The University of Newcastle
CONFIDENTIAL
Report from the External
Review of Research Safety and Ethics Processes
December 2013
Dr Mark Hochman
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
Table of Contents
Page
1.
Executive Summary .....................................................................................................
2.
Review Process ............................................................................................................
3.
Terms of Reference – Findings and Recommendations .................................................
4.
Appendices ..................................................................................................................
A. Terms of Reference ......................................................................................................
B. List of Submissions.......................................................................................................
C.
List of Interviewees......................................................................................................
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
1. Executive Summary
An External Review of Research Ethics and Safety Processes was commissioned by the
Deputy Vice-Chancellor (Research) (DVCR) of the University of Newcastle in December
2013 and relevant stakeholders from across the University were invited to make
submissions addressing the Terms of Reference (see Appendix 1). A total of 30
submissions were received, which are listed in Appendix 2.
The Reviewer visited the University on Thursday 12 December and Friday 13 December to
conduct interviews with key stakeholders. Those interviewed are listed in Appendix 3.
Prior to the interviews, the Reviewer was provided with background documents relevant to
the Terms of Reference including committee terms of reference, membership and usage
statistics.
The key findings and recommendations are outlined below.
Summary of Recommendations
Recommendation 1: It is recommended that the chair of the human research ethics
committee convene a meeting of Heads of Schools and REAs to discuss development
of mandatory checklists within the peer review form as appropriate to each faculty. At
this meeting the chair should also outline expectations for the Head of School sign off
on peer review forms.
Recommendation 2: It is recommended that the current PIS be re-examined by the
Chair of the HREC with a view to shortening and simplifying the content. If considered
necessary it may be also appropriate to allow researchers to develop their own PIS
tailored to the research and research populations they are engaging with.
Recommendation 3: It is recommended that the ACEC Chair facilitate a series of
workshops with research fellows and newly arrived research staff to examine current
ACEC evaluation processes. Such a group could function as a group of “critical
friends” and meet quarterly with a view to growing the stock of SOPs, building a
shared understanding of sector practices and generally facilitating effectiveness of
current ACEC practices. It may be feasible to invite persons from external
organisations (other universities, NHMRC etc) to some meetings where they bring
specific expertise on issues under discussion.
Recommendation 4: The University consider providing resources to develop a
searchable web-based database of approved Standard Operating Procedures (SOPs)
for safety to simplify the application process. The Research Office should also
investigate the feasibility of making approvals facility-based ie approval for a group
of researchers using common SOPs in a specific facility.
Recommendation 5: That the university establish an over-arching sub-committee, the
Research Integrity, Accountability and Compliance Sub-Committee (RIACC) to
oversee and coordinate Ethics and Safety processes, to identify the best ways to
streamline processes and forms between systems and to monitor institutional
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
compliance with appropriate ethics and safety related Codes and legislation.
Recommendation 6: It is recommended that the DVC Research discuss with the
human research ethics committee chair, deputy chair(s) and REAs appropriate
workload recognition and that this be further discussed with relevant line managers
with a view to formalization in workload models in 2014.
Recommendation 7: It is recommended that the university apply formal limits on
membership of ethics and safety committees, including community membership.
Membership should be normally limited to two terms with extension for a third term
only in exceptional circumstances.
Recommendation 8: It is recommended that the DVC Research meet with Ethics
Committee Chairs to consider payment of honoraria to external committee members
at levels in keeping with sector practice.
Recommendation 9: It is recommended that the UoN ethics and safety committees
implement full-day, externally facilitated training sessions aimed at building
understanding of national Codes and legislation, new interpretations and research
practices.
Recommendation 10: It is recommended that the Research Office collect statistics on
processing times for ethics and safety applications and make these widely available
through governance structures and key stakeholder groups. These statistics should
be used to identify process inefficiencies and any improvements in processing times
should be widely communicated throughout the research community within the
university.
Recommendation 11: It is recommended that the Research Office, in consultation with
Ethics and Safety Committee Chairs develop a comprehensive communication
strategy to improve interactions with researchers and ensure that researchers have
all relevant ethics/safety information required in an easy to access format.
