The Prospective Investigation Pesticide Users’ Health (PIPAH) Study

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

Objective for processing

Health and Safety Executive (HSE) requires access to NHS England data for the purpose of the following research project: Prospective Investigation of Pesticide Applicators' Health (PIPAH) Study The following is a summary of the aims of the research project provided by HSE: [2 paragraphs unchanged] PIPAH was established in 2013, and participants were initially recruited from two central registers of pesticide sprayer operators maintained by City and Guilds: The National Register of Sprayer Operators (NRoSO) and the National Amenity Sprayer Operators Register (NAsOR). In 2014, participants from the PUHS who had previously completed a survey of pesticide usage in 2005/06 were also invited to take part. Annual, on-going recruitment focusses on new members of NRoSO. 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 inform government policy with respect to potential health risks linked to working with pesticides and thereby protect the health of the men and women who use pesticides as part of their employment. HSE has determined that there are no moral or ethical issues, or harm to the public from dissemination of data for this purpose. Once received from NHS England, the data being processed by HSE will be pseudonymised. [9 paragraphs unchanged] This is ongoing research with no set end date, and so data [46 words unchanged] met without knowledge of deaths and cancer registrations for participants, and there are is 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 England 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. The following NHS England Data will be accessed: • Civil Registration Deaths and Cancer Registration – necessary because monitoring long-term health is the main aim of the study and, as such, mortality and cancer incidence is one of the main health outcomes the investigators look at • Demographics – necessary for the following reasons: o to ensure the researchers do not contact participants who has died and cause distress to family members. o To identify who has emigrated to Scotland, allowing researchers to flag those participants in the relevant country. o To know current status (e.g., alive, dead, emigrated, registered in Scotland, etc) so researchers can accurately calculate follow-up time in analyses of mortality and cancer incidence. The level of the Data will be: • Identifiable – necessary to check data linkages with Scottish data and to ensure no duplication of cancer data with MRIS data. The Data will be minimised as follows: • Limited to a study cohort identified by HSE – using two central registers of pesticide sprayer operators maintained by City and Guilds to identify the cohort: The National Register of Sprayer Operators (NRoSO) and the National Amenity Sprayer Operators Register (NAsOR). In 2014, participants from the PUHS who had previously completed a survey of pesticide usage in 2005/06 were also invited to take part. Annual, on-going recruitment focusses on new members of NRoSO. HSE is the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above. The lawful basis for processing personal data under the UK GDPR is: 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; The lawful basis for processing special category data under the UK GDPR is: 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. This processing is in the public interest because it aims to inform government policy with respect to potential health risks linked to working with pesticides and thereby protect the health of the men and women who use pesticides as part of their employment. The funding is provided by HSE. The funding is specifically for the study described. The funder will have no ability to suppress or otherwise limit the publication of findings. Iron Mountain provides IT back up services to HSE and will store copies of the Data as contracted by HSE. The will not have any access to the data. Public and Patient Involvement and Engagement groups helped refine the purpose of the research. The groups supported the collection of the data for the purposes described above. The groups have conducted the following: • established an internal (HSE) stakeholder group involving colleagues from Chemicals Regulation Division (the group responsible for pesticide regulation), the Chief Scientific Advisor and the Chief Medical Advisor. They support the request for data. • discussed the study design with external organisations, such as City and Guilds, and with people from the target population during development. • Ensured that all participants are fully aware of the linkage with NHS data and have provided informed consent; hence, demonstrating their support for the linkage and use of data. Participants can remove their consent or opt-out of data linkage at any time. • have established a small, postal, user-testing group to trial any new questionnaires and we will be able to ask them about future data linkages. Researchers will not be seeking their opinion on the current data linkage, since this was already in the study design and all participants have agreed/consented

