Research integrity is a way of thinking and behaving that ensure that research undertaken is trustworthy.

Melbourne Health (MH) is committed to supporting a research culture that encourages responsible research practices based on the principles of research integrity. Responsible research practices guide researchers in the conduct of their work as well as in their engagement with the practical, ethical and intellectual challenges inherent in research.

Principles of research integrity

  • honesty and integrity.
  • respect for human research participants, animals and the environment.
  • good stewardship of public resources used to conduct research.
  • appropriate acknowledgment of the role of others in research.
  • responsible communication of research results.

MH responsibilities

  • promoting the responsible conduct of research.
  • establishing good governance and management practices.
  • providing inductions, training and continuing education for all research staff and students.
  • promoting effective mentoring and supervision or research staff and students.
  • ensuring researchers have access to a safe working environment in which to conduct each research project.

Researcher responsibilities

All MH staff and affiliates, including students, who are involved in research associated with the MH should:

  • conduct research safely.
  • adhere with ethical standards.
  • respect research participants, animal used in research and the environment.
  • participate in ongoing training programs including in research integrity.
  • provide mentoring, training and support of fellow researchers including new researchers.
  • disclose financial or other conflicts of interest.
  • employ appropriate methods and use a high level of rigour and objectivity in research activities.
  • manage research data responsibly including making and securely storing complete, clear, attributable, accurate and enduring records of all research.
  • share findings and data openly, honestly and promptly, as soon as they have established provenance, ownership claims and if there are any barriers to sharing the data such as legal requirements of contracts, intellectual property claims, or the uniqueness of the data may lead to privacy issues.
  • appropriately cite and, where applicable, obtain permission for the use of all published and unpublished work.
  • acknowledge in research outputs all contributors and contributions to the research described in the research output.
  • be listed as an author of a research output only when they have made a significant intellectual or scholarly contribution that they are willing to be accountable for and agree to be listed as an author.
  • participate in the peer review process. Give fair, prompt and rigorous evaluations, and respect confidentiality when participating in peer review.
  • respect Aboriginal and Torres Strait Islander heritage in ways that promote Aboriginal and Torres Strait Islander cultures and understanding and respect between indigenous and non-indigenous Australians in the conduct of research in Australia.
  • provide complete and accurate information in all research applications including ethical, governance and funding applications and related documents.
  • use funds for research in accordance with relevant funding agreements.
  • ensure future use of research results are in accordance with applicable requirements and permissions.
  • seek advice and discuss any concerns about the conduct of research with research integrity advisers and report any suspected research misconduct.

These principles and responsibilities are influenced by the Australian Code for the Responsible Conduct of Research (2018) and the Singapore Statement.

Responsible Conduct of Research

MH requires research practices conducted under our auspices to be ethically sound and have integrity.

All MH staff and affiliates, including students, who are involved in research associated with the MH should be familiar with and must comply with:

Further, it is the responsibility of staff in supervisory positions to ensure that staff and students involved in research projects at MH have the appropriate education, training, experience, mentoring and support to conduct quality research, safely and responsibly.

Who Can I talk to for advice & support?

For advice, support or further information about the policies, guidelines and codes that apply to researchers at the MH, you can talk to any of the following:

  1. Office for Research
  • By calling 9342 8530
  • By email research@mh.org.au
  1. Research Integrity Advisor (RIA)

MH’s RIAs are a key resource for advice and support with regard to research integrity and misconduct, and also MH’s processes and procedures related to research integrity. RIAs are able to provide advise on research integrity and misconduct matters to any member of the MH community.

For more information on RIAs and what do they do visit the RIA webpage.

Contact list for MH RIAs [link to list]

Research integrity matters

At MH research integrity matters.

MH is committed to supporting a research culture that encourages and nurtures responsible research practices. Responsible research practices guide researchers in the conduct of their work as well as in their engagement with the practical, ethical and intellectual challenges inherent in research.

The information and resources listed below are not exhaustive and researchers should seek further information as required.

Research Governance

Research governance is a framework through which organisation 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 and involves the organisation undertaking a feasibility review of all aspects of the study. 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 projects may not commence until after written approval of the site-specific research governance application has been issued by the Office for Research.

