Greater than Low Risk Research

Greater than low risk research is classified as any research that either leads to or potentiates harm(s):

• Human research, procedures, or activities where a person, organisation, vulnerable population, broader community, or the research team are exposed to physical, psychological, social, economic, legal, or travel harms.
• Human research procedures or activities where a person may experience distress or devaluation of personal worth.
• Research involving or about Aboriginal or Torres Strait Islander People or their communities.
• Any research activity involving the following:
• People highly dependent on medical care who may be unable to give consent (National Statement 5.1.6) 
• People with cognitive impairment, an intellectual disability, or a mental illness (National Statement 5.1.6) 
• People who may be involved in illegal activities.
• Research involving active concealment or planned deception.
• Research that aims to expose illegal activity. 
• Waiver of consent for research using personal information in medical research or personal health information.
• Prospective collection of humans biospecimens for research (National Statement 3.2.1) 
• Genomic research (National Statement 3.3) excluding projects using secondary data which is non-identifiable (anonymous).
• Clinical Trials Involving Investigational Medical Products, Devices, Surgery, Surgical Procedures, or Ionising Radiation use.
• Clinical Interventions

Harms are defined in the National Statement (2023) and include the following:

• Physical harms: including injury, illness, pain; 
• Psychological harms: including feelings of worthlessness, distress, guilt, anger or fear related, for example, to the 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; 
• Cultural harms: including misunderstanding, misrepresenting or misappropriating cultural beliefs, customs or practices; 
• Social harms: including damage to social networks or relationships with others; discrimination in access to benefits, services, employment or insurance; social stigmatisation; and findings of previously unknown paternity status; 
• Economic harms: including the imposition of direct or indirect costs on participants;  
• Legal harms: including discovery and prosecution of criminal conduct. 
• Travel harms: Research is being conducted in a country where the travel advice is a level 3 – reconsider your need to travel or level 4 – do not travel for research. 

You can navigate through the iRECS New Ethics Online Updates  for further info on the iRECS background, transition timeline, and FAQs. Please note that Human Ethics is not utilising the correspondence feature in iRECS. For further submission advice, the RECS Human Ethics team is contactable at humanethics@unsw.edu.au.

All active Human Ethics projects have been migrated onto the iRECS Portal. Only the Chief Investigator (CI) will have read, write, and submit access to previously approved legacy projects that have been migrated into the iRECS Portal. Chief Investigators must grant collaborator access to any co-investigators, student investigators, and research personnel who require read/write access to previously approved legacy projects. If you cannot immediately view the project you will need to follow the instructions in the following help guide:

• I cannot see a previously approved legacy project how do I get access?