Every study needs a well-written, comprehensive research protocol. All research, including low-risk studies, require a protocol with sufficient detail for ethical, governance, and methodological appraisal. Even Quality Assurance and Improvement projects, along with clinical audits, should be grounded with a well-designed protocol.
The protocol should be considered a living document and if researchers need to adjust or amend their processes related to their project, an updated protocol will be required. In some cases it is necessary or expected to register a protocol, further information is available here.
Preparing a research protocol
The Gold Coast Health protocol template provides researchers with a step-by-step guide on how to complete the necessary background work for their project.
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.
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.
In order to improve and refine project design and proposed outcomes, researchers are encouraged to submit their protocol for peer-review.
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.