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Monash University Policy Bank

Ethical Research and Approvals Policy

Purpose

The aim of this policy is to ensure that research conducted at Monash University is of the highest ethical standard by incorporating ethical review of all research activities involving human or animal subjects conducted by staff and students.  By subjecting research to appropriate review Monash will ensure maximum compliance with current ethical guidelines and legislative frameworks as they apply to research.

All research-related policies and procedures at Monash University are being reviewed to ensure compliance with the Australian Code for the Responsible Conduct of Research (2007) and to comply with the new Monash University Policy Bank format.

Scope

This policy applies to all Monash University staff and students, full time, part time, casual or adjunct, from any Monash University campuses, national and international, who host, conduct, participate in or disseminate the results of research involving human or animal subjects. Visitors to the University who participate in research are also covered by this policy.

Policy Statement

As an educational and research institution, Monash recognises its responsibility to the community to ensure all research activities are conducted in accordance with the highest ethical standards and to ensure that staff and students are seen as positive role models amongst their peers and in the wider community. It is committed to protecting the rights, dignity, health, safety and privacy of the community, including research subjects, and to the welfare of animals and the integrity of the environment.  While acknowledging all mandated requirements for secure data retention, protection of privacy and confidentiality, the University is also committed to promoting access to the benefits of research through collecting, storing and making research data accessible in such a way that it can be used in future by members of the research community and other interested parties.  By achieving the above, the University also aims to protect the health, safety, rights and academic freedom of researchers and the reputation of the University for excellence in research.  

Some subsets of research conducted at Monash will come under the purview of either an animal ethics committee or the human research ethics committee while others will not. It is to be understood by all researchers that an approval by the appropriate ethics committee is a necessary but not sufficient assurance that the research complies with ethical standards.  At all times all research will still require self reflection and review: while acknowledging that there are conflicting and contested interests, a researcher must choose where the greatest good or least harm may be done.

In conducting research of the highest ethical standard the University is committed to complying with all relevant Australian, Malaysian, South African and other relevant countries’ applicable laws, codes of practice and guidelines as they apply to research including, but not limited to, all those listed in relevant sections of this policy. Responsibility for ethical review of all research involving animals is invested in departmental/school-based Animal Ethics Committees (AECs) and the Monash University Animal Welfare Committee (MUAWC) as described in accompanying procedures. All research involving human participants requires approval from the Monash University Human Research Ethics Committee (MUHREC), as described in accompanying procedures.

The University aims to achieve maximum compliance through continually improving the level of consideration for ethical issues associated with conducting research involving human and animal subjects.  This will be achieved by:

  • continual education of its human research and animal ethics committee members on the content of the relevant legislation and other developing ethical issues relating to research;
  • continual education of the Monash research community about ethical issues as they relate to research and the ethical clearance framework described in the procedures supporting this policy;
  • the monitoring of research activities to ensure researchers are aware of their obligations under the relevant legislation and Monash policy and procedures and are maintaining compliance.

Supporting procedures

Ethical Research and Approvals: Human Research Ethics Committee Procedures
Ethical Research and Approvals: Research Involving Human Participants Procedures
Ethical Research and Approvals: Scientific Activities involving Animals Procedures

Supporting guidelines

Responsibility for implementation

Deputy Vice Chancellor (Research)
Campus Research Committee (Sunway)
Deputy Pro Vice-Chancellor Research (South Africa)
Monash Research Committee (MRC)
Monash University Human Research Ethics Committee (MUHREC)
Monash University Animal Welfare Committee (MUAWC)
Departmental/School Animal Ethics Committees
Monash Research Office
Heads of academic/administrative units and controlled entities
Research supervisors and managers
Research staff
All Students

Status

New

Key Stakeholders

Deputy Vice Chancellor (Research)
Campus Research Committee (Sunway)
Deputy Pro Vice-Chancellor Research (South Africa)
Monash Research Committee (MRC)
Monash University Human Research Ethics Committee (MUHREC)
Monash University Animal Welfare Committee (MUAWC)
Departmental/School Animal Ethics Committees
Monash Research Office
Heads of academic/administrative units and controlled entities
Research supervisors and managers
Research staff
All Students

Approval body

Name: Academic Board
Meeting: 06/2009
Date: 25-November-2009
Agenda item: 17.1.1

Endorsement body

Name: Monash Research Committee
Meeting: 04/2009
Date: 07-July-2009
Agenda item: 9.1

Definitions

Legislation Mandating Compliance

All relevant legislative instruments that stipulate requirements with which members of the Monash community (all of whom are subject to the law) are obligated to comply.

Australia


Prevention of Cruelty to Animals Act, 1986 and Regulations
Research Involving Human Embryos Act 2002
Prohibition of Human Cloning Act, 2002


 South Africa


South African Constitution Act, 1996
South Africa: National Health Act, 2003

Related policies

Use of Animals in Coursework Programs Policy
Use of Animals in Coursework Programs Procedures
Conduct and Compliance Policy
Conduct and Compliance Procedures - Conflict of Interest (including Conflict of Interest in Research)
Conduct and Compliance Procedures - Privacy
Recordkeeping Policy
Monash University Procedures for Dealing with Allegations of Research Misconduct

Related documents

All campuses


International Ethical Guidelines for Biomedical Research Involving Human Subjects
World Health Organisation, Operational Guidelines for Ethics Committees that Review Biomedical Research
ICH Guideline for Good Clinical Practice



Australia


Australian Code for the Responsible Conduct of Research 2007
Australian Code of Practice for the Care and Use of Animals for Scientific Purposes
National Statement on Ethical Conduct in Human Research
Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practices and Research



South Africa


South African, Ethics in Health Research: Principles, Structures and Processes



Sunway


Malaysia Guidelines for Good Clinical Practice, Ministry of Health Malaysia, 2nd Edition 2004
National Institutes of Health Guidelines for Conducting Research in Ministry of Health Institutions and Facilities: KKM/NIHSEC/03/0301-01 Circular Ref. 9/2007

Date Effective

25-November-2009

Review Date

25-November-2012

Owner

Manager, Research Ethics and Compliance

Author

Manager, Research Ethics and Compliance

Content Enquiries

Manager Research Ethics

University Policy Use

Version Number: 1.1

Contact: adm-PolicyBank@monash.edu

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