MR110 - UKAEA Mortality Study

*** This amendment (version 5) to the agreement is to add Data Processing and Storage locations which were identified as missing by a NHS Digital remote Data Sharing Audit. No other changes have been made to this agreement and new data has been requested since version 4.2 ***

Study MR110 is a long standing study of the effects of occupational radiation exposure in the nuclear industry. Much of the knowledge in this area has been gained from studies of the survivors of the two atomic bombs detonated over Japan at the end of the war. However, it is not clear how relevant this study of high doses received instantaneously is, to those exposed in an occupational context, or as members of the public, to much lower doses received over many years. This is why studies of nuclear workers have been, and continue to be, important in setting acceptable exposure levels at work and for the public in the wider environment. MR110 is a study of mortality and cancer morbidity in the past and present employees of the UK Atomic Energy Authority, the government organisation responsible for the initiation and technical and scientific development of the UK’s civil nuclear energy programme. It is among the small group of UK studies that lead the world in this area partly because of the quality of the national mortality and cancer registration systems.

The study commenced in 1979, designed by a team from the London School of Hygiene and Tropical Medicine. The MR110 cohort included everyone ever employed by UKAEA from its foundation in 1946. Since then all new recruits have been added to the study, which now includes around 75,000 individuals. Of these only some 28,000 are dead, which is why continued long-term follow-up, with a corresponding increase in statistical power is so important.

The study was initially funded by UKAEA and largely carried out by a team from UKAEA, but with reorganisation and privatisation in the nuclear sector responsibilities have changed and it is now mostly funded by the Nuclear Decommissioning Authority (NDA), overseen by the Public Health England (PHE), Centre for Radiation, Chemical and Environmental Hazards, and carried out by Nuvia Limited. The NDA is an executive non-departmental public body, sponsored by the Department for Business, Energy & Industrial Strategy to ensure the safe and efficient clean-up of the UK’s nuclear legacy (https://www.gov.uk/government/organisations/nuclear-decommissioning-authority)

The follow-up data provided by NHS Digital for the MR110 study has been used and will be used in wider collaborative studies taking in the nuclear workforces of several European countries. Such data is, of course, shared with collaborators and only with explicit agreement from the data providers, including NHS Digital, and from workforce representatives. Where data to be shared is anything other than data aggregated with small numbers suppressed the study will seek explicit permission from NHS Digital on a case by case basis via an amendment to the application.

LAWFUL BASIS FOR DATA PROCESSING UNDER GDPR

The lawful basis for processing data under GDPR has been reviewed against the guidance provided by IGARD and been assessed as acceptable. Public Health England are using Article 6 (1) (e); “processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller” as they are a public authority. The Data Protection Act 2018 s7(1)(a) defines ‘public bodies’ for the purpose of the GDPR as “a public authority as defined by the Freedom of Information Act 2000”. The FOI Act 2000 Part 1, section 3 (1)(a)(i) specifies that a public authority means any body which is listed in Schedule 1. Schedule 1 of the FOI Act 2000 lists. Furthermore, Public Health England is performing a ‘Public Task’ - a task carried out in the public interest or in the exercise of the controller’s official authority includes processing of personal data that is necessary for… ‘(d) the exercise of a function of the Crown, a Minister of the Crown or a government department’.

Public Health England adds that it’s role is “To ensure the public health system maintains the capability and capacity to tackle today’s public health challenges and is prepared for the emerging challenges of the future, both nationally and internationally. This will mean: undertaking research and development and working with partners from the public, academic and private sectors to improve the research landscape for public health; supporting and developing a skilled workforce for public health; supporting local government to improve the performance of its functions; providing the professional advice, expertise and public health evidence to support the development of public policies to have the best impact on improving health and reducing health inequalities; and collecting, quality assuring and publishing timely, user friendly high quality information on important public health topics and public health outcomes.”

As Health Data is a special category of Health data, Public Health England are also using 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” and the data are required for research purposes in the public interest – meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data. The ways in which the processing of data will be of benefit to the public – thereby demonstrating that the processing is in the public interest – are described in section ‘5d. ii. Expected Measurable Benefits to Health and/or Social Care Including Target Date’.

