Archives: <span>FAQs</span>

As part of our commitment to ongoing training and development, we provide for a number of attendees at Ethics training sessions, conferences/seminars and networking events. We were pleased to sponsor several Members attendance at the Australasian Association of Bioethics and Health Law Conference, ACTA International Clinical Trials Symposium, Monash Intensive Bioethics Course and Monash Intensive Research Ethics Course.

Thank you to Kerrin Falconer, June Challen, Sharonne Price, Jenni Hughes and Tracy Mitchell for representing Bellberry and for providing a summary of the program elements that were of particular interest. Member 2015 Conference Reports (1 download )

13 and 14 August

Genetics and Stem Cells/Cell Therapy was chosen as the theme for the third Bellberry Education Weekend given the growth in clinical trial activity in these areas. The timing coordinated nicely with the recent announcement of Bellberry being selected to pilot the NHMRC National Scientific Committee to review complex genetic research.

We are delighted with the extremely high calibre of presenters who generously donated their personal time to speak at our event, and for their enthusiasm for being involved with Bellberry.

Please click on the individual session name below to view the video footage:

We are pleased to have sponsored several members’ attendance at external educational events during 2016. Thank you to June Challen, Greg Crawford, Margy Hewetson, Natalie Clark Reynolds, Di Sutton, Andrew Davis, Peter Morel, Tracy Mitchell, Paula Swatman, Michael James and Ian Leader-Elliott for representing Bellberry and for providing a summary of program elements that were of particular interest.

Congratulations to June, Di and Natalie who have successfully completed the PRAXIS HREC Essentials Training Course.

Masterclass in Clinical Trials: Methodology & Conduct – Masterclass in Clinical Trials: Methodology & Conduct (1 download )
Australasian Ethics Network Conference – Australasian Ethics Network Conference (1 download )
Australian Association of Bioethics & Health Law Conference & the Monash Intensive Bioethics Course – Australian Association of Bioethics & Health Law Conference & the Monash Intensive Bioethics Course (1 download )

Thank you to Sid Baxi, Anne Ozdowska, Cecilie Lander and John Hackett for representing Bellberry and for providing a summary of the program elements that were of particular interest. Click here to view their reports: Member 2016 Conference Reports (1 download )

Intensive Bioethics Course (IBC) & Intensive Research Ethics Course (IREC) – December 2017

We proudly sponsored the attendance of HREC members Paula Swatman at the IBC, and Brian Creese and Andrew Davis at the IREC. Thank you for representing Bellberry and for providing feedback. Member Conference reports - Fourth Quarter (1 download ) . Please click this link to review their individual reports.

Introduction to Economic Evaluation in Health – 31 March 2017

HREC members Ian Roberts-Thomson, David Ng and John Hackett represented Bellberry at this one day course held in Sydney. Our thanks to each of them for providing a summary report of the course. Member Conference Reports - First Quarter (2 downloads ) Please click this link to view the reports.

Participation that is free of coercion and pressure.

An adverse reaction, the nature or severity of which is not consistent with the applicable scientific information (e.g. Investigator’s Brochure for an unapproved investigational product or Product Information (PI) document or similar for an approved, marketed product).

Intervention directed towards the wellbeing of the individual concerned.

An individual, company, institution or organisation that takes responsibility for the initiation, management, and/or financing of research.

Single ethics review is a process whereby one Human Research Ethics Committee (HREC) provides the ethics review for a research proposal that is accepted by the other institutions participating in the multi-centre research.

A serious adverse event (see definition above) for which there is some degree of probability that the event is an adverse reaction to the administered drug, and the adverse reaction is unexpected.

Any untoward medical occurrence that:

results in death;
is life-threatening (NOTE: The term “life-threatening” refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/reaction which hypothetically might have caused death if it were more severe);
requires inpatient hospitalisation or prolongation of existing hospitalisation;
results in persistent or significant disability/incapacity;
is a congenital anomaly/birth defect; or
is a medically important event or reaction.

The function of the magnitude of a harm and the probability that it will occur.

Recognition that each human being has value in himself or herself.

Includes fabrication, falsification, plagiarism or deception in proposing, carrying out or reporting the results of research, and failure to declare or manage a serious conflict of interest. Also includes failure to follow research proposals approved by a research ethics committee, particularly where this failure may result in unreasonable risk or harm to humans, other animals or the environment. Also includes the wilful concealment or facilitation of research misconduct by others.

Includes at least investigation undertaken to gain knowledge and understanding or to train researchers.

Intensive Bioethics Course (IBC) & Intensive Research Ethics Course (IREC) – December 2017

Introduction to Economic Evaluation in Health – 31 March 2017

HREC Member Expression of Interest form

AEC Member Expression of Interest form

CCAP Member Expression of Interest form