How to complete an outputs management plan
An overview of things to consider as you develop your outputs management plan.
We expect the researchers we fund to manage their research outputs in a way that will achieve the greatest health benefit.
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:
- datasets generated by your research
- original software created in the course of your research
- new materials you create – like antibodies, cell lines and reagents
- intellectual property (IP) such as patents, copyright, design rights and confidential know-how.
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:
- clear and concise. Don’t repeat methodological detail included elsewhere in your grant application
- proportionate to the scale of the outputs generated and their likely level of value to researchers and other users
- focused specifically on how outputs will be identified, managed and used to advance potential health benefits
- structured to address the key issues outlined below.
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.
Read some real examples of what we consider to be good output management plans. [PDF 130KB].
The examples are written by researchers working in a range of areas and at different career stages:
- Senior researcher – neuroimaging data sharing
- Senior researcher – genomic data sharing
- Clinician – controlled access to sensitive data
- PhD student – population modelling data sharing
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:
- FAIRsharing – a curated and searchable portal of data standards, databases, and policies in the life sciences and other scientific disciplines.
- Digital Curation Centre – the UK's leading centre of expertise in data curation. The DCC provides a range of resources and training opportunities for the UK higher education sector, and has developed an online tool for developing data management plans in line with funder requirements.
- Medical Research Council guidance and resources – the MRC has developed detailed practical guidance for researchers on data sharing.
- re3data.org – a global registry of research data repositories across different academic disciplines.
- UK Data Archive – an internationally recognised repository of digital research data in the social sciences and humanities, with associated guidance and services for researchers.
- Wellcome Sanger Institute data sharing guidance – the Wellcome Sanger Institute has a policy setting out the principles that underlie data sharing at the Institute, with associated guidance for researchers.
- TGHN Data sharing toolkit – specifically for clinical data management and sharing advice and resources.
- Software Sustainability Institute – the UK’s leading source of expertise in research software sustainability. SSI offers training and advice targeting the specific concerns of research software, including a series of online guides on best practice in software development, licensing, repositories and using a software management plan.
- Software Carpentry – since 1998, Software Carpentry has been teaching basic software skills to researchers in science, engineering, and medicine. They run a worldwide training programme, and provide open access material for self-instruction.
- eScience Lab – eScience Lab host a suite of tools designed to support the creation of e-science laboratories. The tools have been adopted by a large variety of projects and institutions.
- Open Source Initiative – OSI provide the definition for open source software and maintain a list of licences that comply with that definition.
- GitHub and SourceForge – GitHub is the current preferred repository for software collaboration, code review, and code management for open source projects. SourceForge has also been heavily used within the research community for open source development in the past.
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
Addgene is a global, nonprofit repository created to help researchers share and access plasmids.
Contact our information officers if you have a question about funding.
Consider and briefly describe:
- the types of data and software the proposed research will generate
- which data and software will have value to other research users and could be shared.
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:
- how existing data/resources will be accessed
- if there are any constraints on re-use of existing data
- how data provenance will be documented.
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:
- provide sufficient, high quality metadata to allow the dataset to be discovered, interpreted and used by others
- adopt agreed best practice standards for metadata provision, where these are in place.
You must specify the timescale for sharing datasets and software, using any recognised standards of good practice in your research field.
Researchers have the right to a reasonable (but not unlimited) period of exclusive use of the research data and software they produce.
As a minimum, you should make the data and software underpinning research articles available to other researchers at the time of publication, providing this is consistent with:
- any ethics approvals and consents that cover the data
- reasonable limitations required for the appropriate management and exploitation of IP.
Please read [[{"fid":"54","view_mode":"wysiwyg","fields":{"format":"wysiwyg","field_file_title[und][0][value]":"our requirements for publishing Wellcome-funded research papers"},"type":"media","link_text":null,"field_deltas":{"1":{"format":"wysiwyg","field_file_title[und][0][value]":"our requirements for publishing Wellcome-funded research papers"}},"attributes":{"class":"file media-element file-wysiwyg","data-delta":"1"}}]] for more information.
Where research data relates to a public health emergency, quality-controlled data must be shared as rapidly and openly as possible. This is in line with the joint statement on data sharing in public health emergencies and GLOPID-R principles for data sharing in public health emergencies.
We encourage researchers to consider opportunities for timely and responsible pre-publication sharing of datasets and software. Where appropriate, you may use publication moratoria to enable pre-publication sharing with other researchers, while protecting your right to first publication.
Any restrictions on data and software use should be reasonable, transparent and in line with established best practice in the respective field.
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:
- how potential users will be able to discover, access and re-use data or software outputs
- any associated terms or conditions.
Enabling discovery
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:
- made aware of its availability
- updated on significant revisions and releases.
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.
Access procedures for data
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.
Open software and database licences
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.
Safeguarding research participants
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.
Clinical trials
For clinical trials you should mention specifically how you will share individual-level patient data. This should include:
- a plan to seek patient informed consent that allows data to be shared in the way outlined
- the level of identification risk and method of de-identification you will adopt
- the repository you plan to use
- any managed access arrangements, such as a data access committee.
Intellectual property (IP)
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.