Date: 21 September 2023
Time: 2pm - 3.30pm (BST)
Course overview
Over the course of this webinar, our expert speakers Sarah Edwards and Dr. Rakhshi Memon will guide you through the following aspects:
The role of research ethics in regulatory affairs
Social value, study design, equipoise and scientific necessity
Cultural challenges and 'harmonisation' of regulatory rules
Limits to consent and as fair research eco-system
Discussion and Q&A
The webinar will take place over the course of 90 minutes, with a one-hour presentation, with 20 minutes for a Q&A session with our webinar presenters, followed by a 10-minute assessment. The assessment will take place in our virtual learning environment and you will be set details after the session has finished.
Agenda:
2pm - The role of research ethics in regulatory affairs
2.15pm - Social value, study design, equipoise and scientific necessity
2.30pm - Limits to consent in a fair research eco-system
2.45pm - Cultural challenges and ‘harmonisation’ of regulatory rules
3pm - Discussion and Q&A
3.30pm - Close
Audience:
Delegates from the regulatory affairs industry who wish to obtain a better insight into the current discussions around ethics in regulatory affairs
MSc and PhD students who are preparing for their dissertations
Regulatory professionals who wish to gain a comprehensive understanding of the subject.
Speakers:
Sarah Edwards
Sarah JL Edwards is the Professor of Bioethics at UCL having trained in Psychology, in Philosophy, and in Medical Ethics and Law, concentrating her research career on research ethics in health. She has a track record of interdisciplinary research publications and policy impact. She currently leads several research projects on use of real-world evidence in regulatory decision making, on using social sciences alongside clinical trials eg to improve recruitment rates, and on cultural challenges to harmonisation of regulatory rules. She is currently collaborating with members of international bodies such as CIOMS and WHO as part of these projects. She also leads the new professional education programme in science, technology and engineering policy and co-leads new health route through the Masters in Public Administration at UCL having taught medical ethics and law to medical students, translational clinical science and regulatory affairs for postgraduates, and research ethics and governance to clinical researchers and managers.
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Dr Rakhshi Memon
Rakhshi Memon has a PhD in bioethics from University College London, UK. Her main area of interest is in concepts such as equipoise and consent with a focus on culture and research ethics. She has extensive experience working with research teams in LMICs such as Afghanistan, Bangladesh, India, Nigeria, UAE and Turkey. In the UK, she has facilitated numerous workshops on community engagement and research projects with British South Asian and Black African and Caribbean populations. Her background is in the NHS specialising in improvement sciences with a particular focus on change management and human dimensions of change. |
Learning outcomes:
To appreciate research ethics as the study of moral values in research
To identify moral values at stake in research
To outline potentially conflicting moral values
To demystify review by research ethics committees
To assess the cultural context of systems of research ethics governance
Non-member: £114 (Including VAT)
Member: £84 (Including VAT)