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Monitoring of Approved Research Policy

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Section 1 - Purpose

(1) The purpose of this Policy is to outline how approved research is monitored by the University and the University Review Bodies to support Research Governance (Research Governance Framework) and the responsible conduct of research (QUT Code for Responsible Conduct of Research).

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Section 2 - Application

(2) Monitoring of approved research applies to all research activities undertaken by staff (regardless of employment type), students and visitors within or in association with QUT (including use of QUT facilities by external entities) that requires review and approval from a University Review Body and/or other review body.

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Section 3 - Roles and Responsibilities

Position
Responsibility
Head of Research Portfolio
Responsible for ensuring that approved research is monitored.
Approves clinical trials regulated by the Therapeutic Goods Administration (TGA) involving QUT investigators.
Executive Director, Office of Research Services
Manages sponsor responsibilities for clinical trials where QUT is the Sponsor.
Director, Office of Research Ethics and Integrity
Oversees the conduct of QUT’s monitoring obligations under the Australian Code, National Statement, Scientific Use Code, Good Clinical Practice (ICH/GCP), and the Gene Technology Act 2000 and associated regulations.
Executive 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
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.
Responsible for ensuring that clinical trials are adequately monitored.
University Review Body
Committee responsibilities are described in the respective committee charters:
  1. University Human Research Ethics Committee;
  2. University Animal Ethics Committee;
  3. University Biosafety Committee.
Staff, students, honorary QUT title holders and visitors involved in research activities
Share responsibility and accountability for the University’s research being conducted according to appropriate regulatory, ethical and scientific standards.
Provide authorised QUT staff, University Review bodies and external regulators access to research related records.
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Section 4 - Relationship to TEQSA Threshold Standards

(3) This Policy assists the University to satisfy the provision of standards within 4.1 Research, specifically Standard 4.1.1a and 4.1.2 of the Higher Education Standards Framework (Threshold Standards) 2021.

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Section 5 - Policy Principles

(4) Monitoring of approved research is a component of QUT's Research Governance Framework and QUT's commitment to the Australian Code for the Responsible Conduct of Research, 2018 ­(Australian Code), the National Statement on Ethical Conduct in Human Research 2023 (National Statement), Australian Code for the Care and Use of Animals for Scientific Purposes, 2013 (Updated 2021) (Scientific Use Code), Gene Technology Act 2000 and the requirements of other external regulators.

(5) Monitoring of approved research is part of a wider project monitoring program conducted by the university to ensure research is conducted responsibly, ethically, with integrity, and complies with institutional and regulatory requirements in a manner approved by a review body.

(6) Monitoring of approved research is conducted in accordance with the principles of QUT’s Research Governance Framework.

(7) Procedures for monitoring approved research aim to foster education and promotion of ethically responsible research practices.

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Section 6 - Obligations

(8) Research that is reviewed and approved by a review body must comply with University policy and all relevant legislation and regulatory guidelines.

(9) Monitoring is the mechanism by which:

  1. the University meets its obligations to monitor approved research for which it is responsible;
  2. the University meets its obligations to promote and support a high level of research governance practice and support responsible, ethical research conducted with integrity; and
  3. the University meets its sponsor responsibilities for QUT sponsored clinical trials.

(10) All individuals conducting research associated with the University must maintain adequate records relating to their research and make these records available to authorised individuals and external regulators involved in the review and monitoring of their research and related activities.

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Section 7 - Frequency and Duration

(11) The frequency and type of monitoring should reflect the degree of risk to research participants, animals and the environment and any regulatory requirements.

(12) 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.

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Section 8 - Mechanisms

University

(13) The University is responsible for ensuring research is conducted responsibly, ethically and with integrity. To achieve this the University exercises appropriate quality control and risk management of approved research, including compliance with the following processes throughout a project’s duration.

  1. Health, Safety and Environment;
  2. Contracts and Legal Instruments Management;
  3. Indemnity and insurance;
  4. Finance (Budgets and Grants);
  5. Management of Research Data and Primary Materials;
  6. Conflicts of Interest;
  7. Responsible research practices;
  8. Trade Controls for Goods, Software, Technology and Services
  9. Defence Industry Security Program (DISP).

(14) Monitoring may include a wide range of mechanisms and strategies to monitor approved research, including research approved by a University Review Body, non-HREC pathways or other research governance processes (e.g. Administrative Review, Tissue use, Exempt applications). The University is responsible for the selection of approved research projects to be monitored. The Office of Research Ethics and Integrity is responsible for coordinating and conducting post-approval monitoring activities in consultation with the relevant University Review Body.

(15)  Monitoring of specific approved research projects by request may occur, 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.

(16) 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 regulations.  

University Review Body

(17) The University Review Bodies have a role in monitoring research to ensure ethically responsible research practices.

(18) Monitoring is undertaken in accordance with the relevant University Review Body Standard Operating Procedures for monitoring approved research.

Researcher

(19) 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, risks and emergencies.

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Section 9 - Coordination and Efficiency

(20) Monitoring of approved research must be undertaken in a manner that reduces duplication and minimises disruption to the day to day activities of the University.

(21) Where approved research is being conducted under the auspices of QUT and includes additional institutions, the Office of Research Ethics and Integrity in collaboration with the relevant parties (e.g. University Review Body) will make reasonable arrangements to ensure appropriate monitoring occurs.

(22) Where a University Review Body does not review and approve a research project as the lead committee, it will not have a monitoring role with respect to that project and cannot accept the delegation of responsibility from another review body to perform such a role, unless otherwise stipulated (e.g. via a collaborative or inter-institutional agreement).

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Section 10 - Reporting

University

(23) Reports on monitoring activities conducted by the University may be provided to the relevant University Review Body or responsible party, for endorsement and where necessary assistance in addressing recommendations.

(24) Investigators are informed of the outcomes of any monitoring activities in which they are involved and provided the opportunity to comment.

(25) As Sponsor the University must notify the Principal Investigator of the outcomes of all monitoring processes and report to the Therapeutic Goods Administration and other relevant parties any findings that could adversely affect the safety of participants, impact the conduct of the trial or alter the Human Research Ethics Committee approval to continue the trial.

University Review Body

(26) The University Review Body must notify the Chief investigator of the outcomes of any monitoring process.

(27) The University Review Body reports its monitoring of approved research activities annually to the University Research Committee.

Researcher

(28) Researchers must report any adverse events or unexpected outcomes and must notify the University Review Body promptly.

(29) Researchers must provide reports to the relevant review body and the University in accordance with reporting requirements.

(30) For QUT sponsored clinical trials Principal Investigators must report to the Sponsor all significant safety issues, serious adverse events, protocol deviations and any other reporting requirements as outlined in the protocol and in accordance with QUT’s Clinical Trial Standard Operating Procedures.

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Section 11 - Delegations

(31) Refer to Register of Authorities and Delegations (VC165) (QUT staff access only).