CHIPS+

Background

The CHIPS+ study is investigating the long-term health of young people who were born with HIV or acquired it in early childhood. The health of this group during childhood has been tracked through the national “CHIPS” study (add link). This follow-on study of young people born with HIV is called “CHIPS+” (CHIPS plus). We would like to continue to follow-up young people as they move from paediatric to adult care, to check their health in adulthood. We want to make sure that young people have the best possible health outcomes in the future.

Ongoing monitoring of the health of people with long-term conditions is important, and some studies show that health outcomes in young people are worse than in both children and adults.

Aim

The aim of the CHIPS+ study is to continue to monitor the clinical care of young people with HIV acquired in childhood as they move from paediatric to adult care, to assess their longer-term health outcomes.

Ethics

CHIPS+ has ethics approval from West Midlands – Coventry and Warwickshire Research Ethics Committee (2017).

How CHIPS+ works

Young people aged 15 years and over who were born with HIV or acquired it in early childhood are approached in participating clinics and given a Patient Information Sheet to read. If the young person agrees to take part they will be given a Consent Form to sign. If the young person lacks capacity, so is unable to make the decision about whether to take part in the study themselves, their parent/carer will be given the Patient Information Sheet to read and will be asked to sign the Consent Form; the child will be given an ‘Assent Form’ (link to essential documents’). Once the young person consents a screening/registration form will be completed by the clinic team and sent to the MRC CTU.

The young person’s name, address and contact details will never be used for the study. Instead, a study code is used and all information is stored with that code, along with the patient’s date of birth, initials, and hospital number. The clinic will also give the young person a “Soundex” code, which is generated using their surname, but it is not possible to recreate a surname from the Soundex code, so we will not know who each person is. CHIPS+ will also ask young people for their permission to link their data to existing national datasets of people living with HIV, using their initials, Soundex code and date of birth. We would also like to collect their NHS number, which together with date of birth and sex will be used to link their data to databases held by NHS Digital. NHS Digital will then let us know about any serious health problems (for example cancer) that patients in CHIPS+ may have in the future. This information is extremely important, as it will enable us to better understand the long-term health issues arising in people who have had HIV since childhood, and tailor future HIV care accordingly.

Once NHS Digital has undertaken the linkage, they then destroy the personal identifiers.

CHIPS+ Privacy Notice

Introduction

The Medical Research Council Clinical Trials Unit at University College London (MRC CTU at UCL) invited you to participate in the CHIPS+ study to learn more about your transition from paediatric HIV care to adult care, and how this transfer affects your health outcomes. The study will establish the means to collect valuable long-term health information about you and others like you with HIV.

This privacy notice explains who we are, the personal data we collect, how we use it, who we share it with, and your legal rights. This notice is in addition to UCL’s privacy policy (https://www.ctu.mrc.ac.uk/privacy/) and applies specifically to personal information held for research purposes in the CHIPS+ study.

We keep this notice under regular review. It was last updated on 3rd December 2020.

About MRC CTU at UCL

The MRC CTU at UCL is one of the UK’s leading centres for clinical trials. Our research helps to improve health care in the UK and around the world, resolving internationally important questions in infections and cancer, and delivering swifter and more effective translation of scientific research into patient benefits. The MRC CTU at UCL obtains appropriate ethical and legal approvals for all trials and studies that it runs. You can find out more about the MRC CTU here: https://www.ctu.mrc.ac.uk/.

The MRC CTU is part of the School of Life and Medical Sciences at UCL, and is running the CHIPS+ study. UCL is the study sponsor and is the data controller.

You were invited to participate in CHIPS+ because you were involved in CHIPS, an HIV paediatric surveillance study in the UK. The main aim of CHIPS+ is to evaluate short- and medium-term health outcomes of patients with perinatal HIV following transition to adult care.

Collecting personal information

Personal data, or personal information, means any information about an individual from which that person can be identified. It does not include data where the identity has been removed (anonymous data). Information about your health is a special category of personal data.

To safeguard your rights we will collect the minimal personal information necessary. We collect personal information, which includes information about your health and treatment, from the following sources:

  1. Directly from you with your consent
  2. From third party sources which routinely collect your health data (such as NHS Digital, other UK NHS bodies, and the HIV and AIDS Reporting System (HARS) which is held by Public Health England) with your consent.