Recommendation 12: In regard to the Research Information Management System
(RIMS), it is recommended that the UoN consult with other users of InfoEd products,
such as University of Western Australia (UWA) to ascertain whether UWA has been
able to overcome the software issues currently experienced by RIMS users.
Depending on the outcome of consultation with UWA to then consider (a) whether it
would be advisable to roll-back RIMS until the next major upgrade is implemented, or
(b) to proceed with minor modifications around the submit function and relaunch a
university wide training and communication campaign on the use of RIMS. If the
latter option is chosen then it is further recommended that the role of the RIMS
Manager be changed to emphasise user training.
Recommendation 13: It is recommended that the University establish a mechanism to
provide essential equipment/infrastructure for projects which have been signed off by
the University. This may be accomplished through development of a university wide
research infrastructure priority plan, a modification to the existing Master Planning
process, or through provision of a discretionary fund administered by the DVCR or
the Faculty PVCs to provide for these needs.
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
2. Review Process
Dr Mark Hochman was engaged to undertake this review. Dr Hochman has over 20 years’
experience as a senior manager in research administration and has completed similar
reviews in a number of higher education institutions over the last three years, including
Swinburne, Flinders, RMIT, UniSA and Southern Cross. He has also recently completed a
review for the Tasmanian Department of Health and Human Services, looking at their
compliance against the HoMER (single site assessment) requirements.
The Reviewer was supported by Ms Jenny Kirkby from the Office of the Deputy ViceChancellor (Research).
Interviews were held in camera with only Ms Kirkby in attendance. The report was prepared
in confidence by the Reviewer and is based on evidence presented in the submissions and
interviews, as well as additional documentation provided during the three-day review.
The Reviewer acknowledges the valuable contributions of staff of the University, who
participated openly and honestly in the review process and in particular the very helpful
support of Ms Jenny Kirkby in all aspects of the review.
3. Terms of Reference – Findings and Recommendations
General Observations
The Terms of Reference (Appendix 1) were designed to elicit a broad response, so prior to
addressing them individually, I have thought it best to make some general comments.
It was apparent simply from the volume of submissions received that there is widespread
concern among researchers about the administrative effort required in complying with ethics
and safety processes. The majority of submissions were thoughtful and constructive and
many researchers made the point that the service provided by Research Office (in ethics
processing) and HR staff (in service of safety committees) was excellent, within the
constraints of the systems, and that no personal criticism was intended of the ethics and
safety teams.
Similarly, the submissions from the Ethics and Safety teams recognised limitations of
systems such as RIMS and showed a genuine commitment to improve processes wherever
possible. It is clear that lack of resources, including technology support resources, is a
barrier limiting such initiatives, and that Ethics and Safety staff are working diligently to keep
the current system running, with little additional capacity to work on improvements.
The Ethics team itself has provided several implementation level suggestions for improving
processes and the supporting Research Information Management System (RIMS). Whilst
many of these are too detailed to list in this report it is important that these suggestions for
improvement are provided an avenue to be acted upon.
However there is also clearly considerable frustration caused by what researchers see as
unnecessary duplication of effort, dissatisfaction with the Research Information Management
System (RIMS) and a feeling that some Committee members may have become inflexible in
their views. Researchers believe that the Committees are slow in responding to
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
applications, while the Committees feel that researchers are slow in responding to their
requests for further information.
Overall, the area which aroused the greatest discussion was Safety procedures, followed by
Animal Ethics, with Human Research Ethics of less concern, although there were many
comments relating to the use of RIMS. This seems understandable, given that the
University undertook a major revision of its Human Research Ethics systems quite recently,
moving to a 3 tier system based on risk, implementing the “Griffith model” for human ethics
review.
Specific Findings addressing Terms of Reference
a.
