Concord Hospital Concord Hospital
The Concord Research Office

Is my project ‘low or negligible risk’ (LNR) or ‘greater than low risk’ (GTLR)?

This is a guide for researchers who are applying to a NSW Health Human Research Ethics Committee (HREC) for ethics review of a research study.  

In a Nutshell: A summary of the two ethics review pathways and who to contact

Low-negligible risk (LNR) research studies (Foreseeable Risk < Discomfort) may involve surveys/short interviews with staff or medical record review (with a waiver of consent). The LNR pathway is expedited review by the HREC Chair (or delegate). There are no closing dates.

Greater than low risk (GTLR) research studies (Foreseeable risk is Harm > Discomfort) require full HREC review (closing dates; monthly meetings). The GTLR pathway is also required for certain types of research; certain participant groups; and research involving Indigenous Australians or their data.

If an LNR application is submitted using the LNR protocol template but is a GTLR study, the Executive Officer of the HREC may require the application to be re-submitted using the GTLR Protocol template and selecting the GTLR review pathway in the HREA (ethics application) in REGIS (and vice versa).

Before completing your application, you should discuss the study with the Executive Officer to confirm the correct pathway. Or you can get advice at the monthly Ethics Drop-in Clinics hosted by RPAH and CRGH HREC Executive Officers (see HERE for details). For information about How to Apply, see HERE.

How does the National Statement on Ethical Conduct in Human Research (2007, updated 2018) (the National Statement) categorise risk?

The National Statement defines ‘risk’ as a potential for (foreseeable occurrence of) Inconvenience; Discomfort; or Harm. The risk may be borne by participants and/or others involved in the research. Examples of risks to non-participants include the risk of distress for a participant's family member identified with a serious genetic disorder, the possible effects of a participant’s biography on their family or friends; or infectious disease risks to the community. Some social research may carry wider social or economic risks.

Where the foreseeable risk is no more than Inconvenience or Discomfort, the research is reviewed by the HREC Executive under the LNR pathway (very occasionally the Executive may refer an LNR research to the full HREC). Where the foreseeable risk is Harm, research must be reviewed under the GTLR pathway at a meeting of a fully constituted HREC. The greater the risks the more certain it must be both that the risks will be managed as well as possible, and that the participants and others clearly understand the risks they are assuming. Research is ethically acceptable only when its potential benefits justify any risks involved in research.

In ‘Negligible Risk‘ research, the foreseeable risk is no more than Inconvenience and there is no risk of Discomfort or Harm. Examples include filling in a form; participating in a survey; giving up time. Research is 'Low Risk ' where the magnitude of risk is no more than Discomfort, which can involve body and/or mind, and there is no foreseeable risk of Harm. Discomfort may include discomforts associated with measuring blood pressure or mild anxiety induced by an interview. Where a person's reactions exceed discomfort and become distress, they should be viewed as harms.

Research that is eligible for the LNR review pathway includes, but is not limited to:

·  Questionnaires and general surveys on non-controversial, non-personal issues that also include only basic demographic data and where respondents are not identified

·  Research involving only the use and/or disclosure of information from existing data collections, where the identity of the person cannot reasonably be ascertained from the information to be disclosed to researchers

·  Research involving human tissue held in a research tissue bank for which consent was obtained for its use in research at the time of its collection and storage

·  Research involving human tissue where participant consent is not required because broad consent has been provided for use of the tissue in research and specific individuals cannot be identified from specimens used, e.g., where specimens have never been labelled with individual identifiers or individual identifiers have been permanently removed

·  Research involving personal health information held in a research database for which consent was obtained for its use in research at the time of its collection and storage

·  Research requiring access to individual medical records or to information stored electronically, through the site’s Medical Records Department or other department, but where participant consent is not required because, in all instances, individuals cannot be identified from data extracted or provided.

Research that is not eligible for LNR review for which review under the GTLR pathway is required
Studies where the foreseeable risk is Harm, which is more than Discomfort, require full HREC review under the GTLR pathway. No list of harms can be exhaustive, but the National Statement describes the following types of potential harms in research, for which GTLR review pathway is required:

·  Physical harms: including injury, illness, pain

·  Psychological harms: including feelings of worthlessness, distress, guilt, anger or fear related, for example, to disclosure of sensitive or embarrassing information, or learning about a genetic possibility of developing an untreatable disease

·  Devaluation of personal worth: including being humiliated, manipulated or in other ways treated disrespectfully or unjustly

·  Social harms: including damage to social networks or relationships with others discrimination in access to benefits, services, employment or insurance; social stigmatisation

·  Findings of previously unknown paternity status

·  Economic harms: including the imposition of direct or indirect costs on participants

·  Legal harms: including discovery exposure of illegal activities and prosecution of criminal conduct.

The GTLR pathway is also required for certain research types and certain categories of participants. Research projects that include any of the following are not eligible for LNR review and will require full review by an HREC under the GTLR pathway:

·  Interventions and therapies, including clinical and non-clinical trials and innovations or new treatment modalities

·  Active concealment or planned deception of participants

·  Research specifically targeting Aboriginal and/or Torres Strait Islander peoples – even when the research uses collections of non-identifiable data about Aboriginal and/or Torres Strait Islander peoples. This research requires approval by Aboriginal Health and Medical Council HREC in advance of applying to an SLHD HREC.

In addition, research that includes any of the following are not eligible LNR review, except where the research uses collections of non-identifiable data and involves only negligible risk:

·  Human genetics

·  Human stem cells

·  Women who are pregnant and the human foetus

·  People who are highly dependent on medical care who may be unable to give consent

·  People with cognitive impairment

·  People with an intellectual disability or a mental illness

·  Children and Young People

·  People who may be involved in illegal activities.

4. Quality improvement (QI) / Quality assurance (QA) activities
Quality improvement (QI) and quality assurance (QA) activities may raise ethical issues requiring review. Individuals engaged in these activities within the NSW public health system should
refer to the NSW Health Guideline Human Research Ethics Committees – Quality
Improvement & Ethical Review: A Practice Guide for NSW
 (GL2007_020) and the National Health and Medical Research Council’s Ethical Considerations in Quality Assurance and Evaluation Activities (March 2014).

Before commencing a QI/QA activity, you should consult with the Executive Officer to ascertain whether ethics review is required for the QI/QA project.  The Ethics Committee will not grant retrospective ethics approval if the project has already been conducted.

5. Cell therapy
Studies involving cell therapy should be discussed in advance with the Director of the Department of Cell and Molecular Therapies, Professor John Rasko c/o: