The event will take an in-depth look at how and why ethical considerations are embedded in the practices of health research. These discussions come at an important juncture in the evolution of the research ethics landscape both in Ireland and internationally – as we emerge from the COVID-19 pandemic into a research environment full of new ethical challenges in areas as diverse as artificial intelligence, genetics and genomics, and how to best safeguard the rights of research participants. 

Due to the strong interest in the event, we are currently at full capacity for the conference and registration has closed. Recordings of most presentations will be made available after the event.

The programme is outlined below, and further details on speakers can be found on the HRB website. Check back here or follow the National Office on Twitter or LinkedIn for the latest updates.

This will be a full-day in-person event. 

Programme

08.00 Registration and coffee

09.00 Opening and welcome words

Dr Emily Vereker, Head of the National Office for Research Ethics Committees

09.15 Session 1: Research ethics – where we’ve come from, where we’re going 

Our first session will set the scene with an overview of what research ethics is and how it has developed over time.

Session chair: Prof. Dirk Lanzerath, EUREC (European Network of Research Ethics Committees)

09.15 Keynote: A short history of research ethics

Prof. Deirdre Madden, University College Cork

09.45 Overview of the Irish research ethics landscape

Prof. Andrew Green, University College Dublin

10.05 The European landscape – a regulator’s perspective

Peter Arlett, European Medicines Agency

10.25 Research ethics governance in a changing global landscape

Dr Laura Merson, International Severe Acute Respiratory and Emerging Infection Consortium

10.45 Panel discussion

11.15 Coffee break

11.35 Session 2: Research ethics in action – inclusive research

In session 2 and 3, we will explore key debates and emerging issues in research ethics, and delve into the substance of how ethics is practised in real-world health and social care research.

Session 2 will focus on the ethics of inclusive research, beginning with a keynote on current debates in this area. Researchers and study participants will then share their experiences navigating ethical challenges in trials involving groups such as pregnant women or children, who can face specific challenges when it comes to being included in research.

Session Chair: Dr Avril Kennan, Health Research Charities Ireland

11.35 Keynote: The ethics of inclusive research 

Dr David Shaw, Institute for Biomedical Ethics, University of Basel

12.05 Case study 1: The inclusion of pregnant women in research

Prof. Fidelma Dunne, University of Galway

12.20 Case study 2: Paediatric clinical trials

Noreen Doyle, PPI representative

12.35 Case study 3: The inclusion of vulnerable or marginalised groups in research

Clíona Ní Cheallaigh, Trinity College Dublin

12.50 Panel discussion

13.15 Lunch

Session 3: Research ethics in action – emerging technologies

Session 3 will begin with a keynote on the ethical challenges related to research in new technologies: from artificial intelligence, to connected healthcare, to big data.

We will then hear from researchers and patients/participants on their experience in real-world studies where emerging tech played a central role. Speakers will discuss what the future holds for unlocking the potential of new innovations, while respecting the dignity and well-being of research participants.

Session Chair: Prof. Barry O’Sullivan, University College Cork

14.15 Keynote: Ethical challenges in emerging healthcare technologies

Prof. David Archard, Chair of the Nuffield Council on Bioethics

14.45 Case study 1: Artificial intelligence

Prof. Derek O’Keeffe, University of Galway

15.00 Case study 2: Biobanking 

Dr Michaela Mayrhofer, BBMRI-ERIC

15.15 Case study 3: Genomics

Prof. Sally-Ann Lynch, University College Dublin

15.30 Panel discussion

Case study presenters and keynote speaker will be joined by PPI representative Dr Kate Gajewska, Clinical Manager for Advocacy and Research at Diabetes Ireland

16.00 Closing words

Dr Mairead O’Driscoll, Chief Executive, Health Research Board

16.15 Event close

If you have any questions related to registration or the details of the conference, please contact the organising team at hrb@conferencepartners.com. 

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We will be discussing the work of the National Office and the National Research Ethics Committees (NRECs), including emerging trends in research ethics more broadly. Programme highlights will include a presentation from our guest speaker, Professor David Archard, Chair of the Nuffield Council on Bioethics, an address from the Department of Health, and a panel discussion on topical issues in ethics with NREC members. We will also answer questions submitted in advance and invite attendees to submit their questions via the registration page – more details below.

The webinar will be held on 27 October 2022 from 10am to 1pm.

Registration is now open via Zoom platform – please register here.

Preliminary programme

Session 1: The National Office and Committees – the journey to date

This session will provide an overview of the journey of the National Office and NRECs since the establishment of the office, with contributions from the Head of Office and the Department of Health. The National Office team will provide insights into the work of the NRECs for clinical trials for investigational medicinal products (NREC-CT) and the NREC for clinical investigations of medical devices and performance studies for in vitro diagnostics (NREC-MD).

