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Home > Researchers > I need help designing my research > Regulatory approvals and governance

Regulatory approvals and governance

You need to seek regulatory approval for your research project and register it with an appropriate database. You also need to adhere to the highest standards of research governance.

Protocols

You should write and publish a protocol for your NIHR-funded research project.

For clinical trials, you must publish trial protocols within 12 months from completing the primary study.

Guidance templates

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 help applicants provide all the information required in their protocol.

See protocol information on the HRA website

Medicinal products

For qualitative research and for clinical trials of investigational medicinal products,  you’ll need to look at specific protocol guidance and templates.

The SPIRIT Statement provides 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.

See further guidance on Clinical Trials Toolkit.

Approvals

The Health Research Authority (HRA) needs to approve most NIHR-funded research projects. The HRA 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

You need to register NIHR-funded clinical trials before the first participant receives an intervention.

In most cases you should register clinical research studies with the International Standard Randomised Controlled Trial Number Register (ISRCTN), which is our registry of choice.

However, you can register with another registry if required to do so by a regulator or if another registry is more appropriate.

You only need to register once.

Updating registry information

You should update registry information regularly, following the guidelines from the relevant NIHR team and ISRCTN (or relevant registry). This includes any changes to recruitment data and key outcomes.

Read more in the NIHR policy on clinical trial registration and disclosure of results.

Systematic reviews - register on PROSPERO database

If your project includes a systematic review in the protocol, you need to register your 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

Research projects we fund must:

Pharmaceutical product trials - guidance

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

You also need to set up 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
  • 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 steering committees.

Programme Grants for Applied Research (PGfAR)

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

Trial management

You should appoint a dedicated trial manager.

This generic job description can 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 we fund or support follows best practice in consent and the preparation of information for participants.

See informing participants and seeking consent on the HRA website

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.

See GDPR guidance for researchers and study coordinators on the HRA website.

Read more about requirements around research governance on our policies and guidelines page.