Low Risk and Negligible Risk Research

Research risk level

The National Statement on Ethical Conduct in Human Research (2007) describes ‘low risk research’ as research in which the maximum foreseeable risk is discomfort, and ‘negligible risk research’ as research in which 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

In SESLHD Low and Negligible Risk Research proposals are usually reviewed by the Low/Negligible Risk (LNR) committee, a sub-committee of the Human Research Ethics Committee (HREC). Review by the LNR committee is called the 'Low Risk Review Pathway.'

The SESLHD LNR Committee can review and approve Low/Negligible Risk research undertaken in any NSW Health site. If your research involves sites or patients outside of NSW we recommend you submit Ethics Application via the 'Greater than Low Risk' pathway.

It is important to understand that Risk Level and Review Pathway are not the same thing. Some projects must be reviewed by the HREC even though the risk level appears to be low. Examples include, and are not limited to:

Research where the level of complexity or subject matter warrants a more specialised or rigorous review
Research that makes direct comparisons between groups of people
Research that involves randomly allocating people into different groups
Research involving prospective collection of bio-specimens; including tissue normally removed and discarded as part of usual care
Research involving vulnerable participants (including women who are pregnant and the human foetus; people highly dependent on medical care who may be unable to provide consent; people with a cognitive impairment, an intellectual disability or a mental illness; people who may be involved in illegal activities - see Chapter 4 of the National Statement)
Research involving risk to the risk to the researcher
Use, collection or disclosure of identifiable information without the participants’ consent
Research involving genetic analysis
Establishment of data registries
Low risk research involving sites outside of NSW

Low Negligible Risk Submissions

New submissions for low and negligible risk ethics applications must be made via REGIS. Low and negligible risk research ethics applications are submitted using the HREA i.e. the same form as used for greater than low risk applications.

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

Data Security

Data must not be stored on personal laptops or external hard drives/USBs. 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.

REDCap (Research Electronic Data Capture) is a secure, web-based data capture and data management software tool designed for research purposes. REDCap is the SESLHD HREC's preferred data management software.

For SESLHD researchers, REDCap can be accessed via https://redcap.sesi.health.nsw.gov.au/ or by contacting SESLHD-REDCap-admin@health.nsw.gov.au. Data collected by REDCap is stored on SESLHD servers and has undergone security testing.

Please see the Protocol template on the Guidelines, Forms & Templates page.

Common Types of Low Risk Research

Retrospective Audit of Medical Records

A retrospective audit of patient data usually comes under the Low Negligible Risk umbrella. The LNR committee meets fortnightly and the meeting and submission closing dates can be found here.

What information is required by the LNR Committee?

Please provide the following within the LNR Application:

Background and rationale for audit
Dates 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**
Who will be collecting the data
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.***

If you intend to request that the HREC waive the requirement of individual patient consent for this study, please contact the Research Office. If you are accessing and/or using identifiable patient data (i.e. eMR) without consent, you must apply for a waiver of consent and specific information will be required in your study protocol.

*For projects of this nature 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 avoid using the term ‘de-identified data’, as its meaning is unclear. While it is sometimes used to refer to a record that cannot be linked to an individual (‘non-identifiable’), it is also used to refer to a record in which identifying information has been removed but the means still exist to re-identify the individual (re-identifiable). When the term ‘de-identified data’ is used, researchers and those reviewing research need to establish precisely which of these possible meanings is intended, therefore please describe the precise method of how the data will be managed.

Survey of Patients and Staff

In most cases a patient or staff survey would come under the LNR umbrella. The LNR committee meets fortnightly and the meeting and submission closing dates can be found under Committee Details & Meeting Dates.

What information is required by the LNR Committee?

Please provide the following information within the LNR Application:

Background and rationale for the survey
Estimated sample size and rationale (e.g. it may be a convenience sample)
How will potential participants be identified?
How and where will potential participants be approached and by whom?
List any additional data to be collected from other sources such as contact lists, medical records, eMR, specific 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 under Forms & Templates. 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 avoid using the term ‘de-identified data’, as its meaning is unclear. While it is sometimes used to refer to a record that cannot be linked to an individual (‘non-identifiable’), it is also used to refer to a record in which identifying information has been removed but the means still exist to re-identify the individual (re-identifiable). When the term ‘de-identified data’ is used, researchers and those reviewing research need to establish precisely which of these possible meanings is intended, therefore please describe the precise method of how the data will be managed.