Low Risk Human Research

Level of risk in research

  • The National Statement on Ethical Conduct in Human Research, 2007, Updated 2018 (N.S.) 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, QA, and Case Studies (Northern Territory only)

  • For clinical audits, quality assurance activities, or case studies 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, Quality Assurance, and Case Studies. 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.

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 2007 (updated 2018) (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.
  1. AUDIT QA CASE STUDY FORM

    AUDIT QA CASE STUDY FORM

    Attachment
    PA1-Ethics Clearance Form for Clinical Audits Quality Assurance and Case Studies_02122022.docx