Asbestos Workers' Survey (consent cohort)

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

On 1 February 2023, NHS Digital merged with NHS England. NHS England has assumed responsibility for all activities previously undertaken by NHS Digital. The merger was completed by a statute change. Any reference made to NHS Digital within this Data Sharing Agreement is in reference to the merged organisation known as NHS England. [1 paragraph unchanged] A cohort of Asbestos workers were recruited by HSE from 1971 onwards. [44 words unchanged] two as the data for the pre-2006 cohort is disseminated by NHS Digital England under a different agreement (ref: DARS-NIC-337801-K2N5Y) using section 251 for the Common [60 words unchanged] of this agreement, in addition to the 9,776 already held by NHS Digital. England. [1 paragraph unchanged] HSE has determined that there are unlikely to be any moral or [6 words unchanged] public from dissemination of data for this purpose. Once received from NHS Digital, England, the data being processed by HSE will be pseudonymised. [9 paragraphs unchanged] HSE is the sole data controller and data processor of the data supplied by NHS Digital England under this Agreement. Iron Mountain provides storage for backups, but does not [16 words unchanged] to this data or are involved in this study in any way.

Processing activities

The electronic data are stored on servers at the Health and Safety Executive’s (HSE’s) Bootle location. The data are accessed via HSE hardware in HSE’s Buxton location, Bootle location, or employees’ home address, connecting to the HSE network. Archived paper records are stored at the Buxton location. Data processing is only carried out by substantive employees of HSE who have been appropriately trained in data protection and confidentiality. Servers are backed-up to tape, which are stored at the Iron Mountain location. Iron Mountain provides storage for backups, but does not access or process the data. Most study members who consented to participate from 2006 onward had already been flagged with NHS England, but they were flagged in the same cohort as members recruited prior to 2006 for whom section 251 support had been granted. To enable Type 2 Patient Objections to be appropriately applied to the data of study members who have not given sufficient informed consent, the cohort flagged on NHS England’s system was deleted and the cohort re-flagged in separate subsets: those without consent (DARS-NIC-337801-K2N5Y) and those with consent (DARS-NIC-183842-H8L1J). Most study members who consented to participate from 2006 onward had already been flagged with NHS Digital, but they were flagged in the same cohort as members recruited prior to 2006 for whom section 251 support had been granted. To enable Type 2 Patient Objections to be appropriately applied to the data of study members who have not given sufficient informed consent, the cohort flagged on NHS Digital’s system was deleted and the cohort re-flagged in separate subsets: those without consent (DARS-NIC-337801-K2N5Y) and those with consent (DARS-NIC-183842-H8L1J). [1 paragraph unchanged] 1) There are some study members who could not be flagged under [11 words unchanged] information will be cleaned (by HSE) and will be sent to NHS Digital England for flagging under the correct subset for that individual. [1 paragraph unchanged] 3) The study currently has participants flagged with NHSCR Scotland (application renewal [16 words unchanged] Wales, then HSE will request that the participant is flagged with NHS Digital. England. This participant may be added to the subset with consent or the subset without consent depending on whether section 251 support applies to the individual. [2 paragraphs unchanged] NHS Digital England will provide to HSE notifications of participants' deaths (including date and cause), cancer registrations and exits from or re-entries to NHS registration (including Health Authority Cipher). All data transfers between NHS Digital and HSE will be undertaken using NHS Digital's secure electronic file transfer system (SEFT). Any information received from NHS Digital will be downloaded onto a restricted access encrypted network drive for the study. The Data will be stored on servers at HSE. HSE uses offsite back-up services provided by Iron Mountain. The Data will be accessed onsite at HSE premises in the UK. Data will also be accessed by authorised personnel via remote access from locations within the UK. The Controller must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract. For remote access: - Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA; - Access controls granting users the minimum level of access required are in place; - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; - Multifactor authentication (MFA) is required for remote access; - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; - All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy. The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose). The Data will not leave the UK at any time. All data transfers between NHS England and HSE will be undertaken using NHS England's secure electronic file transfer system (SEFT). Any information received from NHS England will be downloaded onto a restricted access encrypted network drive for the study. [1 paragraph unchanged] 1) Recruitment is ongoing and so there will be a number of [6 words unchanged] under this Data Sharing Agreement. The HSE study team will send NHS Digital England the following identifiable information on new study members where available: study ID; [11 words unchanged] Address (including postcode). This will enable linkage to be undertaken by NHS Digital. England. 2) NHS Digital England will provide the HSE study team with the requested records, which includes health data (special category personal data). 3a) The current database for the study is an encrypted SQL database, and holds data from NHS Digital England and its predecessors up until 2015. HSE are no longer uploading NHS Digital England information onto this database since they are looking to update their systems (see 3b below). Until the new data management system is finalised, the information provided by NHS Digital England will be stored electronically on HSE’s restricted access encrypted network drive. 3b) HSE are currently investigating the potential for using an off-the-shelf cloud-based clinical data management system to manage all study data, including data received from NHS Digital. England. HSE have already sought advice from NHS Digital England on the acceptability of such a system and what security assurances would be needed. Once an appropriate system is identified, and before implementation, NHS Digital England will be consulted to ensure its suitability to hold their data. Once in place, all information received from NHS Digital England will be uploaded onto the new data management system. [1 paragraph unchanged] 4a) The information from NHS Digital England will be linked by HSE to research data collected directly from the participants throughout the duration of the study to enable analysis. This includes the following information: [7 paragraphs unchanged] The HSE study team linked the NHS Digital England mortality data for the 745 individuals identified to the demographic and exposure [85 words unchanged] from this project will be an important contribution to the knowledge base. 5) HSE are currently renewing their application with National Records Scotland (NRS). [25 words unchanged] to England or Wales, HSE will send identifiable participant information to NHS Digital England so that the participant entering England/Wales can be flagged. It is proposed [9 words unchanged] by NRS to HSE, to help successful flagging of participants in England/Wales. [2 paragraphs unchanged]

