• Section 1 - Introduction
• Section 2 - Purpose
• Section 3 - Scope
• Section 4 - Principles
• Section 5 - Roles and Responsibilities
• Research Integrity Senior Manager and Officers 
• Research Integrity Advisors
• Chief Investigators and Research Staff
• Head of School 
• Pro Vice-Chancellor Research and College Pro Vice-Chancellor
• Section 6 - Project Selection 
• Section 7 - Monitoring Approaches
• Section 8 - Scope of Review 
• Section 9 - Reporting and Outcomes 

Section 1 - Introduction

(1) Responsible, ethical, and integrity led conduct is a core expectation of the University of Newcastle (University) and the wider research community. The Australian Code for the Responsible Conduct of Research (the Code) establishes the principles and responsibilities that underpin responsible research conduct in Australia and applies to all research conducted under the auspices of Australian institutions. The University's Responsible Conduct of Research Policy further establishes how the University and its Researchers will comply wtih the requirements under the Code.

(2) The Research Integrity Monitoring and Support (IMAS) Policy establishes a structured, proportionate, and supportive post-approval monitoring program designed to strengthen responsible research conduct and provides the University with assurance that research is conducted in line with approved protocols, regulatory obligations, and the Code.

Section 2 - Purpose

(3) The IMAS Policy is designed to promote a collaborative approach to research oversight, with a strong emphasis on early guidance, education, and tailored support. 

(4) The purpose of this Policy is to provide proactive, risk based post approval monitoring that:

1. supports Researchers to understand and meet their responsibilities for responsible research conduct;
2. facilitates early identification and mitigation of potential non-compliance or emerging integrity risks; and
3. strengthens institutional assurance that approved research remains compliant with ethical, governance and legislative requirements throughout its life cycle.

Section 3 - Scope

(5) This Policy applies to all University approved research projects, including human research, animal research, clinical trials, Indigenous research, industry engaged research and externally funded projects. Projects that are suspended, subject to an active research integrity investigation, or approved by an external review body will not be selected for IMAS review.

Section 4 - Principles

(6) The IMAS program will be delivered using principles of proportionality, fairnesss, accountability, transparency, procedural fairness, and collaboration. 

(7) Monitoring activities will be scaled according to risk and designed to minimise burden on Researchers.

(8) IMAS is not an investigative or disciplinary process. It is a supportive monitoring and assurance activity focused on education, guidance and continuous improvement. 

(9) Standardised tools and processes must be used to ensure fairness and transparency.

(10) Monitoring must be conducted by appropriately qualified personnel with appropriate independence.

(11) Where issues are identified, most are expected to be minor and managed locally. 

(12) The IMAS process does not involve making breach determinations. Where potential breaches of the Code or Responsible Conduct of Research Policy are identified, the matter must be referred to the Research Integrity Office for consideration under the existing Research Breach Investigation Procedure. 

(13) Findings from IMAS activities will be used to strengthen institutional processes and culture.

Section 5 - Roles and Responsibilities

Research Integrity Senior Manager and Officers 

(14) The Research Integrity Office is responsible for overall coordination and governance of IMAS program. Research Integrity Officers are responsible for providing secretariat support to ensure reviews under IMAS are conducted efficiently, consistently, and in accordance with University requirements.

(15) Research Integrity Officers are responsible for:

1. communication and engagement with relevant stakeholders; 
2. working closely with reviewers to support the planning, documentation, and reporting of IMAS activities; 
3. assisting with the coordination of site visits, the secure exchange of materials, and the preparation of review outcomes; and
4. ensuring that findings are appropriately recorded and managed. 

(16) The Senior Manager, Research Ethics and Integrity will: 

1. review and formally endorse outcomes arising from IMAS reviews, to ensure quality and consistency;
2. approve all formal correspondence associated with IMAS activities, including correspondence with stakeholders;
3. review IMAS outcomes to identify opportunities for continuous improvement, including where findings may highlight the need to refine or update existing policies, procedures, or compliance requirements to ensure they are practical, effective, and aligned with best practice. 

Research Integrity Advisors

(17) Research Integrity Advisors (RIAs) are appointed within each School across the University and serve as a key point of contact for guidance, mentoring, and support across all stages of the research life cycle. 

(18) RIAs are responsible for conducting the IMAS reviews and supporting the research team through the review process within their respective Colleges. RIAs also support the implementation of endorsed outcomes and associated actions.

(19) RIAs will engage with the Chief Investigator and research team to obtain necessary documentation to inform their review.

(20) RIAs will conduct a risk assessment, and conduct activities proportionate to risk, which may include document review, interviews, and observation of research practices.

(21) RIAs are responsible for identifying compliance issues, and documenting findings in IMAS review documentation.