The cohort will increase approximately 500 in this Data Sharing Agreement

The data requested and already disseminated will be accessed and processed by substantive employees of Nuvia and only for the purposes described in the application.

MR110 is a flagging study, so data is provided to NHS Digital by Nuvia to enable the flags to be set. For each individual in the cohort this data comprises, name, date of birth, NHS number, home address, date to address and a unique study identifier.

The data requested by Nuvia from NHS Digital falls into three categories:

1. Mortality Data

Date, causes and place of death, unique study identifier, together with sufficient identity data to confirm that the flag was correctly set, i.e. name, date of birth, NHS number, occupation, home address.

2. Emigrations and Reregistration

Date of event, unique study identifier, together with sufficient identity data to confirm that the flag was correctly set, i.e. name, date of birth, NHS number.

3. Cancer Registrations

Date of diagnosis, disease code, unique study identifier, but no identity data.

The study has a favourable ethical opinion from the NHS Research Ethics Committee, Oxford C. It has approval from, and reports to the PHE/NDA Epidemiology Governance Group, which includes employee representatives.

Nuvia will not provide access to for any third parties to access record level data, even where these third parties are study partners. The use of this data will be limited to Nuvia for the purpose outlined above only. Data published or provided to third parties will be limited to aggregated data, at area, organisational or cohort-level all subject to small number suppression in line with the HES Analysis Guide.

Nuvia is currently part of a European consortium and is seeking funding to conduct a new study, which would entail data sharing with PHE. Any instances of data sharing or processing of data relating to a new study not outlined in this agreement will be subject to separate applications to NHS Digital.

New data subjects are recognised and added to the SHIELD database when their personnel data is sent to the Health Effects team by UKAEA’s contractors CSC, or by DSRL and Magnox. Annually, radiation dose data arrives from the dosimetry services (ADSs) of the same employers and is linked to the data in SHIELD by name, DOB and National Insurance Number (NIN). Periodically the required details for flagging are sent to NHS Digital and Dumfries. When data comes to the study from NHS Digital, either as event notifications or members and postings listings, it is initially linked to the data in the database using name, DOB and NHS Number. Subsequently, if the study are happy that the correct person has been flagged then the study will link on member number. The study have to retain the identity data in the database even after the routine linkage has taken place, because periodically the study add new categories of exposure data. A recent example is the addition of 70 years’ worth of internal radiation contamination assessments to the SHIELD database.

SHIELD is an Oracle 12 database, hosted on a server which is only accessible to authorised SHIELD users. Within SHIELD the followup data from NHS Digital is only available to those with the accredited researcher approvals. Data security is an important part of the culture of SHIELD users.

Typical analyses would be:

• Calculation of Standardised Mortality Ratios (SMRs) and Registration Ratios (SRRs) to compare the cohort with the national population in terms of mortality and cancer morbidity.

• Calculation of Rate Ratios to compare radiation workers with non-radiation workers in the nuclear industry.

• Tests for trends of mortality and morbidity rates with increasing radiation dose.

• Logistic regression analyses to calculate the Excess Relative Risk per unit of radiation dose.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data)”

There will be no data linkage undertaken with NHS Digital data provided under this agreement that is not already noted in the agreement.

Data will only be accessed and processed by substantive employees of Nuvia Ltd and will not be accessed or processed by any other third parties not mentioned in this agreement.

***Equinix do not access data held under this agreement as they only supply the building. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data.***

Outputs were presented as aggregated tables and figures, with suppression of low-numbered cells in line with the HES analysis guide where appropriate. As part of a previous EU funded project, the SHIELD database has been updated with all the internal dosimetry data required to undertake this work. The outputs included peer-reviewed publications and a publicly available web site.

Data from the MR110 cohort has been used in some 20 publications in high-impact peer-reviewed journals. For example:

Beral V, Inskip H, Fraser P, Booth M, Coleman D and Rose G (1985) Mortality of employees of the United Kingdom Atomic Energy Authority, 1946-1979. British Medical Journal, 291, 440-447.

Fraser, P, Carpenter L, Maconochie N, Higgins C, Booth M and Beral V (1993) Cancer Mortality and morbidity in employees of the United Kingdom Atomic Energy Authority, 1946-86. British Journal of Cancer, 67, 615-624.