Benefits reported

The Asbestos Workers Survey is of international importance because of its large [82 words unchanged] situation. Information about long term death and cancer outcomes provided by NHS Digital England (and its predecessors) were critical in all these analyses. [2 paragraphs unchanged]

Unchanged: Expected output, Expected measurable benefits.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

The Health and Safety Executive's aim of the Asbestos Workers Survey is to monitor the long-term mortality and cancer incidence among asbestos removal workers who are now the main worker group with the highest potential for exposure to asbestos in the UK. This will enable the Health and Safety Executive to continue to evaluate its policy of progressively tightening the regulatory framework with regard to working with asbestos, and to inform future policy decisions. The study will also provide valuable information about the long-term health risks of workers in the British asbestos product manufacturing industry before the mid-1980s which will contribute to improving the evidence base about the general relationship between asbestos exposure and disease which is needed for risk assessment purposes both in the UK and internationally. On 1 February 2023, NHS Digital merged with NHS England. NHS England has assumed responsibility for all activities previously undertaken by NHS Digital. The merger was completed by a statute change. Any reference made to NHS Digital within this Data Sharing Agreement is in reference to the merged organisation known as NHS England. A cohort of Asbestos workers were recruited by The Health and Safety Executive from 1971 onwards. Approximately ninety thousand participants have been recruited thus far, however the cohort has been split in two as the data for the pre-2006 cohort is disseminated by NHS Digital under a different agreement (ref: DARS-NIC-337801-K2N5Y) using section 251 for the Common Law Duty of Confidentiality. This Agreement (DARS-NIC-183842-H8L1J) refers only to those participants recruited post-2006, using Informed Consent as the Common Law Duty of Confidentiality. The size of the cohort currently held for this part of the study is 9,776. Recruitment and data processing is ongoing and it is anticipated that approximately 13,000 further participants will be flagged during the lifetime of this agreement, in addition to the 9,776 already held by NHS Digital. The aim of the Health and Safety Executive's (HSE’s) Asbestos Workers Survey is to monitor the long-term mortality and cancer incidence among asbestos removal workers who are now the main worker group with the highest potential for exposure to asbestos in the UK. This will enable HSE to continue to evaluate its policy of progressively tightening the regulatory framework with regard to working with asbestos, and to inform future policy decisions. The study will also provide valuable information about the long-term health risks of workers in the British asbestos product manufacturing industry before the mid-1980s, which will contribute to improving the evidence base about the general relationship between asbestos exposure and disease which is needed for risk assessment purposes both in the UK and internationally. This work is research in the public interest because it aims to provide the evidence required for the Health & Safety Executive to evaluate the regulatory framework for controlling asbestos exposure at work in terms of disease reduction. This evaluation will in turn feed into future policy decisions. The survey is still running because asbestos is still present in some work places and asbestos-related diseases have a long latent period. A cohort of Asbestos workers were recruited by HSE from 1971 onwards. Initially, workers at asbestos manufacturing sites were recruited into the survey, but now all workers (except firefighters) attending statutory asbestos medical examinations are invited to participate in the study. Approximately 90,000 participants have been recruited thus far, however, the cohort has been split in two as the data for the pre-2006 cohort is disseminated by NHS Digital under a different agreement (ref: DARS-NIC-337801-K2N5Y) using section 251 for the Common Law Duty of Confidentiality. This Agreement (DARS-NIC-183842-H8L1J) refers only to those participants recruited post-2006, using Informed Consent as the Common Law Duty of Confidentiality. The size of the cohort currently held for this part of the study is 9,776. Recruitment and data processing is ongoing, and it is anticipated that approximately 15,000 further participants will be flagged during the lifetime of this agreement, in addition to the 9,776 already held by NHS Digital. The Health and Safety Executive has determined that there are unlikely to be any moral or ethical issues from dissemination of data for this purpose. Once received from NHS Digital, the data being processed by the Health and Safety Executive will be pseudonymised and will be compliant with the ICO's "Anonymisation: managing data protection risk" code of practice. This research is being conducted as a task in the public interest (GDPR Article 6(1)(e)). Health data, which is a special category of data, is processed for archiving, research and statistical purposes (GDPR Article 9(2)(j)). This work is research in the public interest because it aims to provide the evidence required for HSE to evaluate the regulatory framework for controlling asbestos exposure at work in terms of disease reduction. This evaluation will in turn feed into future policy decisions. The survey is still running because asbestos is still present in some workplaces and asbestos-related diseases have a long latent period. HSE has determined that there are unlikely to be any moral or ethical issues, or harm to the public from dissemination of data for this purpose. Once received from NHS Digital, the data being processed by HSE will be pseudonymised. [1 paragraph unchanged] • Compare cancer incidence and mortality among the asbestos workers with the [12 words unchanged] with asbestos in different ways and had different amounts of exposure, for example example, insulation workers compared to manufacturing workers. A specific control group is not required for these types of analyses. [1 paragraph unchanged] The Health and Safety Executive is the sole data controller of the data supplied by NHS Digital under this Agreement. Funding is provided internally by HSE. Sopra Steria are contracted data processors for HSE and maintains the system that holds NHS Digital information, but they do not directly access the data. No other organisation has access to this data or are involved in this study in any way. To meet these objectives, HSE requires identifiable data from the following datasets: - Demographics: Fact of death, death registration details, NHAIS posting, and identifiable information including the individual’s NHS number, name and date of birth. - Civil Registration Deaths: death registration details such as date and cause of death, including identifiable information such as the individual’s NHS number, name and date of birth. - Cancer Registration Data: Cancer date, code, site and type, including identifiable information such as NHS number and cancer registration number. Identifiable data such as name and date of birth are required because HSE are currently quality assuring their data and need to be able to check the study identifiers on their system. No identifiable data is shared with other researchers or organisations. In all cases, any findings from the study are reported in aggregate format and no individuals are identified in these reports. This is ongoing research with no set end date, and so data will be required into the foreseeable future. Participants are based in England, Wales and Scotland, and so the data request covers both England and Wales. Equivalent data is received from National Records of Scotland for participants based in Scotland. The aims of the project cannot be met without knowledge of deaths and cancer registrations for participants, and there are no alternative, less intrusive ways of achieving the purpose of the data request. HSE is the sole data controller and data processor of the data supplied by NHS Digital under this Agreement. Iron Mountain provides storage for backups, but does not access or process the data. Funding is provided internally by HSE. No other organisation has access to this data or are involved in this study in any way.

