Cass Review- Quantitative Research

A number of questions have been raised about the quantitative research that the Cass Review has commissioned our academic partners, the University of York, to undertake. This work involves using healthcare data for approximately 9,000 children and young people who have attended the Gender Identity Development Service (GIDS) at the Tavistock and Portman NHS Foundation Trust, some of whom will now be adults, in order to better understand how to develop and improve the future services provided across the NHS.

We know that the information that will be accessed is very sensitive and both we and our academic partners take very seriously our responsibilities for keeping that information safe.

We would not access such sensitive information if we did not truly believe that it was necessary, or that the outcome of this research could have widespread positive outcomes for children and young people accessing gender services.

We have tried to answer key questions about the research, including those raised by members of the public and other stakeholders. We have collated as many of those questions as we can, along with our answers, on this page.

Health research is subject to strict ethical and governance controls, and also needs to be undertaken in a way which is compatible with legal obligations. We explain how the research is going to be undertaken in a way which complies with these requirements in more detail below.

Why is this research important?

We know little about what happens to children and young people who have accessed GIDS, some of whom are now adults.  In order for the Review to make recommendations on how the NHS should improve services, we need to know more about what support and interventions they received and their outcomes.  It will also ensure clinicians have the best possible evidence when providing care, and that children and young people and their parents/carers can make better informed decisions.

What information will be looked at?

It is important to understand the journeys of children and young people, from the point at which they were referred to GIDS right through to the point they are at now. This will be different for every child and young person.

This means collecting information from four different sets of records. Not all sets of records will be relevant to all service users:

1. Medical records from GIDS
2. Medical records from the endocrine services at University College London Hospitals NHS Foundation Trust (UCLH) and Leeds Teaching Hospitals NHS Trust (Leeds)
3. Hospital admission and attendance, and prescription information held by NHS Digital (which manages health data at a national level)
4. Medical records from NHS Gender Dysphoria Clinics (GDCs) for adults

When looking at these records, the researchers are interested in: who referred you to the clinic; any health conditions you may have; information about your mental health; information about psychosocial support accessed; whether you access adult gender clinic support and any prescriptions you have had, including use of hormones and any other medication.  They may see, but are not interested in, directly identifiable information e.g. your name or whether you have a Gender Recognition Certificate and will not record this data.  We understand the sensitivity of this information, and have taken a number of steps to limit who can see this information and ensure that those who can are subject to strict confidentiality requirements. There is further information about this below.

Who will see my records?

All GIDS service users will be allocated a unique study number in place of any personally identifiable information.  This will be done by NHS Digital, which is the central NHS body responsible for managing ‘coded’ data arising from patients’ care.

NHS Digital manages health data at a national level and is responsible for keeping this data safe. Data that could directly identify you, such as your NHS Number(s) or date of birth, will already be held by NHS Digital to support the management of the NHS. It is this information which will be used by NHS Digital to link your records together to form your unique study number.  You can find out more about how NHS Digital keeps your personal information safe here: Keeping patient data safe – NHS Digital.

The research team from the University of York, who are subject to the same legal and ethical requirements in relation to patient confidentiality as NHS staff, will extract clinical data from the records provided by GIDS and adult GDCs and attach the unique study number to these records.  They may see, but will not record or in any other way use, your name, date of birth or any other information that directly identifies you.  The research team will only use these data for the purposes of the research to inform the Cass Review and will not share any individual level data beyond the research team.

The Cass Review team will not see any of your health records or identifiable information.

Is collecting/collating this type of data normal practice?

Yes, healthcare data on populations of children and young people are routinely used for research projects for the benefit of improving care and services across a wide range of health services. Up until now, this has not been the case for gender questioning children and young people – this research will go some way to address this imbalance. The approach to governance, data protection and confidentiality that we are taking is the same as lots of other research undertaken by the NHS or using NHS data. We are also being careful to ensure that we are complying with any special rules and sensitivities which may apply to information about transgender people, including those with Gender Recognition Certificates.

Who decides that this study can happen?

