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Evaluation and Program Planning 49 (2015) 117–123

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Evaluation and Program Planning


journal homepage: www.elsevier.com/locate/evalprogplan

Progress in centralised ethics review processes: Implications


for multi-site health evaluations
Brenton Prosser a,*, Rachel Davey a, Diane Gibson b
a
Centre for Research and Action in Public Health, University of Canberra, Bruce, ACT 2617, Australia
b
Faculty of Health, University of Canberra, Bruce, ACT 2617, Australia

A R T I C L E I N F O A B S T R A C T

Article history: Increasingly, public sector programmes respond to complex social problems that intersect specific fields
Received 2 April 2014 and individual disciplines. Such responses result in multi-site initiatives that can span nations,
Received in revised form 30 September 2014 jurisdictions, sectors and organisations. The rigorous evaluation of public sector programmes is now a
Accepted 8 December 2014
baseline expectation. For evaluations of large and complex multi-site programme initiatives, the
Available online 14 January 2015
processes of ethics review can present a significant challenge. However in recent years, there have been
new developments in centralised ethics review processes in many nations. This paper provides the case
Keywords:
study of an evaluation of a national, inter-jurisdictional, cross-sector, aged care health initiative and its
Ethics
encounters with Australian centralised ethics review processes. Specifically, the paper considers
Centralisation
Multi-site progress against the key themes of a previous five-year, five nation study (Fitzgerald and Phillips, 2006),
Evaluation which found that centralised ethics review processes would save time, money and effort, as well as
Aged care contribute to more equitable workloads for researchers and evaluators. The paper concludes with
Nurse Practitioners insights for those charged with refining centralised ethics review processes, as well as recommendations
for future evaluators of complex multi-site programme initiatives.
ß 2015 Elsevier Ltd. All rights reserved.

1. Introduction advocacy for the streamlining of ethics approval for all research,
including evaluations of health initiatives.
Historically in western nations, ethics approval processes for International studies point to the significant advantages from
medical and health studies have been localised, unregulated and centralised ethics review processes. For instance, Canadian
not conducive to large projects (Gold and Dewa, 2012; Snooks research in the field of oncology found that centralised processes
et al., 2012). The recent growth in multi-site studies within health sped up approvals, reduced duplication and resulted in higher
research and evaluation has reinforced that previous arrangements quality reviews (Chaddah, 2008). Meanwhile, research from the
were inadequate (Hicks, James, Wong, Tebbutt, & Wilson, 2009; United States highlighted the potential for centralised systems to
Nowak et al., 2006; Studdert et al., 2010). As Gold and Dewa (2012) result in faster approvals for multi-site projects (Wagner, Murray,
explain, local ethics review mechanisms, when used with multi- Goldberg, Adler, & Abrams, 2010), and better targeting of expertise
site studies, can jeopardise the integrity of methodological in the context of increasingly complex proposals (McWilliams,
approaches. Meanwhile, requests for the ethics review of non- Hebden, & Gilpin, 2006). Tellingly, Fitzgerald and Phillip’s (2006)
medical studies also grew dramatically throughout the 1990s. This five-year study of multi-site projects in Australia, Canada, New
was due to both the expansion of evidence-based practices and an Zealand, the USA and the UK, found that centralised ethics review
explosion in applications from the humanities and the social would save time, money and effort, as well as contribute to more
sciences (Fitzgerald & Phillips, 2006). Hence, a growing awareness equitable workload and a stronger focus on issues of ethics (rather
of the inadequacy of ethics review processes led to greater than administration). The idea of a coordinated and centralised
ethics approval system soon took hold in the United States (Nowak
et al., 2006), the United Kingdom (Snooks et al., 2012) and Australia
* Corresponding author at: Centre for Research and Action in Public Health, (Studdert et al., 2010).
Building 22, University of Canberra, Bruce, ACT 2606, Australia. The case study that is considered in this paper is located within
Tel.: +61 2 62012914. the Australian context. The Australian Health Ministers’ Advisory
E-mail addresses: Brenton.Prosser@canberra.edu.au (B. Prosser),
Davey@canberra.edu.au (R. Davey), Davey@canberra.edu.au (D. Gibson).
Council agreed in October 2006 to implement a national system

