A Simple Guide to Approvals for Research Projects at Northern Health
*This guide is available as a pdf download. Click here.
All research activities at Northern Health require appropriate approvals. This Guide will assist you to understand the most appropriate pathway for approval of the project you have planned. However, we strongly encourage you to meet with the Research Development and Governance Unit (RDGU) (ResearchDGU@nh.org.au) early in your project planning process, especially if you are new to Northern Health and/or research. Engaging with the RDGU early supports timely approval and project commencement.
Step 1: Develop your project
In order for your project to be ready for ethics and governance review, the following key project development tasks need to be undertaken:
- Clearly describe the aims, objectives and hypothesis(es) of your project.
- Evaluate the feasibility of your project
- Discuss the project in detail with an experienced research supervisor (if appropriate)
- Decide on the appropriate approval pathway
More information on these steps can be found below.
Step 2: Understand Research Ethics and Governance Approval
Research Ethics
The relationship between researchers and research participants should be one of trust, mutual responsibility and ethical equality. The National Statement on Ethical Conduct in Human Research 2023 (National Statement) sets out the values upon which this relationship should be shaped. These values include respect for human beings, research merit and integrity, justice, and beneficence. To ensure research is conducted in alignment with these values, most research projects (especially those that are greater than low risk) will require review by a Human Research Ethics Committee (HREC). The HREC will use the guidance provided by the National Statement to assess whether a research project meets ethical standards and guidelines, and where necessary, advise on adjustments to the research protocol required to achieve this. While Northern Health does not have an in-house HREC, the required approval can be granted by a HREC from another institution (see below).
Research Governance
Prior to commencing a research project, researchers require both ethics and governance approval. Research Governance refers to the processes that are followed to ensure that the project aligns with strategic intent, is feasible, and satisfies all of the regulatory requirements, including ethical compliance. Approval is managed by the Northern Health RDGU. It is separate to ethics approval, and is commonly referred to as Site Specific Assessment (SSA). The documentation required includes sign-off by relevant persons/departments at Northern Health to confirm that each participating department has the resources, expertise and facilities to conduct the project.
Step 3: Identify the required approval pathway for your project
The level of risk to both participants and organisations that is associated with your planned project determines the approval pathway it will need to follow before your project can commence at Northern Health.
The following table and flowchart aim to assist you to identify and understand the appropriate pathway for your project. Please contact RDGU if unsure.
| Approval Pathway | |||
| Quality Assurance1 | Non-HREC | HREC | |
| Primary purpose | Assessment of current standard of care to compare against established benchmarks or evaluate an established aspect of care. Does not include prospective evaluation of a quality improvement activity or change in standard of care. | Any other quality improvement (QI) or research activity | Any other quality improvement (QI) or research activity. |
| Collection of data | Only data already collected as part of clinical care or hospital processes may be included | Any other data, including surveys and investigations additional to routine clinical care collected prospectively | Any other data, including surveys and investigations additional to routine clinical care collected prospectively |
| Number of centres | Northern Health only | Northern Health only | Northern Health only where activity is more than low risk; Multicentre studies where data is shared across sites |
| Need to discuss with NH RDGU | Yes, if findings from the QA project are planned for dissemination, either via a conference presentation or publication, outside of Northern Health# | Yes | Yes |
| Investigator Team | NH staff with usual access to the required data | Must be led and/or supervised by experienced NH Researcher | Must be led and/or supervised by experienced NH Researcher |
| Risk | No risk to participants or organisation | Low* risk to participants or organisation | Low or More than low risk to participants or organisation |
| Approval method | QA Proposal Form if findings planned for dissemination, either via conference presentation or publication, outside of Northern Health | Non-HREC Pathway | HREC Pathway |
| Examples | Clinical morbidity and mortality audits
Retrospective data collection to evaluate prescribing patterns or clinical investigations Evaluation of a change that has already been implemented in service delivery
|
Projects/Audits where:
NH Patient surveys
|
Projects requiring consent or waiver of consent
Multi-site surveys and other data collections outside routine care
|
| Exemplars | Coming soon | Coming soon | Coming soon |
* The term ‘negligible’ risk has not been used, in line with upcoming changes to the National Statement (2023).
# Northern Health Research Week is considered an external event requiring approval for presentation of QA projects
1Further information about Quality Assurance, Quality Improvement, and Research Projects can be found below.
The following research activities are exceptions to the above pathways:
- Narrative or systematic reviews: no approval required from NH RDGU
- Case reports or series: patient consent required as per NH RDGU Patient Case Report Consent Form.
Step 4: Complete and submit the required forms
The RDGU can provide guidance on the completion of submissions required for your project. Getting it right the first time will mean a shorter time to approval.
Remember that the RDGU does NOT write your ethics and governance applications for you.
All forms can be found under Library of Forms
For projects that will require approval via the HREC Pathway please note you will require external Ethics approval and NH Governance authorisation:
Ethics
Applications for Ethics Approval should be submitted externally to a Human Research Ethics Committee (HREC) certified by the National Health and Medical Research Council (NHMRC). Each HREC may have slightly differing application processes, but all applications are submitted through a central system (ERM).
Further information can be found under Research Ethics
Governance
To obtain NH governance authorisation, applications must be submitted via the same central system (ERM) used for HREC submissions. The site-specific assessment (SSA) governance form can be submitted at the same time as the ethics approval application. However, governance authorisation can only be granted following HREC approval. Please contact NH RDGU for advice and assistance with completing the SSA.
Step 5: Commence your project
Once you have received ethical (if required) and governance approvals, you can commence your project. Congratulations!
Please remember to submit you progress reports, as required.
We look forward to keeping track of your progress and sharing the outcomes of your research with the NH research community.