Processing activities

The electronic data are stored on servers at the Health and Safety Executive’s (HSE) (HSE’s) Bootle location. Servers are backed-up to tape, which are stored at the Iron Mountain location. The data are accessed via HSE hardware in HSE’s Buxton location, Bootle location, or employees’ home address, connecting to the HSE network. Archived paper records are stored at the Buxton location. Data processing is only carried out by substantive employees of HSE who have been appropriately trained in data protection and confidentiality. Servers are backed-up to tape, which are stored at the Iron Mountain location. Iron Mountain provides storage for backups, but does not access or process the data. The data are accessed by authorised substantive employees of the HSE exclusively at the Buxton address. No other HSE employees will access the data at any other location. Sopra Steria are data processors for HSE and maintains the system that holds NHS Digital information. Sopra Steria do not access these data other than for backups and support. Sopra Steria staff with Domain Admin accounts will have the permission to access the data but this should not happen without explicit permission from the data owner (HSE) and should only be applicable in system upgrades and faults etc. There should be no reason as part of the live service that Sopra Steria would need to access live data. If they do need to access the data, then this will be using HSE devices (with explicit permission from HSE). All Sopra Steria staff with HSE accounts adhere to HSE policies. HSE’s contract with Sopra Steria is due to end in August 2021, after which HSE will in-source the management of their IT estate. Most study members who consented to participate from 2006 onward had already been flagged with NHS Digital, but they were flagged in the same cohort as members recruited prior to 2006 for whom section 251 support had been granted. To enable Type 2 Patient Objections to be appropriately applied to the data of study members who have not given sufficient informed consent, the cohort flagged on NHS Digital’s system was deleted and the cohort re-flagged in separate subsets: those without consent (DARS-NIC-337801-K2N5Y) and those with consent (DARS-NIC-183842-H8L1J). The majority of study members who consented to participate from 2006 onward had already been flagged with NHS Digital but these were flagged in the same cohort as members recruited prior to 2006 for whom section 251 support had been granted. To enable Type 2 Patient Objections to be appropriately applied to the data of study members who have not given sufficient informed consent, the cohort flagged on the MRIS system was deleted and the cohort re-flagged in separate subsets: those without consent (DARS-NIC-337801-K2N5Y) and those with consent (DARS-NIC-183842-H8L1J). [1 paragraph unchanged] 1) There are some study members who could not be flagged under [6 words unchanged] to poor data quality. This information will be cleaned (by HSE) and will be sent to NHS Digital for flagging under the correct subset for that individual. [3 paragraphs unchanged] In the case of movement between subsets, two cohort submissions will occur: the first removing the study member previously reliant on Section 251 from DARS-NIC-337801-K2N5Y and a corresponding submission adding the newly consented study member to the DARS-NIC-183842-H8L1J. [2 paragraphs unchanged] 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 - i.e. employees, agents and contractors of the Data Recipient who may have access to that data). For clarification, for the purpose of comparing cancer incidence and mortality among the asbestos workers and subcategories thereof with the general population, the HSE will compare aggregated statistics with publicly available national statistics. The HSE will not link the data further and the only data linkages are those permitted under this Agreement. Aggregated data can be shared with other researchers without additional permission, if it falls within the outlined processing activities of the agreement and adheres to small number suppression as outlined in the HES Analysis Guide. [1 paragraph unchanged] 1) Recruitment is ongoing and so there will be a number of [9 words unchanged] Sharing Agreement. The HSE study team will send NHS Digital the following identifiable information on new study members where available: study ID; NHS number; Forename; [9 words unchanged] (including postcode). This will enable linkage to be undertaken by NHS Digital. 2) NHS Digital will provide the HSE study team with the requested records. records, which includes health data (special category personal data). 3a) The current database for the study is an encrypted SQL database, [18 words unchanged] Digital information onto this database since they are looking to update their systems. systems (see 3b below). Until the new data management system is finalised, the information provided by NHS Digital will be stored electronically on HSE’s restricted access encrypted network drive. 3b) HSE are currently investigating the potential for using an off-the-shelf cloud-based clinical [46 words unchanged] Digital will be consulted to ensure its suitability to hold their data. Until the data management system is finalised, the Once in place, all information provided by received from NHS Digital will be stored electronically on uploaded onto the restricted access encrypted network drive. It is expected that a new clinical data management system will be in place by Summer 2022. system. 3b) Once in place, all information received from NHS Digital will be uploaded onto the new data management system. 4) Data required for the different objectives will be extracted from the data management system by HSE study team members with the correct permissions. All study team members are substantive employees of the data controller/processor. Only the information required will be extracted. Extracted datasets will contain the minimum identifiable fields required and will be saved on the restricted access encrypted network drive for the study. All data processing will be conducted on the restricted access encrypted network drive. 