10.00 – 10.15     Welcome and overview from the National Office

Dr Emily Vereker, Head of National Office

10.15 – 10.25     Message from the Department of Health

Anne-Marie Seymour, Principal Officer, Department of Health

10.25 – 10.55     Insights into Committee business

Dr Susan Quinn, Programme Manager for NREC-CT, National Office

Dr Lucia Prihodova, Programme Manager for NREC-MD, National Office

10.55 – 11.25     Q&A on Committee business

National Office team

11.25 – 11.40     Break

Session 2: Zooming out – surveying the research ethics landscape

In this session, we will broaden the lens to look at the research ethics landscape more broadly, providing a platform for discussion on topical issues. We are delighted to welcome keynote speaker Professor David Archard, Chair of the Nuffield Council on Bioethics, to give an international view. A panel discussion will round out the event, bringing together voices from across the ethics spectrum to answer questions on topical issues.

11.40 – 12.10     Keynote speaker

Professor David Archard, Chair, Nuffield Council on Bioethics

12.10 – 12.50     Panel discussion with Q&A: representatives from a range of perspectives examine topical issues across the research ethics landscape

Panelists: 

• Prof David Archard, Chair, Nuffield Council on Bioethics 
• Prof Mary Horgan, Chair of NREC COVID-19 and Consultant Physician in Cork University Hospital and Professor in the School of Medicine, University College Cork
• Orla Lane, Economist, Patient Advocate and Public Representative, NREC-MD
• Prof Alistair Nichol, Chair of NREC-CT A and Consultant Anaesthetist & Intensivist, St. Vincent’s Hospital, Dublin
• Prof Barry O’Sullivan, Chair of NREC-MD and Professor, Artificial Intelligence, School of Computer Science & Information Technology, University College Cork, Cork

Chair: Dr Mairead O’Driscoll, Chief Executive, Health Research Board

12.50 – 12.55     Reflections on the morning’s discussions

Dr Anne Costello, Programme Manager, National Office

12.55 – 13.00     Thank you and wrap-up

Dr Emily Vereker, Head of National Office

Registration is now open via Zoom platform – please register here.

We are inviting attendees to submit any questions for the webinar Q&As in advance; please use the Q&A boxes on the registration form to do so. Questions will be answered during Session 1 and Session 2:

• Session 1: For the Q&A on Committee business, we are inviting questions regarding the business of the National Office and the NRECs – for example: best practice in submitting applications, how the review process works, or what future developments might mean for the application process.
• Session 2: For the broader discussion, we invite questions on the research ethics landscape more generally and emerging trends in clinical research.

Please note, the National Office will not address queries relating to specific ethics applications during this webinar; these should be directed separately to the nationaloffice@nrec.ie

If you have any questions on the webinar or registration, please contact nationaloffice@nrec.ie

The post National Office webinar: learnings, insights and next steps appeared first on NREC.

The series will present the main changes that those involved in clinical trials in Ireland can expect when the regulation is implemented, as well as throughout the three-year transition period that will follow, with the aim of helping the clinical trial community understand and prepare for the new regulation.

Information sessions will cover a wide range of topics, including an overview of the regulation, post-authorisation and compliance aspects, and guidance on next steps for sponsors and investigators. The Department of Health will also provide an update on the national framework for the regulation.

Register
For more information and to register: visit the dedicated event page on the HPRA website.

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The National Office for Research Ethics Committees was established in March 2020 to deliver a robust, transparent and cohesive research ethics review system that strengthens the national research infrastructure. National Research Ethics Committees (NRECs) will be established in prescribed areas of health research at the request of the Minister for Health. The NRECs will work alongside local RECs to support the spectrum of health research in Ireland through rigorous independent review in a timely and transparent manner. The cornerstone of research ethics review in this mixed model system will continue to be the protection of the safety, dignity and wellbeing of research participants.

In line with pending EU Regulations, NRECs will be established in the initial priority areas of Clinical Trials of Investigational Medicinal Products and Clinical Investigations of Medical Devices. On Thursday 11th of March, the National Office will deliver a webinar to provide information on the NREC launch in 2021, including an introduction to the role of the National Office and the planned transition of ethics review from local RECs to National RECs for these select health research areas.

This webinar is open to all, with content particularly relevant to the academic and industry communities likely to conduct such research.

As we expect the volume of attendees to be high, only questions submitted ahead of time will be answered during the webinar. We endeavour to answer all questions submitted before and after the webinar through an ‘FAQ document’ that will be shared with registered attendees after the webinar. Questions can be submitted to nationaloffice@nrec.ie.

Register for the webinar: https://register.gotowebinar.com/register/5428488330744555023

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Come visit our booth during this engaging programme to learn more about the National Office!

More details and registration at https://www.hrb.ie/news/events/trust-and-truth-in-health-research/

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