Elements of research governance include but are not limited to:

  • Review and approval of all research conducted at MH.
  • Sponsorship activities for MH investigator initiated clinical trials.
  • Financial Management: The budget for all research projects undertaken by staff of MH or involving MH resources must be reviewed and approved by the Management Accountant Research.
  • Grant Management: All applications for research grants to be administered by MH must be submitted to the relevant funding body through the Office for Research. Researchers are not permitted to directly submit applications to funding bodies.
  • Agreements: all MH projects that involve and external party (i.e. are collaborative, use external providers, share data/tissue) require execution of an appropriate agreement before research can commence.
  • Insurance.
  • Indemnities.
  • Personnel resources: adequate numbers of appropriately trained personnel to conduct the project.
  • Monitoring: Monitoring of research is an important means by which MH ensures that research conducted under its auspices is conducted in accordance with good clinical practice and approved ethical guidelines as well as MH requirements. Upon request, the Principal investigator should make available all project related records.

In submitting the MH site specific research governance application and signing the Declarations section of the SSA Form, the Principal Investigator, other investigators and the relevant approving Head of Department(s), each confirm and acknowledge their respective responsibilities to comply with all relevant requirements including the Australian Code for the Responsible Conduct of Research (2018), including all associated guidelines and the Melbourne Health suite of research policies, guidelines and standard operating procedures.

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Research Approvals

All research and quality assurance projects undertaken at MH or involving MH staff, patients or resources must be submitted to the Office for Research for review and approval prior to commencement.

Site-specific research governance approval

Research projects MUST not commence at MH until after written approval of the site-specific research governance application has been issued by the Office for Research.

For more information on research governance or to submit a MH site-specific research governance application go to the Research Governance webpage.

Approval of studies involving human research

National Statement on Ethical Conduct in Human Research (2007 updated 2018) requires each project involving human research to have ethical approval prior to starting. This is consistent with the principles of international ethical statements; the Declaration of Helsinki (1964) and the Nuremberg Code (1947).

All projects involving human research must be reviewed and approved by the MH Human Research Ethics Committee (HREC) or other National Health and Medical Council (NHMRC) National Mutual Acceptance (NMA) review accredited HREC before approval of the site-specific research governance can be finalised.

Note: Any projects involving human participants and genetically modified organisms (GMOs) must also be reviewed by an accredited Institutional Biosafety Committee (IBC).

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Approval of studies involving research with Genetically Modified Organisms

All projects involving genetically modified organisms that require regulation must receive site-specific research governance application approval before research activities can start at MH.

All projects involving genetically modified organisms that require regulation must also:

The IBC must be registered with the Office of the Gene Technology Regulator (OGTR) and have experience and technical expertise to review a specific application.

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Approval of studies involving animal research

All projects involving animals must receive site-specific research governance application approval before research activities can start at MH.

All projects involving animals must also:

The reviewing AEC must be constituted and operated in accordance with the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes and have experience and technical expertise to review the application.

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Data and records

MH recognises that data are a valuable product of research that should be appropriately managed. Good data management practices should be followed throughout the research data lifecycle and are essential to support data integrity.

Research data and metadata must be collected, stored, retained, used and disposed of in a manner that protect the rights, safety, and well-being of the research participants and the wider community, maintains data integrity and is in accordance with all applicable requirements (including MH, legislative, guidelines, legal, ethical, and funding bodies’, study agreements etc.) at each stage of the data lifecycle.

Research staff must plan and document data management requirements and processes for each study as soon as the study planning activities begin i.e. with the start of protocol development or on approach to participate in a research study by an external party (collaborator or commercial sponsor for a feasibility review).

New data management rules introduced by the ARC require that most grant applications contain information about how project data will be managed and shared.

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Peer review of research study protocols

The National Statement on Ethical Conduct in Human Research (2007 updated 2018) requires each institution to be satisfied that human research receiving ethical approval meets relevant scholarly or scientific standards. An important aspect of this assurance is evidence of peer review of the scientific merit of the research protocol.

At MH a peer review is required for all research studies i.e. human research, animal research and research using genetically modified organisms.

Peer review of the research protocol should occur before the study application is submitted to the reviewing committee; MH Human Research Ethics Committee (HREC), Institutional Biosafety Committee (IBC) or Animal Ethics Committee (AEC).

Peer review is the independent and impartial evaluation of work by one or more people with similar competences and discipline. It functions as a form of self-regulation by qualified members of a profession within the relevant field of study. Peer review is also a useful opportunity to improve quality, performance and provide credibility.