4) Data required for the different objectives will be extracted from the data management system by study team members with the correct permissions. All study team members are substantive employees of the data controller. Only the information required will be extracted. Extracted datasets will contain the minimum identifiable fields required and will be saved on the restricted access encrypted network drive for the study. All data processing will be conducted on the restricted access encrypted network drive. 4a) The information from NHS Digital will be linked by HSE to research data collected directly from the participants throughout the duration of the study to enable analysis. This includes the following information: (a) The information from NHS Digital will be linked to research data collected from the participants throughout the duration of the study to enable analysis. This includes the following information: [3 paragraphs unchanged] (b) 4b) A specific project initiated in 2012 on the risk of lung cancer and all cause all-cause mortality associated with exposure to amosite asbestos involves involved further linkages: - In the 1980s the MRC Medical Research Council (MRC) Lifecourse Epidemiology Unit in Southampton collected individual-level data on the workers’ jobs [35 words unchanged] MRC to provide HSE with the job history data for these individuals. HSE sent to the MRC the first three letters of the surname and the year of birth for members of the Asbestos Workers Survey who worked at Cape Uxbridge. This permitted the MRC to identify the individuals who were members of both studies. The MRC sent HSE data on the work history (job titles with corresponding dates in these jobs) of these individuals. Altogether 745 members of the Asbestos Workers Survey were included in this dataset. - HM Factory Inspectorate undertook hygiene surveys at the Cape Asbestos plant, Uxbridge, during the 1970s and 1980s. These data data, which are held by HSE, relate to jobs and not to individuals. These data have been were used in the project to provide quantitative estimates of exposure to amosite for each job described in the MRC dataset. The resulting merged data included in this project are: were: date of birth, sex, smoking history, job, and quantitative estimate of exposure to amosite. The NHS Digital data will be linked to these data by the HSE study team linked the NHS Digital mortality data for this subset of the study population 745 individuals identified to enable the demographic and exposure data listed above. The final dataset was used to estimate of the risk of lung cancer cancer, and standardised mortality ratios for lung cancer, mesothelioma, all cause mortality to be calculated. malignant neoplasms, all circulatory diseases, all non-malignant respiratory diseases, and all-cause mortality. Worldwide there are very few populations of workers who are exclusively exposed to amosite asbestos, and none of the others have been followed up followed-up for this length of time. So A manuscript describing the results has been drafted and will be submitted to a peer-reviewed journal for publication shortly. The results from this project will be an important contribution to the knowledge base. 5) HSE are currently renewing their application with NHSCR Scotland. National Records Scotland (NRS). If approved, NHSCR Scotland NRS will provide HSE with NHS numbers for study participants flagged with them. [33 words unchanged] is proposed that this information will include the NHS number provided by NHSCR Scotland NRS to HSE, to help successful flagging of participants in England/Wales. This data flow has been agreed by the National Research Ethics Committee and, for those without consent (DARS-NIC-337801-K2N5Y), the HRA Confidentiality Advisory Committee. Group. The identifying fields provide an additional check when using the individual ID numbers to match the members and postings list or cancer/death registrations with the individuals in the cohort database. In the past there have been cases where the identifying fields did not match anyone on the study database. Without the identifying fields we would not have been in a position to spot and investigate these cases. Instances of this type of mismatch have arisen in the results of the cohort re-flagging exercise during which NHS Digital identified a number of duplicate ID numbers. The identifying fields enable the study team to investigate and correct the duplicate ID data. 6) For the purpose of comparing cancer incidence and mortality among the asbestos workers and subcategories thereof with the general population, the HSE will compare aggregated statistics with publicly available national statistics. The HSE will not link the data further and the only data linkages are those permitted under this Agreement. Aggregated data can be shared with other researchers without additional permission, if it falls within the outlined processing activities of the agreement and adheres to small number suppression as outlined in the HES Analysis Guide. The study team would like to continue to receive identifying fields at least until such time as the re-flagging exercise is complete and the new data management system is properly established. The members and postings list from NHS Digital provides an additional check on the integrity of the study's data stored in the study database and at NHS Digital. It would be very unfortunate if data collected since 1971 were compromised by dropping the identifying fields prematurely. Stata statistical software will be used to link the files and de-identify the data as much as possible before analysis. No identifiable data is shared with other researchers or organisations. In all cases, any finding from the study are reported in aggregate format and no individuals are identified in these reports.

