Research Governance Handbook:
Guidance for the national approach
to single ethical review
December 2011

© Commonwealth of Australia 2011
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Published: December 2011ii

Introductory comment

BackgroundA critical element of the Harmonisation of Multi-centre Ethical Review (HoMER) initiative1 is theneed for research governance to be understood as comprising distinct elements ranging from theconsideration of budgets and insurance, to the management and conduct of scientific and ethics
review. In recent years, the concept of research governance has grown from being considered
an ancillary responsibility of the Human Research Ethics Committee (HREC) to one that isunderstood as the responsibility of the institution where the research is being conducted.
While this conceptual change and the resulting changes in roles and responsibilities may stillneed further refinement, the requirements of the HoMER initiative have highlighted the need toensure that the different components of research governance are well understood.
Although research governance arrangements inevitably vary amongst institutions, in order for anational 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 ethicalreview processes certified under the HoMER initiative. The process of fostering consistency may
take the form of encouraging standardisation of the site assessment processes used to support
authorisation of a research project at a research site, to developing a consensus about thecomponents of research governance, and how they are structured and allocated in accordancewith an overall governance framework.

Purpose of this document
The purpose of this document 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 humanresearch and describes the roles and responsibilities of key stakeholders within the framework.
An institution’s responsibilities in the governance of research are described in the:••National Health and Medical Research Council (NHMRC)/Australian Research Council(ARC)/Universities Australia Australian Code for the Responsible Conduct of Research(2007) (the Code) http://www.nhmrc.gov.au/publications/synopses/r39syn_intro.htm; andNHMRC/ARC/Australian Vice Chancellors’ Committee National Statement on EthicalConduct in Human Research (2007) (the National Statement) http://www.nhmrc.gov.au/
guidelines/ethics/human_research/index.htm.

Professional judgement is involved in the interpretation of this guidance document as no single
document adequately captures the full range of legislation, standards and guidelines that apply
to human research. Good practice in research governance depends on those with researchgovernance responsibility being appropriately skilled and experienced and working inan environment that enables them to use their professional judgement effectively.

1	The glossary of terms used in HoMER project documentation is found at
www.hrep.nhmrc.gov.au/national-approach/glossary.

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

Introductory comment
This document does not replace existing national guidance documents or override any
jurisdictional administrative and/or statutory requirements. It relates the national guidance to theinternal activities of an institution conducting multi-centre human research.
The issues around research relating to specific population groups, such as Aboriginal and Torres
Strait Islander Research and research in remote communities are not discussed in this Handbook.
As such, adherence to this Research Governance Handbook alone is not sufficient for research
involving Aboriginal and Torres Strait Islander peoples. A separate body of work is underway aspart of the HoMER initiative relating to research involving Aboriginal and Torres Strait Islander
communities. The following NHMRC publications should also be referred to:••

Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander
Health Research (NHMRC 2003), http://www.nhmrc.gov.au/guidelines/publications/e52; andStatement on Consumer and Community Participation in Health and Medical Research(NHMRC and Consumers’ Health Forum of Australia Inc, 2002), http://www.nhmrc.gov.au/
guidelines/publications/r22-r23-r33-r34.

How to use this document
This document may be of greatest assistance to institutional managers, administrators supporting
governance activities and their colleagues supporting research ethics. It aims to provide
investigators engaged in multi-centre human research with a better understanding of governanceactivities that the institution must address before, during and after research has commenced, as
well as how the relationship between the Coordinating Principal Investigator (CPI) and the ethicalreview process supports these activities.
An institution should have specific policies and procedures in place relating to its governance of
all research, whether multi-centre or single centre. This document provides a reference against
which an institution can compare their internal administrative practices, recognising that researchgovernance for single centre research has a high degree of overlap with multi-centre humanresearch governance. This document is recommending best practice in this area and institutions
are encouraged to regularly review their research governance policies, particularly if they areinterested in applying for certification under the HoMER initiative.
In this document, research governance is discussed as an institutional responsibility.
Nevertheless, it is recognised that a critical component of research governance, the authorisationof the commencement of a research project, may reside at a higher level such as a health districtor other government body. The term institution is used broadly to mean a research institution,organisation or, in certain cases, individuals or jurisdictions (States and Territories of Australia),
either in the public or private sector, under whose authority research is conducted.
Further information about jurisdictional level research governance practices in public healthorganisations is outlined in Appendix A.

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

iv

Contents

Introductory comment

Ii

I.

