How to Prepare the Output Management Plan?

Overview

This guidance is developed to help the applicants of SEA DREAM funding call in developing their outputs management plans (OMPs) as required by SEA DREAM’s Data, Software and Materials Management and Sharing Policy, Intellectual Property Policy, Clinical Trials Policy and Open Access Policy. The OMPs must be submitted to SEA DREAM by applicants at the time of full application. The proposed budget should be prepared in accordance with the requirements stated in the OMP. The OMP should be reviewed and updated during the grant period based on the needs, then the revised version should be submitted to SEA DREAM for approval. At the time of end-of-grant reporting, SEA DREAM will check if the grantees have managed and shared their research outputs in line with the approved OMPs.

Overall Guidance 

Read this guidance carefully before you start preparing your OMP to make it as comprehensive and clear as possible. Complete all relevant sections in the Full Application Form and leave ‘NA’ if a particular section is not applicable to your proposed type of research. 

Specific Guidance 

Data and software outputs

1. The data and software outputs your research will generate

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 reused as part of the funding activity, you should consider: 

• How existing data/resources will be accessed; 
• If there are any constraints on reuse of existing data; 
• How you will cite the original source, and credit the original creators appropriately. 

2. The metadata and documentation that will accompany the outputs

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, for example the CDISC standards for clinical research. 

3. When you intend to share your data and software

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.  

You must make sure that these articles include a statement explaining how other researchers can access the data, software or materials. This should be included in the Data Availability Statement field, or if this is not available, the statement should appear within the text of your manuscript. 

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. 

4. Where your data and software will be made available

For data outputs, you must 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 resources 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. You must ensure that your code repository includes a licence, and has a persistent identifier (for example, a DOI). If you are using GitHub, you should use Zenodo to archive a repository on GitHub and issue a DOI for the archive. 

5. How your data and software will be accessible to others

Your plan should set out clearly: 

• How potential users will be able to discover, access and reuse 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 reuse 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 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 – eg 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. 

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 must 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 is clear which licence has been applied, so that users can see whether the data or software is accessible and on what terms. 

6. Whether limits to data and software sharing are required

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 or platform 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. 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. 

Research materials 

1. What materials your research will produce and how these will be made available

Your plan should identify any significant materials you expect to develop using SEA DREAM 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: 

• Depositing in a recognised collection such as the European Collection of Authenticated Cell Cultures (ECACC) or its equivalent in Southeast Asia 
• Licensing to a reputable life science business partner who can handle advertising, manufacture, storage and distribution. 

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 organisation. 
 
When dealing with commercial entities, you must 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. 
 
While your organisation 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.

Publication of research outputs 

1. How you will publish your research outputs to ensure open access

This should explicitly mention types (research articles, monographs or book chapters) and number of research publications you intend to produce in the SEA DREAM funded research project. To ensure open access, also include which journals or platforms you will use for the publication tentatively, whether these are fully open access or not, which version of your research publication (version of record, author accepted manuscript or pre-print) will be made available within Europe PMC, and which Creative Commons licence will be applied for each publication. 

Please note that article processing charges can be claimed only for the research articles published in fully open access journals or platforms indexed in the Directory of Open Access Journals, except monographs and book chapters where open access fees will be funded by SEA DREAM. 

2. How you will retain your rights over the research publications

You should describe here which publication agreements your organisation has established with the publishers or journals where you intend to publish your research, and whether you retain your rights to apply the CC BY licence to allow you to deposit a version of your research publication in an open access platform.

Managing risks of research misuse

1. What potential risks of research misuse may be associated with your research outputs and how you plan to mitigate these risks (If any)

SEA DREAM recognises that some research outputs generated from our funded research may not be free from risks of potential misuse to cause great harm, for example to develop biological weapons. This is often referred to as ‘dual use research of concern’, which the US government defines as “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products and technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material or national security”. 
 
If you see any of such short and medium-term risks that may arise from your research outputs, describe what these risks are and what internal controls you have in place to mitigate these risks.  
 
Your risk mitigation plan could include establishing a process to review dual-use risks on an on-going basis through the project and to gain independent expert advice as appropriate. You must also ensure that all members of your team are aware of these risks in progressing their research and receive appropriate education and training on these issues.

2. Have you identified any tangible risks of this type?

The identification of tangible risks in a research project should be clearly balanced against the benefits and value that is to be gained for health, science and society. If there are tangible risks that the proposed research will generate outcomes that could be misused to cause harm, you (and your fellow researchers and host organisations) must take appropriate steps to monitor the research as it proceeds and minimise these risks.

Resources and costs required

1. What resources and costs you may need to deliver your plan and outline where dedicated resources are required.

This includes people needed for the research as well as associated costs of the research. Examples of resources you can ask for include: 

People and Skills

• Support for one or more dedicated data manager or data scientist (on a full- or part-time basis) 
• Data and software management training for research or support staff that are needed to deliver the proposed research.

We don’t usually consider costs for occasional or routine support from institutional data managers or other support staff. 

Storage and Computation 

• Any dedicated hardware or software that is required to deliver your proposed research  
• The cost of accessing a supercomputer or other shared facilities.  

We would usually expect costs associated with routine data storage to be met by the organisation. We will only consider storage costs associated with large or complex datasets which exceed standard organisational allowances. 

Access

• The reasonable costs of operating an access committee or other data access mechanism over the lifetime of the award; 
• The costs of preparing and sharing data, software or materials with users (and whether cost-recovery mechanisms will be used); 
• The costs of ingesting secondary data, code or materials from users; 
• Costs associated with accessing data, software or materials from other researchers that you need to take forward your proposed research; 
• Article processing charges (APCs) for the research articles to be published in fully open access journals or platforms; 
• Open access fees for monographs and book chapters. 

2. Deposition and preservation of data, software and materials

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 data outputs on a case-by-case basis.  

Intellectual property

1. What IP your research will generate

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. 

2. How IP will be protected

You should describe if and how you will protect significant SEA DREAM-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 SEA DREAM-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. 

3. How IP will be protected

SEA DREAM sees IP as a tool which can be used to advance health benefits. You should therefore focus on: 

• The benefits your use of the IP will bring to the wider research community 
• How this will benefit health. 

If your research output is particularly relevant to humanitarian or developing world issues, your plan should specifically address how: 

• The output can best be made available for use internationally to address those issues 
• Your IP strategy will allow this. 

Where SEA DREAM-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: 

• A market assessment has been carried out and there is no credible prospect of a patent for that invention being commercialised now or soon. 
• A deliberate decision not to patent the invention (and not to allow anyone else to patent) has been taken for policy reasons. Publication instead of patenting in this case should clearly benefit the wider research community and support the delivery of health benefits. Discuss this with your institution if you’re unsure. Contact SEA DREAM for advice before publication if you’re still unsure. 

Revenue generation should only be a secondary consideration. The primary driver for any commercialisation must be to advance health benefits, even if your employer may generate revenue from commercialising SEA DREAM-funded IP.