The EQUATOR network provides researchers with a broad range of reporting guidelines and checklists that can be used when preparing a manuscript for submission. Journal editors must screen many submissions and ensuring research is clearly presented, following journal-specific guidelines is important. 

Each journal has various requirements, including the structure of the manuscript and the number of figures and tables allowed. They can also have stringent word and citation counts. Researchers should check each journal to determine its specific requirements. As a rule, researchers should prepare:

1. Cover letter
2. Manuscript
3. Tables and Figures (if applicable)

Supplementary files can also be submitted with manuscripts as a form of supporting information. This may include: checklists, data, or interview questions.

Ideally, research will be available to all readers, but this is not always the possible. Some journals require a subscription (or payment to access individual articles), some are Open Access only, and some have a hybrid option.

Journals with the option of publishing articles as Open Access provide access to all at no cost to the reader. This provides the opportunity to broadly disseminate work, but generally comes at a cost to the author.

Researchers may need to budget between $3000-$5000 to publish their work as Open Access. Funding options for assistance with publishing fees are available.

Gold Coast Health researchers are strongly encouraged to follow the PRISMA guidelines, and to engage with a research librarian during the planning phase. This will help you to provide accurate and transparent reporting. There are separate guidelines for reporting your protocol and your findings.

Systematic review protocols should be registered with PROSPERO prior to data extraction to let other researchers know you are working on this topic.

Completing a systematic review prior to primary research can have multiple benefits:

• It assures the researchers that there is a need for their primary research,
• It enables a researcher to detect where previous research could be improved, helping them develop their protocol, and
• It may lead to a publication of the review.

Researchers may also find that their proposed study has recommended reporting guidelines, and a relevant protocol template, available at the EQUATOR network.

A comprehensive review of reporting guidelines during project development will ensure researchers collect and account for relevant data, making the execution and reporting of a study robust and complete. Depending on the design of the study, researchers may be required to add further details or sections to the template provided.

Researchers should also think about whether specific measures have been recommended for their specific area of study. This is particularly relevant for clinical trials, but can be useful for other studies too. The use of resources such as the COMET-initiative can be used by researchers to establish whether core outcome measures are recommended for their condition.

Depending on the nature of a study, pre-registration of a protocol may be required.

It is good practice, and mandatory for some journals, to register the protocol for a review before commencement. Registering the study protocol provides other researchers with the plan and serves multiple purposes. 

It provides open and transparent information to other researchers about the planned review and how the data are to be analysed. Crucially, it may reduce duplication as other researchers can see what is being studied and may avoid an unnecessary duplication. Indeed, before starting a study researchers should determine if others have registered their study answering the same question – if yes, they could be contacted to request the results once they are available, or it may be possible to join their research team.

At Gold Coast Health we strongly encourage registering studies with an appropriate registry, which should be done prior to data collection. Some study types have specific registries – such as Systematic Reviews or Clinical Trials (see below). All other study types can be registered with generic registries such as Open Science Framework Registries.

Systematic reviews
Systematic reviews can be registered with PROSPERO prior to data extraction. Other reviews can be registered elsewhere, such as with Open Science Framework Registries.

Clinical trials
All clinical trials should be registered during the planning phase. Researchers are encouraged to familiarise themselves with a registry during the design phase. Given small modifications to the protocol may be required during ethics review, the final registration may occur after ethics approval. 

Clinical trials and observational studies can be submitted for publication on registries e.g. Australian New Zealand Clinical Trials Registry (ANZCTR) or in peer-reviewed journals. Keep in mind that annual updates are required for protocols registered with ANZCTR.

It is recommended that the research teams discuss who will be responsible for each task of the project during the planning phase. A research task should be within the scope of practice of the person completing it and some teams sign of Memorandum of Understanding prior to study commencement to ensure everyone is aware what they are responsible for. Furthermore, Good Clinical Practice certification is strongly encouraged, and indeed mandatory for some study types, as this provides clear direction on expected standards of research conduct. The research team should also be compliant with guidelines for research governance, including applicable regulatory requirements, throughout the life of the project.

Discussion of the proposed list of authors (including the order of authors on a manuscript) should be discussed when completing the protocol. Guidelines from the National Health and Medical Research Councils (NHMRC) on authorship are available here.

Peer-review of the design, methods, results, and conclusions of a research project will be performed at some stage over a project’s life. Some researchers rely on peer-review when trying secure grant funding, but if the project is not evaluated favourably, researchers are unlikely to be successful. Others use peer-review when trying to publish their work, but this often this is too late to do anything about the design and methods, as the project is usually, by definition, complete.

In order to improve and refine project design and proposed outcomes, researchers are encouraged to submit their protocol for peer-review. This involves providing the protocol to people from the same field, but external to the research team for evaluation. This provides researchers with meaningful external feedback to assist in refining their work, but can also be used as supporting documentation to the Human Research Ethics Committee (HREC).

Given HRECs do not contain experts from all fields, evidence of peer-review can provide a HREC with some insight as to how the methods and outcomes are perceived from within a researchers’ discipline. A template for peer-review is available and a guide for researchers and reviewers can be found here. 

