Research code of conduct

Research code of conduct policy

1. INTRODUCTION

This Global Research Code of Conduct Policy (the Code) provides the foundation for responsible, ethical and high-quality research at The George Institute for Global Health (TGI).

The purpose of the Code is to describe the guiding principles for research conducted by TGI and to outline the responsibilities that flow from those principles. The Code is supplemented by a number of Standard Operating Procedures (SOPs) and Associated Documents (ADs), that express the practical application of this policy in the day-to-day operation of the organisation.

This policy is based on the relevant Research Codes of Conduct or equivalent publications for Australia (as allowed under Creative Commons Attribution 4.0 Licence), China, India and the United Kingdom. These references are recorded in section 5 below. Excerpts may not be specifically referenced in each instance.

2. SCOPE

All individuals undertaking any research-related work in any capacity for, or on behalf of, The George Institute (TGI) must comply with the Code. This includes all permanent or temporary employees, students, consultants, contractors, secondees, volunteers, and any other associates undertaking work for or on behalf of TGI.

It should be noted that researchers with appointments at other institutions/universities may have additional responsibilities and obligations in relation to their respective institution/university. It is the individual’s responsibility to be aware of and uphold those obligations.

3. RESPONSIBLE RESEARCH AT TGI

All TGI research must be conducted according to established ethical principles, guidelines for research conduct, relevant legislation and regulations. Research must also adhere to TGI policies and SOPs. This ensures that TGI can:

  • safeguard the individuals participating in our research;
  • protect researchers/investigators (by providing a clear framework to work within);
  • uphold ethical and scientific quality;
  • identify and manage risk;
  • promote good research practice and culture; and
  • maintain the credibility of, and community trust in, research activities.

3.1 Principles of Responsible Research Conduct

The guiding principles for responsible research conduct at TGI are:

Honesty

in the development, undertaking and reporting of research.

Present information truthfully and accurately in proposing, conducting and reporting research.

Rigour

in the development, undertaking and reporting of research.

Underpin research by attention to detail and robust methodology, avoiding or acknowledging biases.

Transparency

in declaring interests and reporting research methodology, data and findings.

Share and communicate research methodology, data and findings openly, responsibly and accurately.

Disclose and manage conflicts of interest in accordance with TGI’s Conflict of Interest Policy.

Fairness

in the treatment of others.

Treat fellow researchers and others involved in the research fairly and with respect.

Appropriately reference and cite the work of others.

Give credit, including authorship where appropriate, to those who have contributed to the research in accordance with TGI’s Authorship Policy.

Respect

for research participants, the wider community and the environment.

Treat human participants and communities that are affected by the research with care and respect, giving appropriate consideration to the needs of underserved or marginalised people.

Minimise adverse effects of the research on the environment.

Recognition

of the rights of all peoples to be engaged in research that affects or is of particular significance to them.

This includes but is not limited to First Peoples, diverse ethnic groups, people from a refugee background, people with disabilities and LGBTQI+ people.

Recognise that factors such as social and historical circumstances, diversity, knowledge, ability, cultural property and connection to land must be considered in shaping how research is undertaken. This includes engaging with communities prior to research so that they freely make decisions about their involvement, and reporting the outcomes of research to those communities.

Accountability

for the development, undertaking and reporting of research.

Comply with relevant legislation, policies and guidelines.

Ensure good stewardship of public and TGI resources used to conduct research.

Consider the consequences and outcomes of research prior to its communication.

Promotion

of responsible research practices.

Maintain knowledge of current best practices in research.

Promote and foster a research culture and environment that supports the responsible conduct of research.

 

3.2 The George Institute’s Responsibilities

TGI is committed to the principles and practice of responsible research, including the following:

  • the provision of the Code and related documents;
  • provision of ongoing training to promote responsible research conduct and integrity amongst all staff involved in research, including trainees and those who supervise trainees;
  •  provision of a Quality, Risk and Compliance Coordinator across TGI offices to assist in the promotion and fostering of responsible research culture and conduct;
  • the provision of clear, transparent, fair and timely processes to receive and investigate complaints about potential breaches of the Code;
  • ensuring that those processes are publicised within the organisation and easily accessible to anyone to whom they apply, including making a summary of complaint processes available on the TGI public website.

3.3 The George Institute as Sponsor

The Sponsor of a project has particular obligations regarding responsible research. The Sponsor is the individual, company, institution, or organisation which takes responsibility for the initiation, management, and/or financing of a research project in an affiliation, collaboration or partnership.

TGI will be a Sponsor in the following scenarios:

  • Peer-review funded projects where the Principal Investigator is employed by TGI
  • Peer-review funded projects where the Principal Investigator is not employed by TGI, but there is an agreement between the Principal Investigator’s organisation and TGI delegating the Sponsor role to TGI.
  • Non peer-review funded projects where the funding body has delegated the Sponsor role to TGI.