Researchers have a responsibility to take part in the peer review process including peer review of applications ethical for ethical approval, grant proposals and publications.

When participating in peer review:

  • Researchers must provide fair, unbiased, prompt and rigorous evaluations.
  • All potential conflicts of interest should be declared to ensure the process is transparent, independent and impartial.
  • Respect confidentiality of all information under review and not use or disclose the information.
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Statistical Reviews of research study protocols

Each research project must be carefully designed to ensure that the methods proposed can answer the research question.

The purpose of the statistical review is to determine if the proposed research is well designed.

All human research protocols will require statistical review before submission to the MH Office for Research, and evidence of this review must be submitted with the application. The MH Health Human Research Ethics Committee (HREC) will not accept for review projects that do not fulfil statistical review requirements.

Investigators must allow sufficient time to find a reviewer, allow the reviewer to conduct the statistical review and to address the reviewer’s comments adequately, prior to submission to the HREC.

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Research Education and Training

The success of any research study depends on highly trained study teams.

All persons conducting research at MH must be appropriately qualified, trained and experienced for their role, and must participate in ongoing training and education appropriate to their role including Good Clinical Practice (GCP), regulatory practices, consent, ethics and any other training appropriate to their role.

The Office for Research supports the ongoing education and training of its researchers and study staff by providing a range of education and training options.

Refer to the Education and Training webpage for further information and links to training including GCP training requirements and online research integrity training.

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Environmental health and safety

All MH staff and affiliates are responsible for conducting activities in a safe manner, maintaining a safe work environment and appropriately responding to and reporting any incidences.

Refer to the MH Occupational Health and Safety webpage

Conflict of interest

What constitutes a conflict of interest?

The Australian Code for the Responsible Conduct of Research (2018) defines conflict of interest as:

“A conflict of interest exists in a situation where an independent observer might reasonably conclude that the professional actions of a person are or may be unduly influenced by other interests.”

Conflict of interest is a serious issue in research as it can compromise the validity of the research process by influencing impartial judgment.

While financial conflicts of interest are foremost in the public mind, other potential conflicts of interest include political or philosophical commitments, private benefits significantly dependent on research outcomes and significant personal or professional advantage.

A perception that a conflict of interest exists can be as serious as an actual conflict, raising concerns about the integrity of individuals or the management practices of the institution. For this reason, the possibility of a perceived conflict of interest must be treated as though the conflict exists.

Researchers are responsible for identifying, disclosing and managing potential or perceived conflicts of interest.

Researchers should disclose any potential conflict of interest that may influence or be seen to influence any aspect of the conduct of the research at the time of proposing and of reporting research. This responsibility extends to matters related to research including investigations, publication, media reports, grant applications, and applications for appointment or promotion.

Provide details of the actual or potential conflict of interest in the space provided below, including any:

  1. Personal involvement or participation in the research
  2. Financial or other interest or affiliation, or
  3. Involvement in competing research

Disclosing conflicts of interest:

Disclose conflicts of interest via:

  1. Ethics applications - conflicts of interest should be disclosed in the ethics application documentation via the HREA form
  2. Site-specific research governance application - conflicts of interest should be disclosed in the governance application via the Site-Specific Application form
  3. MH Gift and Benefits register - includes conflicts of interest
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Publications and research communications

Publication is an essential part of the research process. It informs other researchers, professional practitioners and the wider community of the results of the research. Although the formal publication of the results of research will usually take place in academic journals or books, this may not always be the case.

MH is committed to promoting an environment of honesty, integrity and accuracy in publishing.

It is the responsibility of researchers to disseminate research findings responsibly, accurately and broadly.

The principles underpinning responsible research communication are honesty, accuracy, transparency and openness. This may include reporting results contrary to hypotheses and where necessary, take action to correct the record in a timely manner.

Before publishing research findings, researchers are responsible for ensuring due consideration for any restrictions and responsibilities associated with the research, such as those related with confidentiality, intellectual property, copyright, potential for dual use and any other relevant requirements to ensure that the rights of parties involved in the research are protected.

Additional responsibilities associated with publication and communication of research include:

  • appropriate acknowledgement of authors
  • obtaining peer review
  • disclosing of conflicts of interest
  • acknowledgement of research funding and sources of financial support
  • acknowledgement and citing the work of others and your own work,
  • limiting professional comments and advice to recognised expertise when engaged in public discussions

Redundant publication, where the publication of work that overlaps substantially with that already published, or that is intentionally subdivided into smaller units to increase scholarly productivity, is not acceptable, except where each subsequent publication fully cross-references and acknowledges the earlier work.

