Setting up your study
Starting to think about what approvals are required for your study can be quite daunting, and it can seem as though there is a never-ending list of approvals required, countless forms to fill in and a wide range of organisations to which you have to send documents.
Each study will be different depending on the nature of the research, complexity, participants involved, and so on. Similarly, you may come to a project that is already established, or you might be starting a completely new study alongside your supervisor.
However, it is important that you consider what approvals may be required for your study. Approvals can't be given retrospectively, so you need to make sure you have them in place before the research starts.
Ethical approval for studies
Your supervisor will normally lead on the process of gaining ethical approval for your study.
There are two possible avenues to obtain ethical approval, depending on the type of study:
- The University of Manchester Research Ethics Committee (UREC)
- An NHS Ethics committee (NHS REC)
The University has an online decision tool that will help you determine if you need one of the above, or no ethical approval:
University guidance on research ethics and specific guidance on the UREC process can be found on StaffNet:
Health Research Authority (HRA) approval for NHS studies
If your study is taking place in the NHS, it will need to undergo a governance and compliance review in addition to obtaining ethics approval.
In England and Wales, this means applying for Health Research Authority (HRA) and Health and Care Research Wales (HCRW) approval. In the rest of the UK, this means getting Research & Development (R&D) approval from NHS Trusts.
Further details of the process can be found on the Integrated Research Application System (IRAS) website:
Information specifically for those undertaking research in the NHS is available from the Faculty:
Applying for approvals
If you need to apply for an NHS REC review and/or HRA or R&D approval, you will need to use the Integrated Research Application System (IRAS). For people new to this system, there is an e-learning tool to help you complete the form.
The Faculty Research Governance (RG) Office will also provide a set of IRAS standard answers that can be downloaded as part of the Faculty Research Governance Pack.
If your study needs UREC approval, you will need to complete an application using the University's ERM system.
The UREC application is in addition to any IRAS application. For example, if your study requires UREC approval and HRA approval, you need to complete a UREC application and an IRAS application.
Research passports
Depending on your area of research, you may require an Honorary Research Contract (HRC) or Letter of Access (LoA) to undertake research within NHS Trusts.
You should note that this process requires signatures from your supervisor and the PGR Services Manager before you take the completed paperwork to the relevant NHS Trust R&D office.
If you were asked to get a DBS check at the admissions/registration stage of your programme, you should note that this disclosure can only be used for your research passport application if it is still less than six months old.
More detailed information on applying for a research passport can be found on the Doctoral Academy website:
Useful links
This is useful for:
- University policies and procedures about ethics, human tissue, clinical trials (drugs and devices) and research integrity
- Online ethics decision tool
- Guidance and templates
- Access to the University/Divisional research ethics application system (ERM)
This is useful for:
- Guidance about University sponsorship and managing studies taking place in the NHS
- Information and resources relating to completion of the IRAS form
- Sponsor authorisation for applications and amendments
- Templates and standard guidance for IRAS
This is useful for:
- Essential guidance for undertaking research in the NHS
- Guidance on which approvals may be required for your study
- Detailed guidance on the process for applying for NHS REC, HRA, HCRW and R&D approval
- Templates and model agreements
- E-learning modules