PaCCSC & CST webinar: Consent conversations
Participant consent is an important part of clinical trial recruitment. This webinar is for clinicians and researchers conducting clinical trials and other research involving participant recruitment.
In this webinar, we will explore the challenges of consent in a range of scenarios.
The decision to participate in clinical research is the choice of each eligible person. This requires that they give informed consent, which should be voluntary and based on a clear understanding of the proposed research.
Face-to-face consent conversations between clinicians and patients are important. But, what happens to the consent conversation when the clinician and patient are in different locations? What are the challenges of consent for research that involves vulnerable people? What are the Good Clinical Practice (GCP) requirements for consent and how will this change when R3 is released?
Don't miss out!
Facilitator
Belinda Fazekas
National Project Officer
IMPACCT Trials Coordination Centre
University of Technology Sydney
Program
Dr Sophie Mepham
Group Executive Manager Oncology Research – Global
GCP Consultant
Presentation: Anticipated changes to consent with the release of R3
Dr Anthony Herbert
Senior Lecturer
Children's Health Queensland Clinical Unit
University of Queensland
Presentation: Paediatric Consent
Professor Nikolajs Zeps
Adjunct Professor, Monash University
Director of Research, Northern Health
Presentation: eConsent as an enabler for participant engagement: practice examples for clinical trials and clinical quality registries
Dr Lisa Eckstein
Director, CT:IQ
University of Tasmania
Presentation: The CT:IQ InFORMed Project: Putting Participants at the Centre of Consent for Research
Speaker bios
Belinda Fazekas
Belinda Fazekas leads the IMPACCT Trials Coordination Centre (ITCC) team with over 15 years’ experience in the conduct of clinical trials within palliative care and cancer symptom management. She is integral to site selection and training for new and ongoing trials conducted by the ITCC and international partners.
Belinda is responsible for the development of recruitment strategies, key performance indicators, and standard operating procedures, and for the development of data management and monitoring plans.
Dr Sophie Mepham
Dr Sophie Mepham works in the clinical trials and research sector in Australia and has extensive trial experience within the UK, Singapore and Australia.
Since completing her PhD in Immuno-Oncology in 2001, Sophie has worked in multiple clinical trials roles, including Data Manager and Clinical Trial Assistant (NHS), Clinical Research Coordinator (NHS), Assistant Research Manager (NHS), Clinical Trial Unit manager (Peter Mac), National Research Manager for oncology provider GenesisCare as well as her current role as Global Executive Manager for Research with oncology provider Icon Group.
Sophie received Good Clinical Practice (GCP) facilitator training with the National Institute of Health Research (UK) in 2011 and has subsequently taught GCP to staff at hospitals, academic research institutions as well as public and private research institutes.
She has extensive experience in GCP-compliance audits and inspections and successfully led an MHRA GCP compliance inspection in the UK in 2011 and multiple FDA and sponsor audits in Australia from 2012 onwards.
Sophie has Cert IV in Training and Assessment.
Dr Anthony Herbert
Associate Professor Anthony Herbert has been Director of the Paediatric Palliative Care Service at the Queensland Children’s Hospital, Brisbane for the past 9 years.
He has interests in both research and education and has found perinatal palliative care to be a key component of his clinical work.
Anthony is the project lead for the QuoCCA project (Quality of Care Collaborative Australia) and has research interests supported by the Queensland University of Technology including communication, advance care planning and symptom management.
Professor Nikolajs Zeps
Adjunct Professor Nik Zeps is an experienced Research Director with a demonstrated track record of leadership in clinical trials, biomarker discovery research, medical ethics and regulatory affairs.
Nik is currently the Director of Research at Northern Health and the Director of Operations for the Cancer Registries program at Monash University. He is also an Adjunct Professor through the Eastern Health Clinical School of Monash University and in the School of Public Health and Preventive medicine, and is Clinical Research lead for Monash Partners.
Nik has held leadership roles in National and International research programs including the NHMRC Research Committee and Australian Health Ethics Committee.
In 2017, Nik was commissioned to co-write the current Australian Clinical Trials Handbook for the TGA and was awarded the NHMRC Ethics Prize in recognition of his contribution to human research ethics in Australia.
Nik was a founding Director of the Australian Clinical Trials Alliance (ACTA) and leads the rapid trial start up and teletrials initiatives.
Dr Lisa Eckstein
Dr Lisa Eckstein is the Director of Philanthropic Activities for Bellberry Ltd and the CT:IQ Programme Director.
Lisa’s previous role was as a senior lecturer in the Faculty of Law at the University of Tasmania, where she chaired the Tasmania Health and Medical Human Research Ethics Committee and published on the regulation of clinical trials, genomic privacy, and consent.
Prior to academia, Lisa worked as a legal officer for the Australian Law Reform Commission and for state and federal health departments.
