Southern Adelaide Flinders Clinical
Human Research Ethics Committee
APPLICATION - CLINICAL AUDIT
A.
Audit Site/s
FMC
Southern Mental Health
DASSA
Other (please state)
NHS
RGH
B. Project Title and Timeframe
Title*:
Period approval is sought:
Date data collection is to commence:
Date data collection is expected to be completed:
Date project is expected to be completed:
*A title that indicates the area of clinical activity to be audited.
C. Applicant Details
Name(s) of clinical team:
List principal investigator first
School/Department/
Organisation
C1 Contact Person:
Name
Phone
Email
C2 Students Only:
Student
(SRN)
Record
Number
Degree enrolled for –
5-Feb-16
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D. AUDIT DETAILS:
1. Description of the audit and its purpose.
2. What standards, if any, will be used to evaluate the data obtained?
Note that the response does not have to contain the standards themselves, only a
description of the standard/s that apply.
3. How will the audit be conducted?
Retrospectively or prospectively? If retrospective, will consent be obtained from patients? If
not justification will need to be provided as per the ‘Guidelines approved under Section 95A
of the Privacy Act 1988’. Please include the data collection form, if available.
4. Who will collect the data?
5. How will confidentiality be maintained?
6. Storage and security of data
Please describe how the data will be held, and all relevant information security provisions,
including when the data will be disposed of.
7. How will the data be analysed?
8. How will the audit findings be fed back to the clinical team?
9. How will the impact of the audit be monitored?
E. QUESTIONS TO BE CONSIDERED:
1) Will re-identifiable data be used?
YES
NO
2) Will patients be impacted by the audit beyond that YES
experienced during normal clinical management?
NO
If no, consent is to be obtained
E.g. phone calls, additional hospital visits or completion of questionnaires.
5-Feb-16
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PRIVACY AND CONFIDENTIALITY
3) Does the auditor normally have access to the patient’s YES
records? If yes, who; circumstances; protection of privacy.
NO
A student of a clinical team in a hospital or an authorised quality assurance
officer would not be excluded. A student external to the clinical team would
be excluded.
4) Will confidential information be available to any one who YES
would not usually have such access?
NO
5) Will the audit require a breach of confidentiality beyond YES
that experienced during routine care?
NO
OVERLAP WITH RESEARCH
6) Does the audit alter routine clinical care?
YES
NO
7) Are randomization, use of a control group or a placebo YES
needed?
NO
Application and evaluation of a new technology not previously used in the
hospital may need further consideration.
Proposals involving comparison with published or prior treatment results with
other groups are acceptable.
8) Does the study gather information beyond that collected in YES
the routine clinical care?
NO
9) Will the proposal generate data that are likely to lead to YES
publication in peer-reviewed or professional journals?
NO
Many journals require review and acceptance as ethical by an HREC before
accepting articles for publication. If it is intended that the results of the
quality assurance study will be published, HREC approval is recommended.
Note that the HREC does not provide retrospective approval of quality
assurance activities.
Name of Applicant
Date……………………..
Name of Supervisor
Date……………………..
5-Feb-16
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