The conduct of research in Australia is characterised by high ethical and scientific standards, and the dangers to participants have been few. The continued promotion of ethically good human research – the purpose of this National Statement – will help to maintain these standards.
Application of the values in Section 1, in particular the value of beneficence, requires that risks of harm to research participants, and to others, be assessed. Research will be ethically acceptable only if its potential benefits justify those risks.
While this chapter provides guidance on the assessment of risk, such assessment inevitably involves the exercise of judgment.
What is risk?
A risk is a potential for harm, discomfort or inconvenience (discussed below). It involves:
- the likelihood that a harm (or discomfort or inconvenience) will occur; and
- the severity of the harm, including its consequences.
Assessment of risk
Assessment of risks involves:
- identifying any risks;
- gauging their probability and severity;
- assessing the extent to which they can be minimised;
- determining whether they are justified by the potential benefits of the research; and
- determining how they can be managed.
Assessment of risks engages:
- researchers, who need to identify, gauge, minimise and manage any risks involved in their project;
- institutions, in deciding the appropriate level of ethical review for research projects;
- Human Research Ethics Committees (HRECs) and other ethical review bodies (see paragraph 5.1.7), in reviewing research proposals and making judgements on whether risks are justified by potential benefits;
- participants’ perceptions of risks and benefits. These perceptions are a factor to be considered by review bodies in deciding whether the risks are justified by the benefits.
Harm, discomfort and inconvenience
Research may lead to harms, discomforts and/or inconveniences for participants and/or others.
No list of harms can be exhaustive, but one helpful classification identifies the following kinds of potential harms in 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.
Less serious than harm is discomfort, which can involve body and/or mind. Discomforts include, for example, minor side-effects of medication, the discomforts related to measuring blood pressure, and anxiety induced by an interview.
Where a person’s reactions exceed discomfort and become distress, they should be viewed as harms.
Less serious again is inconvenience. Examples of inconvenience may include filling in a form, participating in a street survey, or giving up time to participate in 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 biography on family or friends, or infectious disease risks to the community. Some social research may carry wider social or economic risks; for example, research in a small community into attitudes to specific subpopulations may lead to unfair discrimination or have effects on social cohesion, property values, or business investment.
Harms that may arise from research misconduct or fraud, and harms to members of research teams from other forms of misconduct (for example, harassment or bullying) are addressed primarily in the Australian code for the responsible conduct of research. These forms of misconduct may, of course, also lead to potential harms to participants.
Low risk and negligible risk research
The expression ‘low risk research’ describes research in which the only foreseeable risk is one of discomfort. Research in which the risk for participants is more serious than discomfort is not low risk.
The expression ‘negligible risk research’ describes research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience.
Requirements for the ethical review of low risk research and negligible risk research are set out in paragraphs 5.1.18 to 5.1.23.
Gauging risk involves taking into account:
- the kinds of harm, discomfort or inconvenience that may occur;
- the likelihood of these occurring; and
- the severity of any harm that may occur.
These judgements should be based on the available evidence. The evidence may be quantitative or qualitative. In either case, the process needs to be transparent and defensible.
For those gauging the severity of the harm, the choices, experience, perceptions, values and vulnerabilities of different populations of participants will be relevant.
In designing a research project, researchers have an obligation to minimise the risks to participants. Minimising risk involves an assessment of the research aims, their importance, and the methods by which they can be achieved.
Where a researcher or review body judges that the level of risk in a research proposal is not justified by the benefits, either the research aims or the methods by which they are to be achieved, or both, will need to be reconsidered if the research is to proceed.
Do the benefits justify the risks?
Research is ethically acceptable only when its potential benefits justify any risks involved in the research.
Benefits of research may include, for example, gains in knowledge, insight and understanding, improved social welfare and individual wellbeing, and gains in skill or expertise for individual researchers, teams or institutions.
Some research may offer direct benefits to the research participants, their families, or particular group/s with whom they identify. Where this is the case, participants may be ready to assume a higher risk than otherwise. For example, people with cancer may be willing to accept research risks (such as treatment side-effects) that would be unacceptable to well people. Those ethically reviewing research should take such willingness into account in deciding whether the potential benefits of the research justify the risks involved.
For ethical review bodies, there can be a profound tension between the obligation on the one hand to give maximum scope to participants’ freedom to accept risk, and on the other to see that research is conducted in a way that is beneficent and minimises harm.
When risks have been identified, gauged and minimised, and the research has been approved, the risks must then be managed. This requires that:
- researchers include, in their research design, mechanisms to deal adequately with any harms that occur; and
- a monitoring process is in place and carried out (see Chapter 5.5: Monitoring approved research).
The greater the risk to participants in any research for which ethical approval is given, the more certain it must be both that the risks will be managed as well as possible, and that the participants clearly understand the risks they are assuming.
2.1.1 Institutions that choose to establish levels of ethical review other than by HREC for research that carries low or negligible risk (see paragraphs 5.1.18 to 5.1.23) should use this chapter (i.e. Chapter 2.1) to inform their identification of the level of risk.
2.1.2 Risks to research participants are ethically acceptable only if they are justified by the potential benefits of the research.
2.1.3 Steps to arriving at a judgement on the ethical acceptability of risks should include:
- identifying the risks, if any;
- assessing the likelihood and severity of the risks;
- identifying whom (participants and/or others) the risks may affect;
- establishing the means for minimising the risks;
- identifying the potential benefits; and
- identifying to whom benefits are likely to accrue.
2.1.4 In determining the existence, likelihood and severity of risks, researchers and those reviewing the research should base their assessments on the available evidence, whether qualitative or quantitative. They should consider whether to seek advice from others who have experience with the same methodology, population and research domain.
2.1.5 In considering whether the potential benefits of the research justify the risks involved, those reviewing research should take into account any willingness by participant populations to assume greater risks because of the potential benefits to them, their families, or groups to which they belong.
2.1.6 Research is ‘low risk’ where the only foreseeable risk is one of discomfort. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk.
2.1.7 Research is ‘negligible risk’ where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk.
2.1.8 The greater the risks to participants in any research for which ethical approval is given, the more certain it must be both that the risks will be managed as well as possible, and that the participants clearly understand the risks they are assuming.