1

Research governance framework

II. The relationship between research governance and ethical review3III. National guidance documents

7IV. 	Linking the components of an institution’s research governance framework
to the lifecycle of a multi-centre human research project

9V. 	Roles and responsibilities of key stakeholders within the institution’s
research governance framework for multi-centre human research

17

Appendix A: Research governance practices for public health organisations22

Appendix B: Extracts from national guidance documents

23

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

I. Research governance framework

Research must be ‘governed’ at all stages of a project. The governance of research will ensurethat its delivery meets its objectives and conforms to relevant institutional, jurisdictional andnational standards and applicable laws.
Research governance implements the principles, requirements and standards of research. It
addresses protection of research participants, the safety and quality of research, privacy andconfidentiality, financial probity, legal and regulatory matters, risk management and monitoringarrangements and promotes good research culture and practice.
Institutions should ensure that their procedures and policies and other documents that guide
good research governance, conduct and management, are open, transparent and available tomembers of the community.
The combination of all institutional activities that govern research, irrespective of who is
responsible for any one activity, is known as an institution’s research governance framework.
An institution’s research governance framework defines the way all staff involved in researchshare responsibility and accountability for the institution’s research being conducted according
to appropriate regulatory, ethical and scientific standards and within the levels of acceptable
institutional risk.
Sponsors of research have parallel responsibilities to properly govern research with which they
are associated. These obligations are independent of the institution’s research governanceframework and are not addressed in this document.
A well-developed research governance framework ensures that:•

research is promoted as a valued activity in the institution;•

activities that the institution offers that will promote good research practice(e.g. appropriate training and education of staff in good and ethical research practice)
are described and promoted;•

responsibilities and accountabilities for individuals and groups are understood,
enacted and maintained;•

processes used are appropriate to the institution’s research environment andsufficiently adaptable to recognise differences in the relative risk of certain types ofresearch (e.g. interventional research in contrast to observational research);•

research governance activities are monitored and evaluated and the framework is
modified as appropriate;•

the self-regulation of all contributors to research upon which the preservation ofresearch integrity depends is affirmed and can be shown to be practiced;•

the framework is accessible to all relevant parties;•

the rights and reputations of researchers and research participants are respected
and conflicts of interest are declared; and•the outcomes of research are communicated responsibly.

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

1I. Research governance framework
Multi-centre research governance that has undergone
single ethical review
The ethical review upon which the institution relies and the responsibilities for managing andmonitoring multi-centre human research may involve external groups or individuals operating
under contract or in another arrangement (e.g. provision of indemnity) with the institution carryingout the research. While an institution’s research governance framework applies to all research,whether multi-centre or not, there are particular responsibilities that need to be set out in a
research governance framework for multi-centre human research projects that have undergone asingle ethical review.
Although some research governance activities supporting collaborative research may becoordinated across centres (e.g. the application for a single ethical review), each institution
remains responsible for authorising the commencement of research and for the appropriate
governance of research activity at each institutional location where the research is carried out.

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

2II. The relationship between research governance andethical review
Ethical review and site assessment are two distinct processes relating to the ethical approval andinstitutional authorisation of research involving humans. They are both components of researchgovernance.
As noted earlier, the concept of research governance has grown from being considered
an ancillary responsibility of the Human Research Ethics Committee (HREC) to one that is
the responsibility of the institution where the research is being conducted. This is because
research governance encompasses both ensuring adequate ethical review and institutional
considerations about undertaking research in the context of the institution’s policies, strategic
priorities, expertise, resources, contractual arrangements, financial issues and approach to risk
management.
As indicated, research governance takes place via an institutional framework that, when followed,
ensures that all research meets applicable legal, regulatory and institutional requirements,
appropriate ethical and scientific standards and standards of quality, safety, privacy, risk
management and financial management.
The ethical review of human research is undertaken by a properly constituted HREC, or for
low risk research, possibly another ethical review body or process.2 This review body assesses
proposed research in the context of the rights, dignity and welfare of participants in research
as well as ensuring that the research is scientifically sound and promotes good research.
The institutional consideration as to whether an individual research project is a good fit for the
institution at the time it is proposed is the ‘site assessment’ process, sometimes known as‘research governance review’. This process takes into account the ethical review upon which
the institution has chosen to rely, institution-specific considerations such as resources, budget,risk management, and applicable legal, regulatory, jurisdictional and other administrativerequirements. The outcome of the site assessment is an institutional authorisation of a research
project or a decision not to authorise a specific project.
However, there may be times when ethical consideration of a project by an HREC will draw onmatters of relevance to the institution’s research governance responsibilities and vice versa. For
instance, a project’s budget may have direct bearing on the ethical appropriateness of the project
when insufficient financial resources compromise the scientific validity of the project or theburden on the participants.
Conversely, a project that an HREC has deemed ethically appropriate may be inconsistent with
one or more institutional policies.

2	Within the National Statement, an institution may implement an alternative process for reviewing the ethicalacceptability of low risk or negligible risk research.

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

3II. The relationship between research governance and ethical review
General requirements of institutional site assessment
and project authorisation in satisfaction of its researchgovernance responsibilities
Before an institution can authorise the commencement of research, the relevant decision
makers will consider the risks involved in conducting the research against the institution’s levelsof tolerated risk.
A range of information will be considered in the risk assessment; including (but not limited to)whether the research project has been ethically reviewed and approved. Ethical approval is a
pre-requisite for research commencement; however, the institution may choose not to authorise
ethically approved research because of other factors. Not withstanding this sequence, aspectsof site assessment may take place in parallel with the ethical review process. This matter will be
discussed in more detail below.
In addition to an HREC, other individuals or groups may provide advice to the institutional
decision maker (and/or their delegate) in order for them to authorise the commencement ofresearch. This may include individuals or groups with legal, financial, technical, scientific or
intellectual property expertise or relevant institution-specific knowledge or information.
The decision maker, generally a senior officer (e.g. the Chief Executive Officer or Deputy ViceChancellor of Research, or equivalent State Public Health Officer) or their delegate, will weighup the advice and information provided by all groups against the levels of acceptable risk, andthe importance of the research to their institution, before authorising research. Institutional
research governance officers have an important role to play in providing the decision maker withappropriate documentation and advice.
As a decision to authorise the commencement of research in an organisation takes into accountthe separate and distinct results of both the ethical review and the site assessment, it is bestpractice for the decision-maker to be a person in the institution who is not the Chair of the HREC.
The National Statement states that the Chair of the HREC should be a person with suitable
experience whose other responsibilities will not impair the HREC’s capacity to carry out its
obligations.3

Requirements specific to the national approach to single ethical review:
In the national approach to single ethical review, site assessment and project authorisation are
the responsibility of each institution participating in a multi-centre human research project while
ethical review is provided by only one HREC using certified ethical review processes.
Each institution collaborating in a multi-centre project utilising the outcome of a single ethicalreview must individually authorise the commencement of research at their institution. To avoid
unnecessary delays in research commencing at all collaborating centres (and sites), each
institution should consider relevant local matters prior to or in parallel with ethical review.

3

The National Statement, Section 5.1.30.

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

4II. The relationship between research governance and ethical review
It is recognised that institutions and jurisdictions will have established policies about
undertaking site assessment in parallel with ethics review. It is recommended that as partof the national approach to single ethical review, institutions establish effective processes
to facilitate parallel review.
It is helpful to consider project documentation related to site assessment as falling into
three categories:(a) t hat which can be assessed independent of ethical review, such as evidence of
research qualifications, supporting department approval forms, contracts, budgets andinsurance and indemnity documents;(b) t hat which is subject to ethical review, but can be submitted prior to or in parallel withethical review to enable independent assessment of other documentation, such as initialproject application documents; and(c) t hat which can only be assessed subsequent to ethical approval, such as approved
project application documents, fully signed regulatory documents and a certificate of
ethical approval.
The site assessment process can be similarly divided into stages of review. Review of
documentation that can be assessed independent of ethical review can be undertaken while
the proposal is being considered by an HREC or earlier. Not doing so may unnecessarily delay
the completion of the site assessment process and extend project authorisation timelines.
As evidence of HREC approval is a component of the site assessment process, authorisationof a research project cannot be given until HREC approval has been provided.
The HREC undertaking the single ethical review may be located at an institution participatingin the multi-centre research, but this is not a requirement of the national approach to single
ethical review.
Researchers should be aware of any specific State or Territory requirements and may choose tosubmit their research proposal to any HREC that uses certified ethical review processes.
The Chief Principal Investigator (CPI) is responsible for submitting the application for ethicalreview to the HREC and notifying the Principal Investigators (PIs) in each participating institutionof the results of the HREC review.
Similarly, the authorisation of research at each institution must be communicated by each PI to
the CPI.

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

5II. The relationship between research governance and ethical review
Likewise, if the HREC that approved the project withdraws its approval at any stage once theresearch has commenced, then the HREC must notify the CPI. It is the responsibility of the CPI
to notify the PI at each participating institution that ethical approval has been withdrawn and for
the PI to notify their institution of this. The institution must then suspend or cease participation in
the research project.
The monitoring of multi-centre research projects is the subject of a separate guidance document.
Further details about individual components of a best practice research governance framework,
linked to the lifecycle of a multi-centre human research project, are discussed below.
The Code and the National Statement address the importance of good institutional
governance and management practices in relation to the delivery of quality outcomes forboth multi-centre and single centre human research. These national guidance documents
form the foundation for good research governance practice. The Code can be found at:
http://www.nhmrc.gov.au/guidelines/publications/r39 and the National Statement at:
http://www.nhmrc.gov.au/guidelines/publications/e72.

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

6III. National guidance documents

The Code – Chapter 1:
General Principles of Responsible Research
Sections 1.1 – 1.5 provide guidelines for the responsibilities of institutions relating to themaintenance of an environment that fosters responsible research. Specific guidelines
for consideration are at Appendix B.
Sections 1.6-1.11 outline the responsibilities of researchers to foster and maintain aresearch environment of intellectual honesty and integrity, and scholarly and scientificrigour and well as respecting research participants.
Sections 1.12 and 1.13 set out special responsibilities. It is acknowledged that researchwith Aboriginal and Torres Strait Islander peoples spans many methodologies anddisciplines.
The Code should be read in conjunction with Values and Ethics: Guidelines for
Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (NHMRC
2003) and the Guidelines for Ethical Research in Indigenous Studies (Australian and
Torres Strait Islander Studies 2002).
Appropriate consumer involvement in research should be encouraged and facilitatedby research institutions and researchers. The Code should be read in conjunction with
the Statement on Consumer and Community Participation in Health and Medical
Research (NHMRC and Consumers’ Health Forum of Australia Inc, 2002).

The Code – Chapter 8:
Collaborative research across institutions
Sections 8.1-8.5 set out the responsibilities of institutions in relation to managing joint
research projects, managing conflicts of interest and managing access to researchmaterials. Specific guidelines for consideration are at Appendix B.

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

7III. National guidance documents
The National Statement – Chapter 5.1:
Institutional responsibilities
Sections 5.1.1 – 5.1.5 provide guidance on the use of, and institutional responsibility
for, research governance activities. Specific guidelines for consideration include:
Section 5.1.2(b)(i-ii) – each institution needs to be satisfied that those conducting its
human research are:•either adequately experienced and qualified, or supervised and•understand the need to assess risks to their own safety and that of participants.

Section 5.1.5 – institutions should use and promote clearly formulated,documented, accessible and current policies and procedures for researchgovernance and ethical review.

The National Statement – Chapter 5.5:
Monitoring of approved research
Sections 5.5.1-5.5.10 provides guidance on monitoring of approved research.
Specific advice on monitoring of multi-centre research projects is currently being
developed and will form part of this handbook once it is completed.

The National Statement – Chapter 5.7:
Accountability
	Chapter 5.7 sets out the different responsibilities the range of stakeholders involved in
the ethical design, review and conduct of human research. Specific guidelines for
institutions are set out at 5.7.3:•

to ensure that ethical review of research occurs. These responsibilities are set
out in Chapter 5.1 Institutional responsibilities: and•for the conduct of research. These are set out in the Code. They include ensuring that
research is both sound and lawful, and is conducted or supervised by educated andexperienced researchers.

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

8IV. Linking the components of an institution’s
research governance framework to the lifecycleof a multi-centre human research project

The components of an institutional research governance framework can be mapped
through four project lifecycle stages:•

Stage 1: Project design (concept)•

Stage 2: Project authorisation (pre-commencement)•

Stage 3: Project delivery (post-authorisation to closure)•Stage 4: Project closure (completion)

The following listing of components of an institutional research governance framework and theactivities supporting those components is not exhaustive and should be read in conjunction
with any institutional and/or jurisdictional research governance policies that may list additional
activities: for example, the Victorian Managed Insurance Authority’s Research GovernanceToolkit.
The listing of the components below is not sequential within each project lifecycle stage,i.e. most of the activities listed occur in parallel rather than in any prescribed order.
Figure 1 is a graphic representation of the elements of research governance.

Flowchart of research governance elements
Project design

Initial assessment

Ethical Review
Finances

Legal & Administration
Project authorisation

Risk Management

Intellectual Property

Complaints Handling
Monitoring

Project delivery
Reporting

Project closure

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

Completion

9

Stage 1: Project design (concept)
Component

Initial assessment of proposed research

Responsible•

Institutional administrators•

Principal Investigator•

Confirmation of the feasibility and alignment of the project design
to institutional and/or departmental strategic plans for research.

