Q&A: Wellcome Trust policy on data management and sharing

1. What is the Trust's data management and sharing policy?

The Trust's data management and sharing policy states the Trust's expectation that the researchers it funds should maximise the availability of research data resulting from Trust funded research with as few restrictions as possible. It highlights the need for all researchers to plan at the proposal stage how they will manage and share their data, and specifies the conditions under which the Trust will require applicants to provide a data management and sharing plan.

2. Why has the Trust published this policy?

In furthering its mission, the Wellcome Trust promotes the sharing of the outputs of its funded research to ensure that these can be utilised to the full by the international research community, and that as a result the public benefit of that research is maximised.

Research data represent a fundamental research output, and the Trust has released this policy statement to make explicit its expectation that its funded researchers make their data widely available as soon as feasible, with as few restrictions as possible.

This policy statement is complementary to the Trust's position statement in support of open and unrestricted access to published research and represents a natural progression of its work in this area.Indeed, the Trust's long-term aim is to support greater online integration between research literature and the data on which it is based.

This policy builds upon, and should be read in conjunction with, the Trust's guidelines on good research practice, which set out a series of good practice standards relating to the dissemination of research results and the recording and management of data with which the Trust expects researchers in receipt of its funding to comply.

3. To whom does this policy apply?

The Trust expects all researchers in receipt of its funding to maximise the availability of their research data as soon as feasible and with as few restrictions as possible.To this end, the Trust expects all researchers to consider at the research proposal stage how they will manage and share the data generated, and that this represents a standard part of good research practice.

Applicants are required to provide a data sharing and management plan if the proposal falls into one of the two categories identified in the policy statement and explained in more detail below.Data management and sharing plans will be requested on application forms from early January 2007.

4. How does this policy apply if I am funded under a Translation Award or a Public Engagement award?

Typically the outputs of these funded activities differ from those undertaken by researchers in biomedicine, ethics and the history of medicine, and the policy is not concerned with these awards.

For Translation Awards the proposed management of the data generated in the award, including the appropriate exploitation of the intellectual property to ensure health benefit, will be assessed as an integral part of the application process without the need for a separate data management plan.

For Public Engagement awards the Trust is exploring the best way to capture, archive and facilitate sharing of the outputs that arise from these activities. We plan to make an announcement on this before the end of 2007.

5. In what circumstances will a data management and sharing plan be required as part of an application?

As specified in the policy statement, applicants will be required to provide a data management and sharing plan in the following two situations:

The specific goal of the proposal is to create or develop a resource for the benefit of the research community
The Trust requires a data management and sharing plan in all situations where the primary goal of the funding is to create a research resource, such as a database or biological sample collection.
The proposal involves the generation of a significant quantity of data that could potentially be shared for added benefit
The Trust will also require a data management and sharing plan where an investigator-led proposal involves the generation of a large quantity of data that could be shared for added benefit.Such datasets will include those where no one research team would have the capacity to undertake all the analyses that the data would allow (within a reasonable timeframe), or those where the data has clear utility to address research questions beyond those that the data generators are seeking to address.Examples of such proposals would include large-scale genetic association studies of common diseases, and genome-wide or large-scale functional genomic studies in a specific organism.

6. What should a data management and sharing plan include?

Your data management and sharing plan should briefly outline the mechanisms through which the data generated by the research will be made available to the wider community and the proposed timeframes over which this will occur.Where any delays or restrictions on sharing are proposed, the rationale for these should be set out.

Data management and sharing plans should take account of the following issues where they are relevant to the proposed research:

Data quality and standards – data should be released in a format that conforms to agreed community standards, especially where this allows interoperability with other relevant datasets.
Use of public data repositories – the Trust will expect researchers to deposit their data into recognised public data repositories where possible and a number all ready exist for many types of fundamental biological data.
Intellectual property – where relevant, any proposed delays on data sharing to enable intellectual property protection to be gained and used should be set out and justified.
Protection of research participants – any limitations on data sharing that serve to safeguard the privacy of research participants should be explained.
Long-term preservation and sustainability – for proposals to establish resources, the long-term strategy for maintaining, curating and archiving the data should be set out clearly.

7. How will my plan be assessed? What criteria will it be judged against?

Data management and sharing plans will be considered by referees and Committee members as an integral part of the peer review process.Reviewers will be asked to consider whether the proposed approach will ensure that the public benefit resulting from the research is maximised.

The timing and nature in which it is appropriate to share data will vary depending on the nature of the research and the type of data involved.For example, projects involving the generation of genetic sequence or protein structure data will clearly raise very different issues from those involving large-scale epidemiological data.Data management and sharing plans will therefore be considered on a case-by-case basis.

In situations where the Trust feels a plan is required but is not provided by the applicant, the applicant will be asked to provide a plan in order for the application to proceed.In situations where a data management and sharing plan is felt by a Committee to be inappropriate or insufficient, applicants may be asked to revise their plan before a funding decision is made.

8. Will the Trust provide funding for data sharing activities associated with grants?

The Trust considers that timely and appropriate data management and sharing should represent an integral component of the research process.Applicants may therefore include any costs associated with their proposed approach as part of their proposal.

