• Section 1 - Introduction
• Section 2 - Purpose
• Section 3 - Scope
• Section 4 - Related Documents
• Section 5 - Collaborative Research Agreements
• Section 6 - Collaborative Responsibilities for Research Data and Primary Materials
• Section 7 -  Authorship, Dissemination and Use of Research Outputs
• Section 8 - Additional Governance Requirements for Collaborative Research
• Section 9 - Collaborative Animal Based Research
• Section 10 - Collaborative Human Based Research
• Recognition of an External Ethical Approval
• Approval for Collaborative Human Research
• Chief Investigators
• Co-Investigators
• Section 11 - Breach Management and Dispute Resolution
• Section 12 - Roles and Responsibilities
• Section 13 - Definitions

Section 1 - Introduction

(1) Collaborative research is central to the University of Newcastle’s (University) research strategy. The University is committed to undertaking world-class research and actively encourages its Researchers to collaborate with external colleagues and institutions to achieve this goal.

Section 2 - Purpose

(2) This Procedure establishes the University's requirements to ensure collaborations are conducted responsibly, ethically and in accordance with the Australian Code of the Responsible Conduct of Research (the Code) and its related guidance documents.

Section 3 - Scope

(3) This Procedure applies to all staff, students, conjoints and adjuncts who conduct their research under the auspices of the University where one or more external parties are involved. It applies to all research, regardless of the funding arrangements, that may involve:

1. Researchers from other institutions;
2. cooperative research centres;
3. industry partnerships;
4. government sectors;
5. not-for-profit organisations;
6. dual higher degree by research arrangements; or
7. data material transfer arrangements.

Section 4 - Related Documents

(4) This Procedure has been prepared in consideration of the following documents, which should be read and understood by Researchers undertaking related collaborative research:

1. Responsible Conduct of Research Policy
2. Australian Code for the Responsible Conduct of Research
3. Collaborative research: A guide supporting the Australian Code for the Responsible Conduct of Research
4. Australian Code for the Care and Use of Animals for Scientific Purposes 8th edition (2013)
5. National Statement on Ethical Conduct in Human Research (2007)
6. Ethical Conduct in Research with Aboriginal and Torres Strait Islander People and Communities;
7. Intellectual Property Policy and Intellectual Property Procedure;
8. Research Data and Primary Materials Management Procedure;
9. Disclosure of Interest Policy and Disclosure of Interest Procedure;
10. Digital Security Policy;
11. Privacy Policy;
12. Privacy Management Plan;
13. Records Governance Policy; 
14. Research Breach Investigation Procedure; and
15. Jointly Awarded Doctoral Degrees and Dual Award Doctoral Degrees Policy.

1. all parties to the collaboration consider it to be a shared research project, including the collaborating researcher/s and any institution/s;
2. there is a clear definition of project scope, milestones and deliverables, and in-kind contributions are considered; and
3. there is a mandatory internal approval process at the collaborating institution/s.

(8) The University's Legal and Compliance team maintains collaborative research agreement templates in serviceNOW for research collaborations.

(9) The roles authorised to approve research collaboration agreements and material transfer or data transfer agreements, on behalf of the University, are documented in Schedule of VC Operational Sub-Delegations – Research.

(10) Where collaborative research involves engagement with Aboriginal and Torres Strait Islander peoples or communities, Researchers are required to:

1. adhere to the requirements of Ethical Conduct in Research with Aboriginal and Torres Strait Islander People and Communities in addition to all other requirements including the National Statement; and 
2. seek advice and endorsement from Wakul Yabang (Aboriginal Research Community Panel) on developing appropriate research protocols with Aboriginal and Torres Strait Islander peoples or communities where recruitment is taking place in the Hunter New England geographical area. 

Section 6 - Collaborative Responsibilities for Research Data and Primary Materials

(11) Where research data or primary materials are generated across multiple institutions:

1. data transfer must comply with the University's delegations of authority, information security requirements, relevant legislation including privacy legislation where relevant, and any contractual obligations. International data transfers must comply with cross-border data protection obligations and the Defence Trade Controls Act (if relevant);
2. Researchers must comply with the University's Research Data and Primary Materials Management Procedure.

Section 7 -  Authorship, Dissemination and Use of Research Outputs

(12) Researchers must comply with the University's Research Authorship Procedure.

(13) Additional obligations for the use of research outputs, including open access, licensing and reuse of research materials are addressed in the Intellectual Property Policy, Research Data and Primary Materials Management Procedure and the Responsible Conduct of Research Policy.

Section 8 - Additional Governance Requirements for Collaborative Research

(14) Additional governance approvals may be required for collaborative projects. Researchers should consult with the Research Ethics and Integrity Unit, the Grants Office and/or Legal and Compliance for guidance. Additional approvals may include:

1. site authorisation or approval for external sites (e.g. NSW Health, Department of Education);
2. safety, biosafety or radiation approvals;
3. institutional cybersecurity or data-management approvals for shared systems;
4. export control assessment where dual-use or controlled technologies, equipment or information are involved;
5. insurance and indemnity arrangements as per the collaborative agreement.

Section 9 - Collaborative Animal Based Research

(15) The Australian Code for the Care and Use of Animals for Scientific Purposes (2013), enacted under the Animal Research Regulation (2010) and Animal Research Act (1985), stipulates that where parts of an animal-based project take place at different institutions, each institution’s Animal Ethics Committee must be cognisant of all aspects of the project and ensure that any cumulative impact of procedures on animals is considered and managed. 

