Open research data: clinical trials and public health interventions
The MRC strongly promotes the principles of open research data and aims to make the research process and findings as open, understandable and reproducible as possible. Sharing data can enhance the use of existing data, avoid duplication of research effort and stimulate new discoveries.
The MRC policy on open research data from clinical trials and public health interventions applies to the following types of MRC-funded study:
- Clinical trials and clinical intervention studies: studies that prospectively assign human participants to one or more health-related interventions to evaluate the effects on health outcomes, including all phases of clinical trials.
- Public health intervention studies: studies of a public health intervention to promote or protect health, or prevent ill-health, in communities or populations.
- Observational studies: studies that assess outcomes in groups of human participants according to a research protocol, in order to investigate the effects of lifestyle or behaviours, or interventions that are part of routine care.
The policy does not apply to studies that involve human tissue only. For applicable studies funded through the MRC Developmental Pathway Funding Scheme (DPFS), this policy is additional to DPFS monitoring requirements.
All MRC-funded studies within the scope of this policy are required to register with the ISRCTN <<add link: www.isrctn.com/>> registry within 12 months of the study or trial starting. The MRC grant reference must be included in the registry entry.
The MRC will cover the cost of ISRCTN registration and this should be included in the application for funding. The ISRCTN number should be provided in the annual project update to the MRC via Researchfish® within 12 months of the study commencing.
The registry entry should be regularly reviewed (at least annually) and updated with any changes until the trial is completed and findings made public. Information about where summary results from the study or trial are publicly available should be included . If the study or trial is extended, then the new end date must be added to the registry entry as soon as possible.
Clinical Trials of Investigational Medicinal Products (CTIMPs) must also register on the EU Clinical Trials Register (EUCTR) and trial results must be posted on the EUCTR within 12 months of completion. Investigators who register a trial that is funded or sponsored by the MRC must comply with this requirement. The EUCTR entry should be regularly reviewed (at least annually) and updated.
Studies funded through the DPFS may defer registration until the completion of preclinical research.
Publishing the protocol and statistical analyses
The MRC requires all funded studies to make the study protocol, analysis plan and all relevant statistical analyses publicly available prior to the start of the study. For clinical trials, the protocol (or information about where to find the protocol) must be added to the registry entry within 12 months of the trial start.
Publishing study findings
Results of MRC-funded studies (whether positive or negative) must be published or made publicly available within 24 months of the end of the study or trial. Publications must include the MRC project reference and ISRCTN registration number.
The MRC is a co-signatory to the WHO Joint statement on public disclosure of results from clinical trials (2017), which supports the timely public disclosure of results from all clinical trials.
Data sharing: Individual Participant Data
The MRC expects valuable data arising from MRC-funded research to be made available to the scientific community with as few restrictions as possible to maximise the value for research and for eventual patient and public benefit. Such data must be shared in a timely and responsible manner.
The MRC is aware of the risks of fully open access to individual participant data (IPD), in particular the need to comply with participant consent and avoid inadvertent or deliberate identification of participants. The MRC expects researchers to follow the guidance in Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials which details good practice principles and practical guidance on sharing IPD in a controlled way. A data sharing policy should be developed for each study.
Research involving the population health sciences, and population and patient cohorts should follow the MRC policy on sharing of research data from population and patient studies.
The MRC expects researchers to publish summary data about the data requests made, including the number of requests fulfilled and reasons for any refusals. The MRC has contributed to the development of the European consensus guidance Sharing and reuse of individual participant data from clinical trials: principles and recommendations.
Applications for MRC funding for clinical and public health intervention studies should include the costs of data curation, including the preparation of metadata, access management and data release, to support re-use.
Secondary use of data
This policy also applies to secondary users of data from MRC-funded clinical and public health intervention studies.
Secondary data analyses should not be registered as separate clinical trials on the ISRCTN, but it is considered good practice to make information about such studies available on a publicly accessible register. Researchers are required to include a reference or link to the original data and trial registration number with any published findings.
If you have any queries about policies related to research involving human participants please contact firstname.lastname@example.org