Low risk and negligible risk research

Research risk level

The National Statement describes ‘low risk research’ as research where the maximum foreseeable risk is discomfort, and ‘negligible risk research’ as research where there is no foreseeable risk of harm or discomfort and any foreseeable risk is no more than inconvenience. Research in which the risk for participants is more serious than discomfort is classed as 'greater than low risk'.

Low risk research review pathway

Low and negligible risk research is reviewed by the Low/Negligible Risk (LNR) committee, a sub committee of the HREC. 

Some projects must be reviewed by the HREC even though the risk level appears to be low. Examples include research:

  • Where the subject matter warrants a more specialised or rigorous review;
  • That makes direct comparisons between groups of people;
  • That involves randomly allocating people into different groups;
  • That involves prospective collection of bio-specimens including tissue removed and discarded as part of usual care;
  • Involving vulnerable participants;
  • Involving risk to the risk to the researcher;
  • That uses, collects or discloses identifiable information without the participants’ consent;
  • Involving genetic analysis.
  • That establishes data registries.

Low negligible risk submissions

LNR submissions must be made via REGIS. 

The LNR committee meets fortnightly and meeting and submission closing dates can be found here.

To submit via REGIS

  1. Register for REGIS access.
  2. Refer to these guidelines to complete the HREA and attach supporting documentation including your protocol and any documents you intend to use (e.g. Patient Infomation and Consent Forms etc.)
  3. The Research Office will receive your submission and allocate it to the next LNR meeting for review.

    Data security

    Data must not be stored on personal laptops or external hard drives/USB's. Please only store study data on secure hospital servers or internal non-mobile hospital computers, if data transfer is required encryption and a suitably secure service must be used.

    Specific approval is required to take any individual level patient data off hospital premises, and data must be rendered non-identifiable.

     

    Common types of Low Risk Research

    Retrospective audits of patient data are usually classified as Low/Negligible Risk. 

    What information is required by the LNR Committee?

    • Background and rationale for the audit
    • The dates the audit will cover and estimated sample size
    • Inclusion/exclusion criteria of records to be audited
    • What data will be collected* and from where i.e. medical records, eMR, specific databases**
    • Details about who will be collecting the data
    • The data analysis plan
    • Outline how the confidentiality of identifiable data will be protected e.g. use of individual codes, removal of identifiers from data set once complete etc***

    *Please submit either a list of all data items you will be collecting or the data collection sheet, including any identifying information that you will collect (such as MRN or DOB) and the source/s of the data (e.g. medical notes, electronic databases, scans etc).

    **Please provide details of the custodian of any specific databases (E.g. department database, private doctors database)

    *** Please be mindful the the terms 'de-identified' and 'non-identifiable' have different meanings that are relevant to the ethical review. Records that cannot be linked to individuals are 'non-identifiable'. Records where information has been removed to protect identities is 'de-identifed'. If there remains a means to identify individuals after removing data it is 're-identifiable'.

    Surveys of patients and staff are usually classified as LNR.  

    What information is required by the LNR Committee?

    • Background and rationale for the survey
    • Estimated sample size 
    • How potential participants will be identified 
    • How and where and by whom will potential participants be approached 
    • List any additional data that will be collected from other sources such as contact lists, medical records or databases
    • Data analysis plan
    • Outline how the confidentiality of identifiable data will be protected e.g. use of individual codes, removal of identifiers from data set once complete etc*

    Including the following supporting documentation:

    • A letter of invitation explaining the survey to potential participants (a template can be found HERE). FYI - written consent is not required if participants receive the letter of invitation, as consent is implied thorough completion of the survey.  
    • A copy of the survey tool including details of any identifying information that you will collect e.g. name, email address etc.

    * Please be mindful the the terms 'de-identified' and 'non-identifiable' have different meanings that are relevant to the ethical review. Records that cannot be linked to individuals are 'non-identifiable'. Records where information has been removed to protect identities is 'de-identifed'. If there remains a means to identify individuals after removing data it is 're-identifiable'.