| Work Package | Brief Overview | Type of Data | Availability |
|---|---|---|---|
| 1 | Linkage and Analysis of healthcare worker (HCW) Datasets | Linked healthcare records | Data not available |
| 2 | Longitudinal cohort study looking at changes in health outcomes, social circumstances and professional roles of HCWs |
Questionnaire data
Linked Healthcare records |
Questionnaire data stored at the University of Leicester. Linked healthcare data stored at SAIL-Databank. (not yet available) |
| 3 | Ethical and legal implications of linking professionals' registration data to healthcare data | Interview transcripts | Via the UK-REACH Team at the University of Leicester |
| 4 | Qualitative research focused on understanding risk perceptions, support and coping mechanisms relevant to COVID-19 | Interview transcripts | Via the UK-REACH team at the University of Leicester |
| 5 | Key recommendations through sustained joint working with a multi-professional, national stakeholder group | Not applicable | No data associated with this work package |
| 6 | Immune response to COVID-19 infection/vaccination and differences by ethnicity in HCWs (National Core Studies Funded) |
Questionnaire data
Linked healthcare records Sample data |
Not yet available; will be governed by a separate policy hosted at direct.uk-reach.org |
2.1 This policy covers the core UK-REACH programme (Work Packages [WP] 2-5 only). A separate policy will be in place for the UK-REACH DIRECT study (WP6). As there are separate data sharing agreements in place with external parties for WP1 we are currently unable to consider requests for access to this data. For more information on UK-REACH visit https://www.uk-reach.org/
2.2 In the absence of a dedicated UK-REACH Data Access Committee, requests for access to the data generated within the UK-REACH study will be considered by the UK-REACH Core Management Group and subsequently the UK-REACH Study Steering Committee, with the exception of linked healthcare data (see 2.4 & 3.1)
2.3 The need for a dedicated Data Access Committee will be kept under review, and should it be determined that there is a need for a committee, this will be set up with guidance from the Core Management Group, the Study Steering Committee and other related research teams at Leicester (i.e. EXCEED, PHOSP) as well as SAIL Databank.
2.4 UK-REACH linked healthcare data, collected as part of the cohort study in WP2, resides in the SAIL Databank, for which there is a separate application process (https://saildatabank.com). Note that this data is not yet available (expected mid-2022).
2.5 Applications to access de-identified cohort data and qualitative research data generated within the UK-REACH study should be submitted to the UK-REACH team. Initial queries should be directed to uk-reach@leicester.ac.uk and should include a brief summary of the proposed data access request. A Data Access Proposal form will then be shared for completion by the team requesting access to the data
2.6 When considering data access requests, wider members of the research team or advisors with specialist knowledge may be consulted and invited to consider requests.
2.7 In assessing UK-REACH data access requests, the Core Management Group and the Study Steering Committee will:
The UK-REACH study encourages requests for collaboration from academic researchers (researchers or employees of an academic institution or the NHS). We are also open to requests for collaboration from third sector organisations, policy or governmental bodies, and commercial organisations with common scientific goals. Given the sensitivity of the data we would not expect to field data access requests from those with a vested interest in the study (i.e healthcare regulators who have entered into data sharing agreements at the outset of the study or specific NHS Trusts who have acted as recruitment sites for the study) except in exceptional circumstances. We would expect applications to identify a research questions that has social and scientific value and is in the public interest. We will not consider requests for research which is being carried out for commercial gain.
4.1 Once a proposal is approved, the UK-REACH research manager will liaise with the researcher(s) to ensure access to the data is provided via the appropriate route (i.e. through the appropriate WP lead). For linked healthcare data this process will be managed by SAIL Databank.
4.2 The final set of variables must be agreed and a signed DMTA received before the data coordinator provides the dataset.
4.3 Instructions determining the manner in which and the purposes for which the data are to be processed, will be set down in writing in the DMTA.
4.4 Note that the data, prior to being shared, may be checked to ensure that small numbers are suppressed. Where it is not appropriate suppress small numbers prior to sharing the data, we ask you consider collapsing categories prior to publication. We will consider the need for small number suppression on a case-by-case basis.
4.5 Responsibility for applying to the SAIL Databank for data access (as well as any SAIL-associated costs) lies with the researcher (applicant) and not with the UK-REACH team.
4.6 For qualitative data (WP3 and WP4) access to raw (un-anonymised) interview transcripts will be not be granted, however anonymised transcripts will be made available for ethically approved research. For anonymised transcripts key details that could lead to identification of participants will be removed prior to sharing.
4.7 Note that the anonymised interview transcripts will be stored for a maximum of 5 years and therefore we will not consider requests to access this data after 31/10/2025.
4.8 The researcher(s) must abide by their responsibilities as defined in the DMTA.
5.1 Participants in both the longitudinal cohort study (Work Package 2) and the qualitative research (Work Package 3 and 4) have provided their consent to be re-contacted. However, any new data collection will require separate funding and ethical approval.
