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!).

Other

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.

Resources