Monitoring process
The Ethics Committee is required to monitor
all approved research in accordance
with the
National Statement on Ethical Conduct in Human Research (2007). Part of
the monitoring process includes the review of progress reports.
Researchers' responsibilities
Submission of progress reports
Researchers are required to submit a
progress report
to the Ethics Manager for each research project. Where the approval covers
more than one site/centre, a report for each site/centre must be submitted.
If there is more than one principal researcher for a project conducted at Alfred Health,
one report is to be submitted, but it must have been reviewed and accepted by the other
principal researcher(s) before submission.
Reports are usually due on the anniversary of
approval, but occasionally they are requested at more frequent
intervals. Reports are also due on the completion of a project or if
the research is discontinued before the expected date of completion.
NOTE
Ethics approval is ongoing but will
lapse if the progress report is not received by the designated date or is not deemed satisfactory
by the Ethics Committee.
If the Committee is not
satisfied with the progress report, researchers will be informed about
subsequent action.
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 Ethics Office.
Audits
of research projects
Self Audit
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 arrangements
to protect privacy and confidentiality of participant data
- Check source data
This process usually takes around two hours. The Research Governance
Officer will contact researchers a fortnight before the audit to set a
mutually convenient time.
Occasionally, the Ethics Committee may recommend that a full audit of a
project is undertaken. This involves the Research Governance Officer
examining all of the study files, observing randomisation procedures etc.
This may take two to three days and can be spread over several sessions if
necessary.
Within a week of completion of the audit,
researchers will receive by e-mail, 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 researchers 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.
Complaints
Researchers must direct all complaints
regarding the conduct of the audit to:
Manager, Ethics & Research Governance
Research & Ethics Unit
The Alfred hospital
55
Commercial Road
Melbourne VIC 3004
Or email
research@alfred.org.au