http://dx.doi.org/10.1016/j.evalprogplan.2014.12.021
0149-7189/ß 2015 Elsevier Ltd. All rights reserved.
118 B. Prosser et al. / Evaluation and Program Planning 49 (2015) 117–123

facilitating the recognition of a single ethical review process within settings. In recognition of these developments, the Australian
and across all Australian jurisdictions (National Health and Government provided $18 m (between 2011 and 2014) to support
Medical Research Council [NH&MRC], 2013), it was named the the Nurse Practitioner – Aged Care Models of Practice Program (the
Harmonisation of Multi-centre Ethical Review (HoMER). It is now NP Program).
over seven years since the establishment of this agreement and the The NP Program aims to establish the role of NP as a key provider
publication of the findings of the Fitzgerald and Phillip’s study. of aged care services across Australia. Thirty-two models were
Hence, we contend that it is timely to consider the progress that selected by the Australian Government to provide a diverse
has been made in centralised ethics review processes in Australia, representation of jurisdictions, locations, service delivery settings,
particularly in relation to the challenges faced by multi-site health aged care service needs and different cultural groups. The Australian
evaluations. Specifically, this paper provides a case study of Government also provided funding for an independent evaluation of
experiences with the HoMER process between 2011 and 2012 for a the effectiveness, efficiency and financial sustainability of each of
national evaluation of diverse Nurse Practitioner models of aged the models. The evaluation of the NP Program was selected as a case
care that spanned Australian jurisdictions, sectors and organisa- for this paper because the authors were chief investigators within
tions. As one case it is constrained in its scope, however, it is this evaluation and, hence, had first-hand access to all information
indicative of potential areas for further examination, it provides relating to the centralised ethics approval process.
insights on which those charged with the process might reflect, The specific objectives and methods of the national evaluation of
and where its insights aligns with existing literature (see Section the NP Program have been documented previously in this journal
4), it reaffirms the need for continued effort in these areas. (Prosser, Clark, Davey & Parker, 2013). However, they can be briefly
summarised as a mixed method evaluation approach (see Box 1),
2. Context: nurse practitioner aged care services in Australia which includes quantitative data on access to health services and the
economic viability of delivery models, as well as qualitative data on
Australia, like many other industrialised countries, faces the critical factors in the effectiveness of these models and different
unprecedented challenges in the provision of health care and accounts of stakeholder experiences. The final evaluation report is
the prevention of disease for an ageing population. Attempts to due to be submitted to the Australian Government in early 2015.
respond to these challenges have resulted in changing models of
health care and shifting professional role boundaries, including the 3. Case study: centralised ethics review of the nurse
development of advanced practice roles for nursing. One such practitioner evaluation
advance practice role is that of nurse practitioners, which are now
well established in the United States and the United Kingdom. In Since 2006, the centralised ethics approval process in Australia
Australia, a Nurse Practitioner (NP) is a registered nurse who has has been similar to that of the United Kingdom, where global
additional training, expertise and endorsement to provide approval is gained prior to seeking local governance approval
specialised health care services (Australian Nursing and Midwifery (Snooks et al., 2012). The NP Evaluation applied for global ethics
Council 2012). This training enables them to take on roles that approval from the University of Canberra Human Research Ethics
support healthier communities, including the management of Committee (the global HREC) in late November 2011. This
medication and disease symptoms. This provides the potential for application consisted of a covering letter, a National Ethics
them to play a valuable role with aged care in a range of health care Application Form (NEAF), and copies of data collection tools,

Box 1. Methodological flowchart.


