In 2018 the National Statement on Ethical Conduct in Human Research (2007) and the Australian Code for the Responsible Code of Research (2007) were updated. These guidance documents set out the principles for research ethics and integrity. At the recent PACE CoP session, Nicola Myton gave an overview of the Australian research regulatory framework and discussed the question:
The National Statement on Ethical Conduct in Human Research and the Australian Code for the Responsible Conduct of Research are guidance documents located in a broad system of research regulation. This system includes national and state legislation, national and international guidelines, and internal and external policies. This system shapes the interactions of institutions, researchers, research participants and research administrators.
A couple of key things to remember:
- The National Statement and Australian Code are guidelines. They are not rules or legislative instruments. They provide guidance on the conduct of ethically good research conducted with integrity. Researchers and institutions have to exercise discretion when designing, implementing or reviewing research as to how these principles will be best achieved.
- Whether a project requires ethical approval should not determine whether a project is conducted ethically. The principles outlined in these documents can be applied to projects that do not require ethical approval.
What’s new in the National Statement?
The major changes are in Chapter 3.1 The Elements of Research. This Chapter attempts to reconcile the four principles – justice, beneficence, merit and integrity, and respect – with three potentially conflicting objects: protecting the privacy of research participants; maintaining good research records; and enabling new research to be built on previous research.
This is primarily addressed in Element 4 on the collection, use and management of data. Advice is provided on practical steps about how to ensure participant privacy is protected while ensuring research records are maintained and research data can be fit for reuse.
What does this mean for PACE?
When considering PACE-related research, frequently asked questions include:
- Do partner organisations need ethics approval for projects that involve data collection from human participants, especially if Macquarie students are working on the project?
- Do academics doing a consultancy require ethics approval for projects that involve data collection from human participants?
- In PACE, often projects begin as a student activity or consultancy, but later have the potential to become academic research. When and how should we seek formal ethics approval in this context?
Because the National Statement and Australian Code are principles-based, these documents may not always provide a clear and simple response to the question of whether ethical review and approval is required. Some questions that may be useful when considering whether a project needs ethical approval include:
- Who does the project belong to? Under whose auspices is it conducted? Does Macquarie University govern this project?
- Who owns and manages the data that is collected? Who owns the IP? Who will be publishing and reporting on the data? Will the student be publishing under the auspices of the University or the partner organisation?
- What is research, and who is a researcher? We often use these words loosely, but the National Statement is targeting a specific audience and it is worth considering whether the project constitutes academic research.
- What is the level of risk to participants and researchers? Negligible, low risk, or higher risk?
In responding to these questions it’s important to look at each project based on the principles in the guidance documents and to consider things on a case-by-case basis. It is also worth remembering that the ethical design of projects and data collection, regardless of whether the project needs HREC review and approval, is always beneficial and will help create a more robust project.
In addition, PACE research might begin as activities or consultancies and then become research. Therefore, it’s best to prepare on the basis that things can change. This could include having a clear and documented process for consent and data management and storage, and a clear record of data provenance and governance. We are also currently creating a suite of resources to help unit convenors, students and partners when they encounter questions about research governance and ethics, mainly to help guide principles-based decision making regarding the conduct of research projects. These will be announced when available.
PACE has developed responses to FAQs based on inquiries about when ethical approval might be required.
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