Standard risk applications
A ‘standard risk’ application is, by virtue of its form and content, an activity which constitutes something more than discomfort or inconvenience for study participants. The National Statement on Ethical Conduct in Human Research (2007) defines ‘discomfort’ as a low level risk activity such as a participant having their blood pressure measured or attending a study interview (NS Chapter 2.1). A standard, full HREA application may need to be submitted when the risk involved is greater than this.
Is my study standard risk?
If any of the following activities are involved, then your study may warrant a standard, full HREA application. If you are unsure of the most appropriate application, please contact the CHQ HREC Office.
- Risk which constitutes more than low or negligible risk (NS 2.1)
The level of ethical review required should be commensurate with the level of risk involved. If a research activity involves more than ‘discomfort’ (emotional, physical, spiritual and psychological), then it is a standard application and warrants a full HREA
- Research that is personally intrusive or confronting or involves potentially embarrassing questions
The study looks at and/or involves subject matters (e.g. in a survey, questionnaire or interview) that participants may be uncomfortable discussing or find distressing (e.g. anxiety, depression or sexuality).
- Staff are participants
Studies involving staff participation generally require a standard, full HREA application. This is to best ensure that the right of the participants in the workplace are protected, and that any participation or refusal to participate does not have a negative impact on the participants’ workplace relations, both now and in the future.
- Any of the following participants groups are specifically targeted:
- women who are pregnant and the human foetus
- children and young people
- people in dependent or unequal relationships
- people highly dependent on medical care who are unable to consent for themselves’
- people with a cognitive impairment, an intellectual disability or a mental illness
- people who may be involved in illegal activities or residents of custodial institutions
- Aboriginal and Torres Strait Islander Peoples
- people who are unable to give informed consent because of difficulties understanding an information sheet (e.g. non English speakers).
- The study involves genetic research
The application requires review by the full HREC. A standard HREA application to the HREC is required (National Statement Chapter 3.5).
- An intervention
The study involves an intervention to routine care (e.g. clinical trial of a device or drug, an educational intervention or an alternate treatment option)(National Statement S2.1.6).
Standard Risk Submission checklist form