The Ethics Committee is required to monitor all approved research in
accordance with the
National Statement on Ethics Conduct in Human Research (2007).
Monitoring adverse events
Researchers must monitor their research in accordance with guidelines
contained in the
National Statement on Ethical Conduct in Human Research (2007). They
must report adverse events where necessary, to the appropriate
authorities including the Office of
Ethics and Research Governance.
Audits of research projects
A Self Audit Tool has been designed to help research personnel
reflect on their research conduct and comply with guidelines for
responsible research conduct.
The Ethics Committee requires that all relevant members of the study
team complete the Self Audit annually, list the names of those who have
completed the Self Audit in the annual Progress Report and retain
completed Self Audits in your study files.
Audit by the Ethics Committee
As part of the Committee's research governance obligations, the
Research Governance Officer regularly conducts short audits of a range
of research projects. This involves meeting with researchers to:
- Examine relevant documentation including signed consent forms,
completed Case Report Forms, data spreadsheets, medical records,
correspondence and approval certificates
- Check on arrangment to protect privacy and confidentiality of
- Check source data
This process usually takes around two hours. The Research Governance
Officer will contact researchers a fortnight before the audit to set up
a mutually convenient time.
Occasionally, the Ethics Committee may recommend that a full audit of
the project is undertaken. This involves the Research Governance Officer
examining all of the study files, observing randomisation procedures
etc. This may take two or three days and can be spread over several
sessions if necessary.
Within a week of completion of the audit, researchers will receive by
email, an audit report including a summary of the main findings and a
list of items that require action in order to comply with guidelines for
good clinical practice. Researchers are expected to take appropriate
action and notify the Ethics Secretariat within a month of receiving the
report. If this is deemed satisfactory by the Committee, the audit will
be considered closed. If the Committee is not satisfied, the researcher
may need to discuss the issues with nominated members who can assist
with resolving specific issues.
If researchers do not notify the Ethics Secretariat of the action
taken within a month of receiving the audit report, the Ethics Committee
can recommend that approval for the project be withdrawn.
Common problem areas
Issues that surface most often during audit of research projects
include compliance with privacy and confidentiality requirements,
participant recruitment numbers and timelines, notification of research
participation in the participant's medical records and registration of
clinical trials with the WHO trials registry.
Researchers must direct all complaints regarding the conduct of the
Manager, Ethics & Research Governance
Research & Ethics Unit
The Alfred Hospital
55 Commercial Road