Apply for research governance authorisation

Welcome, everyone, to today's Metro South Research education session. We have a small group online, and today’s topic is quite interesting and, dare I say, a bit controversial. I’ll do my best to help you, Vanessa, as we go along, so I apologise if my wording is a bit off. I’m Liz, the Research Navigator for Community and Oral Health Services. Before we start, I would like to acknowledge the Yuggera and Turrbul peoples as the traditional custodians of the land we meet on today, or in my case, from Brisbane. Even though we’re meeting online and are physically dispersed, we are united virtually. This is a good time to reflect on the meaning of place and acknowledge the traditional lands where we conduct our work today. I pay my respects to Elders past, present, and emerging.

Just a bit of housekeeping—most of your microphones and cameras are muted to prevent disruptions during the presentation. We’ll enable them later when we open the floor for questions. This session is being recorded, and the link will be available on the Metro South Research website afterwards. Also, there’s a feedback form we’ll share in the chat at the end of the session. Your feedback is valuable as it helps us improve these education sessions. We appreciate you taking the time to fill it out.

You may also get a chance to hear from the navigators toward the end of the session if time allows. Today’s session focuses on Site-Specific Assessments (SSAs), part of the research governance process. While these sessions are designed for novice researchers, it’s a helpful refresher for everyone. We know the research governance process can be complex, which is why we’ve invited Vanessa, an experienced governance officer, to help guide us through.

Before Vanessa begins her presentation, let me briefly introduce her. Before joining Queensland Health, Vanessa trained as a high school teacher. However, her passion for commerce and business led her back to university, where she developed risk analysis skills working in ammonia plants, a role that took her around the globe for two decades. Vanessa later transitioned into research, where her career took off at the PA Hospital under the mentorship of Areti, a former Executive Director. Her experience expanded as she moved to the statewide Office of Research and Innovation, where she managed PHP applications and oversaw statewide research initiatives. More recently, at the Gold Coast Research Office, Vanessa transformed a small team into a robust department of 19, covering statistics, grants, and more. With 15 years of experience in research ethics and governance, Vanessa is uniquely equipped to deliver today’s presentation with insight and authority. Thank you for sharing your time with us, Vanessa—we look forward to hearing from you.

Hello everyone. I recognise some familiar names in the attendee list, and to those I haven’t met yet, welcome. I’m excited to be here today. When Liz asked me to present, I thought, “No worries, I’ve done similar presentations recently.” In fact, I was looking at a diagram this morning from Sonia Hancock, who’s online, showing research governance. The image struck me—it really isn’t always a clear process, and it can feel quite hazy at times, especially with SSAs.

Before diving into the specifics of the SSA process, I want to clarify the differences between ethics and governance for research conducted within health services. Many of you are familiar with the need to obtain ethical approval from an HREC for studies conducted in hospitals or universities. The HREC’s focus is on principles like beneficence, respect, merit, and justice, as outlined in the National Statement. Ethics committees evaluate whether the benefit of the research outweighs the risk to participants and how participants’ privacy will be respected. Sometimes, committees even question whether the research question can be answered statistically, based on the sample size and recruitment plan.

Ethics approval can be obtained from any accredited committee across Australia, but if you’re conducting research in Queensland, it’s best to use a Queensland committee. Universities usually accept the approval given by our committees.

Now, where does governance fit in? Governance focuses on the institution and its risk management. That’s why you need to undergo a separate governance process at each site involved in your study. Each site has its own procedures, and governance ensures that the institution is protected. Governance assesses elements like data custodian approval, alignment with institutional policies, and whether the research contributes to the organisation’s strategic priorities. A key consideration is the plan for translating the research findings into practice.

When you submit your SSA, the governance team checks several key components to ensure everything is in order. You submit your SSA via the ERM system, and it’s important to fill in all the necessary details, as it’s quite a detailed application process. That detail is collated at a national level. The items you enter at the start of the SSA form are sent to each state jurisdiction. These are then compiled quarterly with other states, and metrics are extracted from that data, which is then provided to both industry and the government. This process gives a framework for understanding what’s happening at a national level.

I know it can feel tedious to fill in these forms, but there is a purpose behind the questions. One question at the start of the SSA asks whether you are willing to allow your data and application to be uploaded to DORA. DORA is the database of research activity in Queensland, compiling research from low-risk studies, investigator-initiated projects, and clinical trials. This listing allows the public to see what research is happening in their area. I always encourage researchers to tick that box because it’s beneficial for the public to know what’s happening at both local and state levels.

Regarding the five components, we focus on ensuring that these items meet elements of respect, beneficence, integrity, and merit. I understand that legal contracts can take a long time to finalise. This is an issue not only in Metro South but also statewide, and efforts are being made to improve this process. Under the Australian Code for the Responsible Conduct of Research, we must ensure that authorship, intellectual property, insurance, liabilities, and warranties are all considered in our projects.

I recently spoke with Fiona Simpson at Tri, and she made a good point. When conducting research, commercial sponsors or universities need to ensure that there is sufficient financial backing. They must provide guarantees or funds to support the research. This leads us back to the importance of legal contracts. It’s always helpful to reach out to the relevant RGO at your site to make sure they understand your contract needs. They can also advise whether legal teams will need to be involved, especially if the contract isn't standard.

In the last ten years, we’ve introduced standard contracts, such as the Medicines Australia contracts for clinical trials. In Queensland, we have the HTQ agreement, which has proven very useful. It clearly outlines what activities will be undertaken, who is providing funding, and how it will be managed. Beyond indemnities and insurance, financial arrangements must be transparent. When submitting an SSA, the budget should only reflect the costs relevant to the specific site, not the entire project. This might include whether the site is receiving money or equipment, or if there are any no-cost contributions.

