When Aileen Sheehy started work at the National Office for Research Ethics Committees, she looked forward to getting her feet under this new desk. Her plan was to spend the first weeks getting to grips with the complexities and nuances of ethics in health research and clinical trials.
But that’s not what happened.
“My first day of work here was in March 2020, which was also the day when Ireland went into lockdown,” recalls Sheehy.
“And so the National Office, which had been set up to centralise ethics reviews for clinical trials, immediately needed to direct our resources towards dealing with the COVID-19 pandemic.”
Sheehy was one of only two people in the fledgling organisation, which had been set up as a business unit in the Health Research Board.
In its first five months, the National Research Ethics Committee (NREC) for COVID-19 became the first committee to offer a single, national ethics opinion for Irish health research, and returned decisions on 93 applications for ethics approval, with most applicants receiving their outcomes within one or two days of the committee meetings.
“It was an intense time,” says Sheehy. “And it was exciting to be part of the national response to the pandemic.”
Focus on patients
Today, the National Office team of around 15 people look to streamline ethics reviews for clinical trials, medical devices and in vitro diagnostics across Ireland and Europe.
“We have a close working relationship with the HPRA,” says Sheehy. “We work closely together to issue a single national decision to authorise trials in Ireland.”
Ethics is a huge issue for patient safety and safeguarding, adds Sheehy, who is Programme Manager for the National Office with particular responsibility for clinical trials.
“Ethics helps to ensure any trial is safe and appropriate for patients, and that includes the impact not only of the scientific protocol but also of what is asked of patients who take part,” she says. “We have to think about the burden of the schedule, how many visits might the patient need to make to a trial site, how many blood samples would they have to give, what kinds of psychological supports are in place in some cases.”
One of the big issues for every ethics committee is that the materials and information provided to patients needs to be clear and accessible, she adds: “Quite often the doctors and scientists who provide this information think it is clear, but that may not be the case for the patient.”
Building harmony across Europe
Ireland has historically had a decentralised system where local hospitals and research institutions review ethics applications for clinical trials locally, but this approach led to challenges with trials being approved according to legislative timelines, creating delays in patients accessing trials, explains Sheehy.
“This has since changed, with new EU legislation where all clinical studies are carried out under the same rules and within set timelines,” she says.
The National Office seeks to streamline the process, supporting the national research ethics committee to deliver ethics opinions within legislative timelines, so that clinical trials can be set up in good time and patients can access the benefits of being involved.
As well as focusing on Ireland, the National Office is also linking in with Europe, which is a streamlining mindset too, according to Sheehy.
“The new European Clinical Trials Regulation was implemented in 2022, and its aim is to harmonise the clinical trial approval process across Europe,” she says.
“In practice, this needs closer collaboration between national competent authorities, so at the National Office we are now working more closely with our counterparts in other European countries, and we are involved in several networks, agencies and initiatives.”
They include MedEthics EU, a forum where members share best practices for ethics committees. Sheehy and her colleague Dr Susan Quinn represent Ireland’s interests on this forum. Sheehy became a board member in 2023.
Dr Quinn is also involved with the Accelerating Clinical Trials in the European Union initiative, sitting on on the working group that looks at clinical trials and pandemic preparedness.
Meanwhile, Dr Jane Bryant leads a track in the Clinical Trials Regulation COLLABORATE initiative, Dr Laura Mackey and Dr Lucia Prihodova play active roles in the COMBINE Project, which seeks to address challenges faced by clinical trials sponsors, and Dr Emma Heffernan is a collaborator in the European Network of Research Ethics Committees.
These initiatives aim to make it easier for clinical trials to take place in Europe while ensuring patients’ and research participant’s safety, dignity, and wellbeing are at the heart of these trials, explains Sheehy.
“We want to make Europe and Ireland a more attractive place for pharma, academics, hospitals and patients to be involved in clinical trials,” she says.
Getting the chemistry right for ethics
Sheehy’s journey into research ethics started with a degree in pharmaceutical chemistry at University College Cork, which has given her a solid foundation in science, but no love of the lab.
“I loved science, but I learned very quickly that lab work was not for me,” she says.
After a year spent travelling and living in Japan, Sheehy did an MSc in Chemistry and Science Communications at the University of Warwick and an MSc in Global Health Policy at the London School of Hygiene and Tropical Medicine. She worked as a press officer with the Sanger Institute and on data sharing platforms at the University of Oxford to tackle viral and parasitic infections.
When Sheehy moved back to Ireland in 2018, she continued to work in data policy with the HRB, then took up the new role at the National Office just as lockdown hit.
She has witnessed important changes in research ethics in the almost five years since.
“It’s an exciting time,” she says. “When I started with the National Office, there were many delays in Ireland in getting research ethics approvals, there were inconsistencies, it wasn’t viewed positively. Now everyone is working towards same goals, people want better outcomes, and we are heading for a more harmonised approach in Ireland and right across Europe.”
Working directly with the NRECs themselves has been one of the most enjoyable and rewarding aspects of her career to date, says Sheehy: “The breadth of expertise and life experiences on the committees means that you are continually learning and growing in the role.”