Justice Health NSW Human Research Ethics Commitee
The Justice Health NSW Human Research Ethics Committee (HREC) is accredited by the National Health and Medical Research Council. It aims to support research that is carried out in an ethical manner that will lead to improvements in policy and in service delivery while protecting the welfare, rights, dignity and safety of research participants.
The Justice Health NSW HREC, in alignment with the policies of the Aboriginal Health and Medical Research Council of NSW (AH&MRC), requires ongoing oversight by an Aboriginal Advisory Group, which can be involved in the conception, design, conduct, reporting and dissemination of findings.
Meet our HREC members
| Name | Membership category |
|---|---|
| Prof Deborah Debono | Co-Chairperson |
| Dr Paul Simpson | Co-Chairperson |
| Ms Gabrielle Gibson | Professional care |
| Dr Trevor Ma | Professional care |
| Mr Craig Locke | Professional care |
| Dr Kerryn Butler | Researcher |
| Prof Andrew Hayen | Researcher |
| Dr Bradley Gooding | Legal |
| Brenda Tronson | Legal |
| Bill Ramage | Pastoral care |
Do I need ethics approval?
The following checklist of questions will help you determine if ethics approval is required for your research project
1
Is your project considered research?
Human research is conducted with or about people, or their data or tissue. Human participation in research broadly includes the involvement of human beings through:
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taking part in surveys, interviews or focus groups
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undergoing psychological, physiological or medical testing or treatment
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being observed by researchers
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researchers having access to their personal documents or other materials
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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
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access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.
Source: National Statement on Ethical Conduct in Human Research (2007), updated 2018
2
Who does your project involve?
Does it involve the health and wellbeing of:
- people in custody in NSW
- Justice Health NSW staff
- program services or specific populations
- or is the research carried out by Justice Health NSW staff?
If the answer to any part of this question is yes, then you need to apply to the Justice Health NSW HREC for ethics approval.
3
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.
4
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 NSW 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 NSW. Any projects intending to do any external reporting should apply to the HREC.
If it's determined that HREC application for QI or QA is required, activities can commence, after adhering to any other institutional requirements.
It’s important to note that HREC approval cannot be applied for or provided after QI and QA activities have begun, or retrospectively.
Contact Justice Health NSW Governance Ethics Officer on (02) 9700 3443 or email JHFMHN-Ethics@health.nsw.gov.au
Resources
The following documents will help you determine if your activities are QI and QA, and if they require HREC approval.
NHMRC’s Ethical considerations in quality assurance and evaluation activities
5
Is this the right ethics committee?
The Justice Health NSW HREC reviews human research application where the proposed research involves:
- the health and wellbeing of people in custody in NSW
- Justice Health NSW staff, program services or specific populations or
- is carried out by Justice Health NSW 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 Justice Health NSW. This includes:
- Parklea – MTC Australia
- Junee – GEO Group
- Clarence Correctional Centre – Serco.
Please seek advice from the relevant organisations.
6
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
- 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 through REGIS.
If the answer is yes to any question:
- A new application is likely to be needed, submitted through REGIS. You can discuss this with the Research Governance and Ethics Officer by calling (02) 9700 3443 or emailing JHFMHN-Ethics@health.nsw.gov.au.
Aboriginal stakeholder support
Justice Health NSW’s research involving Aboriginal participants needs the involvement of Aboriginal peoples. It is important this engagement begins as early as possible, through the connection and support of an Aboriginal Reference Group.
Justice Health NSW’s Aboriginal Strategy and Culture Unit (ASCU) supports Justice Health NSW-led research and aims to improve stakeholder engagement with the Aboriginal community controlled sector.
Gaining Aboriginal support for the proposed research is mandatory for Justice Health NSW-led research and not available to externally-led research. This applies to all research involving people in custody, and all workforce research with a focus on Aboriginal staff.
