1. Definitions and Interpretation

This publication should be interpreted with reference to the BREATHE Publication Policy and with the Funder Terms and Conditions.

2. Objective of the Study

For information on UK-REACH refer to www.uk-reach.org and Ethics Ref: 20/HRA/4718.

3. Data and materials access policy

3.1 Request use of data and materials

To access data or samples produced by the UK-REACH study, the working group representative must, in the first instance, contact the UK-REACH Research Manager (uk-reach@leicester.ac.uk) with a brief summary of the request. A formal application should be made by completing a Data Access Request Form, this will be reviewed by the UK-REACH Core Management Group. For ancillary studies outside of the core deliverables, the Steering Committee will make final decisions once they have been approved by the Core Management Group . Decisions on granting access to data/materials will be made within 6 weeks of an application being received.

Third party requests from outside the Project will require explicit approval of the Steering Committee once approved by the Core Management Group.

Note that should there be significant numbers of requests to access data and/or samples then a separate Data Access Committee will be convened to appraise requests.

3.2 Rules for using data and materials

• All data/materials must be used in a manner that protects the privacy and confidentiality of the study participants, and in accordance with the Data Protection Impact Assessment (DPIA).
• No attempt must be made to identify participants or link data/materials to external data sources outside those specified in the consent and participant information sheet.
• Authors must ensure that they apply small number suppression to prevent re-identification. If any tables contain cell counts less than 5 (including zero), we ask you to consider collapsing categories if possible. If this is not possible, then please replace the cell count with ‘<5’. If a cell contains zero then please include a footnote to indicate “this many include zero”. Please note, this also implies to any imputed data. Please also ensure that any percentages are dealt with in a similar manner when exact numbers can easily be inferred from information in the table.
• The data/materials cannot be distributed to third parties (organisations of a different legal entity), and a written tracking list of individuals accessing data in their own organisation must be maintained.
• No additional studies outside the study deliverables using the data/materials can be performed without approval from the Core Management Group, and without a final decision from the Steering Committee and associated stakeholders with whom we have data sharing agreements (i.e. healthcare regulators).
• All data/materials must be returned or destroyed after analyses are complete. Data that is housed in SAIL will not be released from SAIL, all analyses will be completed within the safe haven. Those wanting access will need to apply through the Core Management Group, and undertake the required training, to access this. The study proposal form must identify whether data/materials will be destroyed or returned to the project, and specify a date by which this will occur. No data/materials should be destroyed without the permission of the Core Management Group, and a letter confirming destruction should be sent to the Core Management Group on completion.
• An extension to the original objectives can be requested by letter to the Core Management Group (via the project manager).
• Data protection laws differ between countries. If this leads to any divergence from this policy, the applicant must receive written approval of the Steering Committee.
• Loss of data on any media must be reported to the Core Management Group within 48 hours.
• All data must be held securely and encrypted.

4. Ancillary Studies Policy

Ancillary studies in collaboration with Industry require a Head of Terms explicitly providing information on intellectual property ownership and exploitation plans for the Core Management Group to consider and approve prior to drafting of contracts. Relevant stakeholders (i.e. regulators with whom we have data sharing agreements) will also need to be consulted where appropriate.

The Core Management Group can request that UK-REACH partners with a special interest in the topic of the proposal be invited to participate in the ancillary studies. Inclusiveness is encouraged.

All ancillary studies are expected to provide a regular progress report to the Steering Committee through the Core Management Group.

5. General Policies covering core and ancillary publications

• It is the policy of the UK-REACH Study that all preprints, manuscripts, policy reports and presentations derived from UK-REACH Study data (core and ancillary), be submitted for review by work packages (WPs) and for approval by the Core Management Group. If necessary, the Core Management Group will also establish priorities to process, re-analyse, and/or verify data, or send out for further review.
• Where industry are involved, manuscripts will be subject to review by UK-REACH industry partners in line with their internal publication review policies.
• WP leads will monitor and facilitate the necessary processes for proposal submission and provide routinely updated progress reports of all submitted and approved publications and abstracts (e.g., approved, in preparation, submitted, in press, published) to Core Management Group and the Stakeholder Group.
• WP leads will share draft versions of policy reports with the Steering Group for input prior to wider dissemination outside the core study researchers.
• It is the responsibility of WP leads to regularly update the UK-REACH outputs database and provide copies of all approved proposals, published abstracts and manuscripts. The project manager together with the WP leads will keep oversight of database. Outputs will be made publicly available on the UK-REACH website.
• Based upon ICMJE guidelines for reviewers, members of the study should keep manuscripts, study data abstracts, presentations and the information they contain strictly confidential. Study members and study-appointed reviewers must not publicly discuss authors’ work and must not appropriate authors’ ideas before the manuscript is published.
• Partners should declare any conflict of interest and if necessary recuse themselves. Early disclosure of any conflict (e.g. on-going studies pre-dating the UK-REACH cohort) is recommended.
• Preprints are a valuable way for researchers to publish their results; in particular to establish early claim to research findings; bring to the attention of others, particularly other researchers, the most recent research findings (before peer review); publish the outputs of research that may not be suitable for a full research paper; provide additional (or earlier) evidence of productivity, while avoiding deliberate ‘salami-slicing’, i.e. publishing research that could form one coherent paper into several different papers; enhance openness and speedy dissemination of research findings.
• Authors are encouraged to upload preprints to an online a preprint repository or service after internal review and formal approval from the Core Management Group.
• All manuscripts must refer to the study clinical trial registration number (Trial ID: ISRCTN11811602)