The effectiveness of practices and processes supporting ethical and safety
reviews at the UoN, with reference to (i) their efficiency and support of research
at the UoN; and (ii) their consistency with higher education sector norms and
expectations
The material presented to the review, complemented by face to face interviews, suggest that
the current practices supporting ethics and safety reviews of research at UoN are of a high
standard and conform to national codes, norms and expectations. This is not to say that they
cannot be improved, but the effectiveness of current practices should be recognised. The
Chairs of each of the three major committees (Human Research Ethics Committee (HREC),
Animal Care and Ethics Committee (ACEC), Chemical and Radiation Technical
Committee(CRTC)) are each aware of the major points of concern and are keen to address
issues to enable research to proceed in an expeditious manner whilst ensuring all ethics and
safety requirements are met.
Human Ethics: The University of Newcastle has implemented the “Griffith model” for human
ethics assessment incorporating three levels of review and Research Ethics Advisors
(REAs) in each faculty. It is estimated that the committee currently considers approximately
1,000 applications per year (including expedited reviews and progress reports). The major
issues raised for consideration of human ethics proposals were the length of time taken to
consider applications and receive approval (discussed under term of reference C), the
attention paid by the HREC on research methodology and time available to those supporting
the ethics review process (principally the chair and REAs). Some respondents also raised
the issue of complex Participant Information Sheets (PIS). Comments regarding the IT
support for all ethics processes (the Research Information Management System, RIMS) will
be discussed under term of reference E.
The University has a policy on peer review of human ethics proposals prior to submission to
the HREC. This is not widespread in the sector and has been introduced to ensure that the
HREC can be confident of the methodology underpinning proposed research. As such it
could be considered to constitute good, or even best practice within the higher education
sector, however comments received suggest that the HREC still spends much time
discussing research methodology and is not convinced that the peer review sign off is
consistent among the university’s faculties or by the university’s Heads of Schools. The
Chair of the HREC considers that the committee would have greater confidence in
methodology with the introduction of a mandatory checklist for completion on the peer review
form, such as that currently used in the Faculty of Health.
Recommendation 1: It is recommended that the chair of the human research ethics
committee convene a meeting of Heads of Schools and REAs to discuss development
of mandatory checklists within the peer review form as appropriate to each faculty. At
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
this meeting the chair should also outline expectations for the Head of School sign off
on peer review forms.
Several comments were also received concerning the university’s PIS. Whilst the move to
standardize a PIS could be helpful, it appears that the current PIS is considered to be written
at a higher level than that required to be helpful. One comment was that such a sheet should
be pitched at Year 8 level in terms of participant’s understanding whilst the current sheet
was felt to be pitched at Year 11/12 level. Another comment suggested that this “pitch” could
be disenfranchising low SEO groups as participants in UoN research results resulting in nonrandom participation in research projects.
Recommendation 2: It is recommended that the current PIS be re-examined by the
Chair of the HREC with a view to shortening and simplifying the content. If considered
necessary it may be also appropriate to allow researchers to develop their own PIS
tailored to the research and research populations they are engaging with.
Animal Ethics: Responses concerning the Animal Care and Ethics Committee (ACEC)
focused mainly on the length of time to process applications (see term of reference C),
ACEC’s consideration of methodological issues, the need for variation approvals when
experimental design was changed during research and the difficulties associated with RIMS
(term of reference E).
Equally there are a number of new initiatives recently introduced to improve the
effectiveness of ACEC processes including development of Standard Operating Procedures
(SOPs), introduction of pre-review of application forms and introduction (November, 2013) of
animal welfare phenotype reports. In addition the on-line training modules, Research Animal
Training Scheme (RATS) are comprehensive and once again could be considered sector
good practice. The new chair of ACEC has also undertaken to communicate with animal
researchers via an ad-hoc open letter which provides information on national developments
in animal research and addresses issues that the UoN research community has raised
concerning ACEC operations – many of these new initiatives are comparatively recent and
may need time to become known.
In terms of this specific term of reference several responses to the review made unfavorable
comparisons between ACEC processes at UoN and other Australian and overseas
institutions. Such comparisons can often reflect one’s familiarity with a previous institution
and processes, nevertheless the repetition of these sentiments suggests that there is a need
for UoN to examine whether all current ACEC processes reflect sector norms. Many of these
processes need to be considered individually with both ACEC and researchers given
opportunity to explain the need for change/no change.
Recommendation 3: It is recommended that the ACEC Chair facilitate a series of
workshops with research fellows and newly arrived research staff to examine current
ACEC evaluation processes. Such a group could function as a group of “critical
friends” and meet quarterly with a view to growing the stock of SOPs, building a
shared understanding of sector practices and generally facilitating effectiveness of
current ACEC practices. It may be feasible to invite persons from external
organisations (other universities, NHMRC etc) to some meetings where they bring
specific expertise on issues under discussion.
Interviews with Chairs of both the HREC and ACEC indicated concern with the rising number
of applications, variations and progress reports and the associated workload. Both Chairs
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
commented on the workload and the absences of committee members at certain times of the
yearly cycle, and raised the option of two separate committees, ie two HRECs and two
ACECs. Anecdotal evidence suggested that some larger universities had moved to duplicate
committees for both human and animal ethics.
Given the size of the existing UoN HREC and ACEC and the membership and administrative
overhead associated with servicing committees it is not possible to recommend the
establishment of duplicate committees at this stage. The scale of research at UoN (2012
HERDC income $93 million) is still considerably less than the Go8 examples presented as
having duplicate committees and it would be preferable to keep a watching eye on
committee work at this stage as recommendations in this report are implemented.
Safety: The most pressing concern regarding Safety applications is the very high rate of
duplication of effort involved in making project-based applications, where identical or very
similar procedures are being used repeatedly in a particular facility. Current practice
requires that each project is separately assessed, and all procedures to be used must be
fully detailed. The majority of submissions on this issue related to the Chemical and
Radiation Technical Committee (CRTC).
Two alternative approaches were suggested by researchers: (a) move to a facility-based
approval, where research groups who share facilities and common procedures would be
approved on a laboratory basis, for a defined period (say 3-5 years) or (b) produce a library
of approved SOPs, stored in a searchable on-line database, which would allow a much
quicker application test, since the approved SOPs would be listed by number and only
variations or new SOPs would need to be fully detailed.
The case for facility based approval was not universally held by interviewees and the
legislative basis for such approval was contested by different persons. It seems that prior to
any recommendation on facility based approvals that it will be necessary for the UoN
Research Office and/or Chairs of relevant ethics and safety committees to seek advice from
the OGTR and other relevant NSW and Commonwealth regulatory bodies concerned with
safety and radiation as to whether such approvals are within the scope of their legislation.
The second suggestion of a library of SOPS would seem to meet the legislative
requirements, while remaining project-based, and make integration with Ethics and IBC
approvals simpler. To produce such a database would require that considerable resources
be made available, but if it were to be implemented, it would not only reduce the amount of
time and effort required of researchers, but would greatly reduce the workload of the CRTC.
This would allow the CRTC to increase monitoring and site visits, and to spend more time on
training researchers, which is an important factor in an area where legislation changes
frequently and researchers must be kept up to date.
Recommendation 4: The University consider providing resources to develop a
searchable web-based database of approved Standard Operating Procedures (SOPs)
for safety to simplify the application process. The Research Office should also
investigate the feasibility of making approvals facility-based ie approval for a group
of researchers using common SOPs in a specific facility.
b.
Compliance of the review models with national and state legislation, codes,
and other relevant requirements
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
The review models for all ethics and safety committees appear to be robust and consistent
with national and state legislation, codes and other relevant requirements. As noted above
the HREC has sought to implement the “Griffith Model” of ethical review which is widely
considered to be best practice in Australia. The introduction of peer review for both HREC
and ACEC applications also constitutes best practice and the university is to be
commended for introducing this component into its review cycle.
Whilst all committees appear to be compliant with national and state legislation it is not
apparent that the university itself has mechanisms in place to ensure a coordinated
overview of policy and practices relating to ethics and safety. There were several comments
from committee members and chairs that the pathway for raising pressing concerns
(resourcing, process disjoints, IT issues, issues arising from statutory reports etc) was
unclear. The common observation was that such issues should be escalated to the DVC
Research but also an acknowledgement that such issues may not be high in the busy life of
a DVC.