(22) RIAs will articulate recommendations and corrective and preventative actions arising from the review and support their implementation.

(23) Where a potential breach of the Code is identified, RIAs will refer the matter to the Research Integrity Office.

Chief Investigators and Research Staff

(24) Chief Investigators and members of the research team must constructively engage with the IMAS program and cooperate with all monitoring activities. Their responsibilities include: 

1. responding to communications and providing requested information in a timely manner;
2. cooperating fully with monitoring activities, including ensuring that information is not withheld, concealed, or misrepresented;
3. where reviews are conducted virtually, providing the designated reviewer with access to relevant information and documentation; 
4. participating in monitoring activities, as requested; and
5. implementing agreed corrective and preventative actions. 

(25) The Chief Investigator will act as the primary point of contact for all IMAS review activities and is responsible for responding to all IMAS outcomes. This includes overseeing the implementation and formal sign-off of any corrective and preventative actions arising from the review process.

Head of School 

(26) The Head of School, relevant to the Chief Investigator, will be formally notified at the commencement of an IMAS review to ensure appropriate School-level awareness and oversight. Where an IMAS review identifies findings, recommendations, or required corrective and preventative actions, the Head of School will be engaged, as appropriate, to support the facilitation of oversight and management.

Pro Vice-Chancellor Research and College Pro Vice-Chancellor

(27) The Pro Vice-Chancellor (Research) (PVCR) and relevant College Pro Vice-Chancellor will be informed by the Senior Manager, Research Ethics and Integrity of any IMAS findings that present an immediate risk, or where there is a potential breach of the Code.

Section 6 - Project Selection 

(28) Research projects may be selected for review through one or more of the following pathways: 

1. random selection, to ensure there is broad coverage of research projects, including the use of a random project number generation applied to an approved project register;
2. risk based or cause triggered, for example, where there are unexpected adverse events, emerging concerns, repeated errors, or associated research integrity matters;
3. governance referral, such as the Animal Care and Ethics Committee or Human Research Ethics Committee Chair and other senior leaders including Heads of School, where there is a demonstrated need based on risk, potential non-compliance or alignment with institutional priorities; 
4. context-based considerations, including where a Chief Investigator is new to their role; and 
5. proactive requests from project Chief Investigators.

(29) Projects that have been suspended or are subject to an open research integrity matter will be excluded from selection. Consideration will also be given to coordinating review activities to minimise burden on research teams, including avoiding selection for multiple reviews in close succession. 

Section 7 - Monitoring Approaches

(30) A range of monitoring approaches will be used to suit different research contexts and risk profiles, including self-assessment checklists, desktop reviews, virtual or in-person site visits for observation of research activities, and interviews with Researchers or participants, where appropriate.

(31) The use of self-assessment tools prepares Researchers for review and encourages reflective practice, while site visits and interviews provide deeper insight into research conduct.

(32) Monitoring frequency must balance assurance with proportionality. Each RIA will typically conduct a minimum of two monitoring reviews per year, subject to risk and capacity. Individual projects are generally not reviewed more than once per year unless a higher risk profile is identified.

Section 8 - Scope of Review 

(33) The scope of a review, determined by the IMAX reviewer based ona risk assessment, is intentionally broad to accommodate the diversity and complexity of research activities across the University. IMAS reviews will encompass all aspects of a research project and may include, but are not limited to:   

1. ethics and regulatory compliance (human, animal, Indigenous research, clinical trials, safety);
2. research governance and management (data management, conflicts of interest, industry engagement, intellectual property, publication practices);
3. funding and financial management consistency with grant conditions;
4. training, supervision and Researcher capability.

Section 9 - Reporting and Outcomes 

(34) Reporting outcomes must be structured, clear, consistent, and proportionate to the issues identified. Outcomes categories include:

1. No issues identified;
2. Minor or moderate issues (administrative issues and improvement opportunities);
3. Serious issues (potential breaches of the Code requiring further consideration).

(35) Minor or moderate issues may be managed by the Chief Investigator and RIA's through local corrective and preventative actions (CAPA), while serious issues are referred to the Research Integrity Office for consideration under the Research Breach Investigation Procedure.

(36) IMAS reports should also document examples of good practice, consistent with the Code’s emphasis on recognising and promoting responsible research conduct.

(37) Chief Investigators must be informed of IMAS outcomes and provided with the opportunity to respond to findings, clarify information, and engage in discussion regarding corrective and preventative actions.

1. IMAS findings may be aggregated and de-identified to inform continuous improvement activities across the University, including:
   1. policy and procedure refinement.
   2. targeted training and education initiatives.
   3. identification of systemic risks or recurring issues.
2. s summary of IMAS findings, including identified trends, outcomes, and escalations, will be provided in the Research Integrity Annual Report.