6. Collaborative Authorship

• Authors of any publication using data from the UK-REACH Study (core and ancillary) should meet the ICMJE requirements for authorship; these requirements include having:
  1. made substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data;
  2. drafted the article or revised it critically for important intellectual content; and
  3. approved of the final version to be published.
• As part of initial manuscript review the Core Management Group will review included authors to ensure compliance with ICMJE criteria and the coronavirus public health emergency terms and conditions (see schedule 1 for publication conditions). Any uncertainties about authorship will be settled by the Core Management Group.
• The full UK-REACH Study group must be acknowledged in all publications using the following structure
  • After manuscript title quote UK-REACH Study Collaborative Group*

    *Provide a complete list of collaborators in the UK-REACH study in the Supplementary Appendix

  • Writing Group - assume responsibility for the overall content and integrity of the publication. These members will be listed in the main publication. Membership of a Work Package does not alone constitute eligibility for writing group authorship.
  • Supplementary Appendix - provide details of the UK-REACH Study Collaborative Group.
• All manuscripts (and publications) should acknowledge the Professional Expert Panel (PEP) group, the Professional Healthcare Regulators and the UK-REACH Stakeholder Group.
• All manuscripts (and publications) must acknowledge BREATHE (The Health Data Research Hub for Respiratory Health), using the BREATHE attribution policy (Appendix 2).
• Publications generated from ancillary projects may use an alternative acknowledgement method with the express agreement of the Core Management Group. To enable rapid response, ancillary manuscripts must be submitted to Core Management Group for approval. Where there are concerns Core Management Group will present to the Steering Committee for decision. The Core Management Group will:
  • Confirm that it is an ancillary study
  • That authorship includes UK-REACH partners appropriately, which for ancillary papers is only those that were involved in the ancillary study and not a wider UK-REACH authorship list.
  • Cross reference rapid response manuscripts against existing proposals in the UK-REACH publication register
• All manuscripts must acknowledge UKRI (MRC) and DHSC (NIHR) funding support to the UK-REACH study using the following wording (this text is relevant to all WPs, additional funding can be acknowledged for individual researchers where appropriate).
  • UK-REACH is supported by a grant from the MRC-UK Research and Innovation (MR/V027549/1) and the Department of Health and Social Care through the National Institute for Health Research (NIHR) rapid response panel to tackle COVID-19. Core funding was also provided by NIHR Biomedical Research Centres. The views expressed in the publication are those of the author(s) and not necessarily those of the National Health Service (NHS), the NIHR or the Department of Health and Social Care.
• An excerpt of the Funder conditions relating to publications is attached as Appendix 1, which shall be applicable as part of this Policy.

7. Abstracts and Presentations Policy

New Scientific Communication: Abstracts

• Principal Investigator and/or WP lead must take responsibility for any abstracts for Regional, National, and International Meetings.
• A title/objective and proposed authorship should be shared with the WP well in advance the conference submission date, but at minimum 20 working days.
• Pre-final draft manuscripts must be submitted to the WP for Core Management Group approval a minimum 10 working days prior to the planned conference submission.
• As a minimum the Principal Investigator should have approved the content before submission
• The accepted abstract must be sent to the Project Manager for documentation and archiving.

New Scientific Communication: Presentations - further specifics

• No approval is necessary for presentation at local talks or grant funding presentations provided only publicly available data are shared. Updates to be provided to Core Management Group through monthly reports.
• Oral and poster presentation of unpublished findings at national and international meetings (including industry organised meetings) must be approved by the Core Management Group.
• It is expected that such presentations will be submitted to Core Management Group in good time facilitating informed review, typically a minimum of 15 working days prior to submission of presentation.

8. Other public dissemination

Use of Data for Grant Application, Contract Proposals or public disclosure of findings that have not been previously published must have prior approval for use by Core Management Group.

Appendix 1

Schedule 1 Extract from the UKRI Grant Conditions

Coronavirus public health emergency additional dissemination grant conditions

RGC 12.4 The Grant Holder shall, subject to the procedures laid down by the Research Organisation, publish the results of the research funded by the Grant in accordance with normal academic practice and Our policy on Open Access: https://www.ukri.org/files/legacy/documents/rcukopenaccesspolicy-pdf/. Other forms of media communication, including media appearances, press releases and conferences, must acknowledge the support received from us, quoting the Grant reference number if appropriate.

In Addition to RGC 12.4, the Grant Holder should inform the UKRI communications team by e-mail (press@ukri.org) at least 24 hours in advance before publication (either via a peer-reviewed publication, a pre-print or a press announcement) of the results of research funded by this grant.

