Study policy on sharing research data
Individual studies articulate their own specific data-sharing policies in terms of the purpose of the study, their sharing priorities and their partnerships.
The ‘In practice’ page illustrates how certain topical aspects can be put into practice.
Requirements
R2. A summary of the principles of the study policy on data-sharing must be readily discoverable by the research community on the study website, in a manner sensitive to the interests of participants. The study policy is consistent with MRC’s overarching policy on data-sharing and preservation.
R3. The priorities and criteria for sharing and access and the various constraints, are transparent and justified. The type and extent of privileged use by the Principal Investigator and study team are clearly defined and justified in relation to the funder-approved research programme. Access to study data is on a non-exclusive basis.
R4. When designing the study and seeking participants’ consent and ethics approval, the Director aims to promote the widest range of possible good uses of the data and seek to establish broad and enduring consent for data-sharing.
R5. The study has robust policies for managing confidentiality and for data security, consistent with legal, good practice and MRC policy requirements.
R6. MRC encourages researchers to work in productive, equitable partnerships. Sharing involving commercial or non-UK based organisations conforms to the same principles and practices as that required of the academic community.
R7. Directors/PIs ensure that intellectual property relating to the value they create is suitably protected and managed, in line with RCUK Knowledge Exchange Principles. Any delays or restrictions on sharing due to managing IP are minimised as far as possible.
Expectations
Transparency
1. The summary (or whole) policy, or the link to a downloadable copy, is easy to find, and no more than one mouse-click from the home page on the study’s website.
Study purpose and data-sharing priorities
2. The policy helps potential new users understand the value of the data and the kinds of new use for which sharing is likely to add value and any constraints on when or purposes for which access can be provided.
3. Where possible the acceptability of the key principles of the study policy on data-sharing to the study participants has been ascertained.
4. The principles of the policy are considered and approved as part of the data-management plan at peer review.
5. The policy provides information on:
- the purpose of the study
- specific opportunities and priorities for sharing
- the terms of any privileged use of data by the study team
- the standard use conditions for secure management of confidential and sensitive information
- how the costs of sharing are met.
Data lifecycle and quality considerations
6. Potential new users can identify the period occupied for data preparation (e.g. collection, ‘cleaning’ and quality control by the study team) before data are ready to be analysed and before they are ready to be shared.
7. A good policy recognises where the strengths and weaknesses of the study data lie, and where additional work and funding would be required to bring data up to the quality necessary for sharing. Experienced researchers understand that data can be “messy” and that data collected in the past (“legacy data”) may not be organised optimally, fully ‘cleaned’ or adequately described with metadata. Some legacy data may have limited value.
Consent and other ethical considerations
8. The sharing policy indicates the ethical principles and conditions that promote (or constrain) the nature and extent of data-sharing, for instance:
- the terms of existing participants’ consent and ethical approvals pertinent to sharing of data already collected
- whether broad and enduring consent will be sought for future sweeps (collection of new data)
- sharing of data outside the UK, including outside the EU
- whether related genetic data and biomedical materials may be made available
For established studies, the extent to which ethics committees will approve broad consent for future new uses may be constrained by the consent(s) given by participants in the past, which may be rather vague or restrictive (e.g. “…not shared outside the research team”). For new sweeps of existing studies and new studies, it should be reasonably straightforward to establish consent for sharing such that participants’ data are used to maximal good effect.
Capability and capacity to use the data
9. A study may give priority to new uses that are for bona fide research.
Partnerships
10. The policy states the principles of partnership and how partnerships are managed; this may be partnerships with individuals, organisations and industry. Critical obligations are documented in data-sharing or other appropriate agreements.
The costs of sharing
11. Studies set out their policy for meeting the costs of sharing data.
Further information
12. The policy indicates what further information is available either on request or through a hyperlink, and indicates a contact point.
Further good practice
Institutional policies
Institutions hosting MRC studies have robust and compatible policies for handling confidential data and for information security.
- A confidentiality policy that specifies how the identities of, and knowledge about, study participants are protected from unintended disclosure
- Policies which specify how data are handled and protected within a study, addressing information security and statutory and regulatory requirements (e.g. Data Protection Action 1998, health department Research Governance Frameworks).
Resources
Examples of MRC-funded studies with online data sharing policies include:
- The Avon Longitudinal Studies of Parents & Children (ALSPAC)
- Whitehall II, a study of social class, psychosocial factors and lifestyle as determinants of health and ill health.
Studies may share their data by archiving their data collection (or a subset) at a discipline-based repository, for instance the UK Data Archive which serves the wider social sciences community, or at an institutional repository that can preserve the data and make them available to users. This may be particularly suitable for legacy data collections and for studies that no longer actively collect data or receive funding.
The UK Data Archive (UKDA), who manages the Economic and Social Sciences Data Service, provides researchers with guidance on managing, preparing, storing and sharing data. Especially useful may be their guidance on:
- Ethics, consent and data sharing
- Data security
- Quality assurance
- Copyright of research data.
Data Sharing for Statistical Purposes, a practitioner’s guide to the legal framework, Office for National Statistics (2005), includes a code of practice for processing ONS data and a useful explanation of legal terms and concepts.
UK Biobank, a study collecting medical and genetic data from 500,000 middle-aged people across the UK, creating an information resource to study the prevention and treatment of serious diseases, has detailed protocols for ethics, governance, access and intellectual property.
The Intellectual Asset Management for Universities guide of the Intellectual Property Office gives advice and information to universities to help them understand how they can best use their institution's intellectual property.
Copyright and Intellectual Property Law by 8JISC Legal Information Service provides guidance, examples and FAQs on intellectual property rights such as copyright, patents, trade marks, design rights and the protection of confidential information.
IPR and Licensing issues in Derived Data by Naomi Korn, Professor Charles Oppenheim and Charles Duncan analyses the issues of IPR and licensing in text and data mining.
The University of Cambridge provides a useful guide to data and IPR.
The Digital Curation Centre Legal Watch paper on Sharing Medical Data explores the legal consideration for sharing data that contain personal information.
The Research Councils UK Knowledge Exchange Principles explain their position on intellectual property and asset management. The responsibilities of Research Council grant-funded organisations are set out in the Research Council Terms and Conditions (Paragraph GC 21 - Exploitation and Impact).