission for us to collect your NHS number and date of birth, and to share your NHS number with NHS England and other central UK government bodies. We are now planning to share your date of birth with NHS England as well.

Does this change affect you?

If you were consented to Versions 1.4 or later of the PIS and consent form, you have already consented to share your date of birth and this change does not affect you.

For participants who were consented before Versions 1.4 of the PIS and consent form, this change does affect you. We have received special approval (‘section 251’ support) from the Confidential Advisory Group (CAG) to share your date of birth with NHS England without needing to ask for your consent. The CAG is an independent group of people who checks that confidential patient information is used appropriately and is in the best interest of patients and the public.

Why is this change needed?

When NHS England check health records for research, they need two pieces of information to match records. When we wrote the initial PIS and consent form, we did not know we needed to share your date of birth with NHS England. NHS England hold this information already, but need us to confirm it in order to make sure it’s your information that they give us. We need your information from NHS England to collect accurate information about your health and make the results of our research more reliable and useful to patients and people working for the NHS.

How is your data kept safe?

Your privacy is our priority. Access to information that could identify you is strictly controlled and is only accessible by members of the study team. Your data will be in a form that will not contain anything that identifies you personally. We will continue using your allocated study ID number instead of your name or other identifiable information to protect your confidentiality. All identifiable information will be stored in a secure encrypted database at the London School of Hygiene and Tropical Medicine and shared securely with NHS England and other central UK government bodies.

How do I opt out of sharing my date of birth?

If you consent to these changes, you do not need to do anything.

If you do not want your date of birth to be shared with NHS England, you can opt-out by contacting the research team at the hospital where you were involved in the CHIP-BCIS3 trial. This information can be found in the Patient Information Sheet given to you when you decided to take part in the study. If you choose to opt out, this will not affect your medical care or taking part in the study.

Participant documents

• Participant information sheet
• Consent form