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.
It is good practice for all research projects to be registered in a publicly-accessible database, and in certain cases, particularly involving clinical trials, it is a condition of a favourable ethical opinion to do so. For the purpose of clinical trials registration, we recognise any register covered by the World Health Organisation (WHO) list or the International Committee of Medical Journal Editors (ICMJE) list.
Reports of our audits of clinical trials registration are available below:
- 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 EudraCT number is the mandatory reference number allocated by the European Medicines Agency (EMA) for CTIMPs.
- The International Standard Randomised Controlled Trial Number (ISRCTN) is a simple numeric system for the identification of clinical trials worldwide. The ISRCTN Register 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.
- Clinical research may be registered at ClinicalTrials.gov
- The Research Registry, (not a Primary Registry in the WHO Registry Network) accepts observational, interventional studies, systematic review and meta-analyses, including retrospective.
Registration of Research Tissue Banks
It is 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 6 weeks after the favourable ethical opinion letter or 6 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. The HRA 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).
Further information and Q&As on the HRA’s approach can be found here. Applicants and sponsors should contact us for further clarification if they are unsure of expectations or requirements for trial registration.
Clinical trial registration
Since September 2013, the registration of clinical trials has been a formal condition of REC approval.
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.
The simple default is that all clinical trials should be registered and we expect all researchers, research sponsors and others to meet this fundamental best practice standard.
The effect of EU legislation is that medicinal clinical trials are entered in a public register (with a limited exemption for healthy volunteer studies).
- Our key messages and questions & answers
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
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.
All other available project reference numbers should be entered into your IRAS dataset so that they may be included on your application form(s).
HRA publication of research summary records
The HRA publishes details of all research reviewed by RECs in the UK as a research summary record. This record consists of some basic information about the research (e.g. title, available registry reference numbers), 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.
The EQUATOR Network has published an independent report on modifying a question in the Integrated Research Application System to reflect best practice in publication and dissemination. We note the report and will consider its findings, subject to redevelopment of IRAS.