How to apply for ethics approval
1
Ethics submission checklist
We recommend you prepare your submission thoroughly before uploading it. Our ethics submission checklist will help you ensure you have everything you need to apply:
| 1. Cover letter | Letter should be addressed to the HREC Chair, c/o the Research Governance and Ethics Officer. List all documents submitted with the application and provide details of the nominated study contact. The letter should be signed by the co-ordinating investigator and submitted via REGIS alongside the documents described below. |
|---|---|
| 2. CV | Provide short (1-2 page) CVs for all investigators, unless already submitted for another study reviewed by the HREC in the last two years. If this is the case, please make a note of this in the cover letter. |
| 3. Human Research Ethics Application (HREA) | Complete electronically through REGIS. If you are a first time user, create an account and refer to the Quick Reference Guides. |
| 4. Protocol | Project description |
| 5. NSW Privacy Addition to HREA | Complete this form if you are seeking a waiver of consent from the HREC. The form is available upon request. |
| 6. Participant Information Sheet and Consent Form (PISCF) | Provide PISCFs for participant groups as required. Use lay language to describe the procedures, risks, costs and potential benefits. Use standard templates and use Justice Health NSW and other institutional logos as appropriate. Include details for the nominated study contact, the Justice Health NSW HREC and other approving HRECs. |
| 7. Advertising materials | Provide all materials that will be used to promote the study and assist with participant recruitment. This may include posters, brochures, telephone scripts, expression of interest emails and letters of invitation. |
| 8. Data collection and assessment tools | Provide all tools that will be used to collect and analyse data in the study. This may include surveys, questionnaires, interview guides and validated clinical assessment measures. |
| 9. Master code sheets | Information collected for the purpose of research should be stored in a non-identifiable or a re-identifiable format. If data is to be stored in a re-identifiable format, provide a master code sheet that links study participant numbers with identifiable information. This sheet must be stored securely and separately from the study data. |
| 10. Participant tools | Provide other materials that are intended for participant use during the study. This may include diaries, study ID cards and brochures. |
| 11. Clinical trial documents | Provide Investigator’s Brochure, Product Information and all other documents to be used in clinical trials. |
| 12. Other correspondence | Provide evidence of support or approval from other organisations and review bodies. |
Please note that all documents you prepare, apart from standard tools, need page numbers, version numbers and version dates in the footer.
It is important that details of the application are consistent throughout the application. Any significant discrepancies will need to be corrected and may delay approval.
2
Apply for Justice Health NSW HREC approval
You will apply through REGIS, which is the NSW Health’s Research Ethics and Governance Information System.
REGIS helps manage ethics and site governance approvals of human research projects in NSW and ACT public health organisations and local health districts. It replaces AU-RED and Online Forms. Please note that Justice Health NSW has no control in regards to REGIS.
For technical assistance with REGIS, please call 1300 073 447 or email support@f1solutions.com.au. The help desk is open Monday to Friday from 7am to 7pm (excluding public holidays).
When to apply
Applications can be submitted at any time, but please note that deadlines are well in advance of the meeting date. Ensure you apply in plenty of time.
Submission closing dates | HREC meeting dates |
|---|---|
12pm Monday 15 January 2024 | Thursday 1 February 2024 |
12pm Monday 1 April 2024 | Thursday 18 April 2024 |
12pm Monday 3 June 2024 | Thursday 20 June 2024 |
12pm Monday 29 July 2024 | Thursday 15 August 2024 |
12pm Monday 30 September 2024 | Thursday 17 October 2024 |
12pm Monday 18 November 2024 | Thursday 5 December 2024 |
Approval process
Applications are reviewed at meetings held every two months.
Some new applications are approved at the first meeting, but most require more information and are approved at a second meeting. Some take longer and need a number of review/response cycles.
We will notify you of the HREC’s decision within two weeks of the meeting. There are four possible outcomes:
| 1. Ethical and scientific approval |
| 2. Ethical and scientific approval pending AH&MRC Ethics Committee approval |
| 3. Request for more information, to be reviewed by the Chair out of session |
| 4. Request for more information, to be reviewed by the HREC. |
If we ask for more information
If we ask you for more information, we will do so in writing, and will ask you to respond in writing. We will be happy to discuss by phone or email as well.
If the request for more information is minor, and fully met, approval can be granted out of session.
If the request for more information is significant, approval can be granted only by the HREC.
How long does the process take?
In planning your research, you should allow 4-6 months from the time you start to prepare a submission, to gaining approval. Carefully prepared submissions, with a thoughtful consideration of the ethical considerations required, are more likely to be approved quickly.
If you disagree with the decision of the ethics committee
If you disagree with either the decision of the HREC, or with the comments provided, please discuss this with the Research Governance and Ethics Officer. If this does not resolve the issue to your satisfaction, please escalate this to the HREC Chair.
We ask that you don’t speak directly with individual committee members, who are bound by confidentiality agreements and can only discuss an application outside of the meeting with the express permission of the committee.
3
Apply for Aboriginal Health and Medical Research Council (AH&MRC) Committee approval
Research involving Aboriginal people and communities will require review and approval by the Ethics Committee of the Aboriginal Health and Medical Research Council (AH&MRC), which is a properly constituted ethics committee registered with the National Health and Medical Research Council.
Note that the Justice Health NSW HREC considers that all research involving people in custody in NSW will involve at least some Aboriginal peoples.