B. Prosser et al. / Evaluation and Program Planning 49 (2015) 117–123 119

questionnaires and personal information and consent forms existing global NEAF), as well as a separate NP PICF (edited down
(PICFs). Provisional approval was granted on the 9 December from the existing PICF). This administrative requirement resulted
2011 with a request for minor changes (as listed later in this in a further eight-week delay in approval of the evaluation.
paper). The response of the global HREC noted that ‘‘all areas have The approval of this HREC was provisional on the successful
been thoroughly detailed and ethical issues have been very well completion of Site Specific Assessments (SSA) for each site under
considered in this proposal’’. It also instructed the NP Evaluation its jurisdiction. Site Specific Assessments are a form of assess-
team to access the HoMER process to streamline local governance ment that support centralised processes by considering local
approval for the thirty-two NP models which spanned several impact. Their purpose is to ensure that each site has the
jurisdictions. National ethics approval was granted on 18 January resources and governance structures necessary to support the
2012. research. The SSAs were completed and sent to the relevant sites
In line with the instructions of the global HREC, the NP for comment and signatures before sending to the jurisdictional
Evaluation team accessed the HoMER process. In theory, this HREC for approval. For one site, the approval of SSAs was
involves contacting one centralised body in each of the eight straightforward. However in another, the local site requested
Australian states and territories, a process that was relevant in this that an individual legal agreement between the universities
case for all jurisdictions other than one (due to it only having one conducting the evaluation and the state government site. The
model in the NP Program). While information endorsing the research team explained that legal agreements already existed
HoMER process was found on all jurisdictional websites, most did between the Australian Government (the funding body) and the
not provide a single point of contact for ethics approval. However, site, and between the Australian Government and the universi-
one jurisdiction had a centralised service to allocate multiple-site ties (the NP Evaluation team). Further, no other site in the project
applications to one local HREC. What follows is a short description had required a third legal agreement between the site and
of the approval process for this jurisdiction. evaluation team (due to there being no exchange of financial
resources between these bodies). The site insisted on its
3.1. Systematically centralised review processes conditions and the evaluation team then took legal counsel to
produce a legal agreement. This requirement delayed the
The central coordinating system (CCS) for ethics approval approval of the evaluation by a further five months, which
allocation was contacted in early February 2012. A questionnaire meant that the particular site was unable to participate in the
was completed over the phone and the application was automati- first of two national data collection periods and a planned site
cally allocated to a local HREC, with its next meeting on 6 March. visit was delayed. This highlights the significance of administra-
Subsequent to this meeting, a letter was received which stated that tive delays in the ethics review process.
approval could not be given without the provision of a research
protocol and PICF for Nurse Practitioners. In response, the 3.2. Informally centralised review processes
evaluation team explained that the application had already
provided a national research protocol (in the form of the NEAF) Of the remaining six jurisdictions, three expressed support for
and all consent forms (including one that combined NPs and allied the centralisation of ethics review processes (see Box 2), but had no
health professionals). The HREC replied that an appropriately formal processes in place. It should also be noted that at the time
formatted protocol and PICF had not been supplied, without which none of these jurisdictions accepted the global NEAF document.
the application would not be progressed. In response, the research Rather, each jurisdiction had their own unique requirements and
team created a new protocol document (reformatted from the NEAF forms. This involved transferring information across from the

Box 2. Ethics approval overview.


120 B. Prosser et al. / Evaluation and Program Planning 49 (2015) 117–123

global NEAF to jurisdictional NEAF documents, and while a departmental HREC agreed to accept all applications for that
national website has been developed to facilitate this administra- state. However, once the application was considered by the HREC it
tive task, it was still detailed and time consuming. was returned stating it did not have the authority to consider non-
Of the three jurisdictions that expressed support for centralisa- departmental models and the evaluation team was instructed to
tion, informal arrangements were swiftly put in place for two. In make other arrangements. This points to a key challenge for
the third jurisdiction, the evaluation team was advised by the complex evaluations that include private business, community and
central ethics contact in the health department to send an sole practitioner provided health services, in this case, the
individual ethics application to each of the six local HRECs. difficulty was in identifying a HREC that would accept responsi-
However, an administration officer at one of the regional HRECs bility for NP models. Of the thirty-two models in the project, fifteen
intervened in February 2012 and made arrangements with did not have existing HREC affiliations or established institutional
colleagues at the other relevant HRECs to bundle the applications arrangements for ethical approval. In many cases, when the
for consideration by one local HREC. This highlights the importance evaluation team contacted potential ethics committees, they
of administrative support and individual initiative in the applica- responded that they could not, or would not affiliate with the
tion of HoMER principles. particular NP model. This process again resulted in significant
However, securing local approval in the third jurisdiction was delays. Representatives of the NP models had been asked to
complex due to the SSA requirements imposed by this HREC. The nominate a potential local HREC for affiliation, and for four sites,
evaluation team was instructed to provide details in relation to approval was negotiated. If not recognised by an established HREC,
governance arrangements and the resources available for individ- a request would then be sent to the governing body for the model
ual models. This request created some difficulty as the university- to request a letter accepting an affiliation with the global HREC and
based evaluation team were not privy to the confidential funding acceptance of its approval (see Box 3). The period after global
agreements between the Australian Government and the models, approval to secure the local approval for these non-affiliated sites
which worked in both private and public sector context. Nor was it was five months.
able to access information about other matters (including
insurance, funding sources, and staffing allocations) prior to ethics 4. Discussion: progress in centralised ethics review in Australia
clearance being granted. Completing the SSA thus required an
additional effort by model representatives to obtain approval to Although these changes are relatively recent and there is (as
release governance and funding arrangements, to provide finan- yet) limited literature within the Australian context, the introduc-
cially confidential information and to secure multiple signatures of tion of centralised ethics review processes in Australia has not
approval. In particular, this process of securing multiple signatures been without some criticism. Researchers using the HoMER system
from various levels of authority (for whom an ethics process is of initially found little change in approval times (Hicks et al., 2009),
varying levels of priority), was extremely time consuming. This with any time gained in centralised ethics approval absorbed by
process resulted in a further four-month period before ethics expanded local approval processes. Olver, Falleiro, Marson, &
approval was granted. Bishop (2011) reported that while centralised ethics approval may
be faster, the associated administration procedures still need
3.3. Non-centralised review processes serious reform. Meanwhile, Shelby James and colleagues (2010)
concluded that the new arrangements added cost and time (but
The remaining three jurisdictions provided no support for not value), to the ethics review process. The specific case of the NP
centralisation of ethics approval for the NP Evaluation. That said, in Evaluation provides little evidence to contradict these broad
one of these jurisdictions, an administrative officer to a criticisms.

Box 3. Identifying ethics affiliation flowchart.


B. Prosser et al. / Evaluation and Program Planning 49 (2015) 117–123 121

However, we argue that more case studies and a more detailed programmes. As Australians live longer than previous generations,
assessment of the progress of centralised ethics review processes more people require care for the complex and chronic conditions
in Australia are warranted. Further, it is our view that the case of associated with greater longevity (Australian Productivity Com-
the NP Evaluation (as a thirty-two site, inter-jurisdictional, mission, 2011). These health trends present specific challenges for
programme evaluation in an area of national health priority), is centralised ethics review processes. For instance, early stage
an example of the sort of study that Fitzgerald and Phillips (2006) dementia affects concentration and short-term memory, which
had in mind when they conducted their detailed analysis of issues has implications for the informed consent of participants. While
for greater centralisation. In that paper, a five-nation study of standardised documentation can support centralised processes, it
multi-site ethics review processes was presented and an argument can also result in the production of complex and lengthy
was made for improvement of both ethics and administrative documentation which can be less accessible to elderly cohorts.
review procedures. Fitzgerald and Phillips made the distinction by In this case study, nurse practitioners expressed concern on
defining administrative processes as providing documentation, numerous occasions that the required format of the PICFs
managing applications, reviewing the format of documents, (including legal terms and complex language) made them
ensuring that all forms had been completed, and providing a inaccessible to their aged care service clients (which had an
conduit between the applicant and the committee. In contrast, impact on rates of participation). Meanwhile, later stage dementia
ethical processes were defined as the assessment of substantive also presents challenges for the NP Evaluation in relation to
ethical issues related to the proposed research as considered securing consent from guardians with enduring power-of-attor-
through a full committee process. Building on this distinction, we ney. Australian jurisdictions have different legal arrangements, use
will examine the challenges for centralised review according to different terminology and require different documentation as
their ethical and administrative aspects. evidence of such arrangements. Having to address these complex-
Before doing so, it is important to place the following critique in ities within standardised ethics documentation as well as provide
context. In their review, Fitzgerald and Phillips reported that additional documentary evidence to substantiate a dependent
multi-site approvals take a minimum of two months, but on relationship, resulted in additional layers of complexity and
average between six and twelve months. That the above case administration for the nurse practitioners (and again had an
included thirty-two sites and that full ethics clearance for the NP impact on rates of participation).
Evaluation was secured in eleven months demonstrates that the Another ethical consideration for evaluations of health service
above case is not unique, but is broadly representative of other provision to aged cohorts was the complex and rapidly changing
complex, multi-site evaluations. nature of illness trajectories. The requirement to pre-identify the
number of participants and the full nature of their needs proved
4.1. Insights into ethical approval processes exceedingly difficult in this case study as it has with studies of
other vulnerable groups (Studdert et al., 2010). This difficulty was
The global ethics approval request resulted in three requests for not limited to mobile or community clinic contexts, where ‘who’
amendments. These were that the language of PICFs be simplified will present with ‘what’ was unknown on a daily basis, but also
(given the inclusion of aged care participants), that it be made included ensuring consent continued when health conditions
clearer that the choice not to participate by elderly clients would changed rapidly or after a client died. Further, a tension emerged
not impact on their care, and that more guidance be provided to between the need to put in place processes that were sensitive to
NPs around the appropriate collection of client consent forms. Each the changing needs of palliative clients and the requirement to
of these requests were addressed to the satisfaction of the HREC produce standard protocols for all participants (Cadell et al., 2009).
without problem. Meanwhile, the local governance ethics approval Together, these examples point to issues of justice in relation to
identified resulted in seven requests in relation to ethical matters. recruitment and inclusion of aged care research participants, as
These were: well as fair distribution of, and participation in, the benefits of
evaluations by significant groups within aged care client cohorts
1. the dependence of elderly clients on NPs and preventing their (NH&MRC, 2007).
coercion to participate (4 HRECs);
2. the freedom of NPs to participate in the national evaluation, 4.2. Insights into administrative approval processes
when funding requirements made involvement in NP Program
compulsory (2 HRECs); While matters related to gaining ethical approval were not
3. the protection of identity, confidentiality and privacy for substantial in our case, there were notable challenges associated
participants included in low unit or unique context data (2 with the administrative aspects of centralised ethics review
HRECs); processes. For instance, Shelby James and colleagues (2010)
4. the simplification of documentation to make it more accessible propose that the introduction of a ‘standardised’ NEAF has
to aged care clients (1 HREC); increased (rather than reduced) paperwork, while Fitzpatrick,
5. the dependence of elderly clients on NPs and any preventing Boult, & Fitridge (2010) have argued that the failure of jurisdictions
change in care if clients decline to participate or withdraw (1 to uniformly accept the NEAF has meant that there has been little
HREC); positive impact for large inter-jurisdictional, multi-site studies.
6. the adverse time impact associated with NP participation (1 The experience of the NP Evaluation reaffirms past findings that
HREC); and unless all HRECs consistently adopt standardised administrative
7. the clarification of provisions for indigenous Australian parti- procedures, then the practical result will be increased time,
cipants (1 HREC). replication of tasks and, consequently, greater costs.
Issues also emerged that were linked specifically to an
evaluation involving non-government health practitioners. One
Again, each of these requests were addressed to the satisfaction of these limitations was their lack of recognition within existing
of the particular HREC without problem. centralised ethics review organisational structures. Another was
However, the process of accessing centralised ethics approval the lack of recognition of the unique contribution of these
processes identified a number of other specific ethical challenges practitioners within administrative procedures. For instance,
for evaluations of health practitioner-based aged care policy completing current NEAFs encouraged an ‘either/or’ assessment
122 B. Prosser et al. / Evaluation and Program Planning 49 (2015) 117–123

for researcher and participant. However, documenting nurse 3. The production of standardised administrative processes for the
practitioners as ‘associate researcher’ was misleading as it handling of applications to local HRECs;
suggested a role for the nurse practitioner in evaluations that is 4. The acceptance and endorsement of standardised national ethics
not appropriate, while it also implied that the independent document templates by global and local governance HRECs;
evaluation team had a degree of authority over the actions of 5. The introduction of mechanisms to enable mediation with
nurse practitioners that we did not have. Meanwhile, document- HRECs to reduce time delays and the need for appeals against
ing nurse practitioners as solely ‘participants’ overlooked their decisions (which can act as coercive forces for applicants);
contribution to participant recruitment and consent, as well as 6. The need to foreground the educative role of all HRECs, both in
support for data collection within the evaluation. Further, the providing detail to ethics applicants and guidance to local SSAs;
complexity of standard recruitment procedures across diverse 7. Greater recognition within centralised ethics processes of the
aged care services models resulted in time consuming adminis- workload demands placed on health practitioners that are
trative processes for nurse practitioners. A key insights was that required to participate in evaluations of health programmes; and
centralised processes should take into account the contribution of 8. Greater recognition within centralised ethics processes that
practitioners in evaluations of health service delivery and raises programme evaluations (as different from traditional research
questions of unfair administrative burdens being placed on them projects) are required to report on emerging models of practice and
(NH&MRC, 2007). inform future programme development, hence, exact parameters
Adding further complexity, the national evaluation is being cannot always be pre-identified for ethics applications.
conducted while the various models are in the process of
establishment. Hence, it was difficult to pre-determine the full
scope of potential ethics issues for models as they are emerging Based on our case study of the NP Evaluation experience with
and developing – yet this is an administrative requirement of the HoMER centralised ethics approval process, we suggest that
current ethics processes. Further, the requirement to consult all the above refinements would benefit national health evaluations
stakeholder communities (even before all could be fully identified), within the Australian context, but are also worthy of consideration
was a requirement that ran the risk of making the ethics review for the evaluation of complex, multi-site, programmes interna-
reductionist and artificial (Studdert et al., 2010). While some might tionally.
argue that evaluation should wait until needs are fully identified,
models are established, stakeholders are known and policy cycles 6. Lessons learned
have gone full turn, this creates an un-reconcilable tension for
health programme evaluations whose benefit, merit and integrity The encounter of the NP Evaluation with centralised ethics
(NH&MRC, 2007) include making formative contributions to approval processes in Australia points to a number of insights that
current and future policy development (Pawson, 2006). In might guide those planning similar evaluations in the future.
response, we would stress that a key insight from this case is
that should centralised systems make it even more difficult, time- 1. We suggest that evaluation planners should allow for up to one
consuming and costly to gain ethics approval for studies that year to be devoted to securing ethics approval, even when
explore areas of national health priority, then this may have the accessing centralised processes. We also note that this is a
perverse consequence of presenting an ‘unethical barrier’ (Gold significant time and cost commitment in the context of three-
and Dewa, 2012) to future evaluations. year health programme evaluations.
2. We concur with the NH&MRC (2013b), that researchers and
evaluators seeking to conduct multi-site projects in the future
5. Recommendations for improving centralised ethics review should identify and approach the relevant local HREC organisa-
processes tions well prior to application. Doing so cannot only streamline
the administrative process, but in cases where the correct
While the case of the NP Evaluation confirms the finding of affiliation is unclear, it can save time once global approval has
Fitzgerald and Phillips that centralised ethics approval processes been granted.
result in a stronger and more efficient focus on ethical issues, it also 3. When designing PICF and other documentation, identify and
aligns with existing literature on key challenges to be addressed. consult all relevant HRECs about their requirements prior to
Most notably, the referral to local level or organisational governing submitting an application to the global HREC. This will minimise
bodies for around half of the sites in this case echoes findings in the later difficulties in maintaining consistency between documents
UK (Snooks et al., 2012) that one of the challenges for medical and approved at global and local governance levels.
health studies is local site committees working in isolation as 4. In projects that include private health service providers,
pseudo ethics committees. Hence, we would suggest more planning should include provisions for when individual models
attention be given to how centralised ethics review processes are not accepted by a certified HREC.
might more effectively and efficiently cover evaluations of those 5. Although public health service providers are usually affiliated
involved with health services across private and public sectors. with a certified HREC, specific consideration should be given to
Meanwhile, there appears to be much more work ahead to potential requirements at the local level to prevent lengthy
prevent administrative demands resulting in more time, money delays.
and effort, as well as inequitable workloads for researchers and 6. In evaluations involving community-based or private health
evaluators. Important improvements to address these demands practitioners, planning should take into account any potential
could include: administrative burdens associated with centralised ethics
approval and provide for appropriate compensation for their
1. The introduction of a formal procedure that results in the involvement.
approval by global ethics review bodies triggering access to 7. When working with elderly or vulnerable groups, consideration
centralised local governance approval processes; should be given to reconciling any tensions between the specific
2. The introduction of formal coordinating systems to streamline ethical requirements of the group and the broader ethical and
the centralisation of local governance applications with one administrative requirements of centralised approval processes
HREC in all jurisdictions; (Table 1).
B. Prosser et al. / Evaluation and Program Planning 49 (2015) 117–123 123

