Defence Human Research
Human research is that which is conducted with or about people, their data or tissue.
The National Statement on Ethical Conduct in Human Research (National Statement), as issued by the National Health and Medical Research Council, recognises that human research involves a wide range of activities that have variable risks and potential benefits.
Sections on this page:
Risk in Research
The National Statement establishes different levels of ethical review, based on the degree of risk involved.
There are three levels of risk:
Researchers, Institutions, and HRECs are required to determine the existence, likelihood and severity of these risks based on the research methodology and design, participant population and research activity.
It is important to note that:
- Low risk is not defined by what is lower clinical risk in a given medical specialty but by the National Statement and the Ethics Committee.
- Risk is not just physical but may incorporate social, psychological, financial or cultural risks or risks such as breach to privacy.
Research Greater than Low Risk
If the project includes any of the following types or research and/or participants it will require full review by the Australian Defence Human Research Ethics Committee (ADHREC) and will not be eligible for low risk review:
- External registries: The project involves establishing an external registry where external is defined as one or more of the following: non-Defence data custodian, data contribution by other institutions to Defence registry, data access and use granted to researchers from outside Defence.
- External researchers: The research is being conducted by a person not associated with Defence and there is no one on the research team from Defence.
- Genetic research: The project involves the study of single or multiple genes, gene-to-gene interaction or gene-environment interaction; acquired somatic variation; inherited gene sequences, and their variants or their products; gene expression, including the influence on those genes of environmental factors, pharmaceutics and other therapeutic products; the genes of individuals, families or populations; epigenetics; use of informatics and genetic information; and clinical phenotypes.
- Human biospecimens: The research involves studying biological materials obtained from a person to develop new therapies.
- Illegal Activities: The research intends to study or is likely to discover illegal activity. Examples include questioning about illicit drug use.
- Interventions and therapies, including clinical and non-clinical trials, and innovations of new treatment modalities: The research involves providing an intervention. Examples include testing; drugs, surgical procedures, therapeutic procedures, therapeutic devices, preventative procedures, diagnostic devices or diagnostic procedures.
- Pregnancy and the foetus: The research involves the foetus or foetal tissue or has the potential to impact on the wellbeing of the foetus through involvement with a woman/ women who is/are pregnant.
- Research specifically targeting Aboriginal and/or Torres Strait Islander Peoples.
- Student researchers: The project involves a student accessing identifiable information.
- Vulnerable participants: The project requires obtaining consent from vulnerable people, where competence to provide consent is diminished. Examples include children, ventilated patients, those dependent on care, those with a mental health condition, cognitively or intellectually impaired persons and the elderly.
Low Risk Research
The National Statement Section 2.1.6 describes research as “Low Risk” where the only foreseeable risk is one of discomfort. Discomforts may include minor side-effects of medication, discomforts related to measuring blood pressure or anxiety induced by an interview. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk. However, for research involving certain groups, methodologies or procedures only full HREC review is allowable, irrespective of the level of the risk. While some research may appear to be low risk activities, others may require detailed justification including:
- Externally funded research where there is a commercial interest.
- Data access, collection or use of identifiable information that is not secondary use and is without consent.
- Use of already collected tissue and blood samples without the prior consent of the patient.
- Transfer of tissue and blood samples without consent to external researchers.
- Access/collection/use of sensitive information.
- Access/collection/use of information that has regulatory and/or legal reporting requirements.
- Personally intrusive/confronting or quite inconvenient/ embarrassing questioning.
- Providing, or potential to provide, individual health/ medical/psychiatric diagnosis.
- Screening for healthy participant inclusion/exclusion.
- Change or withdrawal of services.
- Conflicts of interest or dual researcher-professional roles.
- Research conducted overseas.
- Deception (participants will receive limited or no information about the research at time of recruitment).
- Participant recruitment/selection via a third party.
- Qualitative research without experience.
- Research involving family members of the patient where participants will recruit family members or where family members may need to help the participant to take part and/or provide extra info, etc.
- Research involving staff where (a) staff may be identifiable in findings, (b) there is a potential to damage or infringe on the rights of staff, (c) there is the potential to cause distress.
- Participation incentives, prizes or significant payments.
- Research placing researchers/assistants at risk.
Defence-related research involving low risk must be reviewed and approved by the appropriate review panel within Defence.
Negligible Risk Research
The National Statement Section 2.1.7 describes research as “negligible risk” where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is not more than inconvenience to the participants. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk. The National Statement describes inconvenience as the least form of harm that is possible for human participants in research. The most common examples of inconvenience in human research are filling in a form, participating in a de-identified survey or giving up time to participate in a research activity.
Negligible risk research is managed via the relevant low risk review panel.
Quality Assurance Activities
Quality Assurance refers to administrative and procedural activities implemented in a quality system so that requirements and goals for a product, service or activity will be fulfilled. It is the systematic measurement, comparison with a standard, monitoring of processes and an associated feedback loop that confers error prevention.
In determining if a quality assurance activity requires ethical review, please review:
Considerations in determining if an activity such as quality assurance requires ethical review
Ethical Considerations in Quality Assurance and Evaluation Activities