Approvals, registration and governance

NIHR-funded researchers are required to seek regulatory approval for their research project and register the project with an appropriate database. We also expect NIHR-funded researchers to adhere to the highest standards of research governance.

Protocols

We recommend that you write and publish a protocol for your NIHR-funded research project. For clinical trials, trial protocols must be made publicly available within 12 months from primary study completion.

The Health Research Authority (HRA) has produced guidance and templates to help researchers develop high-quality protocols for submission for ethical and other approvals. The templates contain all the elements that review bodies consider, to reduce the likelihood that the review body will require clarification from the applicant.

Medicinal products

Specific protocol guidance and a template are available for clinical trials of investigational medicinal products (CTIMPs). The SPIRIT guidelines provide evidence-based recommendations for the minimum content of a clinical trial protocol and the template is in line with these guidelines and all regulatory requirements. More guidance on CTIMPs is available in our dedicated Clinical Trials Toolkit.

Qualitative research

The HRA has also produced guidance and a template for qualitative research protocols.

Approvals

Most NIHR-funded research projects need to be approved by the Health Research Authority (HRA), which oversees ethical, governance and legal aspects of research in England.

Researchers can apply for HRA approval for their research through the Integrated Research Application System (IRAS).

IRAS is a single system for applying for the permissions and approvals for health and social care research in the UK. The system:

enables you to enter the information about your project once instead of duplicating information in separate application forms
uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required
helps you to meet regulatory and governance requirements.

Planning a multicentre study? The Health Research Authority has a Research Passport system that allows you to move easily between NHS Trusts without requiring HRA approval at each organisation.

Study registration

Clinical trials

All NIHR-funded clinical trials must be registered before the first participant receives an intervention.

We recommend that clinical research studies are registered with the International Standard Randomised Controlled Trial Number Register (ISRCTN), which is the NIHR registry of choice.

You may be required to register your project with another recognised registry, for example by a regulator, or another registry may be appropriate. In such cases, you will not need to also register with ISRCTN, because NIHR requires registration only once.

Registry information should be updated regularly as appropriate and in line with instructions from the relevant NIHR team and ISRCTN (or relevant registry) guidelines, including any changes to recruitment data and key outcomes.

Registration advice is provided in the documentation supplied by your programme as part of the application, contracting and start-up processes.

Systematic reviews

All NIHR-funded projects that include a systematic review as part of their protocol (even if embedded within a trial) are required to register their protocols on the PROSPERO database.

PROSPERO is an international database of prospectively registered systematic reviews in health and social care. Registration advice is provided in the documentation supplied by your programme as part of the application, contracting and start-up processes.

Governance

The UK Policy Framework for Health and Social Care Research outlines the principles of good practice in the management and conduct of health and social care research in the UK. All NIHR-funded research must be completed in accordance with this framework.

NIHR-funded research must also comply with the Concordat to support Research Integrity and, if relevant, in accordance with the Governance Arrangements for Research Ethics Committees (GAfREC).

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines provide advice on governance of pharmaceutical product trials.

Steering committees

All primary research projects funded by the NIHR are required have a steering committee. The committee provides overall supervision for a project on behalf of the project sponsor and project funder, and ensures that the project is conducted to rigorous governance standards.

These committees are variously known as a Trial Steering Committee, Study Steering Committee, Programme Steering Committee or Research Steering Group, depending on the type of research and the NIHR research programme. For some types of research, a Data Monitoring Committee is also required.

Please see our research governance guidelines for more information on Trial Steering Committees and Study Steering Committees, and Data Monitoring Committees.

Research funded through Programme Grants for Applied Research (PGfAR) Programme should be overseen by a Programme Steering Committee.

Trial management

All projects are encouraged to appoint a dedicated trial manager. We have produced a generic job description to support you in hiring a trial manager. Please let us know about any appointments you make.

Patient consent

People who are invited to take part in health and care research must give informed consent before being enrolled. For consent to be considered both legal and ethical it must be:

given by a person with capacity
voluntarily given, with no undue influence
given by someone who has been adequately informed
a fair choice.

We expect that research funded or supported by the NIHR follows best practice in consent and the preparation of information for participants, as set out by the Health Research Authority.

Protecting personal data

Researchers and study coordinators must comply with General Data Protection Regulation (GDPR) with respect to processing personal data, such as from research participants.

The Health Research Authority has published operational guidance on the implications of the GDPR for the delivery of research in the UK.

External links

Get more advice from our dedicated Clinical Trials Toolkit.