•

Peer review of scientific, ethical and practical aspects ofproposed project.

•

Confirmation that the institution has appropriate facilities
and other infrastructure.

•

Confirmation that the institution is appropriately staffed to
conduct the particular research and to conduct or support any
necessary initial and ongoing training.

•

Identification of any conflicts of interest.

•

Preparation and review of risk management strategies.

•

Identification of funding sources.

•

Consideration of the suitability of the site for the project(i.e. access to adequate pool of participants).

•

Establishment of communication between the Principal Investigatorand Research Governance Office to help streamline processes andreduce duplication.

Activities

10IV. Linking the components of an institution’s research governance framework
to the lifecycle of a multi-centre human research project
Stage 2: Project authorisation (pre-commencement)
Component

Financial assessment of proposed research

Responsible•

Institutional administrators•

Principal Investigator•

Review of the budget in preparation for final sign off by an appropriate
finance authority (e.g. Director of Finance, Head of Department/Division
and/or delegate).

•

Completion of research grant processes (where applicable).

•

Determination of fees or cost recovery mechanisms (if applicable)
for internal and external service providers.

Activities

Component

Risk management of proposed research

Responsible•

Institutional administrators•

Coordinating Principal Investigator•

Principal Investigator•

Identification of potential risks of the proposed research activities
to the institution.

•

Selection of the appropriate risk management strategy to manage
risks, including consideration of risk transfer or sharing (e.g. appropriate
insurance coverage).

•

Provision of relevant indemnities, where required, based on theinstitutional risk profile and chosen management strategy for the
given research project.

Activities

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

11IV. Linking the components of an institution’s research governance framework
to the lifecycle of a multi-centre human research project

Component

Assessment of legal and administrative requirements
of proposed research

Responsible•

Institutional administrators•

Relevant experts•

Confirmation of roles, responsibilities and accountabilities for all parties
involved in the research project (including investigators, sponsors andparticipants).

•

Affirmation of institutional compliance with relevant guidelines,
regulations, legislation and codes of practice (state and federal)
including meeting obligations to the public or non-public collaborators,
if any.

•Completion of an accepted standard clinical research agreement(where appropriate).

•

Compliance with notification requirements under the Therapeutic
Goods Act 1989.

•

Compliance with requirement to register (where appropriate) clinical
trials on a publicly accessible clinical trials registry that complies with
the International Committee of Medical Journal Editors (ICMJE).

•

Review (and completion) of contractual and other legal documentationand confirmation that documentation appropriately reflects the roles,
responsibilities and obligations of each party.

•

Establishment of agreements between collaborating institutions as
described in the Code (e.g. conflicts of interest, defining shared roles
and responsibilities).

Activities

Component

Credentialing and supervision of proposed researchers

Responsible•

Institutional administrators•

Principal Investigator•

Confirmation that investigators and support staff have the appropriatequalifications, authorisation to practice and experience.

•

Confirmation of arrangements for the supervision and mentoring ofstudent/junior investigators.

Activities

12IV. Linking the components of an institution’s research governance framework
to the lifecycle of a multi-centre human research project
ComponentIntellectual property (IP) arrangements covering
proposed research

Responsible•

Institutional administrators•

Relevant experts•

Assurance of protection for the institution’s intellectual property.

•

Negotiation and settlement of issues about authorship, publication andpotential commercialisation of research.

•

Compliance with institutional policy on intellectual property.

Activities

Component

Ethical review of application for proposed research andtransmission of outcome of review

Responsible•

Human Research Ethics Committee (HREC)•

Coordinating Principal Investigator with support of Principal
Investigators•

Review and provision of an opinion on the extent to which the research
proposal is ethically acceptable and compliant with ethical standards
and guidelines (termed ‘ethical approval’ in the National Statement).

•

Determination of the need for HREC review or an appropriate
authorised alternate review process (e.g. for low risk research).

•

Notification to relevant bodies (e.g. Therapeutic Goods Administrationand the institutions participating in the research) of the outcome of
ethical review.

Activities

Component

Project authorisation

Responsible•

Institutional administrators

Activities•

Assessment that each research governance activity, including site
specific assessment and ethical approval, has been satisfactorily
completed.

•

Authorised research to commence in institution and notification
provided to the Coordinating Principal Investigator.

