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(in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.’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 the health and wellbeing of people in custody in NSW; Network staff, Program services or specific populations or; Carried out by Network staff?
If the answer to any part of this question is yes, then you need to apply to the Justice Health and Forensic Mental Health Network HREC for ethics approval.
Is it low or negligible risk?
No research involving people in custody can be considered low 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 Improvement (QI) and Quality Assurance (QA) projects or activities monitor, evaluate or improve the quality of health care delivered by a health care provider, for individuals or services. In the Justice Health and Forensic Mental Health Network context these are often for example, reviews of information flow and data recording processes and workforce development. These generally do not require clearance by HRECs.
Without HREC approval, the use of data and insights from QI and QA are only to be used internally in Justice Health and Forensic Mental Health Network. Any projects intending to do any external reporting should apply to the HREC.
Documents to assist in determining if your activities are QI and QA, and if they require HREC approval, are:
- NHMRC’s Ethical Considerations in quality assurance and evaluation activities
- NSW Health’s quality Improvement & ethical review: A practice guide for NSW
NSW Health’s document provides a checklist – see Appendix A.
If certainty is gained that no HREC application for QI or QA is required, activities can commence, after adhering to any other institutional requirements.
It is important to note that HREC approval cannot be applied for or provided after QI and QA activities have begun, or retrospectively.
If advice is require, contact Justice Health and Forensic Mental Network Research Governance Ethics Officer on 02 9700 3443 or at JHFMHN-Ethics@health.nsw.gov.au
Is this the right HREC?
The Justice Health and Forensic Mental Health Network HREC reviews human research application where the proposed research involves the health and wellbeing of people in custody in NSW; Network staff, program services or specific populations or; is carried out by the Network staff.
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:
- Parklea – MTC Broadspectrum
- Junee – GEO Group
- Clarence Correctional Centre – Serco.
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?
If you can answer ‘no’ to all questions above, the changes to your research project should be submitted as an amendment for review and approval. Amendments are submitted to the Research Governance and Ethics Officer via REGIS. If the answer is ‘yes’ to any question, then a new application is likely to be needed, submitted via REGIS. You can discuss this with the Research Governance & Ethics Officer at +612 9700 3443 or at JHFMHN-Ethics@health.nsw.gov.au.