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Greater than Low Risk Research at SALHN

Research which involves a risk of harm is considered more than low risk research. (National Statement paragraphs 5.1.19 to 5.1.23).

Where the research may lead to harms. Harms as defined in the national statement are as follows, where a research procedure or activity has the potential to cause any of the following harms the research will be categorised as more than low risk research: 

  • 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; 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. 

Research falling under chapter 4 of the National Statement must be reviewed by a HREC: 

  • Chapter 4.1: Women who are pregnant and the human fetus (National Statement 5.1.6) 
  • Chapter 4.4: People highly dependent on medical care who may be unable to give consent (National Statement 5.1.6) 
  • Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness (National Statement 5.1.6) 
  • Chapter 4.7: Aboriginal and Torres Strait Islander Peoples (National Statement 5.1.6) 
  • Chapter 4.6: People who may be involved in illegal activities (National Statement 5.1.6) 
  • Research involving active concealment or planned deception (National Statement 2.3.4) 
  • Research that aims to expose illegal activity; (National Statement 2.3.4) 
  • Waiver of consent for research using personal information in medical research, or personal health information. (National Statement 2.3.9) 
  • Prospective collection of humans biospecimens for research (National Statement 3.2.1) 
  • Genomic Research (National Statement 3.3)
  • Clinical Trials Involving Investigational Medical Products, Devices, Surgery, Surgical Procedures or the use of Ionising Radiation.
  • Clinical Interventions other than clinical trials.

Documentation

Above Low Risk

Clinical Trials

Non-SALHN employee supporting documentation

Drug and Device Research

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