In addition, the integration of Safety and Ethics processes is complicated by the fact that
responsibility for Safety is with Human Resource Services, and for Ethics with Research
Services, reporting to different members of the University’s executive and with different
objectives.
In order to align and modify processes for maximum efficiency, a coordinating authority is
proposed, which could monitor institutional compliance with various codes and legislation,
while at the same time working to integrate and streamline systems, and to provide training
and communication on the requirements.
Recommendation 5: That the university establish an over-arching sub-committee, the
Research Integrity, Accountability and Compliance Sub-Committee (RIACC) to
oversee and coordinate Ethics and Safety processes and to identify the best ways to
streamlining processes and forms between systems and to monitor institutional
compliance with appropriate ethics and safety related Codes and legislation.
c.
The capacity of the ethics and safety committees to undertake reviews in an
effective and timely manner
The capacity of the ethics and safety committees to undertake reviews in an effective and
timely manner depends on several factors including the knowledge and experience of
committee members, the number of applications, the administrative and IT support available
to support committees.
The knowledge and experience of committee members and the quality of administrative
support was never in question during this review – any comments received concerning
individuals on committees were usually to praise their diligence, expertise or helpfulness. IT
issues will be covered below. Despite this acknowledged helpfulness of members there were
however many concerns expressed about the timeliness of decisions from all committees.
In regards to human ethics, one feature of the “Griffith model” often unrecognized, is the
workload imposed on the chair of the ethics committee, deputy chair(s) and REAs. During
the Review the reviewer was not able to gain a clear answer to the time allocated in
workload models for REAs – it may be that this is an unrecognized duty. Information
provided after the Review visit suggested that REAs would receive up to a day per week in
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
workload recognition – this seems large given that many REAs are reported as underutilized.
Likewise the time allocation for the committee chair was reported as 170 hours per year (3-4
hours a week) – if true then this is a vast under-estimate of the time required to perform this
role. Whilst no system wide data is available on time allocations to support these roles it is
not uncommon for the Chair of a HREC to command a 0.4 FTE workload.
Similarly the workload of REAs must be formally recognised. Anecdotally it appeared to the
Reviewer that REAs were not universally used by applicants wishing to submit applications
to the HREC – yet greater use of REAs could result in higher quality applications coming to
the committee with a consequent reduction in approval time.
Recommendation 6: It is recommended that the DVC Research discuss with the
human research ethics committee chair, deputy chair(s) and REAs appropriate
workload recognition and that this be further discussed with relevant line managers
with a view to formalization in workload models in 2014.
Many comments were received concerning the size of committees and the length of tenure,
particularly for external members. External, or community members play an invaluable role
on human and animal ethics committees that frequently goes well beyond their legislated
requirement. The time to read protocols, undertake training and attend meetings is far in
excess of any recognition that the university can give in appreciation for their input. Several
persons commented that it often took one full two year term for members to acquire the
knowledge and confidence to contribute effectively to committee decisions (both human and
animal ethics).
However, there is a balance necessary in length of committee membership – members need
to be present long enough to become confident and effective in making knowledgeable
decisions (particularly external members), but is it also important that there be regular turnover of members to permit introduction of new ideas and to prevent “group think” or
entrenched views.
Given the above it seems appropriate to recommend a formal limit to membership of ethics
and safety committees, including community membership.
Recommendation 7: It is recommended that the university apply formal limits on
membership of ethics and safety committees, including community membership.
Membership should be limited normally to two terms with extension for a third term
only in exceptional circumstances.
The comments above concerning time allocation and recognition of membership, particularly
community membership raise the issue of payment for community members. University
employees (researchers and administrative staff) undertake committee activities within a
paid workload, community members give freely of their time to serve on such committees –
often large quantities of time.
The trend in recent years has been to recognise community membership of ethics
committees by payment of an honorarium. There was no resistance to this idea during the
Review, indeed such payments would be welcomed by several persons interviewed.
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
Recommendation 8: It is recommended that the DVC Research meet with Ethics
Committee Chairs to consider payment of honoraria to external committee members
at levels in keeping with sector practice.
