Minimising Risks of Harm

Research involving human participants is ethically acceptable only when the potential benefits of the project justify any risks involved in participating. When applying for human ethics approval, the risks of the research project need to be identified and assessed in order to minimise, mitigate and manage them.           

As per the National Statement, Chapter 2.1, a risk is a potential for harm or discomfort.

This may be; 

- the likelihood that a harm or discomfort will occur, and

- the severity or magnitude of the harm or discomfort, including their consequences.

It is important to note that while risk of harm and discomfort usually applies to risk of an individual research participant, it can also apply to groups, communities, as well as non-participants, such as family members, and can also be associated with the conduct of the research or the proposed outcomes. 

The following list of harms (not exhaustive) identifies the potential harms in or from research;

• 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 in other ways treated disrespectfully or unjustly;
• 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.

To justify any risks of harm to study participants, research must have social and scientific value: that is, the potential to generate knowledge and methods that can protect and promote the health, wellbeing and independence of individuals, the population and groups within that population. Researchers must minimise risks and ensure that any that remain are outweighed by the potential benefits. 

To manage risks, researchers must ensure that:

• research participants clearly understand and the risks of harm associated with the research project, and
• mechanisms are in place to adequately identify and manage harms that may occur at any time during the research