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Authorship

Authors are responsible for the publication of the results of research.

Authorship should honestly reflect the contribution to the work being published.

Authorship should be in accordance with the Australian Code for the Responsible Conduct of Research (2018) principles including:

  • Principle 4, ‘Fairness in the treatment of others’, which requires researchers to ‘give credit, including authorship where appropriate, to those who have contributed to the research.’
  • Principle 6, ‘Recognition of the right of Aboriginal and Torres Strait Islander Peoples to be engaged in research that affects or is of particular significance to them’, which requires researchers to credit the contributions of Indigenous people and knowledge.

Authorship should honestly reflect the contribution to the work being published.

To claim to be an author requires that a person is directly involved in the creation of the work – conceiving it, analysing and interpreting the data on which it is based, writing or revising its intellectual content, and taking responsibility for it once published.

No person who is an author, consistent with this definition, may be excluded as an author without his or her permission in writing.

Authors should appropriately acknowledge others who have contributed to the research.

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Plagiarism

The Oxford English Dictionary defines Plagiarism the action or practice of taking someone else's work, idea, etc., and passing it off as one's own. Plagiarism is unethical and is a type of intellectual theft.

Plagiarism in research can take many forms, from deliberate cheating to accidentally copying works, theories, concepts, research data, source material (published or unpublished), and duplicate publication (also known as redundant or multiple publication, or self-plagiarism) without acknowledgment of the source.

Common forms of plagiarism include:

  • Direct plagiarism – copying verbatim another work, in whole or in part, without attribution and without quotation marks.
  • Self-plagiarism – is reproducing/duplication of portions of one’s own work in a publication and submitting it for publication as an entirely new paper, without cross-referencing or acknowledging earlier publication(s)
  • Mosaic Plagiarism – Substantial copying or borrowing phrases from a source without permission and acknowledgement or finding synonyms for the author’s language while reproducing the same general structure and essential meaning of the source.
  • Accidental plagiarism - occurs when a person neglects to cite their sources, or misquotes their sources, or unintentionally paraphrases a source by using similar words, groups of words, and/or sentence structure without attribution.

Therefore, whenever the words or ideas of another person are used in your work (publications, reports etc.) include appropriately acknowledge of the source.

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Intellectual Property

Melbourne Health is committed to advancing its research.

In the current climate, commercialisation and exploitation of scientific discoveries or inventions will add significantly to MH’s reputation as a leading research institution.

Researchers should be aware that Patents and Intellectual Property are important components of research. Researchers should be familiar with the MH Intellectual Property Policy 2017. Researchers should liaise with the Director of Business Development at an early stage in the development of research that may have potential Intellectual Property or Patents.

Where external bodies are involved, MH has an obligation to oversee confidentiality agreements to protect intellectual property rights between MH and the external body. MH will work with researchers and the external body to ensure that where such agreements limit free publication and discussion, an approved process is instigated to ensure that limitations and restrictions are explicitly agreed.

Resources [CHECK THESE LINKS]

Monitoring of Research

Monitoring research involves keeping up to date with the progress of a research study. It includes verifying that the conduct of research conforms to the approved proposal and any applicable requirements, is keeping to time lines and budget, and that the research is being conducted ethically.

Findings arising from monitoring should be used to develop corrective and preventative actions where required, to ensure compliance, the rights and well being of participants are protected and the study data are credible.

The requirement for monitoring is embedded into research legislation and guidelines as well as MH policy and guidelines including:

  • Australian Code for the Responsible Conduct of Research (2018)
  • National Statement on Ethical Conduct in Human Research (2007 updated 2018)
  • The Therapeutic goods Act
  • ICH Good Clinical Practice E6R2 (2016)
  • MH policy and requirements

In all instances, monitoring arrangements should be commensurate with the risk, size and complexity of the research undertaken.

Mechanisms for monitoring can include:

  • reports from researchers
  • reports from independent agencies (such as a data and safety monitoring board)
  • review of adverse event reports
  • random inspections of research sites, data, or consent documentation
  • interviews with research participants

Monitoring activities are undertaken by various stakeholders in research including:

  • the Principal Investigator and study team
  • the reviewing ethics committee
  • funding bodies
  • the governing body or research governance organisation
  • the Sponsor (often via the sponsor representative)
  • a Regulator (Therapeutic Goods Administration, U.S. Food and Drug Administration, European Medicines Agency etc.)

