Research governance is a framework through which institutions are accountable for the scientific quality, ethical acceptability and safety of the research they allow to be conducted under their auspices. Good research governance is an essential component of the responsible conduct of research. It enhances ethical and scientific quality, promotes good research practice and accountability, reduces adverse incidents and ensures lessons are learned, thus reducing the likelihood of poor performance and research misconduct.
Research governance is a way of thinking about and managing research and applies to all individuals involved in research – staff and students, in all professional groups, no matter how senior or junior. Research governance is about how research is conducted and aboutfacilitating good, ethical and worthwhile research. It is about responsibility and about managing risk.
Below is a list of the list of the overarching elements of research governance, required to set up and conduct a research project, for the life of a project.
Many of these elements overlap with one another and this is not necessarily an exhaustive list:
- Compliance with legislation, regulations, guidelines and codes of practice.
- Ethical approval.
- Monitoring and auditing of research projects.
- Legal and Insurance – consent, indemnity, agreements.
- Policies for responsible research conduct, research misconduct, monitoring, complaints, conflicts of interest.
- Credentialling, induction, training, accreditation.
- Intellectual property and managing collaborative research.
- Financial management.
- Performance measurement, reporting and planning.
- Risk management.
There are numerous 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. The principal documents that govern human research in Australia are listed below:
- National Statement on Ethical Conduct in Human Research (2007)
- 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)
In addition to being familiar with the principles and requirements of the above guidelines, all researchers at Chris O’Brien must conduct their research in accordance with the Research Governance Policy.