Deputy Vice-Chancellor and Vice-President (Research)
University Academic Board
Date of Next Review
2.4.1 Policy principles
2.4.5 Roles and responsibilities
2.4.6 Frequency and duration
2.4.8 Coordination and efficiency
THIS POLICY IS CURRENTLY UNDER REVIEW -
Monitoring of research approved by a University Review Body is a component of the QUT's Research Governance Framework (D/2.3) and QUT's commitment to the Australian Code for the Responsible Conduct of Research, the National Statement on the Ethical Conduct of Research, Australian code for the care and use of animals for scientific purposes and the requirements of other external regulators.
Monitoring of approved research applies to research that has been reviewed and approved by a University Review Body and is undertaken to assess that a project is being or has been conducted in the manner proposed to, and approved by a University Review Body and in accordance with institutional requirements.
Research that is reviewed and approved by a University Review Body must comply with the following documents (as relevant):
- Australian Code for the Responsible Conduct of Research (the Australian Code)
- National Statement on Ethical Conduct in Human Research (National Statement)
- Australian code for the care and use of animals for scientific purposes (Scientific Use Code)
- Australian Clinical Trial Handbook
- Note for Guidance on Good Clinical Practice (ICH/GCP)
- Australian Health Ethics Committee Position Statement: Monitoring and Reporting of Safety for Clinical Trials Involving Therapeutic Products
- The Gene Technology Act 2000 (Cth) and The Gene Technology Regulations 2001 (Cth) and corresponding State legislation
- Biosecurity Act 2015
- Defence Trade Controls Act 2012
Monitoring is the mechanism by which the University Review Body meets its obligations to monitor approved research.Monitoring is the mechanism by which the University meets its obligations to promote and support a high level of research governance practice and support responsible research conduct.
Monitoring of approved research applies to all research projects undertaken by staff, researchers, students and visitors that requires review and approval from a University Review Body and/or other ethical review body.
Approved Research means a project ethically reviewed and approved by an ethics review body or other established ethical review process and teaching activities approved by the University Human Research Ethics Committee (UHREC) ,University Animal Ethics Committee (UAEC) or University Biosafety Committee (UBC).
External regulators include the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC), the Therapeutic Goods Administration (TGA), the Queensland Department of Agriculture and Fisheries (DAF), the Office of Gene Technology Regulator (OGTR), Defence Export Control Office (DECO), Department of Foreign Affairs and Trade (DFAT) and the Department of Agriculture (DAg).
Lead Committee is defined as the committee who is allocated to undertake review and approval of a research project.University Review Body means the University Human Research Ethics Committee (D/6.5) and approved review processes, University Biosafety Committee (D/6.6) and University Animal Ethics Committee (D/6.7).
Deputy Vice-Chancellor and Vice-President (Research) has responsibility for ensuring that approved research is monitored and for approving clinical trials regulated by the Therapeutic Goods Administration (TGA) where QUT is undertaking a clinical trial.
Executive Director, Office of Research Services has operational responsibility for monitoring financial and contractual requirements for research and commercial projects in conformity with internal and external obligations and the maintenance of research performance data which is used for QUT’s statistics collection and reporting.
Director, Office of Research Ethics and Integrity has operational responsibility for carrying out QUT’s monitoring obligations under the Australian Code, the National Statement and the Scientific Use Code.
Director, Health, Safety and Environment has responsibility for the implementation of health, safety and environment policies at QUT and, through the department's team of health, safety and environment professionals, provides support to University Officers in meeting their due diligence duty under the legislation.
Research sponsors are internal and external entities that provide funding or in-kind support to a QUT research project and include commercial companies, collaborative research groups and government entities. Research sponsors are responsible for ensuring that clinical trials are adequately monitored.
The frequency and type of monitoring should reflect the degree of risk to research participants, animals and the environment.
Monitoring of approved research begins upon approval of the research and continues throughout the lifecycle of the research project, including the closure of the research project, communication of individual results and publication of outcomes.
(a) University Review Body
Procedures for monitoring approved research should foster education and promotion of ethically responsible research practices.
The University Review Body may delegate its monitoring obligations to the Office of Research Ethics and Integrity for the purposes of coordinating and conducting monitoring activities.
Monitoring will be undertaken in accordance with the University Review Body Standard Operating Procedures for monitoring approved research.
To ensure the University exercises appropriate quality control and risk management of approved research, it must comply with the following processes throughout the project’s duration.
- Health and Safety (A/9.1)
- Management of contracts, deeds and memoranda of understanding (A/1.6)
- Indemnity and insurance (A/7.1)
- Finance (Budgets and Grants)
- Management of research data and primary materials (D/2.8)
- Conflicts of Interest (B/8.7)
- Defence Trade Controls Act 2012 (Cth) and Autonomous Sanctions Act 2011 (Cth)
The University may request monitoring of an approved research project in consultation with the University Review Body unless there are actions or risks associated with the research that can be dealt with under another mechanism i.e. health and safety, fraud and corruption, misconduct.
Where the University is the sponsor of an approved research project (e.g. clinical trial), it is responsible for implementing and maintaining quality assurance and quality control systems to ensure that the research is conducted and data are generated, documented (recorded), and reported in compliance with the protocol, good clinical practice and relevant regulatory compliance.
Chief Investigators are ultimately responsible for ensuring appropriate procedures for monitoring are in place, providing reports, maintaining records and taking prompt actions in response to unexpected adverse events, risk and emergencies.
Monitoring of approved research must be undertaken in a coordinated approach that minimises duplication and unnecessary disruption to the day to day activities of the University.
Where approved research is being conducted under the auspices of QUT and includes additional institutions, the University Review Body in collaboration with the Office of Research Ethics and Integrity will make reasonable arrangements to ensure appropriate monitoring occurs.
Generally, where a University Review Body does not review and approve a research project as a lead Committee, it will not have a monitoring role with respect to that project and cannot accept the delegation of responsibility from an institution to perform such a role.
(a) University Review Body
The University Review Body must notify the Chief Investigator of the outcomes of any monitoring process.
The University Review Body reports its monitoring of approved research activities annually to the University Research and Innovation Committee.
Any adverse outcomes from a monitoring review and any corrective actions are reported to the Risk and Audit Committee.
Researchers must report any adverse events or unexpected outcomes and must notify the University Review Body promptly.Researchers must provide reports to the relevant University Review Body and the University in accordance with reporting requirements.
MOPP A/7.1 Indemnity and insurance
MOPP A/9.1 Health, safety and environment
MOPP D/2.3 Research governance framework
MOPP D/2.8 Management of research data and primary materials
MOPP A/1.6 Management of contracts, deeds and memoranda of understanding
Standing Operating Procedures – University Human Research Ethics Committee (UHREC)
Standing Operating Procedures – University Animal Ethics Committee (UAEC)
Standing Operating Procedures – University Biosafety Committee
|12.12.18||D/2.4.5||Deputy Vice-Chancellor (Research and Innovation)||Revised to include department name change to Office of Research Services|
|13.11.15||All||University Academic Board||New policy|