Human Research Ethics

Human Research Ethics

SUMMARY

The Human Research Ethics Policy establishes how Macquarie University fulfils its responsibilities for ensuring compliance with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2007) and the Australian Code for the Responsible Conduct of Research (2007).

POLICY

1     PURPOSE

To outline how Macquarie University fulfils its responsibilities for ensuring compliance with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2007) and the Australian Code for the Responsible Conduct of Research (2007).

2     BACKGROUND

Macquarie University is committed to conducting its research in an ethical and accountable way to facilitate a pervasive ethical research culture.

    SCOPE

The policy applies to all staff, students, visiting academics, volunteers and other personnel involved in the conduct of human research under the affiliation of, or in collaboration with, Macquarie University.

4     DEFINITIONS

Commonly defined terms are located in the University Glossary. The following definitions apply for the purpose of this Policy:

Human Research: any research activity that is conducted with or about people, or involves the use of their data.

National Health and Medical Research Council (NHMRC): Australia’s peak body for supporting health and medical research; for developing health advice for the Australian community, health professionals and governments; and for providing advice on ethical behaviour in health care and in the conduct of health and medical research.

National Statement: refers to the National Statement on Ethical Conduct in Human Research (2007). The National Statement clarifies the responsibilities of institutions, researchers and review bodies for the ethical design, review, conduct and dissemination of results of human research.

The Code: refers to the Australian Code for the Responsible Conduct of Research (2007). The Code provides guidance to institutions and researchers in responsible research practices.

The Macquarie University Code: refers to the Macquarie Code for the Responsible Conduct of Research. The Macquarie University Code outlines standards of responsible and ethical conduct expected of all persons engaged in research under the auspices of Macquarie University.

5     POLICY STATEMENT

The University will establish systems and processes to ensure compliance with the National Statement, The Code and the Macquarie University Code for research and teaching research projects involving human participants.

GOVERNANCE

The University will:

  • promote ethical research that protects and respects research participants and researchers, and extends benefit to the community.
  • ensure that individual research proposals comply with all relevant policies and legislation
  • maintain two Human Research Ethics Committees (HRECs) and associated Terms of Reference
  • maintain Faculty and school ethics sub-committees of the HREC and associated Terms of Reference.
REVIEW
The University will:
  • maintain mechanisms to review all research proposals and teaching research projects involving human participants
  • ensure that any risks to participants, researchers and the University are identified and managed appropriately
  • establish procedures for monitoring approved research to ensure that all research projects conform with ethical standards and the National Statement.

REPORTING
The University will provide regular reports to the Deputy Vice Chancellor (Research), the Vice-Chancellor, the NHMRC and the Information and Privacy Commission New South Wales.

COMPLIANCE AND BREACHES
In accordance with the Macquarie University Code, the University may commence applicable disciplinary procedures if a person to whom this policy applies breaches this policy (or any of its related procedures).

6     RELEVANT LEGISLATION

Privacy and Personal Information Protection Act 1998 (NSW)
Direction on Disclosures of Information by Public Sector Agencies for Research Purposes under s 41 of the Privacy and Personal Information Protection Act 1998 (NSW) (19 June 2015)
Health Records and Information Privacy Act 2002(NSW)
Privacy Act 1988 (Cwth)
Guidelines under Section 95 of the Privacy Act 1988 (2014)
Guidelines under Section 95A of the Privacy Act 1988 (2014)

7     KEY RELATED DOCUMENTS

National Statement on Ethical Conduct in Human Research (2007)
Australian Code for the Responsible Conduct of Research (2007)
The Macquarie University Code for the Responsible Conduct of Research
Macquarie University’s Release of Student Information Policy and Guideline
Human Research Ethics Committees Terms of Reference and Standard Operating Procedures

8     NOTES

8.1
Contact Officer
Director, Research Ethics and Integrity
8.2
Implementation Officer
Human Ethics Team Leader and Secretary to the HREC
8.3
Approval Authority / Authorities
Human Research Ethics Committee (Medical Sciences)
Human Research Ethics Committee (Human Sciences and Humanities)  
8.4
Date Approved
30 October 2015
8.5
Date of Commencement
30 October 2015
8.6
Date for Review
July 2018
8.7
Documents Superseded by this Policy
Human Ethics Policy approved 25 July 2011
8.8
Amendment History
n/a
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