Facilitating data sharing
Requirements
R11. The principal stages and decisions in providing access and facilitating use are clearly documented, and the mechanisms for informal enquiry and timely feedback are effective.
Expectations
Point of contact
1. There is a contact mechanism for questions about the study, data sets and data-sharing through e-mail.
- Enquiries via the contact point are documented, so that studies can ensure that enquirers are satisfied that their enquiry has been fairly handled, and can monitor the efficiency of the access process.
Practical information available on the study website
2. The study provides information or links to the following:
- A clear visual guide to the data sharing process;
- A data-sharing request form, structured according to the criteria for access;
- An indication of user requirements, as are specified in the study’s standard data-sharing agreement(s).
3. Practical “how to” advice is available, for instance on:
- How to select study variables of potential interest from the Population and Patient Research Data Directory or from accessible documentation of study variables, with at least guidance on those variables most likely to be of value for new uses;
- Consent and other ethical requirements needed for new uses, and how and when permissions should be sought;
- Data security requirements of external users ;
- How data requests should be costed.
Informal discussion prior to submitting a funding request
4. A study may recommend that external researchers consult the study before submitting a research funding proposal that would involve use of the study dataset.
- The purpose is to verify that in the event of an award, the data are likely to be available, and the request is otherwise likely to meet the study policies on sharing and access.
- The process could mirror internal requirements for study team members to receive their director’s approval to develop significant new projects requiring new uses of the data.
Formal request for data access
5. The study provides a formal request form (and/or checklist) designed to elicit the information required for review, in a format compatible with the governance criteria and workflow.
6. On receipt by the study, the request is documented. The request form (and accompanying documentation) is checked to ensure it is appropriate and complete, before initiating the formal review. Receipt is acknowledged, with feedback on whether the request is suitable for formal review.
Informative feedback about a decision
7. Summary feedback is provided within a few days of the formal decision and, if necessary, is followed up with concise written details.
8. For declined requests, the grounds for rejection are explained in relation to the access criteria. The feedback explains what modifications to the research protocol might enable the request to be approved. Options for re-submission are specified.
9. For approved requests, the feedback specifies and explains the following:
- Whether there are conditions or limitations to the kind of data that can be made available, for example if certain variables cannot be provided
- Whether certain parts of the data set will need cleaning prior to use, and whether the requester is expected to assist in this in person or through financial resources
- Precise requirements in relation to existing ethics approval; whether further approval(s) will be required and the roles of the study and data requester in applying for further approval(s)
- Funding implications for data use and collaboration and any costs to be charged for data preparation
- The next steps, including any time constraints, such as a time limit for access to, or use of, the data
- Arrangements for access to samples or the process for adding questions to a future questionnaire, if applicable
- Conditions that will be specified in a data-sharing agreement.
Further good practice
1. A response time is indicated for informal and formal requests. Responses are timely and informative.
2. Studies make appropriate provision for staff to interact with requesters to explain variables in detail, including their context of collection, closely related variables, why particular data quality was observed, the evolution of a variable between collection waves.
3. Each agreed data-sharing relationship has a nominated contact point within the study team whose responsibility is to monitor the progress and outcome of the external research.
4. An escalation procedure enables that contact point to alert senior study personnel if problems or delays arise in the external research or if there are concerns about compliance with the data-sharing agreement.