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 connected to the HSE network, from HSE’s Buxton location, Bootle location, or employees’ home address. Archived paper records are stored at the Buxton location. HSE will transfer data to NHS England. The data will consist of identifying details (specifically study ID, NHS number, Forename, Middle name, Surname, Date of birth, Sex and Postcode) for the cohort to be linked with NHS England data. 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. NHS 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). NHS England will provide the relevant records from the Demographics, Cancer Registration and Civil Registration Deaths datasets to HSE. The Data will: 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. • contain directly identifying data items including Names, NHS Number, Date of Birth, Postcode, Gender which are required to link the Data at record level with data already held by the recipient. The flow of data will be as follows: The Data will not be transferred to any other location. 1) NHS England has already flagged the majority of the study participants. However, recruitment is ongoing and so there will be a number of new recruits that will need flagging under this Data Sharing Agreement. The HSE study team will send NHS England the following identifiable 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 England. The Data will be stored on servers at HSE. 2) NHS England will provide the HSE study team with the requested records, which includes health data (special category personal data). HSE uses offsite back-up services provided by Iron Mountain. 3a) The study does not yet have a study database since HSE are looking to update their systems (see 3b below). Until the new data management system is finalised, the information provided by NHS England will be stored electronically on HSE’s restricted access encrypted network drive. The Data will be accessed onsite at the premises of HSE. 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 England. HSE have already sought advice from NHS 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 England will be consulted to ensure its suitability to hold their data. Once complete, all information received from NHS England will be uploaded onto the study data management system. The Data will be accessed by authorised personnel via remote access. The requested data are needed before the study database is complete for two reasons. First, the data required for objective 1 (alive/dead status) is needed for any mail outs before the database will be complete. Second, it will greatly help with database development to have access to the raw data from NHS England. Finally, the data are used in ongoing analyses. 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. 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. 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. For remote access: The information from NHS 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: - 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; - responses to a baseline questionnaire collecting information on work history, previous work with pesticides, general health, family medical history, lifestyle, diet, tobacco and alcohol use, and socio-economic circumstances; - Access controls granting users the minimum level of access required are in place; - responses to a questionnaire on current pesticide use; - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; - responses to follow-up questionnaires on specific health outcomes and current pesticide use; - Multifactor authentication (MFA) is required for remote access; - future updates to this information. - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; 5) HSE also receives data on participants from NHSCR Scotland. NHSCR Scotland provides 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 England 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. - 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. This data flow has been agreed by the National Research Ethics Committee and National Records of Scotland. 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). 6) For the purpose of comparing cancer incidence and mortality among the study participants, and subcategories thereof, with the general population, HSE will compare aggregated statistics with publicly available National Statistics. 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 Data will not leave England at any time. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. There will be no requirement and no attempt to reidentify individuals when using the Data. Researchers from the HSE will analyse the Data for the purposes described above.

Unchanged: Expected output, Expected measurable benefits, Benefits reported.

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

Objective for processing

The aim of the Health and Safety Executive’s (HSE’s) Prospective Investigation of Pesticide Applicators' Health (PIPAH) Study is the newest of the long term health studies run by the Health and Safety Executive (HSE). PIPAH was established in 2013, with the aim of investigating to investigate whether there is any evidence of a link between working with pesticides and health. PIPAH is the newest of the long-term health studies run by HSE. The PIPAH study builds on the work of the Pesticide User’s Health Study (PUHS) by collecting more detailed information about the study participants. In the long term, the information from the PIPAH study will help to ensure that any risks identified are properly controlled. [12 words unchanged] will provide information on the health risk of individuals working with pesticides. [1 paragraph unchanged] This work is research in the public interest because it aims to inform government policy with respect to potential health risks linked to working with pesticides and thereby protect the health of the men and women who use pesticides as part of their employment. PIPAH was established in 2013, and participants were initially recruited from two central registers of pesticide sprayer operators maintained by City and Guilds: The National Register of Sprayer Operators (NRoSO) and the National Amenity Sprayer Operators Register (NAsOR). In 2014, participants from the PUHS who had previously completed a survey of pesticide usage in 2005/06 were also invited to take part. Annual, on-going recruitment focusses on new members of NRoSO. The Health and Safety Executive has determined that there are no 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 inform government policy with respect to potential health risks linked to working with pesticides and thereby protect the health of the men and women who use pesticides as part of their employment. HSE has determined that there are no moral or ethical issues, or harm to the public from dissemination of data for this purpose. Once received from NHS England, the data being processed by HSE will be pseudonymised. [1 paragraph unchanged] 1) ensure that HSE do not attempt to contact study members who have died or have emigrated outside of Great Britain; Britain. 2) compare cancer incidence and mortality among study members with the general [12 words unchanged] pesticides in different ways, for example comparing people who have used different pesticides; and pesticides. 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 data from the following datasets: - Demographics: Fact of death, death registration details, NHAIS posting, and identifiable information including the individual’s NHS number. - Civil Registration Deaths: death registration details such as date and cause of death, including identifiable information such as the individual’s NHS number. - Cancer Registration Data: Cancer date, code, site and type, including identifiable information such as NHS number and cancer registration number. 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 England 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 connected to the HSE network, from HSE’s Buxton location, connecting to the HSE network. Bootle location, or employees’ home address. Archived paper records are stored at the Buxton location. 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. 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. NHS 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). The data will only be used for the purpose as stated. 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) NHS Digital England has already flagged the majority of the study participants. However, recruitment is [15 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; NHS number; Forename; [8 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. records, which includes health data (special category personal data). 3a) The study does not yet have a study database. database since HSE are currently investigating the potential for using an off-the-shelf cloud-based clinical data management system looking 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 update their data. systems (see 3b below). Until the new data management system is finalised, the information provided by NHS Digital England will be stored electronically on the HSE’s restricted access encrypted network drive. It is expected that a new clinical data management system will be in place by Summer 2022. The requested data are needed before the study database is complete for two reasons. First, the data required for objective 1 (alive/dead status) is needed for any mail outs before the database will be complete. Second, it will greatly help with database development to have access to the raw data from NHS Digital. 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 England. HSE have already sought advice from NHS 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 England will be consulted to ensure its suitability to hold their data. Once complete, all information received from NHS England will be uploaded onto the study data management system. 3b) Once complete, all information received from NHS Digital will be uploaded onto the study data management system. The requested data are needed before the study database is complete for two reasons. First, the data required for objective 1 (alive/dead status) is needed for any mail outs before the database will be complete. Second, it will greatly help with database development to have access to the raw data from NHS England. Finally, the data are used in ongoing analyses. 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 [7 words unchanged] the information required will be extracted. Extracted datasets will contain the minimum identifying identifiable fields required and will be saved on the restricted access encrypted network [5 words unchanged] data processing will be conducted on the restricted access encrypted network drive. 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: [2 paragraphs unchanged] - responses to follow-up questionnaires on specific health outcomes and current pesticide use; [1 paragraph unchanged] 5) HSE will shortly be applying for also receives data on participants from NHSCR Scotland. If approved, NHSCR Scotland will provide provides HSE with NHS numbers for study participants flagged with them. When HSE [8 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 [10 words unchanged] NHSCR Scotland to HSE, to help successful flagging of participants in England/Wales. The ethical approval for this data flow will be submitted shortly. 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). This data flow has been agreed by the National Research Ethics Committee and National Records of Scotland. 6) For the purpose of comparing cancer incidence and mortality among the study participants, and subcategories thereof, with the general population, HSE will compare aggregated statistics with publicly available National Statistics. 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.