Expected output

The Asbestos Workers Survey produces regular updates on mortality in the cohort cohort, which indicate the trends in mortality over time. It is expected that [15 words unchanged] of this is not definite but it is expected to be in the Summer of 2022. 2024. In addition to these analyses, the Health and Safety Executive (HSE) determines the need for additional analyses of the data to address specific questions. questions as they arise. Currently, whether the risks of lung cancer and mesothelioma differ between the [9 words unchanged] output from this investigation, a peer-reviewed journal manuscript, is expected approximately in summer the 2nd or 3rd quarter of 2021. 2023. [1 paragraph unchanged] The survey findings will As a publicly funded research study, it is HSE policy to ensure that outputs are freely available. Outputs may be freely available in research reports published as Research Reports on HSE’s website or in peer-reviewed journals in ‘open access’ format so that they are accessible to all. However, it is not possible to determine exactly where each set of findings will be published. At this point HSE are providing a list of possibilities based on HSE's experience with similar studies. Outputs may be published in peer reviewed journals. more than one format for example as a research report and as a conference presentation. The most appropriate journals will be decided upon the time of publishing publishing, but HSE has previously published findings from this study in the British [44 words unchanged] & Environmental Epidemiology Conference, and the British Occupational Hygiene Society Annual Conference. As a publicly funded research study, it is HSE policy to ensure that outputs are published and that the publications are open access so that they are accessible to all. However, it is not possible to determine exactly where each set of findings will be published. At this point HSE are providing a list of possibilities based on HSE's experience with similar studies. Outputs may be published in more than one format for example as a research report and as a conference presentation. Apart from these traditional publication routes, HSE has developed a much wider dissemination program for its science and research based on electronic communications. HSE’s Science Information, Dissemination and Engagement Team prepares a regular Science e-Bulletin, which they send to over 80,000 subscribers; subscribers include a wide range of stakeholders including from Industry and the Press, and some members of the general public. Any new outputs from the study will be highlighted in the e-Bulletin, thereby substantially increasing the reach of the study. The HSE Annual Science Review is written in an easily understood accessible format and is very widely disseminated to all stakeholders, including the ‘interested public’. This study has featured in the Annual Science Review in the past. Tickets to HSE’s Chief Scientific Adviser’s seminars are available on Eventbite and, as an example, nearly 400 tickets were registered for the last seminar. Ticket holders came from all across the UK, and the majority of them also subscribed to HSE’s Science e-Bulletin. Targeted invitees to the seminars include the general press and Trade Unions. Findings from this study are within the scope of these seminars, and may be presented if appropriate. These seminars and new scientific outputs are also circulated using the Chief Scientific Adviser’s twitter account. The Asbestos Workers’ Survey has a website, which provides information about the study and the study team’s contact details. Overall, the outputs from the study now reach a far larger audience than was possible previously. HSE policy advisers are key stakeholders in the Asbestos Workers’ Survey. As such, they are involved in discussions about any developments in the study and they review all outputs. This ensures the relevance of the study and that outputs are communicated to those who influence, or are interested in, health and safety policy in this area. [1 paragraph unchanged]