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

13

Stage 3: Project delivery (post-authorisation to closure)
Component

Monitoring of proposed research

Responsible•

Institutional administrators•

Human Research Ethics Committee (HREC)•

Principal Investigator (reporting to HREC via Coordinating Principal
Investigator)•

Monitoring and review of safety of all research participants andcompliance with adverse event reporting requirements.

•

Management of data management and storage.

•

Management of privacy requirements and confidentiality of research
data.

•

Delivery of quality control processes (including supervision of staff andrecord-keeping).

•

Training and/or mentoring of investigators regarding monitoring
requirements.

•

Monitoring of expenditure and budget.

•

Clarification and assignment of responsibility within institution formonitoring conduct of research. Typically, this responsibility is delegatedto the Research Governance Office or an equivalent individual or group.

•

Demonstration that relevant institutional staff understand and follow theprocess for information sharing between the institution, collaborating
institutions and the HREC that conducted the review. The Coordinating
Principal Investigator has the lead role for communication between the
Principal Investigators at each institution and the HREC.

•

Compliance with the requirements of and timeframes for reporting on
project progress.

•

Measurement of performance against agreed targets (whereappropriate) and modification of processes as needed.

Activities

14IV. Linking the components of an institution’s research governance framework
to the lifecycle of a multi-centre human research project

Component

Complaints management and management of allegations
concerning research misconduct

Responsible•

Institutional administrators•

Principal Investigator•

Human Research Ethics Committee (HREC)•

Compliance with institutional process for managing allegations ofresearch misconduct and complaints.

•

Incorporation of the principles of natural justice and independence into
management of complaints and allegations.

•

Assurance that the complaints process is transparent andcommunicated to relevant stakeholders and is undertaken inaccordance with the requirements set out in the Code.

Activities

Component

ReportingResponsible•

Principal Investigator•

Coordinating Principal Investigator (to HREC)•

Institutional administrators•

Conduct of self-audit on compliance with good research practiceguidelines.

•

Safety reporting.

•Compliance with internal and external reporting obligations, including
safety reporting and reporting to the HREC.

•

Provision of training on reporting for investigators and administrators toencourage culture of oversight and review.

Activities

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

15IV. Linking the components of an institution’s research governance framework
to the lifecycle of a multi-centre human research project
Stage 4: Project closure (completion)
Component

Completion

Responsible•

Principal Investigator•

Institutional administrators•

Confirmation that project closure is orderly and systematic.

•

Completion of an end-of-project checklist.

•

Provision of research outcomes to participants (where required).

•Compliance with record storage policies (including future destruction).

•

Follow up on intellectual property and commercialisation activities(where applicable).

•

Reporting of outcomes to participants, funding bodies and otherstakeholders (where applicable).

Activities

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

16coordinating the on-going reporting of the ethical progress of theresearch project to the HREC and/or sponsors (where required).

•Note: It is considered best practice for all multi-centre research
projects undergoing single ethical review to have a designated CPI,
regardless of which sector the research is occurring in or the type of
research project being conducted.

This person may or may not be employed by an institution participating in
the research project.

communicating the outcome of the single ethical review to Principal
Investigators at each institution

The person who has overall responsibility for coordinating theadministrative processes of the ethical review of a multi-centre humanresearch project. This includes, but is not limited to:

Coordinating
Principal
Investigator (CPI)

•

Role

Key stakeholder

Compile a National Ethics Application Form (NEAF) with input fromparticipating institutions.
Submit the NEAF, with supporting documentation, to an HREC thatuses certified ethical review processes.
Relay information as necessary and in a timely manner between
Principal Investigators and the HREC (e.g. queries, notificationof project authorisation and research commencement, required
reporting).
Submit reports related to the ethical conduct of an approved multicentre human research project as required by the HREC.
Co-ordinate the provision of necessary documentation in the event of
an investigation of research misconduct.

•
•
•

•
•

Responsibility

The table below expands on the roles and responsibilities of institutional stakeholders in the governance of multi-centre human research.

In the context of the HoMER initiative, good practice in research governance of multi-centre human research demonstrates a clear distinction between institutional researchgovernance responsibilities and the ethical review responsibilities of an Human Research Ethics Committee (HREC). Everyone involved in human research has a personal
responsibility to understand and comply with the relevant administrative or statutory arrangements of the institution, the relevant jurisdiction and national guidance documents.

V. Roles and responsibilities of key stakeholders within the institution’s research governanceframework for multi-centre human research

17

The person(s) responsible, either as an individual or as the leader ofinvestigators within an institution, for the conduct of a research project atthat institution.