Expected output

The expected outputs from processing are threefold: Following the three objectives for processing, the expected outputs are: 1) The study participants are contacted annually in order to send them [24 words unchanged] attempt to contact any deceased participants. Receiving information on death registrations and the Members and Postings lists demographics will enable the study team to keep the mailing list up-to-date into the future. 2) The main outcomes of interest to from the study are cancer incidence and mortality. The statistical analyses will use [40 words unchanged] end of follow-up dates can be incorporated in any prospective data analysis. The resulting outputs from this research study will be published. How the outputs will be published will be determined by the study team to ensure that the findings reach the most appropriate audience. The resulting outputs from the analysis of the study data may be published in Health & Safety Executive Research Reports (http://www.hse.gov.uk/research/rrhtm/), which will be made freely available to researchers and the public on the Health & Safety Executive website. Peer-reviewed journal publications will be prepared where appropriate, and these will be 'open access' so that both researchers and the public can view papers. The most appropriate journals will be decided upon at the time of publication. Examples of journals other similar studies have published in previously include 'Occupational Medicine', 'British Journal of Cancer', and 'Annals of Occupational Hygiene'. The results will take the form of aggregated data, and will typically include summary statistics, and standardised mortality/incidence ratios or relative risks. Individuals will not be identifiable in these results and if there are small numbers involved in any aggregated data, these will be suppressed in accordance with current guidelines. As a publicly funded research study, it is HSE policy to ensure that outputs are freely available. Outputs may be 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 more than one format for example as a research report and as a conference presentation. The most appropriate journals will be decided upon at the time of publishing, but HSE has previously published findings from similar studies in the Occupational Medicine Journal, the British Journal of Cancer, and the Annals of Occupational Hygiene. The baseline data analysis is on-going; the first publications (two Health & Safety Executive Research Reports) have been published on the HSE website (Research Report numbers RR1103 and RR1119). The first peer reviewed paper describing the establishment of the cohort was published in 2017 (DOI: 10.1136/bmjopen-2017-018212). Further baseline data analyses (for example of specific groups of self-reported ill health, such as respiratory health) will not be undertaken until sufficient follow-up data is available for prospective analysis. The timetable for the periodic analyses will be determined by the HSE to meet its requirements. The first publication based on follow-up questionnaire data, which describes asthma amongst the cohort members, was published in 2021 (doi:10.1136/ oemed-2021-107486). A second manuscript, which describes other respiratory outcomes, is in preparation. [1 paragraph unchanged] To date, the Early presentations using data received from NHS Digital, in the early presentations the study team England, were promoting used to promote the new study and then began presenting study. More recent presentations focussed on the cross sectional cross-sectional data collected through questionnaires. In addition to these conferences the first peer -reviewed paper describing the PIPAH was published in 2017 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’. 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 PIPAH study 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. 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. HSE policy advisers in the Chemical Regulations Division (CRD) are key stakeholders in the PIPAH study. 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. Using the networks and fora that CRD have, the policy advisers will disseminate study findings to policy makers further afield when appropriate. A newsletter is produced annually to keep study members up-to-date with progress on the study. This will also include study results and details of where to find more information. The results will take the form of aggregated data, and will typically include summary statistics, and standardised mortality/incidence/admission ratios or relative risks. Individuals will not be identifiable in these results and if there are small numbers involved in any aggregated data, then these will be suppressed in accordance with the HES Analysis Guide. This is a long-term cohort study which will entail the initial analysis of the baseline data, followed by periodic analysis of the health outcome data (self-reported ill-health, cancers and deaths) collected during follow-up. The baseline data analysis is on-going; the first publications (two Health & Safety Executive Research Reports) have been published on the HSE website (Research Report numbers RR1103 and RR1119). The first peer reviewed paper describing the establishment of the cohort was published 2017. Further baseline data analyses (for example of specific groups of self-reported ill health, such as respiratory health) will not be undertaken until sufficient follow-up data is available for prospective analysis. The timetable for the periodic analyses will be determined by the HSE to meet its requirements. [2 paragraphs unchanged]

