These guidelines provide an overview of things to consider as you develop your outputs management plan, in line with our policy on data, software and materials management and sharing and our policy on intellectual property.
Your outputs management plan should set out your approach for maximising the value of the following types of outputs:
Research papers and scholarly monographs must be published in line with our open access policy. These don’t need to be addressed in your outputs management plan.
You will need to submit your plan as part of your grant application. Wellcome staff, the advisory committees and/or peer reviewers will assess the appropriateness and adequacy of your outputs management plan when considering your application.
As part of the end-of-grant reporting process, we will consider the extent to which outputs have been managed and shared in line with our expectations – taking into account your outputs management plan and recognising that this may have been revised as your research progressed.
Outputs may be shared with end-users (openly or otherwise) or be made available commercially by licensing for a fee.
Your outputs management plan should set out which approach is most likely to maximise the adoption and use of the output by the wider research community and the resulting health benefit.
For example, if creating a new software tool, an open approach might be appropriate if others could make immediate and sustained use of it, (for example under a GNU General Public Licence or other licence approved by the Open Source Initiative).
However, a commercial approach might be better if you need further funding or a commercial partner to develop, market, distribute or support the ongoing use of the software.
You should also consider whether the output would have greater value to the research community if it was incorporated into an existing commercial product or an existing open resource, rather than making it available as a standalone product.
In your application, your plan should be:
You should have a flexible and dynamic approach to outputs management. Output management plans should be living documents. You should review and adapt your plan as your research progresses so your outputs deliver the greatest health benefit.
Timely publication of results in peer-reviewed journals and presentations at conferences are important forms of dissemination, but they are not equivalent to outputs sharing. An intention to publish does not constitute an acceptable outputs management plan.
The examples are written by researchers working in a range of areas and at different career stages:
If your plan relates to more than one type of output, please identify the different types it covers.
Your plan should address the following, where relevant:
Consider and briefly describe:
We recognise that in some cases it may not be appropriate for researchers to share data and software outputs (for example, for ethical or commercial reasons). If you don’t intend to share outputs, you must justify your reasons.
Software should be shared in a way that allows it to be used effectively, and we encourage you to provide appropriate and proportionate documentation for the user community.
We encourage you to share null and negative findings and data, as well as data supporting new findings, where this may have value to the community. This helps to avoid unnecessary waste and duplication.
When existing data/resources are being re-used as part of the funding activity, you should consider:
Data should be shared in line with recognised data standards, where these exist, and in a way that maximises opportunities for data linkage and interoperability. FAIRSharing is one directory of available data standards.
You should deposit data in recognised data repositories for particular data types where they exist, unless there’s a compelling reason not to do so. The FAIRSharing and Re3Data sites provide lists of data resources, and Wellcome Open Research maintains a curated list of approved repositories suitable for Wellcome-funded research.
Where there is no recognised subject area repository available, we encourage researchers to use general community repositories and resources, such as Dryad, FigShare, the Open Science Framework or Zenodo.
If you intend to create a tailored database resource or to store data locally, you should ensure that you have the resources and systems in place to curate, secure and share the data in a way that maximises its value and guards against any associated risks.
You need to consider how data held in this way can be effectively linked to and integrated with other datasets to enhance its value to users.
For software outputs, use a hosting solution that exposes them to the widest possible number of users. GitHub allows revision control and collaborative hosting of project code for software development, with associated archiving of each release in Zenodo. A suitable revision control system and issue tracker should be in place before programming work begins. This should be available for all members of the research team.
Your plan should set out clearly:
Where a data or software resource is being developed as part of a funded activity, you should take reasonable steps to ensure that potential users are:
Your plan should outline your approach for maximising the discoverability of your data or software.
We encourage all researchers to use digital object identifiers (DOIs) or other persistent identifiers for their data and software outputs, to enable their re-use to be cited and tracked.
The DataCite initiative provides a key route through which DOIs are assigned to datasets. Many repositories assign DOIs on deposition.
Where appropriate, you may also publish an article describing dataset or software output to help users discover, access and reference the resource. You can use venues such as Scientific Data, Giga Science and Wellcome Open Research.
Where a managed data access process is required – for example, where a study involves identifiable data about research participants – the access mechanisms should be proportionate to the risks associated with the data. They must not unduly restrict or delay access.
You must describe any managed access procedures in your outputs management plan. It should be consistent and transparent and documented clearly on your study website.
Depending on the study, you may want to establish a graded access procedure where less sensitive data – for example, anonymised and aggregate data – is made readily available, and more sensitive datasets have a more stringent assessment.
Where a Data Access Committee is needed to assess data access requests, the committee should include individuals with appropriate expertise who are independent of the project.
The Expert Advisory Group on Data Access has set out key principles for developing data access and governance mechanisms, to which applicants should refer.
If you’re sharing your output through a repository, the terms by which you do so are likely to be set by the repository itself. If you’re sharing directly with the research community, you need to consider the most appropriate way to do so, for example by an appropriate open licence or public domain dedication.