5.2 Investigators are strongly encouraged to discuss plans informally at an early stage, and well in advance of any funding application deadlines. New data collection will generally require formal collaboration between UK-REACH study investigators and the researchers(s) and as such the costs of UK-REACH investigators’ time may be included in the overall cost of support.
5.3 In addition to the Core Management Group and the Study Steering Committee the UK-REACH study may also consult with their Stakeholder Group (STAG) and their Professional Expert Panel (PEP) on any requests for the collection of new data prior to approving such requests.
5.4 Preliminary estimates of costs can be provided prior to completion of a Proposal Form, but actual charges will depend on the final, approved agreement.
5.5 As a general principle, new data collection involving all participants or a large proportion of participants will usually be undertaken by the UK-REACH team to allow coordination with any ongoing follow-up and reduce the burden on participants. The researchers requesting collection of, and access to, these new data would generally be expected to fund the cost of the new data collection.
5.6 It may be appropriate for data collection from a small number of participants (for example, in the case of a recall-by-genotype study) to be led by the collaborator. However, initial contact with participants will be made by the UK-REACH team. Participants will then be free to contact the collaborator and their research team if they wish to participate in the new data collection. They will be free to decline or withdraw at any time.
5.7 All collaborators will be expected to abide by policies relevant to UK-REACH, including the UK-REACH publication policy, and any requirements from external funding bodies.
5.8 Collaborators are required to return a copy of the final dataset used in their analyses, any derived variables and descriptions of the variables. In general, the expectation will be that these should be returned at the point of pre-print submission, publication, or 12 months after the original dataset was provided, whichever is the earlier. Other investigators may then apply to access these.
6.1 Researchers will be expected to fund the costs of support for the proposed project, including UK-REACH staff time (i.e. administrative, project management, IT staff members and infrastructure), costs associated with accessing data held in the SAIL Databank, and investigator time if appropriate.
6.2 If a funding application is being made by the researcher(s), a Proposal Form must be submitted well in advance of the deadline for submission of the funding application. Up to two months may be required for review and response to the proposal. Any approval in these circumstances will be subject to funding being obtained.
6.3 Commercial organisations may be charged a commercial rate.
6.4 Contact with study members and confidentiality
6.5 Contact details for participants will not be provided. New data collection from study participants will be facilitated by the UK-REACH team as outlined in section 5.
6.6 Potentially identifiable details will not be provided. In addition, it is possible that combinations of fields may make participants identifiable in aggregate and this will be taken into consideration when considering requests for access to data, and subsequently when generating data extracts.
6.7 Statistical disclosure control measures must be adequate to ensure participant confidentiality, and beyond that, as comprehensive as can be achieved without unduly compromising relevance, integrity and quality of the data.
6.8 If the standard variables are not sufficient, analysis may be undertaken by the UK-REACH team using code provided by the researcher. Any costs arising must be met by the researcher(s). Any such requests will be considered on a case by case basis.
6.9 Alternatively, it may be possible for researchers to access data within University of Leicester IT systems, subject to approval from all relevant University bodies. Any costs arising must be met by the researcher(s). Any such requests will be considered on a case by case basis.
6.10 Protecting confidentiality will be the primary concern when considering any such requests. Researchers will be bound to treat all participant information with absolute confidentiality, and should not seek to identify themselves or any other participants within the dataset, according to the terms of the DMTA.
7.1 Researchers are expected to publish their findings in journals providing open access unless there is a strong justification for not doing so.
7.2 Members of the Core Management Group and/or their nominees should be included as co-authors on published papers, provided that they fulfil standard requirements for authorship.
7.3 UK-REACH publication guidelines should be followed (available on the UK-REACH website).
7.4 Researchers will include reference to the UK-REACH study in all outputs as outlined in the UK-REACH publication policy.
7.5 Manuscripts should be sent to UK-REACH for review prior to submission for publication. This should be at least 14 days in advance of your planned submission date. This is for the purposes of assurance that confidentiality has been maintained and that any stipulations around small number suppression have been followed. It is also to ensure that any potential intellectual property has been disclosed, that it upholds the reputation of the study, and that authorship and acknowledgement requirements have been followed.
7.6 Conference abstracts need not be approved prior to submission, but should be provided to the UK-REACH study. We reserve the right to request that a presentation is amended or withdrawn where it may impact on the reputation of the study.
7.7 Copies of all publications (including abstracts) should be provided once accepted/published. Researchers should also provide a short summary of any published papers to include on the UK-REACH website and in reports to funders and in future funding applications.
7.8 All press releases must be approved by the Core Management Group (and any relevant third parties). The researcher(s) will be expected to lead the response to media enquiries or interview requests but the Core Management Group should be kept informed and may be involved.
8.1 Any commercial exploitation will be without payment to or acknowledgement of individual participants.
8.2 Charges applied to commercial partners will be in keeping with university policy. Commercial price negotiations will be undertaken by the University Research and Enterprise Division.
Version 1.2 16/12/21