Content
Harmonisation of Multi-centre Ethical Review (HoMER)
on this page
- » Overview
- » What is meant by 'single ethical review'?
- » HoMER tools that enable single ethical review
- » Current and future activities
- » Implementing the HoMER initiative
- » Useful Links
- » Glossary and abbreviations
Overview
In 2006, the Australian Health Ministers Advisory Council (AHMAC) requested the National Health and Medical Research Council (NHMRC) facilitate the development and implementation of a national system where the single ethical review of a Human Research Ethics Committee (HREC) would be recognised by all institutions participating in a collaborative research project. By having a single ethical review outcome accepted by collaborating institutions, protection of human participants would be maintained while delays due to the practice of seeking multiple ethical reviews would be mitigated and timelines for research start-up and results would be shortened.
Several States have developed formal systems for streamlining ethical review processes in public health organisations. Other jurisdictions have informal arrangements operating as agreements of acceptance between institutions in the private and the public sectors and between public health organisations and universities.
AHMAC’s direction that State and Territory systems should be ‘harmonised’ recognised that jurisdictional statutory and administrative frameworks impacting research in public health organisations differ.
The benefits of adopting a national approach to single ethical review are many:
- The amount of time from ethical review application to research start-up is shortened with the resultant savings in human and monetary resources
- Australia’s attractiveness as a place for international investment in commercial sponsored clinical trials is enhanced
- Public confidence in the rigour of Australia’s system of ethical review of human research is increased due to the standardisation of ethical review processes
- The roles and responsibilities of the researcher, the institution, the HREC and other key stakeholders in the conduct of multi-centre research are transparent and consistent
The uptake of the national approach for single ethical review will respect institutional autonomy to determine whether research should be conducted at a given site. Advice received from a HREC undertaking the single ethical review will not replace the need for local institutional decision making on matters of research governance.
In 2009, AHMAC noted the progress-to-date in delivery of the HoMER initiative and re-affirmed the need for on-going national collaboration.
[top]
What is meant by ‘single ethical review’?
The practice of seeking an ethical review1 from each institution participating in multi-centre research has meant that multiple ethical reviews are being carried out for the one research proposal. This ‘multiple ethical review’ is often a time-consuming and confusing process for the collaborating investigators. Responses from each of the reviewing HRECs must be coordinated and communicated with multiple HREC administrators. The complexity of such an ethical review process is shown below:
The NHMRC/Australian Research Council/Australian Vice-Chancellors Committee National Statement on Ethical Conduct in Human Research (2007) (the National Statement) states that institutions have a responsibility to eliminate unnecessary duplication of ethical review processes (Chapter 5.3).
Single ethical review removes unnecessary duplication in the ethical review of a given research proposal. Single ethical review separates the roles of the Coordinating Investigator (CI) and the Principal Investigators (PI) in relation to the ethical review process, and the institutions’ research governance processes. The CI then provides the outcome of the single ethical review to the PI at each participating institution.
It is important to note that each institution wishing to participate in a multi-centre research proposal will conduct their site-specific research governance assessment. Principal Investigators at each site engage with their institutional research governance processes to obtain the authorisation to commence research.
1‘Ethical review’ is used for both ethical and scientific review
[top]
HoMER tools that enable single ethical review
Single ethical review is supported by tools that assist the Coordinating Investigator and other stakeholders. The ‘tools’ being developed by the HoMER initiative are:
The HoMER tools are designed to deliver three key outcomes:
- Trust building between institutions and their HRECs
- Information sharing to enable single ethical review across jurisdictions
- A better understanding of the ethical review of multi-centre research.
HoMER tools will be implemented in existing and planned State and Territory systems for streamlining ethical review in public health organisations. Institutions outside of the public sector will have access to all HoMER tools through a national website and information portal maintained by NHMRC.
[top]
Current and future activities
2010
| January – July | Certification scheme implementation |
| February – June | Public consultation on proposed standardised forms |
| February onwards | Institutional pilots to build trust for single ethical review of multi-centre research |
| March | Public consultation on Best Practice in Research Governance Handbook |
[top]
Implementing the HoMER initiative
The approach for implementing single ethical review nationally is underpinned by the following principles:
- Efficiency – agreed timeframes for processes and procedures are adopted in all jurisdictional systems.
- Authority – the single ethical review of a multi-centre research proposal is accepted by institutions without re-review by their institutional HREC.
- Respect – the national approach accommodates the differences in jurisdictional statutory and administrative frameworks and institutional arrangements.
- Verifiable – the capacity of the HREC carrying out the single ethical review is subject to independent verification.
- Compliance – multi-centre single ethical review meets the requirements of the National Statement to protect human research participants as well as relevant jurisdictional statutory and administrative frameworks.
The HoMER initiative timeline for the implementation of single ethical review (revised December 2009) outlines the anticipated timing for the development and implementation of the HoMER tools.
