WACHS Human Research Ethics Committee and …...WA Country Health Ser vice Our Ref: ED-CO-18-87874 WACHS Human Research Ethics Committee and Research Governance Annual Report Reporting

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Government of Western AustraliaWA Country Health Service

Our Ref: ED-CO-18-87874

WACHS Human Research

Ethics Committee and

Research Governance

Annual Report

Reporting Period:

1 January 2018 to 31 December 2018

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Contents 1. Executive Summary 3

2. Background 3

3. HREC Membership 7

4. HREC Meetings 8

5. WACHS Research (Ethics and Governance) Unit 9

6. National Mutual Acceptance 9

7. Research Governance Service Information Technology System 10

8. Review of Ethics Applications 10

9. Review of Governance Applications 12

10. Duration of Ethics and Governance Review Process 14

11. Ongoing Governance and Monitoring of Projects 15

12. Project Completion Compliance 20

13. Other Reporting 21

14. Reference List 21

Appendix A – WACHS HREC Approved Projects by Organisations 23

Appendix B – WACHS HREC Approved Projects by WACHS Region 24

Appendix C – WACHS HREC Approved Projects by Research Theme 25

Appendix D – WACHS Research Governance Approved Projects by Organisations 26

Appendix E – WACHS Research Governance Approved Projects by WACHS Region 27

Appendix F – WACHS Research Governance Approved Projects by Research Theme 28

Appendix G – WACHS In-Kind Support approved in 2018 Research Projects 29

Appendix H – Approved ethics applications in 2018 31

Appendix I – Approved governance applications in 2018 32

Appendix J – Approved governance applications in 2018 33

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1. Executive Summary

This report provides a summary of the WA Country Health Service (WACHS) Human

Research Ethics Committee (HREC) activities from 1 January 2018 to 31 December 2018. It

includes information on:

Committee members and their expertise;

The number of applications and reports submitted to the WACHS HREC and their

status; and

The predominant research themes, locations and applicants undertaking research

involving WACHS.

This report also details the number of governance applications submitted to WACHS,

encompassing research projects ethically approved by WACHS HREC, other WA Health

Lead HRECs or National Mutual Acceptance (NMA) certified HRECs.

In 2018, the WACHS HREC provided ethical review and approval for 13 new projects out of

a total of 20 new applications submitted for ethical approval.

For the same reporting period WACHS provided governance review and approval for 22

new projects. Out of the 22 governance applications, 12 were ethically approved by

WACHS HREC, six were granted ethical approval by another WA Health Lead HREC and

four were granted ethical approval by a NMA certified HREC.

In regards to monitoring activities, 28 annual progress reports were approved by the HREC

and an additional 13 reports were approved by research governance (where ethical

approval had been obtained from another WA Health Lead or NMA HREC). In terms of

amendment requests, 24 were approved by the WACHS HREC and 14 for research

governance only projects. No serious adverse events were received by the WACHS HREC,

however four were received and resolved for research governance only projects. One

protocol violation was reported by the WACHS HREC in 2018 and for research governance

only projects there was one other protocol violation and two protocol deviations. A total of

11 final reports were received for closed projects approved by the WACHS HREC and an

additional five were approved for research governance only projects.

2. Background

The WACHS Research Governance Framework (endorsed in mid-2016 by the WACHS

Executive Committee) is overseen by the WACHS Health Service Board, with the Chief

Executive Officer (CE) responsible for setting policy framework and strategic direction, the

Executive Director Medical Services (EDMS) responsible for overseeing the corporate and

clinical governance in addition to the operationalisation of the Research Governance Unit.

The Clinical Research Manager manages the unit and the Ethics and Quality Improvement

(QI) Coordinator and Research Governance Coordinator coordinate the functions within it.

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The framework includes the:

1. Ethics Review Function; and

2. Research Governance Function

which are the two tiered system of review, approval and monitoring of research activity.

2.1 Ethics Review Function

The WACHS HREC ensures all research undertaken within WACHS sites or accessing

WACHS participants whether by WACHS employees or external applicants meet the ethical

and scientific standards established by the National Health and Medical Research Council

(NHMRC). The WACHS HREC is a WA Health Lead HREC. It is registered with the

NHMRC and is constituted in accordance with the National Statement on Ethical Conduct in

Human Research 2018 (National Statement) as well as the WACHS HREC Terms of

Reference and the WACHS HREC Standard Operating Procedures, which were both

updated in late 2018.