Researchers should develop a plan of how they will extract, capture, and manage data before commencing a project. They should also explain why the volume of data requested is required, and therefore consultation with a statistician may be necessary for assistance with sample size calculations.

Nomenclature is also important when data are considered, definitions for data types can be found here. For example, whether data are confidential, sensitive, identifiable, or anonymous need to be made clear from the outset. Terms such as de-identified and anonymous are not interchangeable, although they can be confused. Researchers may find this guideline from the Office of the Information Commissioner Queensland useful when considering their access to data and what de-identification means.

Collecting data directly from a participant via informed consent is considered by many as the gold standard for data collection in research. In this case an individual explicitly consents to the use of selected data for a research project. People may also consent to the use of their data for future projects, or in the case of parents and guardians, the use of other peoples' data.

Researchers will carefully plan data collection, understanding that their study hinges on robust data collection. Various tools can be used to collect and store data, some researchers will use generic platforms e.g., spreadsheets while others prefer specific applications e.g., REDCap.

For research activities with HREC approval and SSA authorisation, QH-REDCap is now available for Gold Coast Health staff. Please complete this application form to commence the process. If there are any queries, please contact Technology Operations on gcclinicalinformatics@health.qld.gov.au. 
 

How researchers plan to manage their data can be overlooked, but it is integral to protecting the researcher, the organisation and importantly, the participants and their data. Detailing who will have access, where it will be stored, how it will be destroyed (and when) should be considered at the start of a project. Further details, including examples, are available here on the importance and the practicalities of developing a robust data management plan. A comprehensive data management plan is required for all research project proposals submitted to Gold Coast Heath.

Data management throughout the research activity must be in accordance with the National Statement on Ethical Conduct in Human Research (2007) – updated 2018, noting in particular Chapter 3.1, Element 4: Collection, Use and Management of Data and Information.

All research projects should have a well-developed data analysis plan prior to submission for ethics approval. The data analysis plan should be detailed in the protocol, and be written in a way that others could replicate. Taking the time to formulate a data analysis plan before commencing their study will ensure researchers can best answer their research question. Gold Coast Health has biostatistician services available to assist staff plan and execute their projects.

Extracting data from other sources, e.g., patient records, can also be approved via other mechanisms. Access to data held by Queensland Health is protected under the Information Privacy Act (2009), the Hospital and Health Boards Act (2011), the Public Health Act (2005), the Guardianship and Administration Act 2000 (Qld), and the Coroners Act 2003 (Qld). A comprehensive list of requirements and items for Queensland Health researchers to consider regarding the secondary use of data are available here.

Queensland Health provides information on research and reports for current research projects, ethics and governance, intellectual property, available data sets, including how to request data through various avenues (open data, clinical, hospital and patient data, and Public Health Act (2005)). 

Data Custodians manage and maintain data throughout each stage of its lifecycle.

Researchers are strongly encouraged to engage with Data Custodians during the design phase of their project to determine which data can be used for research purposes.

The Data Custodians can advise researchers which data are readily available and which will require more time-intensive processes, e.g. a medical chart review. They can approve or decline the access to data prior to ethics submission and allow researchers to determine whether their project is feasible. The members of the research team and the type of study conducted are factors a Data Custodian must consider when access to data is requested.

The list of Data Custodians across Queensland Health is available here (accessible on the QH network only).

If data were collected for another purpose e.g., medical records, they generally cannot be used for research without permission. Although clinicians access medical records for patient care, and may access them for quality assurance projects, their use for research will in most cases require ethical approval and authorisation by the relevant Data Custodian.  

When conducting research, unless specifically advised, researchers should not access data themselves, instead they should request datasets from their relevant Divisional Analytics & Reporting Team or Data Operations. In addition to providing the data, these teams can advise researchers which data are available, who holds them, and whether manual extraction (chart review) is required. Researchers can also be advised how the data can be provided to them, including whether they can be de-identified or anonymised for use. 

The use of ieMR data is commonly requested by researchers at Gold Coast Health. The Data Custodian for this dataset can be accessed by emailing GCHHIM@health.qld.gov.au. But there are many other sources of data that can be accessed, find the list of Queensland Health Data Custodians in the box above. To enquire about the availability and permission to access data for research, the pre-submission data access request form can be completed by the researcher and the relevant Data Custodian. This can be completed prior to ethics application and may provide researchers with reassurance that the data they need are available to them and their team. Once completed, it can be submitted as part of their ethics application. 

To use confidential health information without consent some research projects require application under Section 280 of the Public Health Act (2005), commonly called a ‘PHA application’. Further information about this process is available here. 

A waiver of consent can be requested by researchers – this may be for projects considered either low- to negligible-risk through to medium-high risk. In either case, a waiver of consent must be justified against the criteria listed in the National Statement (Chapter 2.3.10), so researchers will need to detail why their request should be approved. It is a requirement to publish the list of projects with approved consent waivers. These are available here.