Expected measurable benefits

[1 paragraph unchanged] The benefit from the progressively tighter regulation of asbestos exposure at work is expected to be a reduction in the number of asbestos related deaths among men and women occupationally exposed to asbestos. The findings from the Asbestos Workers Survey and this data request will help to demonstrate whether there is evidence that the regulations are [6 words unchanged] Previous analysis of the survey data suggested that men and women who are were first occupationally exposed to asbestos in more recent times are at lower risk of these diseases. However, the nature of the diseases associated with asbestos means that longer follow-up is required to provide more conclusive evidence. Without longer follow-up, HSE would no longer be in a position to track the trend in asbestos related disease in these workers. This would have a major impact on this survey which has been running for more than 40 years, and would negatively affect HSE’s ability to monitor the long-term health of asbestos workers. The study was established with the main aim of providing HSE a means of assessing the effectiveness of its measures to control exposure to asbestos in the workplace. Consequently, the periodic analysis of mortality among these workers is the principal outcome that addresses this aim. HSE policy advisers are the key end-users and principal beneficiaries of the outputs from the Asbestos Workers’ Survey. As such, they are involved in discussions about any developments in the study and they review all study outputs. This ensures the relevance of the study and that outputs are communicated directly to those who are involved in developing health and safety policy in this area. The policy advisers include the study findings in the evidence base they use when determining the regulatory regime for working with asbestos in Great Britain. The findings from this survey will be used by HSE to inform its policy with respect to regulating exposure to asbestos at work. Dissemination to as wide a reach of potential beneficiaries as possible is important to ensure transparency, to increase public understanding of how HSE develops its policies based on evidence, and to ensure that research findings become part of the knowledge base on asbestos in the workplace. Dissemination of the study findings is in the public interest because it shows that HSE is taking the health concerns associated with occupational exposure to asbestos seriously and is actively monitoring the health of these workers. If the downward trend in risk observed for those exposed more recently is shown to continue in the long term, then the public will also be reassured that effective steps are being taken to mitigate the risks associated with occupational exposure to asbestos. Disseminating the study findings widely may help to promote greater understanding of the range of work that HSE undertakes in its role as the regulatory body and demonstrate that its policies are evidence based. The dissemination activities described in 'Specific Outputs Expected, Including Target Date' focus on disseminating outputs to the public. The ability to assess the incidence of asbestos related cancers and deaths among these workers is the key benefit that HSE achieves from the study. Without ongoing follow-up, HSE would no longer be in a position to track the trend in asbestos related disease in these workers. This would have a major impact on this survey, which has been running for more than 50 years, and would negatively affect HSE’s ability to monitor the long-term health of asbestos workers. The findings from this survey will be used by HSE to inform its policy with respect to regulating exposure to asbestos at work.

