Content
HoMER tools - HoMER initiative national processes
The processes appearing in the table below underpin the national implementation of the single ethical review of multi-centre research carried out across and/or within jurisdictions. The list is not exhaustive. Additional processes supporting single ethical review may be found under HoMER national guidance.
The HoMER processes are ‘in-common’ and have national agreement to be implemented in existing and planned jurisdictional systems for streamlined ethical review of multi-centre research carried out in public sector organisations. Specific information on the implementation of HoMER processes into an individual State or Territory system of streamlined ethical review may be found on relevant State and Territory websites (see Useful links).
Institutional adoption of HoMER processes is recommended. Unless required by a State or Territory administrative framework, institutional adoption of HoMER processes, guidance and standardised forms is voluntary. Institutions sitting outside the public sector may also use the HoMER processes.
The HoMER processes may also be applicable in the ethical review of human research that is not multi-centre.
Process Title |
Descriptor |
Flowchart of single ethical review process for multi-centre research | The flowchart depicts operational steps in single ethical review. The flowchart provides a high level description of the operational responsibility of the following key stakeholders:
|
Depending on the approach adopted within a State or Territory system of streamlined ethical review, demonstration of public health institutional compliance with statutory or administrative frameworks related to the ethical conduct of research may require:
|
|
The Handbook describes the process for certification of institutional ethical review processes. |
[top]
Flowchart of single ethical review process for multi-centre research
The Coordinating Investigator’s role is central to the submission of the multi-centre research proposal for ethical review, as he/she manages the dialogue between the reviewing HREC and the Principal Investigators (i.e. lead researcher at each centre).
The Coordinating Investigator submits, on behalf of all centres participating in the research, the completed ethics application form to the reviewing HREC and communicates the outcome of the ethical review to the Principal Investigators.
The reviewing HREC uses certified ethical review processes to carry out the single ethical review of the multi-centre research proposal.
The Principal Investigator at each centre ensures the outcome of the ethical review and other relevant information about the proposed research is communicated to and/or shared with the research governance office (or equivalent administrative area) of their institution. This information will assist each institution to assess whether the proposed research is suitable for that institution. The institution will determine whether the ethically approved research will, or will not, commence at their centre.
The HoMER processes describe the institutional determination of commencement of research as ‘authorisation’. In some States and Territories, the institutional process underpinning authorisation to commence research is also called ‘site specific assessment’.
Generally speaking, the person with the authority to authorise research start-up is a senior manager (e.g. CEO or Deputy Vice-Chancellor of Research) within an institution. Institutional autonomy is paramount within the HoMER initiative and, as such, the authority to authorise research may be delegated to any appropriate person. It is considered undesirable for such a delegation to be held by the Chair of the institutional HREC, as it is not appropriate for a HREC to act beyond to scope of its prescribed responsibilities under the National Statement.
More specific information on the roles and responsibilities of key stakeholders in the national approach can be found under HoMER national guidance.
Process for assuring consideration of specific jurisdictional statutory and administrative frameworks related to ethical conduct of research
The table below lists State and Territory health department requirements for public health organisations to provide assurance of compliance with the relevant statutory and administrative frameworks relevant to the ethical conduct of research.
The table provides summary information only. To access further detail on the requirements of a specific State or Territory system for the streamlined ethical review of multi-centre research, see Useful Links.
For an institution outside the public sector, managing its compliance with relevant jurisdictional statutory frameworks is the responsibility of the institution and sits outside of multi-centre ethical review.1
Jurisdiction |
How Institutional Compliance with Jurisdictional Statutory and Administrative Frameworks related to the Ethical Conduct of Research is Demonstrated2 |
Western Australia | Module to be completed if research is to be undertaken at a Western Australian public sector institution. |
Victoria | Victorian Specific Module to be completed where Victorian organisation(s) are intending to conduct a clinical trial. Section 4 – ‘Use of Ionising Radiation’ to be completed by each Principal Investigator at all participating Victorian sites and submitted to the HREC with a letter of risk assessment where the protocol involves the use of ionising radiation. |
Queensland | Included in public health institutional research governance processes. Research Governance requires the use of the Queensland Health On-line Site Specific Assessment form which is electronically linked to the On-line ethics application form https://ethicsform.org/au/SignIn.aspx Access to tissue and/or confidential information held by Queensland Health has separate processes that are not captured in the Site Specific Assessment form but make up research governance. If a study requires access to tissue and/or access confidential information - these processes must be completed along with SSA before final authorisation may occur in Queensland Health. In Queensland, research involving access to coronial material must be referred to the Queensland Health Forensic and Scientific Services Research Ethics Committee (FSS-HEC) for ethical and legal approvals. This also applies to clinical research projects where there is a component involving coronial material. In this context, examples of coronial material include tissues from coronial autopsies, slides and blocks, blood samples, autopsy reports and other documents and data relating to coronial autopsies. These processes must be completed before final authorisation for the commencement of research and make up part of the research governance requirements. |
South Australia | Included in public health institutional research governance processes. |
New South Wales | No additional requirements for public health institutions. |
Tasmania | No additional requirements for public health institutions. |
Northern Territory | No additional requirements for public health institutions. |
Australian Capitol Territory | No additional requirements for public health institutions. |
Footnotes
1NHMRC/ARC/AVCC National Statement on Ethical Conduct in Human Research (2007) p.9
2Information provided by State and Territory Health Departments
[top]