The AH&MRC Ethics Committee seeks to ensure that research is conducted in an ethical and culturally appropriate manner. This means that there is community consultation at all levels, and that the project has been designed with the relevant Aboriginal community.
You'll need to visit the AH&MRC website to apply.
AH&MRC Ethics Committee approval can be sought concurrently with Justice Health NSW HREC approval.
4
Assess whether further approvals are needed
You'll need to assess whether your research needs other approvals. In addition to the Justice Health NSW processes, research studies may also require review by other groups including:
- other HRECs
- the Corrective Services NSW Ethics Committee for any research involving inmates, offenders, Corrective Services NSW staff or access to Corrective Services NSW records or facilities
- the Youth Justice NSW Research and Information Unit for any research involving young people involved in the youth justice system of staff employed by Youth Justice NSW.
Researchers are encouraged to seek advice from the relevant organisations regarding review and approval processes that apply to each study.
Applications may be reviewed concurrently via different processes. However, all required approvals must be obtained prior to site-specific authorisation, enabling the commencement of research at any Justice Health NSW sites.
5
Apply for site authorisation
All human research that takes place in NSW public health organisations, or that requires support from a NSW public health organisation in the form of access to participants, tissue or data, must be reviewed and authorised by that organisation’s Chief Executive.
You can’t start your research until this authorisation is granted, and site authorisation can’t be granted until you have obtained Justice Health NSW HREC approval and AH&MRC Ethics Committee approval.
Types of site authorisation
There are 2 types of site authorisation:
- a site-specific assessment (SSA) if the research involves using a NSW public health organisation in any way to:
direct contact with any potential participants into research, which includes screening for eligibility and gaining informed consent
carry out protocol-specific research procedures with or on participants
manage and analyse data, tissue, and responses from surveys and questionnaires collected at the public health organisation.
- an access request review (ARR) if the research involves using a NSW public health organisation in any way to:
- recruit participants through posters, leaflets, handouts, and letter of invitation
- distribution of surveys and questionnaires through staff of the public health organisation
- access to data or tissue held at the public health organisation.
In general, an ARR is sufficient if you have no plans to attend a site or speak to anyone on site. But please confirm this with the site/s in question.
Site authorisation checklist
You can use our site authorisation submission checklist to review what is required.
| 1. Cover letter | Ensure your cover letter is:
|
|---|---|
| 2. CV | 1-2 pages |
| 3. Site Specific Assessment (SSA) form or Access Review Request (ARR) form | Complete electronically through REGIS and seek Head of Department sign-off from the relevant Justice Health NSW Executive Director. |
| 4. Letters of approval |
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| 5. JH&FMHN HREC approved documents | Provide all documents that were approved by the HREC for use at Justice Health NSW sites. |
| 6. Research budget | Provide a budget for research studies that have allocated funding. If funds will be used or received in a Justice Health NSW cost centre, provide details and evidence of support by the cost centre authority. A template is available upon request. For any studies involving the use of drugs, whether they are already approved for the intended indication or not, a pharmacy budget should be specified, given the pharmacy will be dispensing the drug regardless of the regulatory status of the drug. |
| 7. Documents for clinical trials supported by a commercial sponsor |
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| 8. Documents for investigator-initiated clinical trials |
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How to apply for site authorisation
To seek SSA approval, view the REGIS quick reference guides. Note that you need support from the relevant Justice Health NSW Executive Officer.
To seek ARR approval, complete a NSW Health access request form and send it to the Research Governance and Ethics Officer at JHFMHN-Ethics@health.nsw.gov.au.
SSA and ARR applications can be completed and submitted while generating an ethics application in REGIS but cannot be authorised until ethics approval has been obtained.
Approval process
For research through Justice Health NSW or Corrective Services, the Research Governance and Ethics Officer will recommend approval or not to the Chief Executive, who makes the final decision. That decision will be made independent of HREC approval.
The Research Governance and Ethics Officer will notify you of the Chief Executive’s decision in writing.
Research ethics resources
Access resources to help you develop your research ethics application. Download PICF templates, policies, guidelines and legislation.
What happens after ethics approval
After you receive ethics approval and your research project commences, there are requirements around changes to your research, safety monitoring and reporting and protocol deviation and violation.
Changes to research
If you change aspects of the research protocol after ethics approval, you need to inform the HREC and seek approval to continue the study.
Relevant changes include:
- changes to the research team, whether that is adding or discontinuing a researcher
- changes to the research protocol
- changes to the recruitment procedure
- changes to the sites nominated
- changes to a data collection tool
- changes to the use of the data.