Benefits reported

The Asbestos Workers Survey is of international importance because of its large size and length of follow-up and its findings have made significant contributions to the knowledge base. Survey findings have been published in HSE Research Reports and in peer reviewed journals. Peer reviewed articles have covered mortality among all asbestos workers; mortality among asbestos removal workers; asbestosis and mesothelioma mortality among all asbestos workers; the joint effect of smoking and asbestos exposure on lung cancer mortality; and the latency period of mesothelioma. Together these articles have been cited over 160 times. In addition, McCormack et al used published data from the study to estimate the asbestos-related lung cancer burden from mesothelioma mortality (Br J Cancer, 2012). Information received from NHS Digital and its predecessors were critical in all these publications. The Asbestos Workers Survey is of international importance because of its large size, its longitudinal design with extensive follow-up, and high ongoing coverage of a key group of British workers (asbestos removal workers) with the highest potential for exposure to the more hazardous forms of asbestos (blue and brown), which were used particularly extensively in the UK built environment. Analyses of asbestos-related disease risks among this population have made a significant contribution to the international evidence base about the health effects of asbestos exposure, as well as providing specific insights relevant to the UK situation. Information about long term death and cancer outcomes provided by NHS Digital (and its predecessors) were critical in all these analyses. Survey findings available to date, published via a range of Health and Safety Executive Research Reports and peer reviewed journal articles, have addressed questions such as: the extent of the reduction in risks over time as regulations were made progressively more stringent; the contribution of the UK asbestos industry made to the overall burden of asbestos related disease in Britain; how cigarette smoking and asbestos interact as risk factors in the causation of lung cancer; the extent to which risks of asbestos-related disease vary according to type of work and asbestos materials encountered; and how exposure relates to the latency of the asbestos-related cancer, mesothelioma. The research has also contributed to emerging evidence about asbestos exposure and cardiovascular disease risk. A recent analysis – which in autumn 2022 has just been finalised for submission for journal publication – has addressed lung cancer and mesothelioma risks in relation to quantitative exposure to brown asbestos. This will enhance the select group of studies available internationally that characterise asbestos-related disease outcomes in relation to quantitative asbestos exposure estimates to specific types of asbestos. Previously published articles have together been cited over 160 times. Asbestos removal workers continue to be a crucial worker group within the regulatory regime for asbestos in Britain in which risks of exposure are sought to be minimised through appropriate management and removal of asbestos from buildings. This was recognised at a recent Work and Pensions Select Committee examination of the current policy and ongoing debate about whether an accelerated programme of asbestos removal with targets for the eradication of asbestos from buildings should be implemented. The changing nature of asbestos-related diseases risks among removal workers therefore remains a key research priority within this policy context. This question is planned to be addressed directly in the next phase of analysis of the study.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

[1 paragraph unchanged] A cohort of Asbestos workers were recruited by The Health and Safety Executive from 1971 onward. onwards. Approximately ninety thousand participants have been recruited thus far, however the cohort [57 words unchanged] cohort currently held for this part of the study is 9,776. Recruitment and data processing is ongoing and it is anticipated that approximately 5,000 will be added to the cohort in 2019, and approximately 4,000 being added in both 2020 and 2021. It is therefore anticipated that a total of approximately 13,000 further participants will be flagged during the life-time lifetime of this agreement, in addition to the 9,776 already held by NHS Digital. [5 paragraphs unchanged] The Health and Safety Executive is the sole data controller and data processor of the data supplied by NHS Digital under this Agreement. Funding is provided internally by HSE. Sopra Steria are contracted data processors for HSE and maintains the system that holds NHS Digital information, but they do not directly access the data. No other organisation has access to this data or are involved in this study in any way.

