Navigating your way through the ethics application process

Though not the most exciting part of your research journey, obtaining ethical approval is essential before your research can commence. This video provides a good overview of why research ethics matters and how research ethics procedures have come about.

Who’s who: Roles and responsibilities

Research is a team sport. Your project will gather a team of people and it is likely you will need to interact with different teams, committees or steering groups to plan the research before putting an ethics application.

For those new to research it can be a bit confusing to know who’s who and what their responsibilities, so before discussing the ethics process this is an overview of key people and groups you will interact with.  

• Chief investigator (CI): Overall lead and responsibility for the project

• Principal Investigator (PI): The main investigator (locally) with oversight and responsibility for conducting the research). This may be you if you have had experience of research before but most likely if you’re newer to research this will be your supervisor. 

• Research sponsor: This is usually an NHS trust and the associated R&D department, or University affiliated with your research. Other sponsors include commercial sponsor i.e. pharma sponsored. The sponsor is responsible for hosting the research, ensuring scientific quality through peer review and ensure researchers have necessary expertise and resources.  

• Research Ethics Committees (REC): Located nationwide, these comprise individuals drawn from the public as well as health professions and can include patients, clinicians, nurses, pharmacists and allied health care professionals. Their main responsibility is to provide independent review of research involving patients or volunteers, their organs, tissue or data. Their remit is to consider the dignity, rights, safety and well being of participants for example, by ensuring written informed consent and data protection are obtained. 

• NIHR Clinical Research Networks (CRN):  These are local research networks which increase opportunities for participants to take part in clinical research, ensure that studies are carried out efficiently, and support the Government’s Strategy for UK Life Sciences by improving the environment for commercial contract clinical research. These receive funding from the Department of Health and Social Care (DHSC). Talk to your supervisor to see whether your research requires input from CRN. See the NIHR website for more information.
• Patient and Public Involvement and Engagement (PPIE): NIHR defines public involvement in research as research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them. PPIE is conducted throughout the whole research process – from designing the research to disseminating results. Examples of PPIE include focus groups, seminars or engagement events, as well as activities such as reviewing the study literature. Most ethics applications require you to demonstrate evidence of PPIE, so think about this early and talk to your supervisor and/or local PPIE manager about this before the ethics application.  

Application process

Most ethics applications within healthcare research will be done via a single point of access form called the Integrated Research Application Service form (IRAS) which you can register for via www.myresearchproject.org.uk.

The form allows you to enter data that, through filters that you set in the beginning of the form, automatically populates other sections of the form for necessary permissions from review bodies. IRAS captures in a single form the information needed approvals/permissions from the following review bodies: 

• Administration of Radioactive Substances Advisory Committee (ARSAC) 
• Confidentiality Advisory Group (CAG) 
• Gene Therapy Advisory Committee (GTAC) 
• Health Research Authority (HRA) for projects seeking HRA Approval 
• Medicines and Healthcare products Regulatory Agency (MHRA) 
• NHS/HSC R&D offices 
• NHS/HSC Research Ethics Committees 
• National Offender Management Service (NOMS) 
• Social Care Research Ethics Committee 

Summary of required core data on the IRAS form: 

• Study background and rationale 
• Chief and Principal investigator details 
• Research Summary (maximum 300 words): the summary should be written in Plain English, using language easily understood by lay reviewers and members of the public. Bear in mind the average reading age in the UK is 9 years old. For tips on how to write a good lay summary see here and here.
• Summary of the main ethical and design issues, how you have addressed them and who you have consulted in developing the proposal. IRAS suggests key areas you may wish to address include: purpose and design of the research; recruitment; justification of inclusion/exclusion criteria; consent; risks, burdens and benefits to participants; confidentiality; any conflicts of interest; use of tissue samples in future research (if applicable).  
• Research questions and objectives 
• Scientific justification for the research 
• Design and methodology 
• Patient/public involvement  
• Data storage and management 
• Dissemination of the results and publication 
• Statistical review, sample size justification  
• Randomisation (if applicable) 
• Methods of analysis 
• Who is funding the research 
• Who is the research sponsor 

The form will filter different questions depending on whether your study is a Clinical Trial of Medicinal Product (CTIMP) or non-Clinical Trial of Medicinal Product (non-CTIMP) if your study uses ionising radiation, existing or new human samples, and inclusion of adults unable to provide informed consent. To determine whether your project is a CTIMP vs non-CTIMP you need to work through the MHRA algorithm. Your research sponsor should be able to assist you with this - some sponsors have an electronic system to log this others require you to annotate on the algorithm PDF.