In addition to RCG 12, Grant Holders undertaking work relevant to coronavirus public health emergency are required to share their research data and findings as rapidly and widely as possible, including with public health and research communities and the World Health Organization in accordance with the statement on sharing research relevant to Covid-19 set out here: https://wellcome.ac.uk/coronavirus-covid-19/open-data

Grant holders should therefore ensure:

1. research findings are made available via preprint servers such as https://arxiv.org/, https://www.biorxiv.org/, https://psyarxiv.com/, https://www.medrxiv.org/ or https://socopen.org/welcome/, as soon possible and in any event before journal publication, or via platforms that make papers openly accessible before peer review.
2. research findings that are submitted to journals are made openly available at the time of publication and released under the Creative Commons Attribution license (CCBY), see https://creativecommons.org/licenses/ .
3. all submissions (to platforms, preprint servers and journals) include clear statements regarding the availability of underlying data and/or software/code
4. interim and final data is shared as rapidly and openly as possible - as soon as it is appropriately quality assured, in line with any ethics requirements, disciplinary good practice and irrespective of the timing of journal publication.
   1. It is acknowledged that not all data can be open and often access needs to be managed, however in all cases the discovery of data is a priority. Data should be discoverable via data catalogues like the https://www.clinicalstudydatarequest.com/ and access conditions clearly laid out.
   2. Examples of suitable data repositories for data sharing and access include, UKRI-funded data services such as the EMBL-EBI at https://www.covid19dataportal.org/submit-data, the UK Essex Data Archive at https://www.ukdataservice.ac.uk/deposit-data/howto.aspx or the dedicated Coronavirus repository at OpenAIRE that is hosted at https://zenodo.org/communities/covid-19?page=1&size=20. Other repositories can be found on registries such as https://fairsharing.org/collection/COVID19Resources or the https://www.re3data.org/.
5. Software, analysis scripts or modelling codes created as part of the work under this funding are shared as rapidly and openly as possible. a. Software, analysis scripts or modelling codes must be made available with a suitable licence via a platform that supports access and versioning. Suitable software platforms include: https://bitbucket.org/, https://circleci.com/integrations/github/ or https://about.gitlab.com/. If possible, an open source licence should be used, suitable licences that are available can be found at https://choosealicense.com/, however where software or scripts have:
   1. third-party dependency this must be respected.
   2. To support longer term access software and code should be deposited in a repository that supports persistence, many data repositories, such as those referred to at iv) can provide this function or there are others dedicated to software such as https://www.softwareheritage.org/. These repositories support persistence more fully than the software platforms listed above.

Appendix 2

Breathe Attribution Policy

The BREATHE Executive Committee (BEC) has agreed standard templates for the acknowledgements section that should be included in all publications. For more advice please contact BREATHE Admin (breathe.admin@ed.ac.uk)

1.1 For BREATHE-badged project in partnership with SAIL Databank “This work is funded by [funder name] [grant no]. This work is carried out with the support of BREATHE -The Health Data Research Hub for Respiratory Health [MC_PC_19004] in partnership with SAIL Databank. BREATHE is funded through the UK Research and Innovation Industrial Strategy Challenge Fund and delivered through Health Data Research UK. This work uses data provided by [data provider acknowledgement]” Please also note that, as part of the SAIL Publications Policy, for academic publications, SAIL asks that users cite the relevant primary SAIL publications, as found in the SAIL Publications Policy V2.0 document.

1.2 For BREATHE-badged project with a different Trusted Research Environment “This work is funded by [funder name] [grant no]. This work is carried out with the support of BREATHE -The Health Data Research Hub for Respiratory Health [MC_PC_19004] in partnership with [trusted research environment]. BREATHE is funded through the UK Research and Innovation Industrial Strategy Challenge Fund and delivered through Health Data Research UK. This work uses data provided by [data provider acknowledgement]”1‘BREATHE-badged’ is defined as a project of which the research aligns with, and contributes to, one or more of the programmes and/or platforms and which benefits from the resource and funding of the BREATHE Hub.

1.3 To acknowledge BREATHE academic expertise “This work is funded by [funder name] [grant no].This work is carried out with the support of BREATHE -The Health Data Research Hub for Respiratory Health [MC_PC_19004] funded through the UK Research and Innovation Industrial Strategy Challenge Fund and delivered through Health Data Research UK. We wish to acknowledge the support of [name], [name], and the [insert team] from [insert institution]”

1.4 For BREATHE-badged project supported by funds directly from the grant “This work is [supported/funded] by BREATHE -The Health Data Research Hub for Respiratory Health [MC_PC_19004] in partnership with[trusted research environment(s)]. BREATHE is funded through the UK Research and Innovation Industrial Strategy Challenge Fund and delivered through Health Data Research UK. This work uses data provided by [data provider acknowledgement]”

Appendix 4

UK-REACH Collaborative Group

WP2 Also Includes:

• General Medical Council (GMC)
• Nursing and Midwifery Council (NMC)
• General Dental Council (GDC)
• Health Care Professionals Council (HCPC)
• General Pharmaceutical Council (GPhC)
• General Optical Council (GOC)
• Pharmaceutical Service of Northern Ireland (PSNI)
• Serco