Concord Hospital Concord Hospital
The Concord Research Office

Is my project low or high risk?

The following information is intended to provide guidance to researchers in completing an application for ethical and scientific review of research projects by a NSW Health Human Research Ethics Committee (HREC).

Researchers are advised to review these guidelines and to discuss their proposed study with the Executive Officer of the Human Research Ethics Committee before completing an application form. If the Executive of the Human Research Ethics Committee decides that a study presented on the HREA is not listed under the appropriate risk pathway, then the researcher may be required to re-submit the application to amend the pathway on the HREA. This will result in unnecessary delays for the researcher.

The value of beneficence in the National Statement on Ethical Conduct in Human Research (2023) (the National Statement) requires that the risks and benefits of human research (to participants and to the wider community) be assessed and any risks effectively addressed The National Statement Chapter 2.1: Risk and Benefit. describes the types and levels of risk that are relevant to research and the potential for harm, discomfort, burden or inconvenience to occur. Risk may be associated with research conduct and/or outcomes.

When considering risks related to their research, researchers should assess the risks in terms of their likelihood, severity and consequences and put measures in place to minimise, mitigate and manage these. The National Statement recognises risks of physical harms, such as, risk of death and risks of psychological harm, such as, of anxiety-related re-traumatisation. In the National Statement (2023) the concept of cultural harm was introduced, and the unauthorised disclosure of personal information was recognised as a social harm. There is recognition that some participants, by reason of the design study or their specific attributes, may be at higher risk of harm or discomfort from some types of research. Burden and inconvenience are not types of harm or discomfort and, therefore, these should not be viewed as ‘risks’. But researchers should recognise the burdens or inconvenience that research can impose on participants and the impact of these should be balanced against the potential benefits of the research.

Previously, the National Statement (2007) used a three-level model to categorise risk, which depended on distinctions between harm (greater than low risk), discomfort (low risk) and inconvenience (negligible risk). The 2023 National Statement uses a continuum-based model of risk with only two broad categories: Lower Risk and Higher Risk. All higher risk research requires HREC review. The low-risk review pathway is acceptable for lower risk research, regardless of study type or participant group.

1. Lower risk research
The National Statement describes research as “lower risk” where the only foreseeable risk is one of discomfort or potential for minor burden or inconvenience. This may include discomforts or burdens related to measuring blood pressure, anxiety induced by an interview, completing a survey, or filling in a form. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk.

Other examples of research with lower risk include, but are not limited to, the following:
• Research involving only questionnaires and general surveys on noncontroversial, non-personal issues that also include only basic demographic data and where, in all instances, 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; and
• Research requiring access to individual medical records or to information stored electronically, through the site’s medical records department or other department/specialty, but where participant consent is not required because, in all instances, individuals cannot be identified from data extracted or provided.

2. Higher risk research

Research projects where there is foreseeable risk of harm and/or burden is considered “higher risk”. Higher risk research will require full review by an HREC.

The following classifications may be helpful in determining the risk of harm:

•    physical harm: including injury, illness, pain or death
•    psychological harm: including feelings of worthlessness, distress, guilt, anger, fear or anxiety related, for example, to disclosure of sensitive information, an experience of re-traumatisation, or learning about a genetic possibility of developing an untreatable disease
•    devaluation of personal worth: including being humiliated, manipulated, or treated disrespectfully or unjustly in other ways 
•    cultural harm: including misunderstanding, misrepresenting or misappropriating cultural beliefs, customs or practices
•    social harm: including damage to social networks or relationships with others, discrimination in access to benefits, services, employment or insurance, social stigmatisation, and unauthorised disclosure of personal information
•    economic harm: including the imposition of direct or indirect costs on participants
•    legal harm: including discovery and prosecution of criminal conduct

 

 

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