The capacity of ethics and safety committees to provide timely advice also depends on the
committee’s knowledge of new research procedures and interpretations of national
guidelines being adopted by other committees. Both the HREC and ACEC are sending
members to appropriate national conferences – this is good practice but unless mechanisms
for systematic knowledge transfer are in place, this practice can often benefit the individual
more than the committee.
An alternative or perhaps complementary activity is to bring external experts in to the full
committee for training days. Such days could comprise updates on national codes and
legislation and case studies drawing out new interpretations of guidelines or consideration of
new research practices. These are also useful in building a common understanding of
acceptable practice among committee members and building confidence in newer members
who may be nervous of challenging or disagreeing with long-standing members.
Recommendation 9: It is recommended that the UoN ethics and safety committees
implement full-day, externally facilitated training sessions aimed at building
understanding of national Codes and legislation, new interpretations and research
practices.
d.
Researcher interactions with the ethics and safety review process
As has been mentioned previously researcher interactions with ethics and safety personnel
are positive. Many individuals were mentioned for their knowledge and helpfulness,
explaining processes, chasing protocol applications, pre-reading applications prior to
submission to committees, explaining RIMS etc. However many staff were equally critical of
processes considering that review times were lengthy, requests for amendments were often
over minor issues and that processes generally inhibited rather than facilitated research.
Having conducted reviews of ethics processes at several universities it seems that ethics
processing time is an area of university research administration where “anecdotes rule.”
Anecdotal evidence can be damaging and travels quickly, but is quite often out of date –
researchers sometimes complain of problems they had in the past, without acknowledging
that circumstance/systems/processes have changed.
That is not to say that problems may not exist but it is important to have information which
can be used to benchmark, confirm or deny delays in processing times. Data provided to the
Reviewer showed that over the period 2007-2013 the average time taken within the
Research Office to process HREC and ACEC applications had decreased (from 30 days to
10 days for HREC applications and 26 days to 15 for ACEC applications) whereas time that
applications were in the hands of researchers undergoing modifications had increased (from
9 days to 32 days for HREC applications and 14 days to 28 days for ACEC applications).
The overall effect for applications in the period 2007 – 2013 has been an increase in HREC
processing time from 39 to 42 days and similar increase in ACEC application time from 40
days to 43 days.
There may be multiple reasons for the increased time taken by researchers to complete
protocol modifications including additional requests from the committees, unfamiliarity with
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
RIMS, increased demands on time, however a key issue is that the processing time within
the Research Office is not a contributing factor. It would be beneficial however for the
Research Office to further analyse reasons why the researcher processing time has
increased for both HREC and ACEC applications. This could be accomplished by tracking
selected applications, surveys of researchers etc.
The availability of such information can help to analyse process inefficiencies and it would be
beneficial for data on processing time for ethics and safety applications to be made available
on a regular basis to all relevant stakeholders. These may include the ethics and safety
committees themselves, the proposed Research Integrity, Accountability and Compliance
Committee and the UoN Research Committee. It would also be helpful for this information to
be made available to the research community via newsletters or the Research Office
website.
Recommendation 10: It is recommended that the Research Office collect statistics on
processing times for ethics and safety applications and make these widely available
through governance structures and key stakeholder groups. These statistics should
be used to identify process inefficiencies and any improvements in processing times
should be widely communicated throughout the research community within the
university.
Effective communications is essential in building rapport with researchers and disseminating
essential information. Ethics/Safety are fast-changing areas and there is a need for
researchers to be kept up to date on changes to codes and legislation, new practices etc.
Equally it is easy to provide information overload - the key is to ensure that people know how
and where to find the information they need and to make it accessible and easy to use.