All individuals undertaking research activities at TGI where TGI is the Sponsor must ensure that they are fulfilling Sponsor responsibilities.

Sponsor responsibilities are outlined below. ICH-GCP E6(R2) (2016) can be used as a guide to explain the details.

  • Quality management, assurance and control
  • Medical oversight (if applicable)
  • Research project design
  • Research Project management including conflict of interests
  • Data handling and record keeping
  • Investigator selection
  • Allocation of responsibilities
  • Insurance and indemnity
  • Contracting
  • Ethics and Regulatory
  • Intervention management (with or without interventional product)
  • Record access and monitoring
  • Safety reporting
  • Audits and compliance
  • Manage premature termination or suspension of a project if required
  • Research project reports

3.4 Breach of the code

TGI recognises that TGI researchers demonstrate behaviours consistent with the principles set out in the Code. A failure to meet the principles and responsibilities set out in the Code is a breach of the Code. Any suspected or potential breach of the Code will be managed in accordance with GE-SOP-07 Managing Potential Breaches of the Research Code of Conduct.

Breaches occur along a spectrum. The seriousness of a breach will be determined during the processes described in GE-SOP-07. Serious breaches that are “also intentional, reckless or negligent” may be deemed Research Misconduct. Consequential actions for breaches will be determined according to the circumstances and seriousness of the breach.

3.5 References

International

Singapore Statement on Research Integrity (2010). World Conference on Research Integrity.

Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations (2013). World Conference on Research Integrity.

Good Clinical Practice E6(R2) (2016). International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

China

Code for the Responsible Conduct of Medical Research (2014) (医学科研诚信和相关行为规范). National Health Commission.

China Good Clinical Practice (2020) (药物临床试验质量管理规范). National State Drug Administration and National State Health Commission.

India

Ethical Guidelines for Biomedical Research on Human Participants (2017). Indian Council for Medical Research.

India Code of Conduct for Research Scientists Engaged in the Field of Life Sciences (2014). Indian Council for Medical Research.

United Kingdom

The Concordat to Support Research Integrity (2019).

Good Research Practice Principles and Guidelines (2014). Medical Research Council.

Code of Practice for Research (2009). UK Research Integrity Office.

Australia

Australian Code for the Responsible Conduct of Research (2018). National Health and Medical Research Council.

Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research (2018). National Health and Medical Research Council.

Research Integrity and Misconduct Policy (2019). National Health and Medical Research Council.


 

Research Complaints

TGI is committed to resolving all complaints with respect, integrity and confidentiality.

Q: What should I do before making a complaint?

First point of contact should be your supervisor/manager or the Research Integrity Advisor at the Institute. They may be able to advice on whether the matter you are concerned about should be referred to the Research Integrity Office.

TGI can receive anonymous or third-party lodgement of a complaint. However, in some cases it might happen that we will not be able to proceed with the investigation of a complaint until the complainant’s identity is confirmed. If there is a need to identify you during the Institute’s investigation of your complaint, this will be subject to a discussion with you and with your consent only.

If at any time you choose not to proceed with the complaint, TGI still has an obligation to assess whether to proceed to a preliminary assessment with the information already provided.

Q: How do I lodge a complaint?

You can make a formal complaint about a potential breach of Research Code of Conduct by completing the Breach of Research Code of Conduct reporting form or submit the complaint in writing to the Director of Centre for Operational and Research Excellence (CORE). 

Please email to complaintscommitteeAU@georgeinstitute.org

Q: What happens next?

Once the complaint is received, the TGI CORE Director will review and determine if there is a potential breach of the Research Code of Conduct. 

If a potential breach of the Code is identified, the complaint will proceed to a preliminary assessment. If it is determined that a breach of the Code did not occur, the complaint may be dismissed or referred to other relevant processes at TGI. You may be contacted to obtain additional information or with a request further clarification

Following preliminary assessment, the compliant may proceed to corrective and preventative action and or proceed to an investigation

Findings of the investigation will be reported to the Institute’s Chief Scientist, who will assess whether a breach of the Research Code of Conduct has occurred, the extent of the breach and determine the outcome of the investigation and the recommended actions.

Q: Anything else I should know?

TGI will not accept complaints that are malicious, reprisal, threatening behaviour or lacking sufficient information to enable investigation.

TGI may also need to work with other organisations or agencies where a complaint falls outside the scope of TGI responsibilities or control.

TGI will keep the complainant, respondent and related parties always informed of relevant information and processes.

All conversations, interviews, emails and any relevant documentation related to the complaint will be recorded, inventoried and kept confidential.

Q: I’m dissatisfied with the process or outcome. What can I do?

If you are dissatisfied with process or outcome, you may appeal within a month of the final decision in writing to the Director of CORE for consideration.

The outcome of the consideration will be communicated to you by the Institute’s Chief Scientist

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