[top]
Useful Links
Jurisdictional systems streamlining the ethical review of multi-centre research are at different stages of development and/or implementation. Further information about State and Territory systems is found by clicking the following links.
Australian Capital Territory
http://www.health.act.gov.au/c/health?a=da&did=10051705&pid=1054022557
New South Wales
http://www.health.nsw.gov.au/ethics/research/index.asp
Northern Territory
http://www.health.nt.gov.au/For_Professionals/Research/index.aspx (under review)
Queensland
http://www.health.qld.gov.au/ohmr/html/regu/regu_home.asp
South Australia
http://www.health.sa.gov.au/Default.aspx?tabid=334
Tasmania
http://www.research.utas.edu.au/human_ethics/index.htm
Victoria
www.health.vic.gov.au/ethics/
Western Australia
Under development
[top]
Glossary of terms and abbreviations used in the HoMER initiative
Terms and definitions
Accepting (as in ‘accepting institution’)
An institution’s use of the outcome of a single ethical review to inform its decision about whether or not to participate in a given study and/or authorise the commencement of research within the institution.
Administrative framework (see also statutory framework)
The administrative policy, processes, directives and/or instructions within a State or Territory health department that impacts streamlined ethical review of multi-centre research proposals. The administrative framework of a given State or Territory applies only to public health institutions within that jurisdiction.
Australian Code for the Responsible Conduct of Research (the Code)
The Australian Code for the Responsible Conduct of Research, developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia, guides institutions and researchers in responsible research practices and promotes integrity in research for researchers. The Code also provides guidance to institutions in their management of allegations of research misconduct.
Certification (of institutional ethical review processes)
An independent assessment of the conformance of institutional ethical review processes that, when granted, confirms their alignment with a nationally agreed set of criteria.
Certified ethical review processes
Ethical review processes that have been independently assessed and verified as conforming to a nationally agreed set of criteria.
Certifying body
The entity carrying out the assessment of institutional claims about ethical review processes against agreed criteria. The certifying body is NHMRC.
Clinical trial
Research involving an unapproved or approved therapeutic good, intervention or treatment. The HoMER initiative applies to clinical trials where multiple institutions are involved.
Criteria
Statements of institutional policy, practice or structure that are assessed for certification. Certification Scheme criteria are based on the National Statement or are representative of what is regarded as best practice in the ethical review of multi-centre research.
Coordinating Investigator (CI)
The person who is the principal point of contact between the groups of collaborating investigators/researchers and the reviewing HREC.
Desktop assessment
An off-site assessment to validate institutional claims and supporting documentation against the nationally agreed set of criteria. Under the Certification Scheme, the desktop assessment will be carried out by qualified assessors appointed by NHMRC.
Duty of care
A legal obligation imposed on an individual requiring that they adhere to a standard of reasonable care while performing any acts that could foreseeably harm others.
Ethical / unethical
Right or morally acceptable / wrong or morally unacceptable.
Ethical review
A formal process of examination of a research proposal involving humans by a Human Research Ethics Committee (or other mechanism) for conformity with ethical guidelines and/or principles. Under the HoMER initiative, ‘ethical review’ includes both ethical and scientific review of a multi-centre research proposal.
Ethical review body
Body set up by an institution to carry out the ethical review of research involving humans. See: HREC
Human Research Ethics Committee (HREC)
An institutional body that has been established in accordance with Chapter 5.1 of the NHMRC/ARC/AVCC National Statement on Ethical Conduct in Human Research ;and conducts the ethical review of research. Under the HoMER initiative, a single HREC conducts an ethical review that is accepted by multiple institutions.
Indemnity
A legally binding promise whereby a party undertakes to accept the risk of loss or damage another party may suffer.
Institution
The entity responsible for the conduct of research as described in the National Statement and the Code. Alternatively, the entity that has established a HREC as per Chapter 5.1 of the National Statement. This definition of institution is not intended to be restrictive as, in some cases, an individual person may act as an ‘institution’ in multi-centre research.
Insurance
A legal contractual method of risk transfer, by one entity to another, in order to protect or transfer its liabilities that may arise through the course of its activities.; The arrangements are defined through a procured policy or product, and are subject to terms and conditions including limitation on aggregate liability and deductible levels.
Jurisdiction
An Australian State or Territory.
Low risk (research)
Research in which the only foreseeable impact of the research participant is discomfort.
Monitoring (of research)
The process of verifying that the conduct of research conforms to an agreed standard. In the proposed national system, monitoring relates to assessing whether ethically approved research conforms to conditions of its approval.
Multi-centre research
A research project undertaken by a group of institutions (or individuals) at one or more sites.
Multi-site research
A research project undertaken by a single institution at more than one location.