Typically, a good communication strategy would involve a number of tiers:




An informative, up-to-date web page, making use of FAQs and providing information
in a range of accessible forms (eg the University of Western Australia has several
videos available to disseminate information on ethics processes);
Use of existing governance channels/structures – eg Research Committee/Faculty
Research Committees/Academic Senate to communicate information, statistics,
reports on processes, national changes and requirements;
Regular short information pieces in university or Research Office bulletins (working
on the principle that people often need to be informed of a matter several times
before it is recognised as personally relevant);
Face-to-face presentations to stakeholder groups – the Research Office can take the
initiative to invite itself to key stakeholder groups to explain ethics/safety processes,
report on changes, provide updates on processing times, seek input on
improvements etc.
When the above mechanisms are in place then email communication can be used sparingly,
often in targeted form.
Recommendation 11: It is recommended that the Research Office, in consultation with
Ethics and Safety Committee Chairs develop a comprehensive communication
strategy as outlined above to improve interactions with researchers and ensure that
researchers have all relevant ethics/safety information required in an easy to access
format.
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
The interactions between researchers and the ethics/safety processes can also be shaped
by the approach taken by administrative staff and committee members to adherence to
codes and regulations. It is possible to take a compliance driven approach where the
emphasis is on “keeping the rules” or alternatively, a facilitatory approach where ethics and
safety is seen as an integral part of the research process itself and administrative staff
and/or committee members work with researchers to ensure adherence to requirements.
There were was widespread praise for the attitude of support staff in support of ethics
processes and whilst there were some suggestions that support staff for safety committees
be relocated to the Research Office this was not a universal view.
One feature that caused concern with many persons interviewed was the habit of safety
committees to report that applications had been “reviewed.” Researchers need the certainty
that their applications have been not only reviewed but “approved.” The Associate Director:
Health and Safety did report during interviews that the Chemical and Radiation Technical
Committee would revert to the use of “approved” in correspondence with researchers.
Interactions between committees and researchers can also be improved by ease of access
to relevant information. The current UoN website contains a wealth of information related to
ethics and safety. However much information is not intuitively available and so as part of the
communication strategy the Research Office may wish to consider bringing all relevant
information together under a one page framework which shows all the policies, legislation
and tools that researchers need for each committee. A possible layout for such a page could
be as below with each cell containing web links to appropriate information:
Human
Ethics
Animal
Ethics
Biosafety
Chemical
Safety
Radiation
Safety
National and
State
Legislation
University
Policies
University
Procedures
Forms and
toolkits
RIMS
information
e.
The adequacy and suitability of IT systems used to support the ethics and
safety processes
The RIMS system was the subject of many comments. Most were very critical though there
were minority comments that introduction of the system was appreciated. Three things are
clear:



That the RIMS system is not intuitive to use – the printed user manual for human
ethics is more than 30 pages long, that for animal ethics much longer again;
That training for researchers in the use of RIMS has not been adequate and
That there are several, possibly minor, fixes that would remove ambiguity at the end
of the data entry process and which would remove some frustration with the system.
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
It is also clear that researchers consider the entry of ACEC application more onerous and
fraught than HREC application.
The system was demonstrated by members of the Ethics teams, and it is clear that for
anyone who is an irregular user of the system (which means the majority of researchers) the
system is quite confusing. Researchers do not find RIMS intuitive or easy to use and there is
a risk of losing all the data entered if the (quite complex) completion process is not followed
exactly. This is damaging the rapport between researchers and the Research Office and is
consuming much time on the part of the Ethics team who are effectively operating a help
desk. It appears that the roll-out process was not well communicated and that much of the
face to face training accompanying roll-out was neither systematic nor extensive.
The Research Office, recognising the difficulties that RIMS is causing, has suggested that
the best approach may be to temporarily withdraw it, pending a system upgrade, and to
revert to using a Word document, with Ethics staff transcribing to RIMS. However others
users, including researchers, have felt that they are beginning to understand the system and
that minor changes to the final submission process, complemented by more extensive
training, will render the system usable within the university. This latter possibility would
require a substantial change in role of the existing RIMS Manager with the focus changing
from technical updates to focussed training.
The RIMS software is produced by InfoEd, but has needed extensive modification for
Australian use and Newcastle seems to have been a trail-blazer for the Ethics module. It
appears that the next major upgrade will address several of the most prominent issues with
the software, but that upgrade is still some distance away.