If the project involves in-kind work, meaning extra work outside your standard duties, this must be accounted for in the budget. The budget should also reflect the potential impact on the unit, such as whether staff will be withdrawn from their normal duties to work on the research.

Workforce adequacy is another critical aspect. When COVID-19 hit, many projects were paused or terminated due to insufficient workforce capacity. Ensuring the right people are managing the project within their department is essential. For instance, we once had a nurse propose research outside her area of certification, and we advised her to involve appropriate experts.

Research assistants play a crucial role, especially when clinicians are busy. Their responsibilities need to be outlined in the legal contract, particularly regarding data management and privacy. Privacy protection must be adequate, and any access to personal confidential information must comply with Queensland Health’s guidelines and laws. For example, if identifiable data is needed for linkage, a Public Health Act (PHA) application may be required.

It's also essential to ensure that consent is appropriately managed. If a patient is unable to consent, there needs to be an authorised person who can provide consent, or a QCAT approval may be necessary for clinical trials.

When reviewing SSAs, we are mindful of the risks involved and how they are being mitigated. The national statement introduced earlier this year has increased the focus on risk assessment. Metro South has implemented risk assessments for all projects, encouraging teams to regularly update their risk documentation, particularly during annual reviews.

Additionally, Metro South requires Good Clinical Practice (GCP) and Research Integrity training to be submitted with the SSA, as these are essential risk mitigation tools. They provide invaluable education and ensure that researchers understand their responsibilities and the processes involved in their projects.

Regarding the budget, it’s essential to note that when submitting at Metro South or across multiple Metro South sites, the budget should only cover Metro South’s costs. The templates and forms are available on our website, and I encourage everyone to check for updates regularly.

That concludes the essential elements of the SSA submission process. I’m happy to take any questions and discuss how I can assist moving forward.

Q&A Section:

Julie: "If two departments at the PA are participating in a research project, which department signs off on the RCASE form? If the project is conducted entirely in-kind, without funding, do we still need to submit a budget document?"

Vanessa: Usually, the primary department signs off on the RCASE form. However, it's advisable to obtain letters of support from other departments involved, such as radiology, pharmacy, or pathology. Uploading letters of support from the department heads will ensure all parties are willing to undertake the project.

For the second question, if the project costs less than $10,000, there is no need for business manager sign-off. However, it’s still useful to note any in-kind costs in the budget. Even if there’s no funding, time and resources are still being contributed. You can submit a simple budget that identifies the time commitment in hours and the classification level for the personnel involved. This should also be reflected in the RCASE form.

Kirsten: I wanted to provide some perspective from Bayside. We often receive SSAs for multi-site studies where funding may be allocated at larger hospitals, but our contribution to the project is completely in-kind. In such cases, having a budget specific to our site is very useful, especially when asking heads of department to sign off. We can clearly show how much input our site will need to provide, even if there is no funding.

A good example is projects involving staff surveys or qualitative research. The project protocol may detail the number of staff required and the time surveys take, but having that broken down into a site-specific budget really helps outline the operational impact, especially when there's no funding.

Absolutely agree, Dave. There's a big difference between asking two staff members to complete a survey versus 20. The head of department needs to know that.

Does anyone else have questions? You can pop them in the chat or unmute yourself.

Noah (via chat): Vanessa, when do you need an SSA, and when is it considered multi-site? If we conduct a staff survey across Metro South Health, do we need SSAs for all sites? Could you give some examples?

Vanessa: If a facility is providing data, patients, or resources, generally an SSA is required. If a principal investigator or associate investigator is involved in the study, an SSA is usually needed. It’s particularly important when we're dealing with data, as agreements are necessary to maintain privacy and legal permissions for data transfer. So, if a research project uses Metro South’s resources, staff, or data, then an SSA is required.

Timothy: Vanessa, great presentation. I was interested in your comment about the difference between research done within your existing FTE and in-kind research. Can you elaborate on that?

Vanessa: Sure. This is a topic under discussion across various HHSs. How do we capture in-kind costs within an institution? It’s important because capturing these costs helps build business cases for more staff or additional funding for research. There’s often an opportunity cost when a staff member is taken away from patient care to work on a research project.

It can be tricky to quantify because, as you said, certain roles may include an expectation to contribute to research, but the extent is rarely defined. And yes, clinical work tends to take priority, which makes it hard to balance research commitments.

Timothy: That’s true. I hadn’t thought about it in detail before, but it’s difficult to separate work that’s part of someone’s role from what would be considered additional in-kind work. It varies by position, and it’s challenging to quantify what’s within someone’s normal responsibilities versus what’s extra.

Vanessa: Yes, it’s not always easy to quantify, but it gives us an idea of what’s happening in the department and can be useful at higher levels of the organisation. Ross Stanley is currently doing work in this area, which should clarify these definitions further.

Timothy: My other question relates to in-kind costs for external institutions. Recently, we were unclear about whether to include them in the budget. It would be helpful if the budget template clearly indicated that this only applies to Metro South sites.

Vanessa: Thanks for the feedback, Timothy. There is some work being done on updating the template, and we’ll ensure that clarification is made.

Do we have any more questions?

It looks like we’re wrapping up. Thank you so much, Vanessa, for your presentation and answering our questions today. A reminder to fill out the feedback form, and our next education session is on the 12th of September at 12:00 PM, covering research excellence in finance and business management. It might be a good session to attend if you’re looking for more insights into in-kind costs and budgets. Thanks, everyone, for attending, and thank you again, Vanessa.