Expected measurable benefits

The PIPAH study was established by the Health & Safety Executive (HSE) in order to monitor the long-term health of pesticide workers because other systems of surveillance for pesticide exposures only cover acute health outcomes. It is a detailed study of individuals who use pesticides as part of their work and are potentially exposed to low levels of pesticides over a long period. It was established by The ability to assess the Health & Safety Executive in order incidence of cancers and deaths related to monitor the long-term health of these individuals because other systems of surveillance for pesticide exposures only cover acute health outcomes. working with pesticides will be a key benefit that HSE achieves from this study. The study helps the Health & Safety Executive to determine the long-term [16 words unchanged] & Safety Executive's commitment to protecting the health of people at work. The study is a valuable resource that will make a worthwhile contribution [53 words unchanged] by individual studies. Permission to pool data will be requested from NHS Digital England before any data are shared. Aggregated data can be shared with other [13 words unchanged] the agreement and adheres to small number suppression as outlined in the HES Analysis Guide. relevant guidance. This will provide further benefits to the knowledge base on pesticides beyond [24 words unchanged] wider public about the safety of pesticides licensed for use in GB. [1 paragraph unchanged] This Health & Safety Executive funded study is operationally carried by out at HSE Buxton. The outputs from this study will contribute to the body of evidence about the safety of licensed pesticides which the Health & Safety Executive will take into account in any decision process. 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 pesticides 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 pesticides seriously and is actively monitoring the health of these workers. 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 the 'Expected Outputs' section, focus on disseminating outputs to the public. This Health & Safety Executive funded study is operationally carried out at HSE Buxton. The outputs from this study will contribute to the body of evidence about the safety of licensed pesticides which the Health & Safety Executive will take into account in any decision process.

