Is it research?

The first question to ask is – is the activity ‘research’? The National statement on ethical conduct in human research (2007), updated 2018 says:

‘There is no generally agreed definition of research; however, it is widely understood to include at least investigation undertaken to gain knowledge and understanding or to train researchers.’ (p. 6)

It also says:

‘Human research is conducted with or about people, or their data or tissue. Human participation in research is therefore to be understood broadly, to include the involvement of human beings through:

  • taking part in surveys, interviews or focus groups;
  • undergoing psychological, physiological or medical testing or treatment;
  • being observed by researchers;
  • researchers having access to their personal documents or other materials;
  • the collection and use of their body organs, tissues or fluids (eg skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath;
  • access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.’ (p. 7)

Does it involve people who are staff of or under the control of the Network?

All research involving people in custodial or forensic mental health settings, and/or Network staff, must be reviewed by the Justice Health HREC. Such research is not covered by the National Mutual Acceptance scheme, and the Justice Health HREC will not be influenced by any prior ethics approvals granted by other HRECs.

Is it low or negligible risk?

No research involving people under the control of the Justice Health and Forensic Mental Health Network can be considered low risk or negligible risk, in accordance with the National statement on ethical conduct in human research, because such a population is likely to include at least some of the following groups:

  • women who are pregnant and the human fetus
  • people with a cognitive impairment, an intellectual disability or a mental illness
  • people who may be involved in illegal activities
  • Aboriginal and Torres Strait Islander peoples. (p. 61)

Is it exempt from review?

Quality assurance activities, teaching, training and learning projects are not considered research, as long as the use and dissemination of the results remains internal to the Network. Any projects intending external reporting should go through the usual ethics processes. A useful document to assist in determining if your activities are QA is Ethical considerations in quality assurance and evaluation activities.

It is important to note that ethics approval will not be given retrospectively. So think hard about how you may like to use the data – if there are ways you might like to use it, it is better to seek ethics approval now, or at least consent from participants that covers future likelihoods.

Is this the right HREC?

The Justice Health HREC reviews human research applications where the proposed research will impact on or involve the patients or potential patients of the Network, or the staff of the Network, or will take place at any site where the Network provides services to people in custody or in detention.

If you are planning on conducting research at one of the privately operated correctional centres in NSW, you must seek approval from the private institution operating the centre, not the Network. This includes:

Please seek advice from the relevant organisations.

Is it an amendment?

Researchers considering seeking an amendment to ethics approval should ask themselves the following questions about the changes they wish to make to their research.

  • Does the change significantly increase or decrease the number of participants?
  • Does the change alter the approved methodology?
  • Does the change make any difference to the research question/s approved?
  • Does the change increase any risk, or decrease any benefit, to participants?
  • Does the change add or remove any group considered in section 4 of the National Statement? That means women who are pregnant and the human fetus; children and young people; people in dependent or unequal relationships; people highly dependent on medical care who may be unable to give consent; people with a cognitive impairment, an intellectual disability or a mental illness; people who may be involved in illegal activities; Aboriginal and Torres Strait Islander peoples; or people in other countries.
  • Does the change introduce a new conflict of interest, or exacerbate an existing one?
  • Does the change alter the approved need for or approach to consent?

Only if you can answer no to all questions should you consider the changes to be an amendment. If the answer is ‘yes’ to any question, then a new application is likely to be needed. You can discuss this with the Research Governance & Ethics Officer at +612 9700 3443 or at JHFMHN-Ethics@health.nsw.gov.au.