Academic Toolkit - ACT!

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Pre-PhD preparation
Initial planning
Find a supervisor
Develop your research question
Plan for OOP and inform TPD
Find your collaborators
Investigate funders
Think about feasibility
Find a mentor

Approvals for clinical projects

Start 11 months before funding application deadline and complete by 9 months before funding application deadline

It is important to know what approvals your project may require, even though you can’t actually apply for some approvals until after funding is in place. Some approvals will need budget for set-up costs and licences.


You need to consider early what approvals your project may require.

Ethics approval

  1. The Health Research Authority provides tools to determine whether your study is research and whether you need to apply for NHS Research Ethics Committee (REC) Approval. (Also see next section - "Check whether your study is research").
  2. REC Approval and HRA approval are rolled into a single application through Integrated Research Application System (IRAS), which is the system through which you actually submit the ethics application. Studies fulfilling certain criteria may be appropriate for REC proportionate review (i.e. where the research study does not need to go to a full REC meeting – see here). If your research project requires full REC meeting review, dates of local meetings can be found online. If you do not require REC approval you may still require local University Ethical Approval (see local processes). 
  3. Check what other approvals are needed as well as IRAS.

Institutional approval

  1. Local approval/sign-off from your Research & Development (R&D) department may be required for clinical studies (see local processes).
  2. For studies involving “off-site” (i.e. outside of the host sponsoring organisation) analysis, a Materials Transfer Agreement will be required between the relevant organisations e.g. Trust and University (even if physically only 100m apart!).


  1. Other approvals may be needed depending on the type of study, for example: Medicines and Healthcare products Regulatory Authority (MHRA) for clinical trials involving investigational medicinal products or novel treatment approaches; CAG%20approval">Confidentiality Advisory Group (CAG) approval for studies where patient information is used but consent will not be obtained.
  2. Clinical Research Network (CRN) support. Some studies may be eligible for CRN support. The CRN can provide support with recruitment and delivery of the study. You can check the eligibility of your study for CRN support online (including on the IRAS website) and if you are eligible you can apply for CRN support through the Portfolio Application Form (PAF) which is also completed through IRAS.

Note - 

REC and HRA approvals are applied for after funding is in place - you can begin to prepare these in advance but not submit them.  Extra costs include MHRA approval, local R&D set-up costs, government licenses for pre-clinical studies, etc.

CAG - Confidentiality Advisory Group External link

If you intend to access confidential patient information without consent in England and Wales you should apply to the Confidentiality Advisory Group (CAG). You will need to apply whether your project is managed as research or non-research.

Eligibility for NIHR support External link

Getting support for your research via NIHR

Getting the best from IRAS External link

The aim of this online guide is to provide clear instructions on the use of IRAS. This guide is designed to help those who apply for approvals, as well as those who review and/or authorise projects to familiarise themselves with IRAS and get the best out of it.

HRA guidance on ethics submissions External link

comprehensive advice and guidance on applying, whether you can go for proportionate review etc

Is it a clinical trial of a medicinal product? External link

This algorithm and its endnotes will help you answer that question.

Planning and improving research - Health Research Authority External link

The HRA website has lots of really useful information that can help you get started.

Check whether your study is research
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