Table 1
Insights into centralised ethics review processes in Australia.

Key barriers Key enablers

Slow administrative approval procedures National agreement to improve centralised ethics review processes
Complex language in standard PICF documents (particularly for elderly participants) Efficient ethical approval procedures
Ensuring informed consent (particularly for participants with dementia) Single point of contact in each jurisdiction for centralised review processes
Different requirements for guardian consent in different jurisdictions The professionalism and initiative of individual HREC representatives
Predicting participant numbers, health need and all relevant stakeholders
(when models were still in ‘set up’ and some models provided ‘walk in’ services)
Predicting participant vulnerabilities (when the health of elderly participants can
decline rapidly)
Lack of affiliated HRECs for privately provided service models
Lack of provision within standard documentation for professional partners
(as both participants and co-researchers)
Local site assessment bodies operating in isolation as pseudo HRECs

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made. Notably, however, in relation to their call for administrative Hicks, S. C., James, R. E., Wong, N., Tebbutt, N. C., & Wilson, K. (2009). A case study
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Competing interests Prosser, B., Clark, S., Davey, R., & Parker, R. (2013). Developing a public health policy-
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Department of Health and Ageing. The authors also wish to Wagner, T. H., Murray, C., Goldberg, J., Adler, J. M., & Abrams, J. (2010). Costs and
benefits of the nation cancer institute central institutional review board. Journal of
acknowledge the contribution of the following University of
Clinical Oncology, 28, 662–666.
Canberra and Australian National University researchers to the
conceptual development and implementation of this project: Dr
Shannon Clark; Adjunct Assoc. Professor John Goss; Dr Catherine Dr. Brenton Prosser is a senior research fellow to the Nurse Practitioners Aged Care
Hungerford; Dr Carmel McQuellin; Assoc. Professor Rhian Parker. Models of Practice Evaluation within the Centre for Research and Action in Public
Health, University of Canberra. He is an adjunct in the School of Sociology at the
Australian National University and in the School of Education at the University of South
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