Researcher responsibilities

Researchers are responsible for notifying the review body (HREC, RGO, funding body etc.) that mechanisms for monitoring are in place, and for satisfying the review body that the mechanisms are appropriate to the research. This is most often achieved by inclusion of a monitoring plan on the protocol.

Researchers are required to provide progress reports to the HREC, RGO etc. annually, or at more frequent if directed, and including information on:

  • progress to date, or outcome in the case of completed research
  • compliance with any conditions of approval
  • compliance with the approved proposal
  • maintenance and security of records
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Research Integrity Advisors (RIAs)

A RIA is someone in the organisation that you can ask for help if you have questions about research integrity or if you have concerns about the conduct or in collaboration with of research at Melbourne Health.

Find a MH RIA

Go to the RIA webpage for information on:

  • What does an RIA does
  • What does an RIA does NOT do
  • When should to speak with an RIA
  • What you should know and do before meeting with an RIA
  • Confidentiality and meeting with an RIA

Research Integrity FAQs

What is the Australian Code for the Responsible Conduct of Research?

The current Australian Code for the Responsible Conduct of Research 2018 (Code) was jointly developed by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia. The Code has broad relevance across all research disciplines.

The Code provides guidance to institutions and researchers in responsible research practices. It provides guidance on good research practice and how to deal with departures from best practice.

The Code should be read in conjunction with:

What is the Singapore Statement?

The Singapore Statement on Research Integrity (2010) was drafted at the Second World Conference on Research Integrity and is the product of a global effort toward promoting ethical conduct among scientists around the world. The Singapore Statement includes four principles and fourteen responsibilities for the ethical conduct of research. The principles and responsibilities are comprehensive, clear, and thoughtful, and they can play an important role in promoting global research integrity.

When things go wrong: the difference between a breach of the Code and research misconduct

The Australian Code for the Responsible Conduct of Research 2018 (Code) represents the core behaviours that characterise the responsible conduct of research.

A breach is a failure to meet the principles and responsibilities of the Code. May refer to a single breach or multiple breaches. A breach of the Code occurs on a spectrum from minor breaches to those that are more serious.

Research misconduct is a serious breach of the Code which is also intentional or reckless or negligent. Research misconduct does not include honest differences in judgement or minor or unintentional errors which are not dishonest, reckless or persistently negligent.

https://www.nhmrc.gov.au/about-us/publications/guide-managing-and-investigating-potential-breaches-code

Examples of breaches of the Code include, but are not limited to, the following:

i. Not meeting required research standards

    • Conducting research without ethics approval as required by the National Statement on Ethical Conduct in Human Research and the Australian Code for the Care and Use of Animals for Scientific Purposes
    • Failing to conduct research as approved by an appropriate ethics review body
    • Conducting research without the requisite approvals, permits or licences
    • Misuse of research funds
    • Concealment or facilitation of breaches (or potential breaches) of the Code by others

ii. Fabrication, falsification, misrepresentation

  • Fabrication of research data or source material
  • Falsification of research data or source material
  • Misrepresentation of research data or source material
  • Falsification and/or misrepresentation to obtain funding

iii. Plagiarism

    • Plagiarism of someone else’s work, including theories, concepts, research data and source material
    • Duplicate publication (also known as redundant or multiple publication, or self-plagiarism) without acknowledgment of the source

iv. Research data management

  • Failure to appropriately maintain research records
  • Inappropriate destruction of research records, research data and/or source material
  • Inappropriate disclosure of, or access to, research records, research data and/or source material

v. Supervision

  • Failure to provide adequate guidance or mentorship on responsible research conduct to researchers or research trainees under their supervision

vi. Authorship

  • Failure to acknowledge the contributions of others fairly
  • Misleading ascription of authorship including failing to offer authorship to those who qualify or awarding authorship to those who do not meet the requirements

vii. Conflicts of interest

  • Failure to disclose and manage conflicts of interest

iii. Peer review

  • Failure to conduct peer review responsibly

Research misconduct constitutes a failure to comply with:

  • the Australian Code for the Responsible Conduct of Research (2018)
  • MH policies and guidelines
  • other applicable legislation that governs the conduct of research MH researchers.
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