For data, we recommend Creative Commons licences such as CC0 or CC BY. For software, the Open Source Initiative provides access to a range of open software licences, such as the GNU General Public Licence, Apache Licence, and the MIT Licence. Where possible, you should select one of these standard licences (rather than using a bespoke licence).
You must make sure it‘s clear which licence has been applied, so that users can see whether the data or software is accessible and on what terms.
For some research, delays or limits on data sharing may be necessary to safeguard research participants or to ensure you can gain IP protection.
Restrictions should be minimised as much as possible and set out clearly in your outputs management plans, if required.
For research involving human subjects, data must be managed and shared in a way that’s fully consistent with the terms of the consent under which samples and data were provided by the research participants.
For prospective studies, consent procedures should include provision for data sharing in a way that maximises the value of the data for wider research use, while providing adequate safeguards for participants. For more information about consent for data sharing, go to the UK Data Service. Procedures for data sharing should be set out clearly, and current and potential future risks explained to participants.
When designing studies, you must make sure that you protect the confidentiality and security of human subjects, including through appropriate anonymisation procedures and managed access processes.
For clinical trials you should mention specifically how you will share individual-level patient data. This should include:
Delays or restrictions on data or software sharing may be appropriate to protect and use IP in line with our policy on intellectual property and patenting. If this applies, you should only share data or software when it no longer jeopardises your IP position or commercialisation plans.
Your proposed approach for identifying, protecting and using IP should be set out as described in the IP section of this guidance below.
You need to consider how datasets and software that have long-term value will be preserved and curated beyond the lifetime of your grant.
If your proposal is to create a bespoke data or software resource, or to store data or software locally rather than to use a recognised repository, your plan should state how you expect to preserve and share the dataset or software when your funding ends.
Your plan should identify any significant materials you expect to develop using Wellcome funding, which could be of potential value as a resource to other researchers.
You should identify in your plan how the materials will be made available to potential users. For example, by:
If the material is highly specialised and the potential number of users is so small that commercial partners cannot be found, distributing samples yourself to other researchers who have asked for them, may be an acceptable plan. However, where possible, you should find a more sustainable long-term solution that doesn’t put an undue burden on you or your institution.
When dealing with commercial entities, you should retain the right to produce the research materials yourself, and to license others to do so, if your chosen commercial partner is unable or unwilling to continue supplying them to the research community.
Whilst your institution may generate reasonable revenue from commercialising research materials, the primary driver should not be revenue generation. You should ensure that your research materials are made available to the wider research community and thereby advance the development of health benefits.
You should consider what resources you may need to deliver your plan and outline where dedicated resources are required.
Examples of resources you can ask for include:
We don’t usually consider costs for occasional or routine support from institutional data managers or other support staff.
We would usually expect costs associated with routine data storage to be met by the institution. We will only consider storage costs associated with large or complex datasets which exceed standard institutional allowances.
If no repository is suitable, we may consider ingestion costs for institutional repositories.
We don’t usually consider estimated costs for curation and maintenance of data, code and materials that extend beyond the lifetime of the award. But we’re willing to discuss how we can help support the long-term preservation of very high-value outputs on a case-by-case basis.
Your plan should describe any significant IP that is likely to arise during your research. You should identify what processes you have in place to identify and capture this IP, as well as any unanticipated discoveries or inventions that result from your work.
You should describe if and how you will protect significant Wellcome-funded IP. For example, if you’re registering a patent or design, you should briefly outline the territories in which you’ll do this.
Publication of details relating to an invention can limit or entirely destroy the potential to patent and commercialise the invention in the future. If you think that patentable Wellcome-funded IP will arise (or when unanticipated IP has arisen), you should explain how you’ll make sure that publications don’t affect your ability to secure and make suitable use of patent protection to advance health benefits.
Wellcome sees IP as a tool which can be used to advance health benefits. You should therefore focus on:
If your research output is particularly relevant to humanitarian or developing world issues, your plan should specifically address how:
Where Wellcome-funded IP comprises a patentable invention, we expect in most cases that it will be protected by filing a patent application. This should be done at a time which maximises the prospects of achieving the desired health benefits, even if this requires a delay to publication. You should only publish details of a potentially patentable invention (without having first sought patent protection) where:
Revenue generation should only be a secondary consideration. The primary driver for any commercialisation must be to advance health benefit, even if your employer may generate revenue from commercialising Wellcome-funded IP.
Public Health England – culture collections
Public Health England is the custodian of four unique collections that consist of expertly preserved, authenticated cell lines and microbial strains of known provenance – namely the European Collection of Authenticated Cell Cultures (ECACC), the National Collection of Type Cultures (NCTC), the National Collection of Pathogenic Viruses (NCPV) and the National Collection of Pathogenic Fungi (NCPF).
Addgene is a global, nonprofit repository created to help researchers share and access plasmids.