All research proposals involving NHS patient data are reviewed by an independent group of people, called a Research Ethics Committee (REC), to ensure that we are protecting the interests, safety and wellbeing of those affected. You can find out more information about this here: Research Ethics Service and Research Ethics Committees – Health Research Authority (hra.nhs.uk)

The research proposal must also be submitted for Confidentiality Advisory Group (CAG) approval. CAG assesses research applications where the research is going to take place without individual patient consent and involve the use of confidential information. During this assessment they will also assess compliance of the research with the Data Protection Act 2018.  You can find out more information about this here: Confidentiality Advisory Group – Health Research Authority (hra.nhs.uk)

Health Research Authority (HRA) Approval brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent ethical opinion by a REC. It applies where the NHS organisation has a duty of care to participants, either as patients/service users or NHS staff/volunteers. You can find out more information about this here: HRA Approval – Health Research Authority

These application processes require the research team to produce a structured protocol outlining how they will carry out the research, which we will publish on the Cass Review website once the research has received REC, CAG and overall HRA approval.

The research cannot and will not commence without these approvals. 

Why is the statutory instrument needed?

For this research, an additional step has been necessary to ensure that the Review can be undertaken in a way which is compatible with the strict legal parameters of the Gender Recognition Act 2004 (GRA). The GRA creates an offence of unlawfully disclosing information about individuals who have obtained a Gender Recognition Certificate (GRC). In some (but not all) cases, the individuals whose data will form part of the research will have obtained a GRC. As we explain below, so that an offence is not inadvertently committed, a ‘statutory instrument’ is currently passing through Parliament (The Gender Recognition (Disclosure of Information) (England) Order 2022). This will permit the handling of information about people with a GRC for very limited purpose of this research. This is required before REC and CAG will consider the research protocol and before NHS Digital and NHS England will support this research. Further information about this statutory instrument is below.

A copy of the Equality Impact Assessment relating to the Statutory Instrument can be found here: The Gender Recognition (Disclosure of Information) (England) Order 2022: equality impact assessment – GOV.UK (www.gov.uk)

The GRA makes it a criminal offence for any person acting in an “official capacity” to disclose information about the gender history of a person with a GRC, or information about someone’s application for a GRC. This information is known as “protected information”.

The GRA goes on to say that:

1. there are certain circumstances in which an offence is not committed, and
2. that additional exemptions to the offence can be created through statutory instruments.

These cover, for instance, direct medical care, social services and pensions.  However, none of the current exemptions would allow the research team to lawfully conduct this research. The GRA allows Parliament to permit other circumstances in which disclosure of protected information would not constitute a criminal offence. This is what has been done through this statutory instrument.

Some of the people whose data will form part of the research will have a GRC and this may already be recorded within data which the researchers need to use to conduct the research. We therefore need to be sure that a criminal offence is not inadvertently committed by the organisations contributing to the research or the researchers themselves. To be clear, the subject of the research is not looking at GRCs themselves, but some people whose data would form part of the research will have GRCs.

The statutory instrument is very prescriptive as to what is allowed to happen with GRA-protected information. Any use of the information outside the scope of the statutory instrument would remain a potential criminal offence.

What is the effect of the statutory instrument?

The statutory instrument ensures that the research does not inadvertently breach the GRA. It does this by providing for a limited exemption, for a closely defined group of people (i.e. those involved in this research), to facilitate, assist and carry out the research without risking criminal liability. The statutory instrument is limited to those working on behalf of the Cass Review and will expire after 5 years, which is the maximum amount of time we think this research will take, including peer review of any publications. Should the research be completed sooner, the statutory instrument would also expire at that time.

The statutory instrument does not allow for any onward disclosure of this protected information, or for the use of this protected information for anything other than the Cass Review. Neither this statutory instrument nor the data created for this study can be used for any other purposes, and the data held in this dataset will be securely destroyed once the research is complete.

Do I have a choice about my records being included?

Because we need to look at a large number of records (about 9,000 records), it is not feasible to get individual consent. However, once the study has approval from the REC and CAG, we will offer the opportunity to opt out of this study via your clinical teams. If somebody opts out, then none of their data will be used in this study.

We recognise that some people may not feel comfortable with the research, but we want as many people to allow us to use their data as possible, so we are working from a representative and accurate sample of data. This is so that we can seek to improve the services offered to children and young people questioning their gender identity, so that they can make informed decisions about their care. Therefore, we hope that when the time comes, you will allow us to use your information as part of this research programme.

How are you engaging with those affected?

There have been a series of patient and public involvement (PPI) sessions aimed at young people, their parents/carers and young adults who attended the GIDS service.  These have been recruited through GIDS and support/advocacy groups to provide further detail on the research, and help manage and design the research with the involvement of those most affected.

Once the research team have started to produce some results from this research, they will be advertising further sessions to discuss these findings, help them with their interpretation of what these findings mean, and how best to make those affected by this research aware of these results.