Guidance for multi-centre research

Framework for Monitoring: Guidance for the national approach to single ethical review of multi-centre research

A critical element of the national approach to single ethical review is the articulation, development and promulgation of a consistent approach to monitoring arrangements for multi-centre human research that has undergone a single ethical review.  Coordinated monitoring processes are critical to ensuring the integrity of multi-centre research.

The Framework for Monitoring (PDF, 367KB) provides a framework for best practice in the monitoring of multi-centre human research that has undergone a single ethical review. The document explores conceptions of monitoring, outlines activities that require monitoring by HRECs, institutions and researchers and proposes a suggested allocation of monitoring responsibilities.

Research Governance Handbook: Guidance for the national approach to single ethical review

Although research governance arrangements inevitably vary amongst institutions, in order for a national approach to single ethical review to be workable there is a need to establish consistency in the area of research governance, particularly among institutions that have had their ethical review processes certified under the national approach to single ethical review.

The purpose of the Research Governance Handbook: Guidance for the national approach to single ethical review (PDF, 342KB) is to articulate best practice in the governance of multi-centre human research as part of the national approach to single ethical review. The document guides the reader through the components of a research governance framework for multi-centre human research and describes the responsibilities of key stakeholders within the framework.

Roles and Responsibilities in Single Ethical Review of Multi-Centre Research

The "Roles and Responsibilities in Single Ethical Review of Multi-Centre Research (PDF, 40KB)" document has been developed with input from public and targeted consultation including representatives of State and Territory health departments, NHMRC Principal Committees, researchers, members of Human Research Ethics Committees, institutional administrators, representatives of Australian Government agencies and Australian pharmaceutical industry representatives.

The information below describes the higher order responsibilities of:

  • Institution where ethical review occurs
  • Institution using the ethical review to determine research start-up
  • Coordinating Investigator
  • Principal Investigator(s)
  • Reviewing HREC
  • State and Territory Health Departments
  • NHMRC
  • Other stakeholders

Best Practice Guidance on Information Sharing Activities for Single Ethical Review of Multi-centre Research

The purpose of the Best Practice Guidance of Information sharing Activities (PDF, 55KB) for Single Ethical Review of Multi-centre Research document is to identify characteristics of best practice for sharing information, irrespective of whether the participating group of institutions is located with or across jurisdictions.

Page Updated: 19-04-2012