National Statement on Ethical Conduct in Human Research (the National Statement)
The National Statement on Ethical Conduct in Human Research (2007), developed jointly by the National Health and Medical Research Council, the Australian Research Council and the Australian Vice-Chancellor's Committee, sets outs standards for the ethical design, review and conduct of research involving humans. It describes the roles and responsibilities of institutions, researchers, sponsors and HRECs in conducting ethical research and applies whether the research is single centre or multi-centre.
Negligence
The commission of an act that a prudent person would not have done or the omission of a duty that a prudent person would have fulfilled, resulting in injury or harm to another person.
On-site visit
An on-site assessment to verify institutional claims against the nationally agreed set of criteria. Under the Certification Scheme, the on-site visit is carried out by qualified assessors appointed by NHMRC.
Principal Investigator (PI)
The person in each of the collaborating institutions who takes responsibility for the research project. The PI assists the CI in developing the ethics application form and ongoing reporting to the HREC.
Protocol
A document that provides the background, rationale and objectives of the proposed research and describes its design, methodology, organisation and the conditions under which it is to be performed and managed.
Recognition
Under the HoMER initiative, the certification of institutional ethical review processes of multi-centre research leading to the acceptance of a single ethical review outcome by multiple institutions.
Research
An investigation undertaken to gain knowledge and understanding.
Research governance
An institutional framework to effectively oversee and administer research so that its conduct complies with relevant legislation and meets appropriate standards of quality, safety, privacy, risk and financial management.;
Reviewing HREC
The HREC conducting the single ethical review of multi-centre research proposals. The reviewing HREC uses certified ethical review processes.
Risk
The magnitude and probability that an event will occur.
Scientific review
A review of proposed research to consider the level of scientific validity of research methodology before the proposal is considered by a Human Research Ethics Committee.
Self Assessment
An assessment carried out by an institution comparing its policies, practices and structures supporting ethical review to the nationally agreed set of criteria. Also refers to the standard form capturing the outcome of the institutional assessment that, along with any relevant supporting documentation, is submitted to the certifying body as part of the institution’s nomination for certification.
Serious adverse event (SAE)
An unforeseen medical event that occurs in the course of clinical research that:
- results in participant death
- is life-threatening to the participant
- requires the inpatient hospitalisation or prolongation of existing hospitalisation for the participant
- leads to the participant having a persistent or significant disability/incapacity.
Serious unexpected suspected adverse reaction (SUSAR)
A serious adverse event for which there is some degree of probability that the event is an adverse reaction to the administered drug and the adverse reaction is unexpected.
Single ethical review
The ethical review undertaken by a single HREC where the outcome of the review will enable multiple institutions to decide whether or not to participate in a given study. The single ethical review includes the scientific review of a research proposal.
Single site
A research project undertaken at a single location
Statutory framework (see also administrative framework)
The national, State or Territory legislation that impacts the conduct of an ethical review of a multi-centre research proposal within that jurisdiction. The statutory framework of a given State or Territory applies to all institutions within that jurisdiction. National legislation, where relevant, applies to all institutions in all States and Territories. Relevant legislation includes (but is not limited to) laws concerning privacy, the use of human tissue and guardianship.
Abbreviations
| ACHS | Australian Council of Healthcare Standards |
| AHEC | Australian Health Ethics Committee |
| AHMAC | Australian Health Ministers’ Advisory Council |
| ARC | Australian Research Council |
| ASC | Aboriginal Sub-Committee |
| ATSIHC | Aboriginal and Torres Strait Islander Health Committee |
| AVCC | Australian Vice Chancellors’ Committee |
| CHREC | Central Human Research Ethics Committee(s) (Victoria) |
| CI | Coordinating Investigator |
| CSV | Comma Separated Values |
| CTA | Clinical Trials Australia |
| CTN | Clinical Trial Notification (TGA) |
| CTX | Clinical Trial Exemption (TGA) |
| DHHS | Department of Health and Human Services (Tasmania) |
| HoMER | Harmonisation of Multi-centre Ethical Review |
| HREC | Human Research Ethics Committee(s) |
| IT | Information Technology |
| KPI | Key Performance Indicator |
| LC | Lead Committee (NSW) |
| MAM4MCR | Mutual Acceptance Model for Multi-Centre Research (Qld) |
| MDB | Microsoft Access Database |
| MOU | Memorandum of Understanding |
| NEAF | National Ethics Application Form |
| NHMRC | National Health and Medical Research Council |
| PI | Principal Investigator |
| Portable Document Format | |
| QH | Queensland Health |
| RGO | Research Governance Officer |
| SAE | Serious Adverse Event |
| SOP | Standard Operating Procedure |
| SSA | Site-Specific Assessment |
| SUSAR | Suspected Unexpected Serious Adverse Reactions |
| TGA | Therapeutic Goods Administration |
| UTAS | University of Tasmania |
| XML | Extensible Markup Language |