RMH has entered into a Memorandum of Understanding with 11 partner organisations to work together to streamline and harmonise ethical and governance review of all multi-centre human health research.

The physical proximity and multiple levels of collaboration across healthcare, medical research and academia throughout Parkville and our affiliated University of Melbourne partners, through the Melbourne Academic Centre for Health, provide us with a great opportunity to build a seamless and streamlined system that facilitates changes in clinical practice in response to evidence generated amongst our group.

To realise this goal, the partners have established a Steering Committee to oversee, develop and implement a comprehensive framework to deliver a highly efficient and effective overarching system for streamlined, harmonised and standardised ethical and governance review within our group. This initiative includes participation in the existing National Mutual Acceptance Program for single ethical review of multicentre clinical trials and any new State or National streamlining initiatives that may arise in the future.

Partners 

  • Austin Health
  • Florey Institute of Neuroscience and Mental Health
  • Melbourne Health
  • Murdoch Children’s Research Institute (MCRI)
  • Northern Health
  • Peter MacCallum Cancer Centre
  • Royal Children’s Hospital
  • Royal Women’s Hospital
  • St Vincent’s Hospital Melbourne
  • University of Melbourne
  • Walter and Eliza Hall Institute
  • Western Health

Objectives

  • To streamline and harmonise ethical (including scientific) and governance review of human research projects within and across Partner institutions.  This will create efficiencies of scale for our Research Offices through the sharing of best practice, resources and processes, saving time and money, thereby facilitating, encouraging and supporting excellent research and health outcomes.
  • To enhance our investigator-led research capacity to utilise advances in genomics and information technology such as data linkage and electronic medical records.  We must do this to stay globally competitive.
  • To facilitate and build our capacity to conduct externally-sponsored clinical trials.
  • Reviewing HRECs

Our model for streamlined ethical review allows investigators to submit  multi-centre human health research ethics applications (involving two or more partners) to any of the five NHMRC-certified HRECs within our group:

  • St Vincent’s Hospital Melbourne
  • Melbourne Health
  • Peter MacCallum Cancer Centre
  • Austin Health
  • Royal Children’s Hospital

Key features of the streamlined model

  • Five NHMRC-certified HRECs - providing Partners access to weekly HREC review (from 2015).
  • Existing NHMRC-certified HRECs retained – line managed by current host institutions.
  • A coordinated centrally located Research Support Service – supporting ethics and governance practices and procedures through provision of resources, information, templates (see below). 
  • Expert Scientific Review Panel (see below).
  • Existing (non-NHMRC certified for multi-centre research) HRECs at partner institutions retained for the review of single-site projects.

Centralised research support service

The model guarantees access to weekly HREC review. It will be strengthened by the establishment of a central shared support service (a “Research Support Service” or RSS), providing a resource for the institutional staff managing research (e.g. Research Ethics Managers, Research Governance Managers and other research staff).  The RSS will carry out, centrally on behalf of all Partners, some of the HREC and governance support activities that are currently delivered in parallel at each institution.  A Research Support Officer will be appointed to coordinate this service.  Services to be provided by the RSS will include, but are not limited to:

  • Development and hosting of research agreements for use by the Partners when collaborating amongst themselves or with external entities (ie agreements other than the current Clinical Trial Research Agreements and Clinical Investigation Research Agreements used for commercially sponsored clinical trials).
  • Establishment of an Expert Scientific Review Panel to be available (if and as required) for all Partners and their HRECs, for consultation in situations where specific expertise is not available within the membership of a given HREC or the staff of a particular institution.
  • Managing HREC membership , in particular assistance with recruitment of new members.
  • Identifying and accessing training opportunities for HREC members, research office staff and investigators.
  • Development of common processes, procedures, forms (i.e. templates).
  • Credentialling of research staff.
  • Development of research KPIs and reporting.
  • Coordinating reporting to external entities (e.g. Department of Health, NHMRC).
  • Establishment of a harmonised clinical and research data sharing agreement across the Partners in accordance with the Victorian Health Records Act 2001 to enable members to share identifiable clinical and research data for treatment and research purposes
  • Establishment of a standardised patient research consent form for use within all clinical specialities across the Partners to better facilitate and support multi-disciplinary and multi-site research. The consent may include:
    • Collection and use of body tissues and fluids including the use of samples from previous procedures.
    • Allowing researchers access to patient information in medical records, personal documents or other sources.
    • Allowing researchers to link patient data within the hospitals to other data sources such as Medicare, the Victorian Cancer Registry, and Births, Deaths and Marriages.
    • Allowing researchers to follow-up and recontact patients in the future.
    • Allowing Partner organisations to share clinical data and specimens to enable multi-site research.
    • Being approached to participate in new clinical trials or other research projects.
    • Allowing contact details to be disclosed to external parties on behalf of a Partner to be approached for participation in research or quality assurance activities.

Principles and operating rules

  1. Streamlined ethical review processes will be used when two or more partner institutions are involved in the same human health research project.  Streamlined ethical review means an institution accepts the outcome of a single review without any additional scientific or ethical consideration. Partners will adopt standardised procedures, processes, forms and templates for all HREC applications.
  2. Retrospective mutual acceptance of prior scientific and ethical review (by one of the Partner NHMRC-certified HRECs) for all existing studies where another Partner institution is to become an additional site for any given research project.
  3. Sharing and uptake of existing best practices at Partner institutions.
  4. Streamlined governance and ethical review processes will apply to all types of multi-centre human health research including, but not limited to:
    1. clinical trials
    2. studies involving tissue and/or data collection/banking studies
    3. genetics/genomics
    4. epidemiological studies
    5. public health studies
    6. low risk projects
    7. audit and QA projects
  5. Only institutions with NHMRC-certified ethical review processes will conduct the single ethical review, aligned to the categories of research in which they hold certification.
  6. Streamlined governance review means adopting standardised procedures, processes (including fees), forms and templates for all site-specific governance applications including, but not limited to:
    1. procedures relating to institutional delegations for ethical and site-specific (governance) approvals
    2. agreed timeframes for providing decisions from HRECs and Research Governance offices.
    3. participation in the National Mutual Acceptance Program for single ethical review of multi-centre research and any new State or National streamlining initiatives that may arise
  7. Each Partner institution retains full autonomy for deciding whether to take part in a given research project.

The project Steering Committee commenced meeting in September 2014 and will work on a number of key priorities over the next 12 months working towards a simple and efficient, harmonised and standardised framework for all human health research within our group.

Cancer Trials Australia and the Victorian Comprehensive Cancer Centre have generously agreed to provide administrative support to the Steering Committee to help ensure the success of this initiative.

First steps

The initiative began on 1 November 2014, with the immediate operation and acceptance of single ethical review of any multi-centre human health research project involving two or more partner institutions.  

In the first instance, the system will operate using the existing procedures and processes of the five designated “Reviewing HRECs”  ie, investigators with a project involving two or more partners can simply choose one of the five HRECs to undertake review of their project using that committee’s existing processes.  Queries should be directed to the secretariat of the relevant HREC.

Over the next 12 months, the Steering Committee will develop new, simpler and standardised procedures and templates for all aspects of ethical and governance review  - ultimately, it is envisaged that applying for ethical and governance review at any of the Partners will involve one standard set of requirements and one way of doing things, regardless of the particular Reviewing HREC or Research Governance Office.

Further information about new developments in this initiative will be publicised widely as they are implemented.