Numerous policies, guidelines and regulations, at national and international levels, which prescribe best research governance practice to help ensure research is conducted to the highest governance and ethical standards possible.
National guidelines
The principal documents which govern human research in Australia are listed below:
- National Statement on Ethical Conduct in Human Research (2007) – Updated 2018
- Australian Code for the Responsible Conduct of Research (2007)
- Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA comments (2000)
- Access to unapproved therapeutic goods – Clinical Trials in Australia (2004)
- The Australian Clinical Trial Handbook – A simple practical guide to the conduct of clinical trials to international standards of Good Clinical Practice (GCP) in the Australian Context (2006)
- Researcher User Guide
The Mackay Institute of Research and Innovation, supports and encourages Researchers who include Mackay Hospital and Health Service in their projects to also consider implementing this policy when publication occurs.
All Australian publicly funded research outputs will be Findable, Accessible, Interoperable and Reusable. Access to research outputs will accord with international practices that are well defined, secure and trusted, and delivered through sustainable, fair, and efficient dissemination models. Publicly funded researchers will be expected, supported and rewarded to disseminate their work in such a way that anyone can find and re-use research publications and research data for further research, policy development, innovation, education and public benefit.
Policy IMPLEMENTATION
By 2020, Australian publicly funded researchers and research organisations will have in place policies, standards and practices to:Make publicly funded research outputs findable, accessible, interoperable and reusable.
Specifically:
- Make research publications immediately free to read at the time of publication through a range of different strategies, either via a publisher’s website or an institutional or other acceptable public repository.
- Make research data directly related to research publications as open as possible and as closed as necessary, in accord with the Australian Government Public Data Policy Statement.
- Apply Creative Commons licences and utilise international metadata standards to research outputs to ensure accessibility, interoperability and reusability.
- Ensure that authors/creators obtain and retain all necessary rights to enable the authorisation of publication and re-use in any format at any time.
- Support the development of incentives for researchers to make research outputs available in accord with this policy.
- Value and practically support a range of dissemination models, recognising discipline diversity, whilst maintaining a commitment to the principles of this policy.
- Ensure that the application of this policy is in accordance with the Australian Code for the Responsible Conduct of Research and other codes of practice which lay out requirements to disseminate research responsibly, ethically and for the benefit of the Australian and international community.