Personal information specifically collected for CHIPS+ include your HIV clinic visits, clinic name, HIV diagnoses information, (eg date of diagnosis, year of arrival in UK if applicable), treatment information (eg date first started ART), clinical information (eg CD4, VL) and information on cancers and death.

Using your personal information

All of the personal information we collect is only used for the purposes of carrying out our scientific research in the public interest.

UCL is the data controller for processing personal data in CHIPS+. This means they UCL is responsible for ensuring that the processing of your data complies with the General Data Protection Regulation (GDPR; https://www.gdpr.org) and related legislation. The lawful basis for processing personal information in CHIPS+ is GDPR Article 6(1)(e) – “processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller,” and Article 9(2)(j) for special category data – “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes.” We demonstrate that our research serves the interests of society by following the UK Policy Framework for Health and Social Care Research (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/).

Data linkage

We will ask for your consent to collect your NHS number, date of birth and sex, to link to databases held by NHS Digital and Public Health England.

NHS Digital will then let us know about any serious health problems (for example cancer) that patients in CHIPS+ may have in the future. If you receive NHS care in Wales, Scotland, or Northern Ireland, we will send your NHS number, date of birth and sex to the NHS regional bodies that hold your records to collect this information.

Public Health England will let us know about your health outcomes as you get older, through their HIV and AIDS Reporting System (HARS), which is a national HIV surveillance system. All patients with HIV who receive NHS care are followed in HARS. This means it is very important we have your correct personal identifiers: (date of birth, initials, sex, Soundex, (this is generated using your surname, but it is not possible to recreate your surname from the Soundex code) and hospital number) so that we can link you to the HARS database for long-term follow-up.

Linkage to both of these databases will enable us to better understand the long-term health issues arising in people who have had HIV since childhood, and tailor future HIV care accordingly.

If we have asked for your consent to process your personal information, you can find more information about this on the CHIPS+ Participant Information Sheet and Consent Form.

Retention and storage of personal information

The MRC CTU stores all personal identifiable data securely, and only authorised trained staff are permitted access. Your NHS number, along with your date of birth, will be stored in the UCL Data Safe Haven (also known as a Trusted Research Environment – a secure space where sensitive personal data is stored and accessed), until they are transferred to NHS Digital for linkage with mortality and cancer datasets. Your NHS number, date of birth and sex will only be used by the data providers to link to your health records in their databases so that they can extract the appropriate data for our use. Once NHS Digital has undertaken the linkage, they then destroy your personal identifiers.

We will use your date of birth and sex to conduct linkage with Public Health England and also for analyses which explore the effect of age, sex and year of birth on health outcomes. We also retain personal information in line with our research retention policies and regulatory requirements.

All electronic data will be held for 15 years and all administrative documentation will be kept in a secure location (for example, locked filing cabinets in a room with restricted access) and held for 15 years after the end of the study.

We have put in place appropriate security measures to prevent your personal data from being accidentally lost, used or accessed in an unauthorised way, altered or disclosed. We have established procedures to deal with any suspected personal data breach and will notify you and any applicable regulator of a breach where we are legally required to do so.

NHS Digital, Public Health England and UCL will access identifiable information on participants. No individual patients will be directly identified through any published results from the study.

Researchers (under the supervision of UCL) who wish to access the data from this study and/or contact participants about future research will have to apply to the CTU’s Data Access Committee.

Your legal rights

You have rights over your personal information by law. Your usual rights to access, change or move your information are limited because of exceptions applicable to some types of research, and also because we need to manage your information in specific lawful ways in order for the research to be reliable and accurate.

You have the right to request the restriction or suppression of your personal data, so you have the right to withdraw your consent to data linkage at any time. Please talk to your study doctor or nurse who will then inform the CHIPS+ study team of your decision. Contact details for members of your study team will be listed within your Patient Information Sheet (PIS). This decision will not affect the care you receive in any way. If you do this, we will use your data up to the point that you say you no longer wish to participate.

If you would like further information or have any concerns about the use of your personal information, please contact our Data Protection Officer by email data-protection@ucl.ac.uk or by writing to Data Protection Officer, University College London, Gower Street, London WC1E 6BT.