The committee follows the guidelines set out by the National Statement to ensure that all approvals meet these ongoing ethical standards in which it sets.
As research is a dynamic space and ever changing, it is necessary for the committee to not rely on previous decisions, but require all approvals met the current standards. In light of this, and in accordance with item 5.1.3, 5.1.13 and 5.1.15 the committee reserves the right to:
- Request amendments or extensions require additional approvals, particularly that of the Aboriginal Health and Medical Research Council, if relevant to the project and/or request, despite not being required in the project’s original approval
- Amendments or extensions may require further scrutiny than the original approval, in order to satisfy the committee’s ongoing scientific and ethical support
- The committee will scientifically and ethically approve a project for a maximum of five years. After this time, a new application will be required, without the opportunity of extension. This is to ensure the project meets any changes to the National Statement, while creating greater ethical practice. This is a necessity to maintain the best interests of the participants by allowing the highest possible standard of research. Annual Statements will remain a requirement of approval. This change came into effect as of 31 December 2022.
You will need to generate an amendment form through REGIS, and you may need to upload supporting documents.
Please contact the Research Governance and Ethics Officer on (02) 9700 3443 or email JHFMHN-Ethics@health.nsw.gov.au.
Annual reporting
If you receive ethics approval, you must submit a progress report to the HREC each year, and a final report on completion.
If the study is a clinical trial, you must submit an annual safety report.
Please note that ethics approval can be withdrawn if these conditions are not met.
Safety Monitoring and Reporting
As of October 3, 2017, the NSW Office of Health and Medical Research (OHMR) have formally accepted the updated NHMRC Safety Reporting Guidance. This will now align with national and international standards. This is effective now, and applies to new and existing trials.
Resources
What changes to reporting requirements have been made?
Fewer reports are required, and all safety reporting to the Human Research Ethics Committee (HREC) and/or Research Governance and Ethics Officer (RGEO) is the responsibility of the sponsor of the trial.
HRECs will no longer receive: Single case AEs, SAE/SARs and SUSARs or device/non-therapeutic good trial equivalents or six monthly line listings.
HRECs will receive: all significant safety issues, annual safety reports and investigator's brochure updates. Significant safety issues can be reported in the Significant Safety Issue Form (the use of which is mandated by OHMR). Annual Safety reports can be reported in the Annual Progress Report, on the sponsor's template or in the form of the most recently updated Investigator's Brochure or DSUR/DSMB report
Significant safety issue
A significant safety issue (SSI) is a safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.
- If an SAE/SAR/SUSAR meets the definition of an SSI, it will be reported to the HREC/RGEO through that reporting mechanism. SSIs that have been implemented as an urgent safety measure should be reported within 72 hours of the sponsor becoming aware of the issue.
- All other SSIs should be reported within 15 calendar days of the sponsor becoming aware of the issue.
- A measure required to be taken in order to eliminate an immediate hazard to a participant's health or safety.
RGEOs will no longer receive: Single case AEs, SAE/SARs and external SUSARs or device/non-therapeutic good equivalents or six monthly line listings.
RGEOs will receive: All significant safety issues (SSIs), any local SUSARs/USADEs/URSAEs and any research-related events that meet the definition of an incident.
Local SUSARs/USADEs/URSAEs can be reported in the Local SUSAR/USADE/URSAE Notification Form (the use of which is mandated by the OHMR).
In trials where Justice Health and Forensic Mental Health Network (JH&FMHN) is the sponsor the sponsor's reporting responsibility is delegated by the JH&FMHN Chief Executive to the Coordinating Principal Investigator or Principal Investigator.
It is the responsibility of the CPI/PI to ensure compliance with NHMRC and OHMR policy and guidance.
Where the sponsor is another entity- for example, a University, you should seek guidance from that institution. It is likely that the delegation will be to the Principal Investigator.
Protocol deviation and protocol violation reports
Researchers must submit reports detailing any protocol deviation or protocol violation to the HREC in a timely matter, with an explanation of how the deviation or violation occurred and what action has been taken to ensure the error will be avoided in the future. This report should be addressed to the HREC Chair, c/o Research Governance and Ethics Officer.
Get support
For further advice and information about the safety monitoring and reporting, please contact Josie Cullen, Research Governance and Ethics Officer at JHFMHN-Ethics@health.nsw.gov.au or the Office of Health and Medical Research on researchethics@doh.health.nsw.gov.au.
Contact Justice Health NSW Research
More options to contact us.
Research Governance and Ethics Officer:
JHFMHN-Ethics@health.nsw.gov.au
General research enquiries:
JHFMHN-ResearchUnit@health.nsw.gov.au
Phone: (02) 9700 3000