9. How quickly will the Trust expect me to release my data?Can I delay sharing until publication?

As specified in its guidelines on good research practice, the Trust expects as an absolute minimum that researchers should make relevant data available to others on publication of their research, providing this is consistent with any ethics approvals and consents which cover the data and any intellectual rights in them.

While this is the minimum requirement, the Trust expects its funded researchers to consider how they can maximise any opportunities for timely and responsible pre-publication sharing of their data, where such data might be of benefit to the wider research community.

However, in those situations where the primary goal of the proposal is to create a resource for the research community, the Trust expects that the data should be made as widely available as possible at the earliest opportunity.In these circumstances, publication will not in itself constitute a sufficient reason to delay data sharing.

Overall, the Trust recognises that delays in data sharing will be appropriate in some situations – for example to ensure the data are of a sufficiently high quality and conform to agreed community standards; or to ensure that intellectual property is protected and developed in an appropriate manner. However, it will expect that such delays are minimised as far as possible.

10. How does the data sharing policy relate to the Trust's policies on intellectual property?

The Trust expects its funded researchers to ensure that any intellectual property in the outputs of their research is suitably protected and is managed in a way that best enables the use of that knowledge for public benefit.The data management and sharing policy does not alter this requirement.

Delays or restrictions on data sharing may be necessary and appropriate to gain such protection, and/or to further develop that technology to maximise public benefit.As noted above, any such delays should be kept to a minimum and justified in the grant application.

The identification, management and exploitation of intellectual property is subject to the Trust's Grant Conditions and policy on intellectual property and patenting.

11. How can I balance data sharing with the need to safeguard research participants?

All research involving human participants, or data or samples derived from human participants (such as cohort studies, clinical trials etc.), must include appropriate safeguards to protect the privacy of research participants.

For such studies, it will often be appropriate that access to the data be managed.This may require the establishment of governance structures specifically designed to ensure that scientific and public benefit is maximised in a manner that is consistent with the interests of participants.

The importance of sharing data to maximise the public benefit therefore, should be considered before seeking consent for such studies, and addressed in the consent process as appropriate.

The Trust recognises that managing and sharing data resulting from epidemiological studies raises complex issues.The Trust intends to further engage the community on these issues, and to develop specific guidance on governance arrangement for cohort studies.

The report on access to collections of data and materials for health research by William Lowrance, which was commissioned by the Trust and MRC, provides an overview of some of the issues relating to the governance of population studies.

12. What support does the Trust provide for the development and maintenance of databases and other research resources?

The Trust has made a major funding commitment to develop and maintain key community resources both through its support of the Wellcome Trust Sanger Institute and its grant funding programmes.In 2005, the Trust announced a funding partnership with the UK Research Councils and European Molecular Biology Laboratory to provide a new building to house the European Bioinformatics Institute on the Wellcome Trust Genome Campus.

Further information on some of the major databases supported by Trust funding may be found on our genomic biomedical resources page.

The Trust will consider applications for equipment, biomedical resources and technology development grants.

13. How will the Trust foster data management and sharing throughout the award process?

As described above, where required, data management and sharing plans will be reviewed as part of the application process.

Although data management and sharing plans will only be requested for new grant applications to the Trust (i.e. the Trust will not retrospectively ask for plans for previously funded grants), data sharing strategies will be considered when making decisions regarding the renewal of support for Trust-funded resources.

All awardees are asked to report back to the Trust on their approach for disseminating their research as part of their end of grant report.

In situations where members of the research community feel that Trust-funded researchers are not sharing data in a manner that reflects best practice, you may contact the Trust with these concerns.The Trust has a range of possible sanctions it will consider if such concerns are felt to be justified.

14. What other work does the Trust undertake to promote data sharing?

In addition to promoting data sharing in its funded research through the mechanisms described above and continuing to support major community resources, the Trust will continue to engage closely with other funding agencies and with the research community in policy discussions relating to data sharing.

15. How does the Trust's policy compare to those of other biomedical funding agencies?

Several other funding agencies have developed data sharing policies that seek to encourage their funded researchers to share data in a timely and responsible manner. For example, the UK Medical Research Council, US National Institutes of Health (NIH) and the NCRI Cancer Informatics Initiative have released policy statements on these issues.

These policies closely reflect the Trust's policy statement in terms of promoting data management and sharing strategies in a way that maximises the public benefit resulting from the research.The policies differ slightly in the circumstances under which applicants are required to address data sharing in their application.For example, the MRC requires all applicants to include a statement on data sharing, whereas the NIH requires a statement for those proposals requesting more than $500 000. At this stage, the Trust has opted to only require applicants to provide plans where their proposal involves the generation of datasets that could be shared for added benefit.

16. What are the responsibilities of researchers and others who access and use data?

In addition to the responsibilities of those generating data, the Trust believes that data sharing for the benefit of the research community as a whole will only proceed if those using the data also adopt good research practice. In recognition of the contribution of the researchers and teams generating data, the Trust expects all users of data to acknowledge the sources of their data and abide by the terms and conditions under which they accessed the original data.

17. What if I have a question not answered here?

For further information and other queries please contact Anne Taylor, Central Services Manager: a.taylor@wellcome.ac.uk.