(16) In accordance with 2.6.8 of the Australian Code for the Care and Use of Animals for Scientific Purposes, animal-based Researchers must notify the Animal Care and Ethics Committee (ACEC) in writing if they are involved in collaborative studies using animals at another institution, or if they are named in an application to an Animal Ethics Committee of another institution.

(17) Animal-based Researchers should refer to the Animal Research Regulatory Manual for advice on the information that needs to be provided to the ACEC.

Section 10 - Collaborative Human Based Research

(18) The National Statement on Ethical Conduct in Human Research (National Statement) recommends that institutions adopt processes that eliminate the unnecessary duplication of ethical review.

(19)  This Procedure outlines the conditions under which the University may recognise an ethics approval granted through an external process, as well as circumstances in which ethics clearance through one of the University’s authorised ethics review processes is not required.

Recognition of an External Ethical Approval

(20) The University may recognise a prior ethics approval granted through an external process where:

1. a formal agreement is in place with the external institution or organisation, and/or the project has been previously ethically reviewed and approved by an Australian institution or organisation; and
2. the process of review by the external review body is commensurate with the level of risk represented by the proposed human research, i.e.:
   1. research that is higher risk must be reviewed and approved by a Human Research Ethics Committee (HREC) that is registered with the National Health and Medical Research Council; and
   2. research that is lower risk must be reviewed and approved by an ethics review body in compliance with the requirements of the National Statement.

(21) In some instances, recognition and acceptance of an external ethics approval may need to be considered by a Chair or Deputy Chair of the University's HREC. Seek advice from the Human Research Ethics team if required (see Human Ethics Officer Contacts). 

(22) In addition to any external ethics approval, approval through one of the University’s authorised ethics review processes may be required for projects which primarily focus on University students and/or staff as research participants. Seek advice from the Human Research Ethics team if required (see Human Ethics Officer Contacts). 

Approval for Collaborative Human Research

Chief Investigators

(23) Where a University Researcher is the Chief Investigator on a research project involving human participants, they must either:

1. obtain ethics approval in accordance with the University's policies, procedures and delegations of authority; or
2. register an external ethics approval with the University where:
   1. research participants are to be recruited from an organisation or site external to the University; and
   2. there is an existing ethics approval from a relevant and eligible external review body or process (see clause 20).

Co-Investigators

(24) A University Researcher who is a co-investigator on a research project involving human participants initiated at another institution, must seek approval through one of the University’s authorised ethics review processes if:

1. the research has not been ethically approved by an Australian institution or organisation in compliance with the requirements of the National Statement, or an equivalent body in other countries; 
2. the project involves the recruitment of University staff and/or students as research participants (see clause 22); or
3. the research has an international ethics approval but one of the situations outlined at clause 20a-b apply.

(25) A University Researcher who is a co-investigator on a research project involving human participants initiated at another institution, which has been previously ethically reviewed and approved by an Australian institution or organisation, will need to register the external ethics approval (see clause 16) where:

1. the research team includes a University student and the research is to be used toward meeting the requirements of a course/program of study; 
2. a research grant or contract for the project is to be primarily administered by the University.

(26) In all other cases of collaborative research involving human participants (i.e, where clause 20 or 21 do not apply), co-investigators who are associated with the University must:

1. hold written evidence that the project has been ethically reviewed and approved by an Australian institution in compliance with the requirements of the National Statement, or its equivalent body in other countries; and
2. prior to the research commencing, forward a copy of the written evidence of ethics approval to the Ethics Officer (Human) (see Human Ethics Officer Contacts).

(27) Where approval must be sought through one of the University’s authorised ethics review processes in addition to an existing external approval, Researchers must include details of the previous ethics approval in their application submission. 

Section 11 - Breach Management and Dispute Resolution

(28) If a potential breach of the Code arises within a collaborative project:

1. the institution employing or supervising the Researcher(s) leading the project normally takes the lead in assessing the matter, unless agreed otherwise;
2. partner institutions must be notified where the issue may affect shared data, publications, participants, or grant obligations;
3. Researchers must cooperate fully with investigations conducted by any involved institution;
4. disputes between collaborators should first be addressed through the dispute-resolution mechanism in the collaborative agreement, and escalated though institutional processes if unresolved.

(29) The University will manage potential breaches in accordance with the Research Breach Investigation Procedure.

Section 12 - Roles and Responsibilities

(30) All University Researchers must follow relevant ethics requirements, relevant legislation and the policies and procedures established by the University.

(31) Chief Investigators must ensure that students involved in collaborative projects are supervised appropriately and that responsibilities are documented in agreements.

(32) Researchers conducting animal research must adhere to the requirements of the Australian Code for the Care and Use of Animals for Scientific Purposes and the ACEC documentation on collaborative research.

(33) Researchers conducting human research must adhere to the National Statement on Ethical Conduct in Human Research and, if seeking to have an external ethical approval recognised by the University, must either:

1. register the external approval with the University via RIMS and provide all of the associated documentation; or
2. where clause 20 applies, provide evidence of approval to the Human Research Ethics Team (see Human Ethics Officer contacts).

(34) Researchers must also ensure they comply with any research governance processes as required by the external sites at which they are conducting their research. Examples of these are site authorisation and access requests for research being conducted in NSW Health sites, and State Education and Research Partnerships (SERAP) approval for research conducted in NSW Government Schools and Pre-Schools.

Section 13 - Definitions

(35) In the context of this document, the following definitions apply:

1. “Chief Investigator” refers to a senior Researcher with primary responsibility for the design, leadership, oversight, coordination and integrity of a research project; and
2. “Co-Investigator” means a person who works in partnership with the Chief Investigator and makes significant contribution to the significant scientific development, management, or execution of the project but is not the project lead.