Benefits reported

Information received from NHS England has been used to update the status of study participants, which is currently the greatest yielded benefit. Study participants are contacted annually as part of the study follow-up, and keeping the mailing list current ensures that only contact study participants who are still alive are sent the newsletter and any follow-up questionnaire. questionnaires. This is important to avoid causing distress to deceased participants' families. The latest newsletter and questionnaire were sent to participants early in 2020, this one is currently providing the greatest yielded benefit. 2022. Processing the data was enabling the investigation of cancer incidence and mortality among the study members. To date one analysis has been undertaken using the mortality data. There is some evidence that populations exposed to pesticides may be at higher risk of developing neurological conditions. So the standardised mortality ratios were calculated for neurological conditions among the study population, using national mortality data as the reference population. As the study matures, the yielded benefits from this expected output will increase because the number of events will accumulate over time. The 2018 follow-up questionnaire on respiratory health has been analysed and the first publication on asthma in the study members was published in 2021 (http://dx.doi.org/10.1136/oemed-2021-107486). This publication showed that pesticide users have high levels of respiratory symptoms and expected levels of asthma. A second peer-reviewed publication on other respiratory outcomes, such as Chronic Obstructive Pulmonary Disease (COPD) is currently under review. Future anticipation is to keep track of study members and making data linkages, will yield benefits in the longer term. Currently there are no plans to make data linkages, and the contact details of the participants in this relatively new follow-up study are still up-to-date. For the last four years, the PIPAH study team has been working with the Institute of Occupational Medicine (Edinburgh), the University of Manchester, and the Institute of Risk Assessment Sciences (Utrecht) on the IMPRESS project, an international collaborative project. The aim of the project is to improve epidemiological methods of assessing pesticide use, methods which are fundamental to the PIPAH study. The study team contacted members of the PIPAH study and invited them to take part in the new project. IMPRESS project participants were invited to complete a questionnaire and optionally to provide biological samples before and after using pesticides. The IMPRESS project (http://www.impress-project.org/) has been proactive in disseminating its findings. Presentations have been made at 11 conferences. Six peer-reviewed papers have been published and a further three are in preparation; of these, four papers include research using data provided by members of the PIPAH study. Note that the mortality data provided by NHS England allowed us to update our mailing list so that we could be certain that we only invited individuals who were still alive. NHS England data were not used for any other purpose in this project. Processing the data has and will enable the investigation of cancer incidence and mortality among the study members. To date one analysis has been undertaken using the mortality data. There is some evidence that populations exposed to pesticides may be at higher risk of developing neurological conditions. The standardised mortality ratios were calculated for neurological conditions among the study population, using national mortality data as the reference population. As the study matures, the yielded benefits from this expected output will increase because the number of events will accumulate over time. PIPAH forms an integral part of the Health and Safety Executive’s commitment to protecting the health of people at work. The UK system for regulation of pesticides is based on a toxicological paradigm in which the use of specific pesticide products is permitted on the expectation that harm is unlikely under typical conditions. In this context, long-term epidemiological follow-up of workers exposed to pesticides is needed to characterise the actual health experience of these workers in order to ultimately demonstrate effective control by this approach overall. PIPAH therefore has the potential to provide reassurance that regulation is effective, and to inform future policy, when considered in the context of the wider body of evidence about the safety of licensed pesticides. As a long-term study, the value of the findings will increase as the length of follow-up increases and so these benefits are expected to increase in the future.

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Objective for processing

The Prospective Investigation of Pesticide Applicators' Health (PIPAH) Study is the newest [68 words unchanged] study will help to ensure that any risks identified are properly controlled. Monitoring mortality and cancer incidence is an important part of this and will provide information on the health risk of individuals working with pesticides. Monitoring mortality and cancer incidence is an important part of this and will provide information on the health risk of individuals working with pesticides. [7 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. [4 paragraphs unchanged] 3a) The study database does not yet have a study database. 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 currently under development. identified, and before implementation, NHS Digital will be consulted to ensure its suitability to hold their data. Until this the data management system is finished, finalised, the information provided by NHS Digital will be stored electronically on the restricted access encrypted network drive. It is expected that development a new clinical data management system will be complete in place by Summer 2022. 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. [1 paragraph unchanged] 3b) Once complete, all information received from NHS Digital will be uploaded onto the study database. Identifying 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 identifying data. Restrictions will be in place so that only study team members with the correct permissions will be able to access data received from the NHS Digital. In addition, all databases will be encrypted. 3b) Once complete, all information received from NHS Digital will be uploaded onto the study 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. [4 paragraphs unchanged] HSE will shortly be applying for data from 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. The ethical approval for this data flow will be submitted shortly. [1 paragraph unchanged]

Expected output

[10 paragraphs unchanged] This is a long-term cohort study which will entail the initial analysis [27 words unchanged] the first publications (two Health & Safety Executive Research Reports) have been written and are awaiting publication published on the HSE website. website (Research Report numbers RR1103 and RR1119). The first peer reviewed paper describing the establishment of the cohort was [36 words unchanged] periodic analyses will be determined by the HSE to meet its requirements. [2 paragraphs unchanged]

Benefits reported

Study participants are contacted annually and keeping the mailing list current ensures [27 words unchanged] families. The latest newsletter and questionnaire were sent to participants early in 2019, 2020, this one is currently providing the greatest yielded benefit. [2 paragraphs unchanged]

Unchanged: Expected measurable benefits.

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

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

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

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