The research question should be something that needs answering. Something that is important to the end users of the research; in health this is often consumers. Involving consumers early in a research study can significantly benefit researchers, as it improves the likelihood that the project is relevant to those who will benefit most from it.

For research to have an impact it must be used and therefore how research-findings can be implemented into practice needs to be considered when planning a project. To that end, Queensland Health have also mandated in a Health Service Directive that all research applications include a statement about how their research will translate into practice.

Planning, and ultimately reporting, the impact of research is encouraged. The National Health and Medical Research Council (NHMRC) recognises four specific types of impact: knowledge, health, economy and society, available here. It is recommended that researchers articulate the type of impact their research may have during the planning phase.

A helpful approach to clearly determine what a researcher will investigate is the PICO(T) acronym:

      
By first determining who and what will be investigated, researchers can then form a suitable working question e.g. In adults with knee pain (P) is paracetamol (I) or ibuprofen (C) more effective in reducing pain (O) within one-week (T)?

The clinical problem being investigated, and the question used, will guide the type of study required. Using the above example on knee pain, researchers would need to consider a clinical trial to answer their question. If the research question relates to the diagnostic accuracy of a test or the risk factors for developing a condition, then a different study design is required. Taking the time to explicitly establish a question will enable a researcher to appropriately design their study. 

It is recommended that the researcher determines if this question has already been answered or is already being investigated elsewhere. Resources from Open Science Framework (all research) and PROSPERO (systematic reviews) provide researchers with information on whether their question is already being investigated by others. A flow chart of proposed steps for researchers to use during the planning phase is presented in Figure 1.

Figure 1: Steps a researcher may consider when developing an idea for a study

Based on the review of literature that further research is needed, a researcher should then turn their thoughts to how this will be answered – the how, the what, and the who.

How will the research question be answered? Which study design might best answer the question?

What resources are needed? This includes equipment, time, funds, and (potentially) participants. Are existing data available, or will new data be required, and how will the data be accessed? How many participants are needed to answer the question?

Who needs to be involved to make the research project a success? This includes having the right mix of people to conduct the study (e.g., clinical experts, methodologists, statisticians etc), but also consumers and other research related personnel. Collaboration with Gold Coast Health academic partners (Griffith University, Bond University, and Southern Cross University) can assist researchers by providing academic stewardship and expertise to projects that may not be readily available, especially within emerging research areas.

Building a team that can answer the question is fundamental. It’s rare that a researcher will conduct a clinical study in isolation. Utilising the experience and expertise of a range of people is encouraged, and this should be done in the planning phase. This may include: clinicians, basic scientists, statisticians, academics, industry, and health economists. Even for highly-experienced researchers, projects can be used as an opportunity to build capacity and capability in junior researchers.

In addition to the above, engaging with consumers and community is now strongly encouraged across research. From question development, design, execution, and dissemination, researchers should consider involving consumers in their research. Gold Coast Health also has a Consumer Advisory Group that researchers may also wish to engage with. Further advice and recommendations on how to meaningfully engage with consumers can be found here.

Research can be expensive. Even small items such as postage and printing need to be funded from somewhere. Equipment, payment for consumers and/or parking, and transcription of interviews may also be required. If research personnel, such as research assistants and external statisticians are needed, then a research grant is generally required. More information on grants is available here.     

Researchers should also not forget about their time, especially if it will be conducted during work hours. Further details on how to appropriately account for time (funded, in-kind, no-cost) is available in the research budget guide. All research conducted at Gold Coast Health requires an approved study budget. A guideline to assist researchers develop their budget is available here. 

Researchers should consider how feasible it will be to recruit participants. Research on common ailments can often be completed at one site, but for niche areas or infrequent injuries or diseases, researchers may need to consider multi-site studies or factor in the additional time required. Recruitment rates are often overlooked during the planning phase, but researchers should provide realistic recruitment estimates, ideally based on local data.

If researchers plan on utilising existing data, participant recruitment is not a consideration. But suitable planning on the type of data and where it can be obtained are needed, further details on data access is available here.

All research will expose some level of risk: Risk to participants; Risk to the institution(s); Risk to Investigators. Prior to conducting a research project, researchers should perform a robust risk assessment to evaluate the likelihood and consequence each risk may pose. Gold Coast Health has provided consequence, likelihood, and risk-rating tables for use (below). Risk is intensified during clinical trials, and for this reason, monitoring is undertaken by Gold Coast Health to ensure the identified risks are appropriately managed. Researchers should work through the four steps to determine a risk rating for potential hazards.

Step 1: Determine the consequence using the ‘worst case’ outcome should the risk event occur.

Step 2: Determine how likely a risk is, or how often a risk could be expected to occur. Likelihood can be assessed quantitatively as a probability percentage (%), or qualitatively using the descriptors and frequency for each risk type.

Step 3: Determine the risk rating by multiplying the risk consequence with the likelihood level on the Gold Coast Health Risk Analysis Matrix.

Step 4: Use the Risk Analysis Matrix by selecting the worst credible consequence and its likelihood to determine the risk rating.