Scope
This policy applies to the following types of research:
Clinical trials and clinical intervention studies
Research which meets the broad definition used by the World Health Organization (WHO) or a clinical trial, which includes all studies evaluating the impact of interventions on human participants: “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”
Interventions may include:
- drugs or medicines
- cells and other biological products
- surgical procedures
- radiological procedures
- devices, behavioural treatments
- changes to the care pathway
- preventive care
- other treatments
Clinical trials at all stages, from Phase 1 to Phase 4, and global health trials are included in this policy.
Public health intervention studies
Research in which there is a public health intervention to promote or protect health, or prevent ill-health, in communities or populations rather than individuals.
Observational studies
Research in which the researcher assesses outcomes in groups of human participants according to a research protocol to investigate the effects of lifestyle or behaviours, or interventions that are part of routine care and not influenced by the researcher. This policy does not apply to studies that involve human tissue only.
MRC Developmental Pathway Funding Scheme (DPFS)
For studies funded through the MRC DPFS, this policy on registration and publication is additional to DPFS monitoring requirements.
Responsibilities
Registration of clinical and public health intervention studies
Any Medical Research Council (MRC) funded clinical trials, clinical and public health studies with a study design that is within the scope of this policy must register with the ISRCTN Registry and obtain a unique ISRCTN number.
The MRC project reference should be included in the registration. MRC will cover the cost of ISRCTN registration where this has been included in the application for funding.
The unique ISRCTN number must be used in publications and provided to MRC by adding it to Researchfish within 12 months of the study or trial starting. If the clinical trial start date is more than 12 months after funding start, the MRC programme manager should be notified.
Publishing study results
Results of MRC-funded studies (whether positive or negative) must be published without unreasonable delay following the conclusion of the study (generally within 12 months of completion).
Research results should be reported in accordance with the recommendations in the CONSORT statement or an alternative reporting guideline appropriate to the study design (reporting guidelines for all study types are available from the EQUATOR network).
If a trial steering committee or study advisory group has been established, then results must be discussed by members before they are published. Further guidance on reporting and disseminating research is provided in MRC good research practice.
MRC is a co-signatory to the WHO joint statement on public disclosure of results from clinical trials, which supports the timely public disclosure of results from all clinical trials.
Details of all publications or publicly available outputs associated with the study must be reported on Researchfish. All publications must comply with the UKRI open access policy.
ICMJE requirements for registration and publication of clinical trials
Members of the International Committee of Medical Journal Editors (ICMJE) will consider a clinical trial for publication only if:
- it has been registered in an ICMJE-approved registry before enrolment of participants
- the manuscript includes a data-sharing statement
- a data-sharing plan has been included in the clinical trial registration
The ICMJE broadly defines a clinical trial as a study that prospectively assigns people to a health-related intervention with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome.
Publishing the study protocol and statistical analysis
MRC requires all funded clinical and public health intervention studies to comply with CONSORT or appropriate alternative reporting guidelines, and to make the study protocol, analysis plan and all relevant statistical analyses openly available.
MRC expects the study protocol and analysis plan to be made publicly available prior to study start, and recommends that details of where and how this information may be accessed is provided on the ISRCTN register. The SPIRIT Statement (Standard Protocol Items: Recommendations for Interventional Trials) provides guidance on creating a study protocol and defines a set of items that should be included.