1. Examples of human research
2. Different levels of review
3. Guiding Documents

1. Examples of human research 

Human research has a broad definition and includes research conducted with or about people, or their data or tissue. Research ethics is the application of fundamental ethos and principles that promote responsible conduct of research and determine the way in which researchers engage in human research.

Human research ethics clearance is required if research includes the involvement of human beings. 

  • Gathering information about human beings (and organisations) through interviewing, surveying, questionnaires, focus groups, observation of human behaviour, audio/video taping, undergoing psychological, physiological or medical testing or treatment
  • The collection and use of their body organs, tissues or fluids 
  • Systematic evaluation of an innovation e.g. clinical trials of new drug, or audit of a new process, 
  • Access to personal documents or other materials
  • Using archived data in which individuals are identifiable
  • Access to information (in individually identifiable or re-identifiable form) as part of an existing published or unpublished source of database.
  • Evaluations and quality assurance activities
2. Different levels of review

The level and type of review is determined by the level of risk and the research governance processes that an organisation might have in place for approving projects of different risk levels. Activities that might be considered to be of negligible or low risk are still required to have a degree of institutional oversight and responsibility and meet the requirements of the National Statement on Ethical Conduct in Human Research. Human research activities that are higher than low risk must be reviewed by an ethics committee. 

Menzies staff and students

Before commencing any new activity, all researchers from Menzies should consult with the ethics office to determine what level of ethics clearance will be required. 

No individual researcher should make their own decision regarding the risk and level of review of an activity whether it is deemed to be research, service provision or some other activity without consultation with their departmental heads and the ethics office.

Low or negligible risk activities assessed by means other than the HREC, e.g. HREC Chair or Research Integrity Officer, can be provided with written evidence for the decision regarding the level of risk and oversight of the activity.

Northern Territory Department Health staff  and researchers wishing to conduct studies at Department of Health (DoH) or Top End Health Services (TEHS) sites, or involving DoH or TEHS employees or clients 

Please consult with the ethics office or the Top End Health Service (TEHS) Research Governance Office (rgo.tehs@nt.gov.au), to determine whether ethical review of your activity is required. 

TEHS sites include:

  • Royal Darwin Hospital
  • Alan Walker Cancer Care Centre
  • Gove District Hospital
  • Katherine Hospital
  • Palmerston Regional Hospital
  • Top End Mental Health Service (TEMHS)
  • Alcohol & Other Drugs Service (AODS)
  • Top End Primary Health Care (urban and remote sites)

All staff undertaking short clinical audits and case studies should apply to the HREC using the Low Risk Ethics Clearance Form for expedited review. 

For any research beyond a simple audit or case study, ethics clearance should be sought using the full HREC application form.

All applications for research at TEHS sites, or involving staff, service provision and data (including audits) require a Site Specific Assessment (SSA) and organisational authorisation.

The SSA process is based on submission of either the full HREC form or the Low Risk Ethics Clearance form and associated documents to the TEHS Research Governance Office (rgo.tehs@nt.gov.au).

Please refer to the stakeholder/site support page for more information.

Medical Students

All students undertaking short clinical audits and case studies should apply to the HREC using the Low Risk Ethics Clearance Form for expedited review. Students should list themselves as 2nd investigator and their supervisor as primary investigator.

Please refer to the form for more information. For any research beyond a simple audit or case study, ethics clearance should be sought using the full HREC application form

All applications for research at TEHS sites, or involving staff, service provision and data  (including audits) require a Site Specific Assessment (SSA) and organisational authorisation. Please refer to the information above and the stakeholder/site support page.

All other researchers

Before commencing any new research activity, please consult with the ethics office to determine what level of ethics clearance will be required.

All applications for research at TEHS sites, or involving staff, service provision and TEHS data  (including audits) require a Site Specific Assessment (SSA) and organisational authorisation. Please refer to the information above.
.

3. Guiding Documents: