As the health research community celebrates International Clinical Trials Day this week, it’s the perfect opportunity to look at the role of research ethics committees (RECs) in supporting safe and successful clinical trials – with a particular eye to Ireland’s own National Research Ethics Committees for Clinical Trials (NREC-CTs).
What is the role of RECs in clinical trials?
Let’s start by asking a simple question: why do we need RECs for clinical trials? At the heart of all clinical trials are the research participants – without patients who are willing to get involved and give their time and energy, these trials cannot succeed. RECs play a key role in protecting research participants’ rights, dignity, safety and wellbeing, by reviewing ethical considerations underpinning research proposals before the trial begins or if substantial changes are made to any aspect of that trial.
NREC-CTs: delivering single national ethics opinions for clinical trials in Ireland
RECs can be situated in hospitals, universities, professional societies and research institutes, providing ethics opinions at local level (i.e., hospital sites or selected regions). In contrast, NRECs are responsible for governing research ethics at a national level. Here in Ireland, the first NRECs were appointed by the Minister for Health in May 2020, and they included two Committees specifically dedicated to reviewing research proposals for clinical trials of investigational medicinal products: the NREC-CT A and B, chaired by Professor Alistair Nichol and Dr Cliona McGovern respectively. The decisions made by these NRECs are respected as a ‘single national ethics opinion’ which is applied to all participating sites by the principal investigators.
Supported in their work by the National Office for Research Ethics Committees, the NRECs operate in a mixed-model system together with local RECs, to ensure that all Irish health research is underpinned by rigorous ethics review. The NRECs and local RECs have defined remits in terms of the types of applications they receive, with the NREC-CTs solely reviewing clinical trial applications of investigational medicinal products submitted by the sponsor to the National Office. The ethics opinion provided by the Committees are then communicated by the National Office and will apply to all hospital sites included in the initial application. Once a favourable decision has been secured from both the NREC-CT and the Health Products Regulatory Authority (HPRA), participant recruitment may begin.
Diverse expertise and experience supporting robust ethical review
Of course ethical questions don’t just concern researchers; society as a whole has a stake in ensuring clinical trial participants are protected during research. So it is important that national decisions on the ethics underpinning Irish health research are informed by the diversity of skills, experience, interests and backgrounds reflective of Irish society. This is why NREC members are appointed from diverse backgrounds, representing a wide range of professional and life experiences. Patient and public involvement (PPI) is integral to the NREC system: of the maximum 21 members selected for each NREC, one quarter appointed are lay, including PPI representatives and members of the general public, and all members’ opinions are given equal weight in the decision-making process.
In the first year alone, the NREC-CTs A and B have reviewed a total of 66 submissions and over 430 substantial amendments to previously approved clinical investigations, in therapeutic areas ranging from cancer and neoplasms, to respiratory, cardiology, or metabolic and endocrine research. Their efficient and thorough review helps researchers ensure that trials rest on solid ethical foundations, while giving research participants peace of mind that their interests are being safeguarded throughout. Ultimately, the NRECs’ work helps strengthen the research landscape for clinical trials In Ireland, supporting our home-grown research teams and attracting leading-edge international research to our shores – benefitting not only trial participants and patients directly, but anyone who has a stake in our health and healthcare system.
Visit the NREC-CT section of our website to read more about the Committee Members and their work.