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Research registration and research project identifiers

Last updated on 12 Oct 2021

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.

Read more information about research transparency.

Research registration

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

Registration of clinical trials is a formal condition of Research Ethics Committee (REC) favourable opinion. 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.

A ‘public registry’ is defined as any register on the WHO list of primary registries or the ICMJE list of registries.

The recognised registries include:

  • International Standard Randomised Controlled Trial Number (ISRCTN) which accepts all clinical research studies. Prospective and retrospective registrations are accepted. ISRCTN is the preferred partner of the Department of Health and Social Care (UK)
  • ClinicalTrials.gov which accepts the registration of medical studies in human volunteers. Prospective and retrospective registrations are accepted
  • 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. For clinical trials (other than adult Phase 1 studies) involving both UK and EU sites a record in the EU Clinical Trials Register will satisfy the REC favourable opinion condition for registration.)

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. Such requests should be made in writing to study.registration@hra.nhs.uk as soon as possible after REC review, and include the following:

  • identification of the research that is the subject of the request (IRAS ID and REC reference as a minimum)
  • clear justification for the request (whilst there is not a single reason for automatic deferral, the HRA does note the potential commercial confidentiality issues around research)
  • the timeframe for the deferral (N.B. 12 months is the maximum allowed time)

The request to defer registration may also include a request to defer publication of the HRA Research Summary.

See our Research Registration Deferrals Policy and Procedure for more information.

Registration of research tissue banks

Since February 2017, it has been a condition of the ethical favourable opinion 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 records

We 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 some fields of the research summary record on the HRA website. However, the remainder of the research summary record will continue to be published. All requests should be made in writing by email to study.registration@hra.nhs.uk as soon as possible after REC review (but no later than 90 days from the date of the final REC opinion letter) and include the following:

  • identification of the research that is the subject of the request (IRAS ID and REC reference as a minimum)
  • clear justification for the request (whilst there is not a single reason for automatic deferral, the HRA does note the potential commercial confidentiality issues around research)
  • clear indication of the fields within the research summary that deferred publication is being sought for (refer to the Research Summary Deferrals Policy and Procedure below for more information)
  • the timeframe within which the deferred information can be published (note 12 months is the maximum allowed time).

See our Research Summary Deferrals Policy and Procedure for more information.

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