Institutional response to the external audit of ethics and safety processes.

Review Recommendation / University Response
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. / Agreed
Meetings of the Chair of the Human Research Ethics Committee, Research Ethics Advisors, Heads of School and Assistant Deans (Research) will be convened to discuss the development of a mandatory checklist within the peer review form as appropriate to each faculty. The consistency of peer review processes and the expectations for the Head of School sign-off on peer review forms will also be agenda items at the meetings.
A meeting of the Chair of the Human Research Ethics Committee and research groups positioned outside of the routine Faculty/School structure will be convened to discuss peer review processes.
A meeting of the Chair of the Animal Care and Ethics Committee and the appropriate Heads of School will also be considered.
The review of the Peer Review of Research Proposals Submitted for Ethics Approval Procedure initiated by the Human Research Ethics Committee late in 2013 will be concluded after the meetings with the Heads of School.
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. / Agreed
The Chair of the HREC will review the information statement template with reference to the requirements for informed consent outlined in the National Statement on Ethical Conduct in Human Researchwith a view to shortening and simplifying the content.
Examples of information statements will be sought from other institutions for comparison purposes.
The development of additional templates for specific types of data collection (e.g. anonymous survey) will be considered.
The development of information statements by researchers tailored to the research and research populations they are engaged with will be reviewed.
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. / Agreed
Should there be a critical mass of senior researchers (category D and E),the ACEC Chair will facilitate a series of meetings. The meetings will include senior researchers who join the University from other institutions within the New South Wales Department of Primary Industries’ jurisdiction. Feedback will be sought on sector practices and the effectiveness of ACEC practices. The feasibilityof inviting persons from external organisations (other universities, NHMRC etc) to draw on their expertise will be considered.
There have been a number of meetings held at different times with different research groups to work through the Health and Safety requirements for research reviews. These have proven to be extremely valuable for both the researchers and the Health and Safety team in demonstrating the process, how the researchers can better understand their role, and to clarify the requirements. Although the recommendation speaks of ACEC, this type of networking would also be of benefit to Health and Safety.
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 i.e. approval for a group of researchers using common SOPs in a specific facility. / Agreed
The Health and Safety team have introduced a program that captures SOP’s which could form the basis of a library. There is however a need to resource the further development of the scope and the system if this is to be available across the organisation. Individual research groups have been advised previously to develop their own libraries and utilise that as part of their application process rather than sending SOP’s with each application for review. This has not had a large take-up rate.
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 compliance with appropriate ethics and safety related Codes and legislation. / Agreed
The University will establish an over-arching sub-committee/advisory group to provide focused academic leadership in the areas of ethics, safety, research integrity, accountability and compliance with research Codes and legislation.
A group that oversee the application processes and provide a consultation mechanism, would be a benefit in defining agreed processes.
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. / Agreed
The Deputy Vice-Chancellor (Research and Innovation) will consult with the ethics committee Chairs, Deputy Chairs and REAs in relation to workload recognition with a view to discussing this with line managers and proposing formal recognition in workload models for 2015.
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. / Agreed
Membership terms on the Animal Care and Ethics Committee, the Human Research Ethics Committee and the Safety Technical Committees will be limited to two consecutive terms with extension for a third term only in exceptional circumstances.
Membership positions on the committees that become available will be filled through expressions of interest.
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. / Agreed
The Deputy Vice-Chancellor (Research and Innovation) will meet with the Chair of the Animal Care and Ethics Committee and the Chair of the Human Research Ethics Committee to discuss payment of honoraria to external committee 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. / Agreed
The Animal Care and Ethics Committee, the Human Research Ethics Committee and the Safety Technical Committees will implement externally facilitated training sessions aimed at building understanding of national Codes and legislation, new interpretations and research practices. Such sessions will be held regularly and may include workshops and conferences.
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. / Agreed
The feasibility of making accurate statistics on ethics processing timeframes available based on information drawn from the Research Information Management System is currently being investigated. Information on human and animal ethics application processing times will be made available on the Research Services web site and communicated to key stakeholder groups subject to accurate information being available for collation.
This is currently being done for Health and Safety reviews and this will be combined with the ethics statistics into a single report.
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. / Agreed
Research Services, in consultation with Ethics and Safety Committee Chairs and relevant staff from Health and Safetywill develop a comprehensive communication strategy to improve interactions with researchers and ensure that researchers have 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. / Agreed
The Australasian InfoEd Community Advisory Group meeting with be held in Sydney in September 2014 and it is anticipated that representatives from the University of Western Australia (UWA) will attend. UWA representatives will be invited to visit the Callaghan Campus and/or provide feedback on the University of Newcastle RIMS system.
A decision on (a) and (b) will be deferred until the RIMS upgrade scheduled for July 2014 has been implemented.
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. / Referred
This recommendation with be referred to the Committee proposed in the response to Recommendation 5.

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