• Section 1 - Introduction
• Section 2 - Audience
• Section 3 - Scope
• Section 4 - Related Documents
• Section 5 - Collaborative Research Agreements
• Section 6 - Collaborative Animal Based Research
• Section 7 - Collaborative Human Based Research
• Recognition of an External Ethical Approval
• Approval for Collaborative Research
• Principal Investigators
• Associate Co-Investigators
• Section 8 - Roles and Responsibilities

Section 1 - Introduction

(1) The University of Newcastle (University) is committed to undertaking world-class research and encourages its Researchers to collaborate with external colleagues and institutions to achieve this.

(2) This Procedure outlines the University's conditions for undertaking collaborative research.

Section 2 - Audience

(3) Researchers undertaking collaborative research under the auspices of the University.

Section 3 - Scope

(4) This Procedure applies to all research conducted by University Researchers:

1. in collaboration with external parties such as other researchers, industry partners and external institutions, including overseas institutions; or
2. where the research project has received or is subject to clearance by:
   1. an internal ethical process;
   2. an external ethical process; or
   3. other research related mandatory process.

Section 4 - Related Documents

(5) 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.

1. all parties to the collaboration consider it to be a common 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.

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

(10) The roles authorised to approve research collaboration agreements on behalf of the University are documented in Schedule of VC Operational Sub-Delegations – Research.

(11) 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. contact the Office of the Pro Vice-Chancellor Indigenous Strategy and Leadership to seek advice on developing appropriate engagement approaches and collaborative agreements with Aboriginal and Torres Strait Islander peoples or communities. 

Section 6 - Collaborative Animal Based Research

(12) The Australian Code for the Care and Use of Animals for Scientific Purposes (2013), enacted by 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. This Procedure outlines the requirements of the regulatory framework in relation to collaborative animal-based research.

(13) 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.

(14) Animal-based researchers should refer to the Animal Care and Ethics Committee Methodology Document 41 “Collaborative research using animals” for advice on the information that needs to be provided to the ACEC.

Section 7 - Collaborative Human Based Research

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

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

Recognition of an External Ethical Approval

(17) The University may recognise a prior ethical 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 was commensurate with the level of risk represented by the proposed human research, i.e.:
   1. research that is more than low risk has been reviewed and approved by a Human Research Ethics Committee (HREC) that is registered with the National Health and Medical Research Council; and
   2. research involving no more than low risk has been reviewed and approved by an ethical review body in compliance with the requirements of the National Statement.

(18) In some instances, recognition and acceptance of an external ethical 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). 

(19) In addition to any external ethical approval, approval through one of the University’s authorised ethical 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 Research

Principal Investigators

(20) Generally, where a University Researcher is the principal investigator on a research project involving human participants, they are required to obtain ethical approval in accordance with the University's policies, procedures and delegations of authority. However, the University Researcher may instead register an external ethical 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 ethical approval from a relevant and eligible external review body (see clause 17).

Associate Co-Investigators

(21) A University Researcher who is an associate Researcher or co-investigator on a research project involving human participants initiated at another institution, will need to seek approval through one of the University’s authorised ethical 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 19); or
3. the research has an international ethical approval but one of the situations outlined at clause 22a-c apply.

(22) A University Researcher who is an associate or 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 ethical approval (see clause 17) 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; or
3. it is intended to use the letterhead or brand of the University in any documentation provided to research participants.

(23) In all other cases of collaborative research involving human participants (i.e, where clause 21 or 22 do not apply), co-investigators who are associated with the University are required to:

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 ethical approval to the Ethics Officer (Human) (see Human Ethics Officer Contacts).

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

Section 8 - Roles and Responsibilities

(25) All University Researchers must follow relevant policies and procedures established by the University and the relevant ethics committee/s.

(26) Animal based Researchers 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.

(27) Human based Researchers 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 23 applies, provide evidence of approval to the Human Research Ethics Team (see Human Ethics Officer Contacts).