Research

Quality assurance, quality improvement and audit

Quality Assurance, Quality Improvement and Research Audit definitions and associated application forms have been retired and replaced by the following guiding principles to ensure proportionate review via one of two review pathways:

  • Research Office Review Pathway (process managed by the Discovery & Innovation Unit (DIU) at Austin Health)
  • Clinical Governance Improvement Pathway (process managed by the Safety & Quality Office at Austin Health).

Please contact the DIU to discuss your project prior to submission so we can advise on the process at research@victri.org.au.

Discovery & Innovation Unit Review Pathway

If your project has a research output and isn’t a clinical trial using drugs or medical devices, or if you require an acknowledgement letter for publication purposes, you will need to use the Health Service Research Protocol template available in the Knowledge Base on Research Architect.

Following that, we will escalate projects to the correct level of review without asking researchers to complete a further set of forms. This review pathway allows projects to go from single to multi-site with fewer issues. If it is part of a trial where Austin is the lead site, we will partially execute agreements so that the agreement can be submitted at the same time. The Discovery & Innovation Unit will advise you on the best agreement to use; please do not submit an agreement with your application.

We will also add any waiver of consent approvals to our approval letters. This will help speed up Site Specific Authorisation for Multi-Site projects.

Clinical Governance Improvement Review Pathway

Improvement in healthcare can be defined as ‘the combined and unceasing efforts of everyone to make the changes that will lead to better patient outcomes (health), better system performance (care) and better professional development (learning)’ (Batalden and Davidoff, 2007). This is achieved by an organised process that evaluates, assesses and seeks to improve an aspect of a Health’s service delivery to patients and community.

There are six dimensions of quality in health care that we may target for improvement (Victorian Department of Health, 2005):

  1. Safety
  2. Effectiveness
  3. Patient-centeredness
  4. Timeliness
  5. Efficiency
  6. Equity

Improvement activities that fit within this framework are to be reviewed via the relevant Clinical Governance Improvement Processes, generally outlined by the Austin Health Quality and Safety Office on The Pulse.

Activities that are covered under the Clinical Governance Improvement Review Pathway:
  • Activities that do not require an acknowledgment letter for publication purposes.
  • Activities involving the collection, use and disclosure of health, personal and sensitive information for the purpose of funding, management, planning, monitoring improvement or evaluation of a single Health Service. Common activities include sentinel event monitoring, incident monitoring, root cause analysis, medical record review and clinical audit.
  • Activities involving staff, patients, and members of the community to assess one or more of the six dimensions of quality healthcare.
  • The proposed Clinical Governance Improvement activity will only involve staff from the same Health Service (including students on clinical placement at the same Health Service).
  • There is an existing departmental mechanism for oversight of Clinical Governance Improvement activities and these activities are registered via the process outlined at the Health Service.
  • There is no intention to present or publish the results in a forum External, to the Health Service.
  • Health Services cannot grant Clinical Governance Improvement (formerly referred to as Quality Assurance/Improvement) Registration/Authorisation/Approval to any organisations external the Health Service where the activity is being conducted. If the activity involves multiple organisations, then it is recommended you proceed with a multi-site research application via the appropriate research pathway.

 If your activity fulfils these criteria contact the check the Pulse for Clinical Governance Improvement Processes.

Summary

Projects that involve:

Type of review
  • Involves the use of existing collections of data or records that contain only non-identifiable data.
  • Data being collected and analysed for the sole purpose of identifying areas for improvement (see clinical governance process)
  • The use of data where consent was provided by the participant to use the data for secondary purposes.
  • If the project meets the definition of activities outlined under the Clinical Governance Improvement Pathway.
 Exempt from ethical review (no submission to the Research Office required)

Research that:

  • Meets definition of low-risk research as outlined in national statement (research in which the only foreseeable risk is one of discomfort)
  • Does not involved any participant groups exempt from low-risk research
  • Does not request a waiver of consent.
  • Research that involves comparisons of two or more health interventions conducted under routine clinical practice conditions (i.e., comparative effectiveness research)
  • Data collected that potentially infringes on the privacy or professional reputation of participants, providers or organisations.
  • Secondary use of data consistent with the primary purpose of collection
  • Information collected beyond that which is collected routinely.
  • The use of identifiable clinical data for education or research purposes where the patient has provided explicit consent
  • Projects using surveys or basic short interviews.
  • Requires an acknowledgement letter for publication purposes.
 Non-HREC level of review
  • Research studies that meet the definition of more than low risk as defined in the National Statement (where the risk, even if unlikely, is more serious than discomfort).
  • Research requires a waiver of consent request to collect health and medical information.

HREC level of review