Processing activities

The electronic data are stored on servers at the Health & and Safety Executive’s (HSE) Buxton, Derbyshire Bootle location. During Servers are backed-up to tape, which are stored at the period covered by this Agreement, the Iron Mountain location. The data will be transferred to HSE’s Bootle location where it will be stored on local servers and backed up in severs in HSE’s Basingstoke location for purposes of contingency, if and when, for whatever reason, the Bootle servers are unavailable. Once this transfer is complete, the data will be accessed via hardware in the HSE’s laboratory in Buxton location, connecting to the HSE network. Until the transfer takes place, the data will be stored and processed directly on the servers in Buxton. Archived paper records are stored at the Buxton location. Access to the data is limited to authorised substantive employees of the HSE exclusively at the Buxton address. No other HSE employees will access the data at any other location. No data will be accessible to third parties outside of HSE. The data are accessed by authorised substantive employees of the HSE exclusively at the Buxton address. No other HSE employees will access the data at any other location. Sopra Steria are data processors for HSE and maintains the system that holds NHS Digital information. Sopra Steria do not access these data other than for backups and support. Sopra Steria staff with Domain Admin accounts will have the permission to access the data but this should not happen without explicit permission from the data owner (HSE) and should only be applicable in system upgrades and faults etc. There should be no reason as part of the live service that Sopra Steria would need to access live data. If they do need to access the data, then this will be using HSE devices (with explicit permission from HSE). All Sopra Steria staff with HSE accounts adhere to HSE policies. HSE’s contract with Sopra Steria is due to end in August 2021, after which HSE will in-source the management of their IT estate. [7 paragraphs unchanged] The electronic data are stored on servers at the Health & Safety Executive’s (HSE) Buxton, Derbyshire location. During the period covered by this Agreement, the data will be transferred to HSE’s Bootle location where it will be stored on local servers and backed up in severs in HSE’s Basingstoke location for purposes of contingency, if and when, for whatever reason, the Bootle servers are unavailable. Once this transfer is complete, the data will be accessed via hardware in the HSE’s laboratory in Buxton connecting to the HSE network. Until the transfer takes place, the data will be stored and processed directly on the servers in Buxton. Archived paper records are stored at the Buxton location. All data transfers between NHS Digital and HSE will be undertaken using NHS Digital's secure electronic file transfer system (SEFT). Any information received from NHS Digital will be downloaded onto a restricted access encrypted network drive for the study. Access to the data is limited to authorised substantive employees of the HSE exclusively at the Buxton address. No other HSE employees will access the data at any other location. No data will be accessible to third parties outside of HSE. All data transfers between NHS Digital and HSE will be undertaken using NHS Digital's secure electronic file transfer system (SEFT). Any information received from NHS Digital will be downloaded onto a restricted access encrypted network drive, dedicated to the study. Access to the data is limited to authorised substantive employees of HSE exclusively at the Buxton site. No other HSE employees will access the data. No data will be accessible to third parties outside of HSE. The data will only be used for the purpose as stated. [3 paragraphs unchanged] 1) Recruitment is ongoing and so there will be a number of [18 words unchanged] Digital the following information on new study members where available: study ID; NHS number; Forename; Middle name; Surname; Date of birth; Sex and Address (including postcode). This will enable linkage to be undertaken by NHS Digital. [1 paragraph unchanged] 3a) The study database is currently under development. Until this is finished, the information provided by NHS Digital will be stored electronically on the restricted access encrypted network drive. It is expected that development will be complete by 2022. 3a) The current database for the study is an encrypted SQL database, and holds data from NHS Digital and its predecessors up until 2015. HSE are no longer uploading NHS Digital information onto this database since they are looking to update their systems. When finished, the database will reside in the HSE data centre on an SQL server, which HSE control. The restricted access encrypted network drive is on an HSE network share within the HSE data centre with access only granted to authorised members of staff. HSE are currently investigating the potential for using an off-the-shelf cloud-based clinical data management system to manage all study data, including data received from NHS Digital. HSE have already sought advice from NHS Digital on the acceptability of such a system and what security assurances would be needed. Once an appropriate system is identified, and before implementation, NHS Digital will be consulted to ensure its suitability to hold their data. Until the data management system is finalised, the information provided by NHS Digital will be stored electronically on the restricted access encrypted network drive. It is expected that a new clinical data management system will be in place by Summer 2022. 3b) Once complete, all information received from NHS Digital will be uploaded onto the study database. Identifiable information that HSE holds will initially be stored on the same database as the research data but partitioned/secured using SQL schema or a bespoke service API. It will be transitioned to separate databases for clinical and identifiable data. Restrictions will be in place so that only study team members with the correct permissions will be able to access data received from NHS Digital. In addition, all databases will be encrypted. 3b) Once in place, all information received from NHS Digital will be uploaded onto the new data management system. 4) Data required for the different objectives will be extracted from the database data management system by study team members with the correct permissions. All study team members [38 words unchanged] data processing will be conducted on the restricted access encrypted network drive. [9 paragraphs unchanged] 5) HSE are currently renewing their application with NHSCR Scotland. If approved, NHSCR Scotland will provide HSE with NHS numbers for study participants flagged with them. When HSE is informed that a participant has exited Scotland to England or Wales, HSE will send identifiable participant information to NHS Digital so that the participant entering England/Wales can be flagged. It is proposed that this information will include the NHS number provided by NHSCR Scotland to HSE, to help successful flagging of participants in England/Wales. This data flow has been agreed by the National Research Ethics Committee and, for those without consent (DARS-NIC-337801-K2N5Y), the HRA Confidentiality Advisory Committee. [1 paragraph unchanged] The study team would like to continue to receive identifying fields at least until such time as the re-flagging exercise is complete and the new database data management system is properly established. The members and postings list from NHS Digital provides [76 words unchanged] reported in aggregate format and no individuals are identified in these reports.

Expected output

The Asbestos Workers Survey produces regular updates on mortality in the cohort [30 words unchanged] not definite but it is expected to be in the Summer of 2020. 2022. In addition to these analyses, the Health and Safety Executive (HSE) determines [35 words unchanged] this investigation, a peer-reviewed journal manuscript, is expected approximately in summer of 2019. 2021. Identifiable data will not be shared with third parties; only the results from statistical analysis will be shared. The results will take the form of aggregated data, and will typically [26 words unchanged] any aggregated data, these will be suppressed in accordance with current guidelines. [3 paragraphs unchanged]

Unchanged: Expected measurable benefits, Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + Cancer Registration Data; + Civil Registrations of Death; + Demographics

Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.