Principal
Investigator(s) (PI)Provide Coordinating Principal Investigator (CPI) with information tocomplete the NEAF.
Provide relevant information to the research governance office (orequivalent body or individual) in a timely manner (i.e. in parallel toethical review process) to enable the institution to begin the site
assessment process where appropriate.
Provide ethical review information to the research governance office(or equivalent body or individual) as the initial review outcome orsubsequent changes become available.
Provide the approving HREC (via the CPI if required) with a regular
report on routine monitoring including concerns or issues arising fromlocal audit.
To comply with Good Clinical Practice guidelines as appropriate.
Conduct multi-centre human research projects in accordance with theagreed protocol, relevant administrative or statutory requirements andnational and international guidance.
Prepare and provide information for participants of multi-centre
human research projects at a local level that relates specifically to theinstitution.
Ensure participants’ safety and welfare during the research project.
Arrange to make findings and/or data accessible following peer
review.
Notify CPI of research commencement, where appropriate.
Comply with institutional reporting requirements related to the multicentre human research project, where appropriate. Provide CPI withinformation to enable reporting to the HREC.
Comply with institutional financial management and otherrequirements regarding research projects.

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Responsibility

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

Role

Key stakeholder

V. Roles and responsibilities of key stakeholders within the institution’s research governance framework for multi-centre human researchInstitution

In this document, the term institution is used broadly to mean a research
institution, organisation or, in certain cases, individuals or jurisdictions(States and Territories of Australia), either in the public or private sector,
under whose authority research is conducted.

The person(s) involved in and/or conducting the research project. May alsobroadly refer to individuals supporting the conduct of research.

Investigator(s)(e.g. Associate orAssistant)Role

Key stakeholder

Determine the level of resourcing for the support of research activities
within the institution (e.g. people and money).
Comply with relevant statutory and administrative requirements
including the establishment of processes that support or monitor
those requirements.
Train investigators and research governance officers to fulfil their
obligations within human research.
Investigate complaints and allegations of research misconduct.
Utilise the outcome of a single ethical review of multi-centre humanresearch conducted by an HREC using certified ethical review
processes.
Authorise, or not, the commencement of research approved by an
HREC.
Foster and support the development of intellectual property.
Provide indemnity and insurance coverage for research (whereapplicable).

•
•

•
•
•

•
•
•

Comply with institutional financial management, institutional policies
on governance (such as Good Clinical Practice guidelines) and otherrequirements regarding research projects.

•

Oversee the conduct of research including establishment of structuresand processes to monitor research.

Ensure participants’ safety and welfare during the research project.

••

Be involved and/or conduct multi-centre human research projects
in accordance with the agreed protocol, relevant administrative or
statutory requirements and national guidance.

•

Responsibility

V. Roles and responsibilities of key stakeholders within the institution’s research governance framework for multi-centre human research

19

The designated administrative area within an institution that is resourced
to enable research proposals to be appropriately assessed so to assist thedecision-maker to determine whether or not the research project will beauthorised.

The officer (or their delegate) within an institution who has the authority toauthorise the commencement of a research project at their site.

Institutional
Research
Governance OfficeInstitutional
authorising officer

Determine and approve the financial management conditions and/or
the funding source for the proposed research for the duration of the
project.
Assess the institution’s risk exposure through risk assessment
processes including choosing appropriate strategies for managing risk(e.g. appropriate insurance cover and/or indemnity agreements).
Review and negotiate contracts, in consultation with relevant
specialists as required, including, but not limited to, clinical research
agreements, confidentiality agreements and those relating toconditions of employment for investigators.
Review intellectual property issues, in consultation with relevant
specialists as required.
Ensure compliance with relevant guidelines, regulations, andlegislation (institutional, State and Federal).
Process complaints relating to the conduct of research at theinstitution in accordance with institutional complaints policy andprocesses.
Monitor conduct of research within the institution.

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•

Provide authorisation for the approval of the commencement of an
ethically approved research project at their institution.

Advise the authorising officer about the strategic fit of a proposed
research project for their institution.

••

Establish efficient processes for site assessment and overall researchgovernance activities to be conducted.

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Responsibility

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

It is best practice for this authorisation to be function of a delegate who is
not a member of the ethical review body that approved the research.

Role

Key stakeholder

V. Roles and responsibilities of key stakeholders within the institution’s research governance framework for multi-centre human researchRole

The body established in accordance with Chapter 5.1 of the National
Statement that conducts the ethical review of a multi-centre humanresearch project using certified ethical review processes. The HREC may
or may not belong to one of the institutions participating in the multicentre research project.

