The National Statement (2007) categorises potential risks to research participants as follows:
- Harms such as pain (including physical, psychological, social, economic and legal harms, and the devaluation of personal worth)
- Discomforts (such as the measurement of blood pressure or anxiety induced by an interview). If discomfort becomes distress, then it is considered to be harm.
- Inconveniences (such as filling in a form).
Please review the section on harms, discomforts and inconveniences in the National Statement to assess the potential risks of your research proposal.
The ethical review of research takes into account the varying level of risk to which participants are exposed:
- Negligible risk: Research in which 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 (NS2.1.7).
- Low risk: 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 (NS 2.1.6).
Research that is exempt from formal review by an HREC
The National Statement allows research to be exempted from ethical review if it is both (a) negligible risk research and (b) involves existing collections of non-identifiable data (NS 5.1.22 b). Your project may also be outside the scope of the HREC (Tasmania) Network if it does not involve human participation in research (when is approval needed?). Please remember that human research is broadly defined to include, for example, researchers having access to existing patient records.
Deciding Whether your Research is Low RiskClick on the 'Is your proposal low risk' accordion below and answer the questions to decide whether you may classify your research as low risk.
The following questions will help you assess whether your proposal is low risk.
If you answer yes to any of the following questions, then your research is likely to be more than low risk and should not be submitted as a low risk application.
- Is your research a clinical trial?
- Does your research involve the administration of medication or placebo beyond the normal routine care of the participant (if under medical care)?
- Does your research involve an innovation in clinical practice or complementary medicine?
- Does your research involve the collection of human tissue samples beyond the normal routine care of the participant (if under medical care) that cause a leve of risk greater than discomfort?
- Does your research involve the use of gametes and/or human embryos?
- Does your research involve the use of human stem cells?
- Does you research involve genetic testing?
- Does your research involve the deception of participants, including concealing the purposes of research, covert observation and/or audio or visual recording without consent?
- Does your research involve the participation of people without their prior consent?
- Does your research involve withholding from one group specific treatments or methods of learning from which they may benefit?
- Does your research involve the access or use of medical records where participants can be identified or linked to their records in some way?
- Does your research involve the use of ionising radiation?a. Women who are pregnant and the human foetus
b. Children and young people
c.Those highly dependent on medical care who are unable to give consent
d. People with a cognitive impairment, intellectual disability or mental illness
e. People who may be involved in illegal activities or residents of custodial institutions
f. Aboriginal and Torres Strait Islander Peoples
g. People in other countries or people who are unable to give informed consent because of difficulties in understanding an information sheet (e.g. non English speakers)
- Does your research specifically target any of the following groups of people? (specifically target,means they are the central group of participants, as opposed to potentially being incidentally recruited as part of the general population):
- Does your research pose any risks for participants under medical care beyond those of their routine care? (Risks include not only physical risks but also psychological, spiritual and social harm or distress eg stigmatisation or discrimination
a. Parenting practices
b. Sensitive personal issues
c. Sensitive cultural issues
d. Grief death or serious traumatic loss
e. Depression mood states or anxiety
g. Eating disorders
h. Illicit drug taking or substance abuse
i. Psychological disorders
k. Gender identity and/or sexuality
l. Race and/or ethnic identity
m. Fertility and/or termination of pregnancy
- Does your research involve an in depth discussion of any of the following topics, whether by interview or as part of a questionnaire or survey?
- Does your research involve the potential disclosure of illegal activities or criminal behaviour?
- Are there any specific risks to the researcher (i.e. will the research involve the use of hazardous materials or be undertaken in a politically unstable area)?
- If your research will take place in an overseas setting do any of the following apply:
a. Is the research to be undertaken in a politically unstable area?
b. Does it involve sensitive cultural issues?
c. Will the research take place in a country in which criticism of the government and institutions might put participants
and/or researchers at risk?
- Does your research explore potentially confidential business practices, or seek to elicit potentially confidential commercial information from participants?
- Does your research explore potentially divergent political views or involve the collection of politically sensitive information?
Research involving more than low risk
All research involving more than low risk must be reviewed by an HREC.
Please note that if your proposal requests a waiver of consent for the use of personal information in medical research, or personal health information, then you must also submit it to the HREC.