B10. The CT:IQ InFORMed Project: Update on Implementing a redesigned Participant Information and Consent Form
Tracks
Clinical Research
| Thursday, June 13, 2024 |
| 1:30 PM - 2:30 PM |
| C2.2+C2.3 |
Chair & Speakers
Dr Lisa Eckstein
Director of Philanthropic Activities
Ct:iq
Chair: The CT:IQ InFORMed Project: Update on Implementing a redesigned Participant Information and Consent Form
Abstract
The CT:IQ InFORMed project was established to provide the Australian clinical research sector with a simplified and respectful Participant Information and Consent Form to facilitate an informed decision whether to participate in a research project. The beta-testing version of the project template and user guide were launched at ARCS 2023 and feedback was open to the end of 2023.
This forum will update attendees on the feedback that CT:IQ has received on the template and user guide and next steps towards implementation. The panel will provide diverse stakeholder perspectives on whether and how to introduce the InFORMed Project template into widespread use in the Australian clinical research sector. Discussion will include the efficiency and effectiveness of the template and user guide for researchers; legal and ethical perspectives; and the role of government bodies in stewarding change.
This forum will update attendees on the feedback that CT:IQ has received on the template and user guide and next steps towards implementation. The panel will provide diverse stakeholder perspectives on whether and how to introduce the InFORMed Project template into widespread use in the Australian clinical research sector. Discussion will include the efficiency and effectiveness of the template and user guide for researchers; legal and ethical perspectives; and the role of government bodies in stewarding change.
Biography
Dr Lisa Eckstein is the Director of Philanthropic Activities for Bellberry Ltd and the CT:IQ Programme Director. Her previous role was as a 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.
Dr James Chan
Senior Research Scientist
Vascular and Endovascular Surgery Unit, Flinders Medical Centre
The CT:IQ InFORMed Project: Update on Implementing a redesigned Participant Information and Consent Form
Biography
James Chan is a medical scientist and professional member of Australian Institute of Medical and Clinical Scientists with more than 15 years of working experience in PC2 laboratories. James receives his PhD conferral in 2021 in the field of analytical chemistry and separation science. Currently, he is working as a senior research scientist in the Vascular Research Laboratory and manages the Vascular Surgery Biobank at Flinders Medical Centre in South Australia. In 2023 he led the Human Research Ethics working group to set up the South Australian CardioVascular Biobank a collaborative initiative with Adelaide Metro Local Health Networks, SAHMRI, FHMRI, Adelaide University and Flinders University. He has extensive knowledge in handling and processing of biological samples and keen interest in contributing to the evolving landscape of cardiovascular research.
Ms Sonja Read
Partner
MinterEllison
The CT:IQ InFORMed Project: Update on Implementing a redesigned Participant Information and Consent Form
Biography
Sonja is a Partner of MinterEllison's health industry group. She advises on the regulation of entities in the health sector, public funding streams, privacy and the management of data and data breaches, medical research and ethics. She has been a member of HRECs for over 15 years, and is currently a legal member with Bellberry HREC. She holds qualifications in science and law, with a LLM from the University of Pennsylvania focusing on health policy and bioethics.
Ms Jerneen Williams
Director of Operations
BELLBERRY LTD
The CT:IQ InFORMed Project: Update on Implementing a redesigned Participant Information and Consent Form
Biography
Ms Melissa Hagan
Director
Queensland Clinical Trials Coordination Unit
The CT:IQ InFORMed Project: Update on Implementing a redesigned Participant Information and Consent Form
Biography
Director of the Queensland Clinical Trials Coordination Unit (QCTCU) in Queensland Health, Melissa leads QCTCU, a Queensland Health focal point for clinical trials in the state. She provides leadership in health and medical research, specialising in clinical trials and research & education with over 25 years influencing strategy and policy in the sector. Melissa’s government role is informed by 15 years of pharmaceutical clinical trials industry experience. She is also the former Co-Chair of the national Clinical Trials Collaborative Forum and serves on national clinical trials advisory bodies.