Key stakeholder

Human Research
Ethics Committee(HREC) reviewing
multi-centre humanresearch

Review a multi-centre human research proposal to form a view on its
ethical acceptability (in accordance with the National Statement).
Ensure project is compliant with relevant guidelines, regulations andlegislation (institutional, State and Federal).
Provide the Coordinating Principal Investigator, and/or the Principal
Investigator, with the outcome of the ethical review of the multicentre human research project.
Advise and receive reports from institutions regarding complaints orreports of research misconduct arising out of the conduct of approved
multi-centre human research.
Monitor research for which it has given approval, through the receipt
of safety, progress and any other required reports in conjunction withthe participating institutions and their research governance offices.

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V. Roles and responsibilities of key stakeholders within the institution’s research governance framework for multi-centre human research21

Appendix A

Research governance practices for public health organisations
The following links to the websites of State and Territory Health Departments provide information
about research governance practices for public health organisations:
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.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/about+us/
research
Tasmania
http://www.research.utas.edu.au/human_ethics/index.htm
Victoria
http://www.health.vic.gov.au/cchre/applications_site_specific.htm
Western Australia
http://www.shrac.health.wa.gov.au/home/

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

22Appendix B

Extracts from national guidance documents
The Code – Chapter 1:
General Principles of Responsible Research
Section 1.2 – Establish good governance and management practices•

1.2.1 – each institution should provide an appropriate research governanceframework through which research is assessed for quality, safety, privacy, risk
management, financial management and ethical acceptability. The framework should
specify the roles, responsibilities and accountabilities of all those who play a part inresearch.

•

1.2.2 – the research governance framework should demand compliance with laws,
regulations, guidelines and codes of practice governing the conduct of researchin Australia. Common law obligations also arise from the relationships between
institutions, investigators and participants, while contractual arrangements may
impose further obligations.

•

1.2.3 – each institution must ensure the availability of the documents that help guide
good research governance, conduct and management.

•

1.2.4 – there must be a clear policy on collaborative research projects with otherorganisations, which requires arrangements to be agreed before a project begins.
As a minimum, these arrangements should cover financial management, intellectual
property, authorship and publication, consultancies, secondments, ethics approval,
and ownership of equipment and data.

•

1.2.5 – each institution must have a well-defined process for receiving and managing
allegations of research misconduct.

•

1.2.6 – there must be a process for regular monitoring of the institution’s
performance with regard to these guidelines.

	Section 1.3 – Train staff•

It is important that institutions provide induction, formal training and continuing
education for all research staff, including research trainees. Training should coverresearch methods, ethics, confidentiality, data storage and records retention, as well
as regulation and governance. Training should also cover the institution’s policies
regarding responsible research conduct, all aspects of this Code, and other sourcesof guidance that are available. Institutions may make arrangements for joint induction
and training with other institutions.

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

23Appendix B
The Code – Chapter 8:
Collaborative research across institutions•

8.1 Establish agreements for each collaborationoOrganisations involved in a joint research project should ensure that anagreement is reached with the partners on the management of the research.
Such an agreement should follow the general principles of this Code,including integrity, honesty and a commitment to excellence.

o

The agreement should be in writing. It must cover intellectual property,
confidentiality and copyright issues; sharing commercial returns, responsibility
for ethics and safety clearances; and reporting to appropriate agencies.
It should address the protocols to be followed by the partners when
disseminating the research outcomes, and the management of primaryresearch materials and research data.

o

The agreement may take various forms, including a legal contract signed by
the chief executive officer, an exchange of letters, or a research management
plan signed by all parties, or management plans signed by appropriate
representatives from all parties.

oEach organisation must ensure that its investigators are aware of, andunderstand, the policy and agreements governing the joint researchcollaboration.

•

8.2 Manage conflicts of interest
Institutions must have a policy for managing conflicts of interest that arise incollaborative research (see Section 7).

•

8.3 Manage access to research materials
The collaborating parties should each identify a person to be involved in
the management of research data, primary materials and other items to beretained at the end of the project.

Responsibilities of investigators•

8.4 Comply with multi-institutional agreements
Investigators involved in joint research must be aware of, and comply with, allpolicies and written agreements affecting the project, particularly those relating
to the dissemination of research findings and the management of research dataand primary materials.

•

8.5 Declare conflicts of interest
When establishing a research collaboration, investigators must disclose as soon as
possible any actual or apparent conflicts of interest relating to any aspect of the project.

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