2754: Database of UK recipients of pituitary-derived human growth hormone
This research seeks to better understand the long-term effects to people in the UK were given human growth hormone extracted from the pituitary gland of people who had died.
About the project:
What the project aims to do
Between 1959 and 1985, nearly 2000 people in the UK were treated with a type of human growth hormone called ’pituitary-derived growth hormone’ (also known as cadaveric growth hormone).
This treatment is no longer used because it was found that some batches were contaminated with proteins called ‘prions’ which caused a rare fatal brain disease called iatrogenic Creutzfeldt-Jakob Disease (iCJD). However, recent research suggests that this treatment might also be linked to other neurological (brain) conditions, such as iatrogenic cerebral amyloid angiopathy (medically-caused brain blood vessel damage or bleeding), stroke (brain bleeds), cognitive decline and seizures.
Researchers at University College London (UCL) believe these conditions may be caused by another abnormal protein, called amyloid-beta, that might also have been present in pituitary-derived human growth hormone.
To better understand whether people who received pituitary-derived human growth hormone are at risk of other neurological conditions, UCL will create 2 new research databases.
Surveillance snapshot research database
UCL will create an observational database linking health records from hospital episode statistics (HES) and Office for National Statistics (ONS) with clinical data from the human growth hormone recipients at Risk of iCJD dataset. UCL will use this data to see whether people who received pituitary-derived human growth hormone are at increased risk of neurological symptoms or diagnoses, or death due to neurological conditions.
Permission to contact research database
UCL wants to ask people who have received pituitary-derived human growth hormone for their consent to be contacted about future research. If the person agrees, their name will be added to a contact list that will be maintained by UCL. This list will be used solely for the purpose of inviting them to consider participation in new research studies as they are established. Inclusion on the list does not obligate participation, and individuals may withdraw their consent at any time.
Why this project is important
Given recent research findings about protein transmission in the brain and other neurological diseases, UCL wants to investigate this as well as monitor the long-term health of people who were treated with pituitary-derived human growth hormone.
In particular, they want to discover whether people who received this treatment develop neurological conditions other than iCJD and if other types of proteins (for example tau protein) can cause other diseases following historical treatment with pituitary-derived human growth hormone. This is important to increase understanding of the risks, of these conditions and to ensure affected patients receive appropriate support.
Who the data is about
People who received pituitary-derived human growth hormone who are included in the human growth hormone recipients at risk of iCJD dataset.
How the data will be used: Surveillance snapshot research database
UKHSA will securely extract confidential patient information (name, NHS number and date of birth) of each person recorded in the human growth hormone recipients at Risk of iCJD dataset. UKHSA will apply the National Data Opt-Out using the NHS England MESH system. This ensures that anyone who has opted out of sharing their data for research or planning will be excluded from the research dataset. The data will be sent to NHS England who will link it to:
- hospital episode statistics (HES) – records of hospital visits
- death certificate information – details about causes and dates of death
NHS England will also exclude anyone who has opted out or moved abroad before sending the linked data back to UKHSA.
Once linked, additional data will be added by UKHSA to the data from the human growth hormone recipients at risk of iCJD dataset, before all personal identifiers are removed and replaced with a unique, project-specific pseudonym.
This pseudonymised data will be securely transferred to UCL by UKHSA using Egress and stored in the UCL Safe Haven.
The research team will use the pseudonymised data to produce summary statistics on:
- numbers of inpatient, outpatient, and emergency care episodes
- reasons for hospital attendance
- number of deaths and average age at death
- neurological vs. non-neurological causes of death
They will also compare these statistics between groups of people who received different types or doses of pituitary-derived human growth hormone.
How the data will be used: Permission to contact research database
UKHSA will securely export confidential patient information (specifically NHS number and date of birth) from the human growth hormone recipients at risk of iCJD dataset. This information will be transferred to NHS England, who will use the NHS Personal Demographics Service (PDS) to identify each individual’s current registered GP.
NHS England will apply the National Data Opt-Out and then the data will then be returned to UKHSA. To this data, UKHSA will add relevant clinical information to help GPs understand why their patients are being contacted and then apply the National Data Opt-Out.
After excluding individuals who have opted out, the research dataset will be securely transferred to UCL and stored within the UCL Data Safe Haven. UCL will then write to each person’s GP, requesting that they send the patient information about the research and a consent form.
GPs retain discretion to withhold contact if they believe it could negatively impact the patient (for example, due to mental health concerns or if the patient has opted out of data sharing). In such cases, the research team will cease any further contact and securely delete that individual’s data.
UCL will also provide a dedicated phone line and email address for questions or concerns. People will be contacted in small batches so the team can respond to any issues before reaching out to more people.
If a patient does not respond after 3 contact attempts, it will be assumed they do not wish to participate and their data will be securely deleted. If consent is provided, the data will continue to be held securely within the UCL Data Safe Haven unless the patient requests removal, in which case it will be fully and safely destroyed.
How often data is needed
One-off
How this research project will benefit public health and the public
To show whether recipients of pituitary-derived human growth hormone are at risk of iatrogenic cerebral amyloid angiopathy and other related conditions, and if they are, to make sure they receive appropriate medical care, including reducing their future risk of stroke.
If recipients of pituitary-derived human growth hormone are at risk of developing iatrogenic cerebral amyloid angiopathy, the study team will educate and update other clinical providers on this risk, so that at-risk individuals can receive relevant information (if they so wish) and care.
To clarify whether recipients of pituitary-derived growth hormone might need to take certain measures in the future to prevent further onward transmission (spreading).
To review whether recipients of pituitary-derived human growth hormone are at risk of other neurological diseases caused by iatrogenic protein transmission.
To update public health bodies about these potential risks which could mean new public health measures will be introduced (for example, relating to sterilising medical instruments) to prevent future cases of disease.
Planned project outputs and communication
- peer reviewed scientific journals
- conference presentation
- website
- press release
Research findings will be communicated in lay terms at meetings of interested stakeholders (including public health officials, the Stroke Association and Alzheimer’s Research UK) through various communication routes, including the dissemination of lay summaries, social media and through the institute website.
Information will also be disseminated at the UCL open day, which is attended by a wide range of stakeholders, including patients and carers, charities, researchers, MPs, and public health specialists.
Lawful processing of personal and special category personal data
Under the UK General Data Protection Regulation (UK GDPR), the data needed for this project is classified as special category personal data. This means that, for the processing of this data to be lawful, there must be both a lawful basis for processing under Article 6 and a separate condition for processing under Article 9 of the UK GDPR.
Legal basis for using personal data (Article 6):
UK 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.
Legal basis for using special category personal data (Article 9):
UK GDPR Article 9(2)(j): processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
Common law duty of confidentiality
The data needed for this project includes confidential patient information - meaning data that can both identify an individual and relate to their health or care, shared in a context where confidentiality is expected and protected.
Confidential patient information is subject to a strict duty of confidentiality. It can only be used with the patient’s explicit consent or under specific legal provisions that permit its use - for example, for medical research or public health purposes.
How is the duty of confidentiality set aside:
Regulation 5, Health Service (Control of Patient Information 2002)
National Data Opt-Out
Will opt-out preferences be applied?
Yes
Where ‘No’, why:
Digital Object Identifier
Not available at time of approval.