InfoEd systems are not widely used within Australia however the University of Western
Australia (UWA) has implemented the human and animal ethics modules. It would be helpful
for UoN staff to spend more time with UWA to better understand their solutions to similar
implementation issues.
Recommendation 12: In regard to the Research Information Management System
(RIMS), it is recommended that the UoN consult with other users of InfoEd products,
such as University of Western Australia (UWA) to ascertain whether UWA has been
able to overcome the software issues currently experienced by RIMS users.
Depending on the outcome of consultation with UWA to then consider (a) whether it
would be advisable to roll-back RIMS until the next major upgrade is implemented, or
(b) to proceed with minor modifications around the submit function and relaunch a
university wide training and communication campaign on the use of RIMS. If the
latter option is chosen then it is further recommended that the role of the RIMS
Manager be changed to emphasise user training.
Additional recommendation outside terms of reference
Some respondents to the Review commented on delays to research arising from inadequate
facilities, fume hoods needing repair etc. In this case applications were apparently
authorised at Head of School level certifying that necessary infrastructure was in place to
allow the conduct of research. One can understand the desire of a line manager to certify an
application as having the necessary infrastructure, but this clearly presents a problem when
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
the infrastructure is not available or budgets are not available to provide the infrastructure
when grants are awarded.
Whilst strictly speaking outside the terms of this reference of this review, these comments do
suggest the need for coordinated research infrastructure planning within the university to
ensure that budget and resources are available to repair/modify facilities to support
successful research applications. The University accepts research funding on the basis that
it will provide the necessary infrastructure and this should not cause long delays to the
research itself.
Recommendation 13: It is recommended that the University establish a mechanism to
provide essential equipment/infrastructure for projects which have been signed off by
the University. This may be accomplished through development of a university wide
research infrastructure priority plan, a modification to the existing Master Planning
process, or through provision of a discretionary fund administered by the DVCR or
the Faculty PVCs to provide for these needs.
4. Commendations
During the review process, the Reviewer noted a number of points which deserve
commendation.





The system of Faculty/School peer review as an integral part of the ethics review
process – this is not widely practiced at other universities and could be considered an
example of Sector best practice;
Introduction of the new Safety interactive PDF form – this has been introduced in
response to researcher concerns about processing information required and shows a
responsiveness to researcher needs;
The helpful attitude of all ethics/safety support staff and committee Chairs
The commitment by the incoming Chair of ACEC to increasing communication with
ACEC users;
The commitment by the HREC Chair to running an on campus ethics workshop in 2014
– this will serve as an avenue for training of HREC members and exposure to new
practices and interpretations elsewhere in the sector.
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
5. Appendices
Appendix 1: Terms of Reference
As a research intensive organisation, the University of Newcastle seeks to facilitate
research. Research in Australia is subject to compliance with ethical and workplace safety
requirements. As part of its commitment to quality the University is undertaking a review of
its research ethics and safety practices and processes to ensure that they achieve the
optimal balance between compliance and ease of research.
The University seeks advice and recommendations from the review on whether changes,
developments and improvements could be made in relation to the provision of ethics and
safety services in order to strengthen effectiveness of the services and better facilitate
research at the University of Newcastle (UoN).
Terms of Reference
2.
The review will undertake an evidence based-review and evaluation of:
a. The effectiveness of practices and processes supporting ethical and safety reviews
at the UoN, with reference to (i) their efficiency and support of research at the UoN;
and (ii) their consistency with higher education sector norms and expectations;
b. Compliance of the review models with national and state legislation, codes, and
other relevant requirements;
c. The capacity of the ethics and safety committees to undertake reviews in an
effective and timely manner;
d. Researcher interactions with the ethics and safety review process;
e. The adequacy and suitability of IT systems used to support the ethics and safety
processes.
With particular reference to examining whether any improvements can be made in
reducing the time and effort involved in review, while remaining compliant with the
requirements of relevant legislation and codes.
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REPORT: External Review of Research Safety and Ethics Processes, December 2013
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REPORT: External Review of Research Safety and Ethics Processes, December 2013