Rooney C, Beral V, Maconochie N, Fraser P and Davies G (1993) Case-control study of prostatic cancer in employees of the United Kingdom Atomic Energy Authority. British Medical Journal, 307, 1391-1397

Roman E, Doyle P, Maconochie N, Davies G, Smith P and Beral V (1999) Cancer in children of nuclear industry employees: report on children aged under 25 years from nuclear industry family study, British Medical Journal; 318, 1443–1450

Atkinson WD, Law DV, Bromley KJ and Inskip HM (2004) Mortality of employees of the United Kingdom Atomic Energy Authority 1946-97 Occupational & .Environmental Medicine 61, 577-585

Atkinson WD, Law DV, Bromley KJ (2007) A decline in mortality from prostate cancer in the UK Atomic Energy Authority workforce. Journal of Radiation Protection, 27, 437-445

Grellier J, Atkinson, W et al (2016) Risk of lung cancer mortality in nuclear workers from internal exposure to alpha particle-emitting radionuclides. Epidemiology 28, 675-684.

Future outputs are expected to focus on the health effects of inhaled or ingested radionuclides which have been little studied anywhere hitherto. Outputs will include peer-reviewed publications and a publicly available web site. In all cases data will be presented as aggregated tables and figures, with suppression of low-numbered cells in line with the HES analysis guide where necessary.

Many thousands of workers, patients and members of the public are subject to regulated doses of ionising radiation. For example, the National Registry of Radiation Workers contains information on more than 200,000 people who have worked with radiation over the last 70 years and according to the Health & Safety Executive, in 2015 there were about 27,000 classified radiation workers in employment. The number of patients exposed is much greater. A recent study estimated that 175,000 cancer patients required radiotherapy in the UK in 2012.

Studies of the MR110 cohort have influenced and are expected to influence the development of the Ionising Radiation Regulations (IRRs) which regulate the exposure of people at work and of the public. The correct regulation of doses benefits the health not only of nuclear workers, but anyone else who works with radiation, such as medical radiographers and members of the public exposed as a result of medical x-rays or radioactive discharges to the environment.

If there is evidence that limits to exposure are too lax these benefits will take the form of lowered exposures and reduced health effects. If, on the other hand, the evidence suggests limits are too rigorous the benefits could include time and cost savings.

The results are expected to influence the development of the UK Government’s Ionising Radiation Regulations (IRRs) which regulate the exposure of people at work and of the public.

The IRRs are directly based on the authoritative recommendations of organisations such as the International Commission on Radiation Protection (ICRP) and the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR). These organisations monitor the latest research literature and will be aware of past and future publications from MR110. In particular the UNSCEAR 2006 and 2012 reports cited various publications which use MR110 data.

No record level data is or will be shared with any other organisation not specified in the application. Any data shared is aggregated with small number suppressed in line with HES Analysis guide.

*** Amendment version 5 excerpt from audit: The MR110 - UKAEA Mortality Study has not published anything since 2017. PHE / Nuvia are not using the data at the moment as they state that the analysis is done periodically due to the scale of the work involved. ***

Studies of the MR110 cohort aim to improve the understanding of the health effects of the low doses of ionising radiation received by nuclear workers. This understanding will benefit the health, not only of nuclear workers, but anyone else who encounters radiation, such as medical radiographers and members of the public exposed because of medical x-rays or radioactive discharges to the environment. If there is evidence that limits to exposure are too lax these benefits will take the form of lowered exposures and reduced health effects. If, on the other hand, the evidence suggests limits are too rigorous the benefits could include time and cost savings.

The benefit will be achieved by the authoritative international bodies, ICRP and UNSCEAR, and Public Health England in the UK, influencing Government regulation. thus the benefits of processing. The UNSCEAR 2006 and 2012 reports cited various publications which use MR110 data. Since then, a new set of IRRs was issued in 2017 which were influenced by UNSCEAR reports. From the last renewal a paper* data from this study has been published which shows a significant effect of inhaled plutonium and uranium on lung cancer rates. This is likely to influence future regulation on exposure to inhale radionuclides.

*Grellier, J, Atkinson WD, Bull R.K. et al (2017) Risk of Lung Cancer Mortality in Nuclear Workers From Internal Exposure to Alpha Particle-Emitting Radionuclides Epidemiology 28, 675-6