Research transparency is essential so that participants and patients are protected from unnecessary research and patients benefit from improved outcomes and are informed by high quality research.
Whether as researchers, sponsors, funders or other organisations involved in health research, we all have responsibilities to participants, patients and the wider public to be transparent in our work. These may be legal requirements or ethical and moral expectations in a framework of best practice and standards.
All research should be registered in a publicly accessible database and we expect all researchers, research sponsors and others to meet this fundamental best practice standard. For clinical trials, it is a condition of a favourable ethical opinion to do so. For all other studies, it is a good practice expectation.
The World Medical Association Declaration of Helsinki states that “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject” and the International Committee of Medical Journal Editors (ICMJE) considers clinical trials for publication only if registered in an appropriate registry.
Registration of clinical trials
Since September 2013, the registration of clinical trials has been a formal condition of Research Ethics Committee (REC) approval. Registration should occur before the first participant is recruited and no later than six weeks after recruitment of the first participant.
‘Clinical trials’ are defined as all studies which fall into the first four categories of question two on the Integrated Research Approval System (IRAS) filter page. These are:
- Clinical trial of an investigational medicinal product
- Clinical investigation or other study of a medical device
- Combined trial of an investigational medicinal product and an Investigational medical device
- Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice.
EU legislation requires that clinical trials of investigational medicinal products (CTIMPs) are entered in a public register (with limited exemptions for healthy volunteer studies).
The recognised registries include:
- ClinicalTrials.gov which accepts the registration of clinical research, including retrospectively.
- InternationalStandard Randomised Controlled Trial Number (ISRCTN) which accepts the registration of randomised controlled trials and any other research study designed to assess the efficacy of health interventions in a human population. This includes both observational and interventional studies, including retrospective.
- EU Clinical Trials Register which consists of information from the EU Clinical Trial Database, EudraCT. It accepts interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA) as well as clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
We recognise that commercial sensitivity may be a concern in some sectors and so it is possible for applicants and sponsors to submit a request to defer registration of clinical trials on a publicly accessible database. Please see the HRA Policy and Procedure for requesting deferral of clinical trial registration.
Clinical trial registration audits
We undertake annual audits to determine the number of clinical trials over a specified time that meet the condition of the favourable opinion to register on a publicly accessible database.
Reports of our audits of clinical trial
registration are available below:
- Clinical trial registration audit report 2015
- Clinical trial registration audit report 2016
- Clinical trial registration audit report 2017
- Our key messages and questions & answers on clinical trial registration and transparency
- Policy and procedure to request deferral of clinical trial registration
Applicants and sponsors may contact the HRA for further clarification if they are unsure of expectations or requirements for trial registration
Registration of research tissue banks
Since February 2017, it has been a condition of the ethical approval that all research tissue banks are registered on the UK Clinical Research Collaboration (UKCRC) Tissue Directory. The research tissue bank should be registered no later than six weeks after the favourable ethical opinion letter or six weeks after the research tissue bank holds tissue with the intention to provide for research purposes.
Registration is defined as having added details of the types of tissue samples held in the tissue bank. We monitor the registration details as part of the annual progress reporting process. Where appropriate, your research registration reference number should be entered in your dataset on the Integrated Research Application System (IRAS), so that this can be included on your application form(s).
Project identifiers, including the IRAS ID
Each project in IRAS is allocated an IRAS ID. This is visible to you throughout the project navigation in the system. We recommend that you quote this identifier as a point of reference when seeking advice from review bodies.
The EudraCT number is the mandatory reference number allocated by the European Medicines Agency (EMA) for CTIMPs.
All available project reference numbers should be entered into your IRAS dataset so that they may be included on your application form(s).
Research summary recordsWe publish details about each research study reviewed by a REC in the UK on the research summaries section of our website. This record consists of some basic information about the research (e.g. title, available registry reference numbers), a summary of the research as submitted to the REC and the REC’s opinion.
We recognise that commercial sensitivity may be a concern in some sectors and so it is possible for applicants and sponsors to submit a request to the REC to defer publication of the research summary and the full study title on the HRA website. However, the remainder of the research summary record will continue to be published.
For more information about research transparency responsiblities, please click here.