Low Risk Human Research
Level of risk in research
  • The National Statement on Ethical Conduct in Human Research (2025),  classifies research according to the potential degree of risk involved. (N.S. 2.1).
  • If research targets specific populations, cohorts or vulnerable groups in the Northern Territory, or if the research requires observation or direct interaction with participants beyond routine care, it is unlikely that the research will be considered by this HREC to be low risk.
Clinical Audits and Quality Assurance Activities (Northern Territory only)
Clinical audits and quality assurance (QA) activities are typically undertaken to evaluate, monitor, or improve healthcare or service delivery. These activities generally involve the use of routinely collected data and do not introduce any deviation from standard care.
Where an activity:
  • uses existing, routinely collected data, and
  • involves no deviation from standard care, and
  • does not introduce additional risk, burden, or intervention for patients or participants, it may be appropriate to classify the activity as audit or quality assurance.

For such activities, applicants should complete the Ethics Clearance Form for Clinical Audits and Quality Assurance. This form can be submitted at any time for consideration via expedited review.

Governance Advice (Important)

If you are unsure whether your activity constitutes audit, quality assurance, or research, you are strongly encouraged to seek advice from your:
Research Governance Office (RGO) or relevant data custodian
The RGO, as data custodian, can:

  • advise on appropriate classification (audit/QA vs research),
  • confirm data access and governance requirements, and
  • guide whether submission to the HREC is required.
When Might Ethical Review Be Required?

Audit or QA activities may require HREC review where there is:

  • an intention to generate generalisable knowledge (e.g., publication beyond local service improvement),
  • additional data collection beyond routine clinical practice,
  • deviation from standard care or introduction of new interventions, or
  • involvement of sensitive data or vulnerable populations.
Additional Guidance
  • Activities should be appropriately classified prior to commencement.
  • Activities initially undertaken as audit or QA should not be retrospectively reclassified as research to support publication without appropriate ethical review.
  • Where there is uncertainty, please contact the ethics office for advice prior to submission.
Case Reports (Northern Territory only)

Case reports are managed by the NT Health Research Governance Office.
Please contact: nthealth.rgo@nt.gov.au for application advice and templates. (https://health.nt.gov.au/data-and-research/nt-health-research/research-governance) 
Definitions

Case Report
A case report is a detailed description of the diagnosis, treatment, and follow-up of a single patient. Case reports are descriptive in nature and are typically used to highlight unusual clinical presentations, novel treatments, or unexpected outcomes.
They do not aim to generate generalisable knowledge. 
Case Series
A case series involves two or more patients who have received similar treatment or share similar clinical characteristics.
While still descriptive, case series may contribute to generalisable knowledge and are more likely to be considered research. Please use the HREC application form for Case Series Applications.
Case Study
The term “case study” is used inconsistently in health research and may refer to either a single case report or a broader qualitative research methodology.
Applicants are encouraged to avoid this term and instead classify their work as either a case report, case series, or research study, as appropriate.

Ethical Review Pathway
  • Case reports (single patient) are managed by the NT Research Governance Office and do not require HREC review.
  • Case series (two or more patients) may constitute research and should be submitted to the HREC or discussed with the ethics office prior to submission.
  • Where there is intent to generate generalisable knowledge, the activity is considered research and requires HREC review.
Ethical Considerations
  • Informed consent must be obtained from the patient for all case reports.
  • Consent should be written and retained in the patient medical record.
  • For NT RGO consent templates click here 
  • All identifying information must be removed from text, images, and supporting materials.
  • Care must be taken to minimise the risk of re-identification, particularly in small or remote communities.
  • Patients should be offered the opportunity to review the report and receive a copy of any resulting publication.
  • Requirements of the target journal (if known) should also be met.
  • Please find the Audit/Quality Assurance form here
Multi-jurisdiction low or negligible risk (LNR) studies including National Mutual Acceptance (NMA)
  • As of 1 September 2021 low risk research proposals, undergoing a non-HREC level review, are accepted under the National Mutual Acceptance (NMA) scheme in all jurisdictions except South Australia. Please see NMA LNR Policy Position for further information.
  • As with all NMA applications, projects meeting the LNR criteria for a non-HREC level of review according to the National Statement on Ethical Conduct in Human Research (2023) (National Statement) will be reviewed under the NMA scheme only if they are submitted on the Human Research Ethics Application form (HREA).
  • For NT submission requirements for multi-jurisdictional low risk studies, please refer to the NMA page. 

Other Low Risk Research

  • Any other research that might be considered to be low risk (including some non-interventional studies, data linkage studies, and evaluations) should be submitted on the full HREC Application Form. This form can be submitted at any time for consideration for expedited and fast track review.

 

AUDIT FORM 
Form For Low-Risk Clinical Audits and Quality Assurance