When it comes to conducting research, it is important to understand the regulatory bodies that govern clinical research trials and their roles. In the UK, the Health Research Authority (HRA) is the regulatory body responsible for protecting and promoting the interests of patients and participants in health research. Before your trial can begin, the HRA is one of the regulatory bodies you must seek approval from so that they can ensure that the welfare of participants is safeguarded.
There’s a lot to cover, but don’t worry, we’re here to give you the information you need to get started.
The Health Research Authority (HRA) is an executive non-departmental body of the Department of Health and Social Care in England, which provides national governance for the country’s health research. They are just one of the regulatory agencies in research, alongside the Medicine and Healthcare products and Regulatory Agency (MHRA).
But how do you know whether your trial needs ethical approval by the HRA?
Any research project that involves recruitment of NHS patients, staff, premises, resources (pharmacy, radiology or laboratories) or data/tissue must go through the HRA approval process.
Whether your study is limited to working with patient data, you’re using human subjects or testing a medical product or drug, even if you are conducting qualitative/quantitative research with a questionnaire, if it is using NHS data, they are the body you will need to go through.
It is safe to say that all clinical trials need to go through the HRA for approval, but if you are still unsure you can use this decision tool to help determine whether your study requires ethical approval from the HRA.
If you read our most recent blog on the 6 principles of ethical research, you’ll know a bit more about why ethical standards are of paramount importance for the efficacy and integrity of your research.
Before you can apply for ethical approval, you need to make sure your research project is effectively planned. That means assembling your team with their roles and responsibilities, knowing that the site(s) you are working with are equipped to support your research, and your research protocol. Let’s look at these in a bit more detail.
Roles and responsibilities: You need to know who is supporting your research; this includes a sponsor, (they will be responsible for overseeing and monitoring the progress of your project), as well as their legal representative. You will need a chief investigator and principal investigator, who are responsible for the leadership and conduct of the research, as well as a data controller.
Working with sites: As an early part of the planning process, you’ll need to identify that the site you will be working at is equipped to provide what you need for your project. For example, if you are working on an NHS site, you need to know if you have access to potential participants and the facility has the equipment you need.
Protocol: Your research protocol is the publication that lays out the methodology of your research that staff and team members will be expected to adhere to. You’ll be able to find templates to help create your protocol and publish your study.
If your research is taking place with NHS data in Scotland or Northern Ireland, you will still need to apply through the Integrated Research Application System (IRAS), which we’ll touch on a bit later. Likewise, if you’re using data from outside of the NHS, you will still need to contact the clinical governance or research and development (R&D) office of the organisation your project is taking place at. They’ll be able to let you know what other local review arrangements or sources of advice may apply.
A quick overview of the application process
The Integrated Research Application System (IRAS) is the portal you will use to submit your application. Although it may seem daunting there is plenty of information in the portal to assist you, as well as a helpline. Once it’s submitted, you’ll await a validation letter which will mean you can proceed to the next stage of the process, where the HRA and/or Research Ethics Committee (REC) will review your application. You will attend a virtual meeting with the REC; they may require additional information before they issue their final opinion. Meanwhile, you will undergo an initial assessment with the HRA. When the assessment is completed and the REC final opinion provided, the final outcome from the HRA for the success of your application will be provided. Throughout the process, you will need to keep your site(s) updated on the application process.
This is just an overview of how to apply for ethical approval, but throughout the process, (especially if this is your first time applying) there are so many tips and tricks you might not be privy to that can smoothen out the journey. It’s easy to make common mistakes when it comes to things like having the correct documentation to the highest standards, submitting your application correctly, getting the authorisations you need in place, as well as preparing for your meeting and assessment with the HRA and REC.
We understand that it’s a daunting and time-consuming task, which is why we at CGX are here to help. At CGX, our mission is to train the next generation of clinical trials researchers and to empower Clinical Trials Professionals (CTPs) and companies alike to excel in their clinical research field with our consultation arm, Clinnovate. If you want to find out more about the ethics, roles and responsibilities involved in clinical research, or you’re looking for consultation for your application, we’re here to help. Our courses are a great place to start if you’re looking to enter the world of clinical trials. If you are a company, then don’t hesitate to contact us and book your 15 minute consultation with CGX’s director Lia Hunter today.
