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.
Audits and Quality Assurance Activities (Northern Territory only)
  • For clinical audits and quality assurance activities using data that will be de-identified and where there has been no deviation from standard care, please use the Ethics Clearance Form for Clinical Audits, and Quality Assurance. This form is primarily designed for health-related studies analysing routinely collected data in a clinical setting. This form can be submitted at any time for consideration for expedited review.
  • If you are unsure if this is the appropriate form to use, please contact the ethics admin office for advice.

Case Reports (Northern Territory only): Case reports and studies are managed by the NT Research Governance Office nthealth.rgo@nt.gov.au. Please contact their office for application advice.

  • Definition - Case reports are professional narratives that outline the diagnosis, treatment, and outcomes of the medical problems of patients. Information from case reports provide feedback on clinical practice guidelines and offer a framework for early signals of effectiveness, adverse events, and cost. They can be shared for medical, scientific, or educational purposes. 
  • Case report - A detailed report of the diagnosis, treatment, and follow-up of an individual patient. Case reports also contain some demographic information about the patient (for example, age, gender, ethnic origin). (NIH National Cancer Institute)
  • Case series - A group or series of case reports involving patients who were given similar treatment. Reports of case series usually contain detailed information about the individual patients. This includes demographic information (for example, age, gender, ethnic origin) and information on diagnosis, treatment, response to treatment, and follow-up after treatment. (NIH National Cancer Institute)
  • Ethical considerations - The review of patients to report as a case study or case series is considered anecdotal and can proceed without Human Research Ethics Committee (HREC) review. While HREC review is not necessary, staff must give due consideration to relevant ethical issues. Where a patient/client case study is undertaken informed consent from the individual/s studied must be obtained. Care must also be taken to ensure confidentiality is maintained during collation of data and preparation of the manuscript.
  • Informed consent should be obtained from the patient. Consent should be written, and the consent form filed in the patient medical record. 
  • Any identifying information must be removed from written text, diagrams, images or photos. Importantly, attention must be paid to removing any risk of incidental identification of the patient. Avoid including too much specific background information (geographic location, date of injury/car) or unnecessary personal information (e.g., race) that when put together might theoretically allow someone to identify the patient.
  • The patient should be given the opportunity to receive a copy of the publication.
  • Requirements of the journal to which the manuscript will be submitted (if known) should be met.

 

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