What is negligible risk research?
Human research that is of negligible risk is where the only foreseeable risk is an inconvenience.
Research involving the following is considered negligible risk:
- Short surveys: Anonymous self-administered short surveys where the research topic and questions are not sensitive and will not induce feelings of anxiety or have the potential to introduce emotional or reputational risks.
- Non-identifiable Social Media Analysis: Collection and analysis of non-identifiable and aggregated social media data, which will not involve the analysis of individual accounts or any identifiable information and will not involve the publication of individual quotes.
- Existing datasets or biobank specimens (with consent): Existing non-identifiable Human Data or biospecimens where consent at the time of collection was obtained to access, share and use the data for secondary research purposes. (Evidence of consent will need to be provided for review for non-public databases).
- Existing datasets or biobank specimens (requesting a waiver of consent): Existing non-identifiable human data or biospecimens where a waiver of consent is required to access, share and use the data for secondary research purposes.
- Short structured interviews: Short Interviews involving a structured set of questions where the research topic and questions are not sensitive, will not induce feelings of anxiety or have the potential to introduce emotional or reputational risks. The interview must not collect identifying information from participants, and the participant must not be (or potentially be) identifiable in publications.
- Observational studies: Observational studies (with no intervention) of people undertaking non-sensitive, benign activities in a public space that will not be recorded or photographed and will not (or have the potential to) identify individuals.
- Interventions/Experiments: Research involving participants undergoing a non-clinical intervention/assessment task (e.g. activity) involving non-sensitive, non-controversial topics, and only non-identifiable data is collected.
Prospective recruitment of participants and data collection involving the following is higher than Negligible Risk:
- Recruitment and inclusion of participants in unequal or dependent relationships with the researchers;
- Recruitment and inclusion of vulnerable populations;
- Recruitment and inclusion of children as participants;
- Research involving active concealment or planned deception; Identification of participants (or the potential to) in the results or publications of the research
- Structured interviews or surveys where participants are asked to disclose or respond to questions of a sensitive nature (see the definition of sensitive topics).
- Structured interviews that collect identifiable information for follow-up, linkage, publication or reporting purposes.
- Surveys that collect identifiable or potentially identifiable information.
- Data collection methods and interventions that have the potential to induce discomforts (For example, feelings of anxiety, negative emotional feelings, employment and reputational risks).
- Research involving focus groups as a data collection method;
- Research where participation leads to more than an inconvenience (for example, participation of more than 30 minutes)
- Research conducted overseas.
Secondary use of existing data or biospecimens involving the following is higher than Negligible Risk:
- Access or use of data or biospecimens where there is the potential for the research team to uncover an individual’s identity.
- Access and use personal, medical or health information without the person’s consent or where a waiver of consent is requested.
- Access and use of data or biospecimens collected for genomic research purposes.
- Access and use of non-identifiable data where the research aims of the project are targeted towards or will have outcomes relevant to Aboriginal or Torres Strait Islander Peoples. Such projects will need to be submitted via the more than low-risk review pathway for review by an HREC.
- Access to or use social media data involving the analysis of individual accounts or any identifiable information.
- Access to or use social media data where individuals or groups of users can be identified through word or phrase searches or the publication of individual quotes.
- Access to or use of social media data from closed groups or forums.
Definition of Sensitive Topics
The following topics and or questions are defined as sensitive:
- Topics, questions or activities that deal with private, controversial, stressful or sacred (as perceived by the participant). E.g. research into sexual or religious practices, death or dying, birth, pregnancy, illness, mental health, grief, sexual abuse, violence, drug use, discrimination, displacement, migration or homelessness.
- Studies where there is a possibility that research may reveal illegal or embarrassing information that is stigmatising, incriminating or may impact employability somehow. E.g. research that may reveal illegal behaviours as part of the data collection.
- Researching the ‘vested interests’ of the powerful in a society where researchers may trespass into areas that involve some social conflict. E.g. investigating participants’ opinions of public policy in politically unstable countries or among migrants, refugees, ethnic minority groups or low-income groups.
Examples of Inconvenience
- Examples of inconvenience may include completing an anonymous online survey containing non-sensitive questions, observing people using public space or analysing de-identified datasets. By comparison, examples of discomforts may include minor side-effects of medication, the discomforts related to measuring blood pressure, and anxiety induced by an interview.