The main roles of the WACHS HREC are to:

Provide ethical approval and oversight of all human research (excluding clinical

trials) undertaken within WACHS sites or accessing WACHS participants such as

patients, their carers or staff (including their data and/or tissue), and ensure

compliance with the ethical standards established by the NHMRC;

Provide advice and guidance on the ethical considerations of proposed research;

Facilitate participation in research within WACHS; and

Operate as a WA Health Lead HREC for multi-center research projects.

2.2 Research Governance Function

Research governance review is a mandatory requirement following ethical approval and

prior to research commencing at any WA Health Service site. It is an institutional site

assessment to determine the suitability of the research to be conducted at site, evaluating

the risks, resources and finances required to complete the project. For WACHS this review

is initially conducted by the Research Governance Coordinator, with endorsement from the

Regional Director(s) and final approval from the CE delegate, the EDMS. Once governance

approval (site authorisation) is obtained the research is able to commence at site.

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Chart 1: NHMRC flowchart which demonstrates the entire research process

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Chart 2: Overview of the ethical and governance review pathways for research

conducted within WACHS or accessing WACHS participants, tissue or data

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3. HREC Membership

Members of the WACHS HREC are volunteers appointed to specific roles in accordance with the NHMRC National Statement. As a minimum, HRECs in Australia are comprised of:

a Chairperson with suitable experience, whose other responsibilities will not impair the HREC’s capacity to carry out its obligations under the National Statement;

at least two lay people, one man and one woman, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work;

at least one person with knowledge of, and current experience in, the professional care, counselling and treatment of people;

at least one member who performs a pastoral care role in the community, for example a minister of religion or an Aboriginal elder;

at least one lawyer who is not engaged to advise the institution;

at least two people with current research experience that relates to research proposals

to be considered at the meetings they attend.

Table 1: The WACHS HREC membership as of 31 December 2018

Position Incumbent (Organisation) Length of service Location

Chairperson Ms Judy Allen (Honorary Fellow, University of Western Australia)

20 months Perth

WACHS CEO representative

Dr David Gaskell (WACHS) 22 months Kimberley

WACHS Aboriginal Representative

Mr Russell Simpson (WACHS) 22 months Perth

Lay person - female Ms Ruth Webb-Smith

(retired)

14 months Perth

Lay person - male Dr Donald Reid (retired) 6 months South West

Lay person - female Ms Therse Hadland (Landgate) 6 months Perth

Lay person - female Ms Tresslyn Smith (retired) 9.5 years South West

Lawyer Ms Julia Barber (Pilbara Lawyers) 20 months Kimberley

Lawyer Ms Jeanette de Klerk (Legal Aid

WA) 20 months South West

Pastoral care Reverend Geoff Chadwick

(Bunbury Cathedral Grammar)

5.5 years South West

Professional care Ms Natalie Rudling

(WACHS)

9 months Great Southern

Professional care Vacant (resignation in late 2018) - -

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On the 8 October 2018 Cabinet approved the establishment of the WACHS HREC as a

Government Board and Committee. Cabinet also approved the appointment of the members

of the HREC by the Minister for Health. Updated appointment letters were endorsed by the

Minister for Health and sent to HREC members outlining their new three year appointment

terms as of December 2018. Remuneration and other allowances to eligible members as

recommended by the Public Sector Commission were also approved by Cabinet. Formal

assessment has been sought by the Minister for Health by the Public Sector Commission

for the WACHS HREC members and at the time of reporting, these amounts had not been

received. It is anticipated by mid-2019 HREC members’ remuneration will be implemented.

Since the establishment of the WACHS HREC as a Government Board and Committee, all

future vacancies must utilise the OnBoardWA Register to canvas for potential candidates in

addition to advertising the vacancy with appropriate organisations, and new appointments

must be formally endorsed by Cabinet and the Minister for Health, with the WACHS CE

delegated to sign the appointment letters.

4. HREC Meetings

The WACHS HREC meetings occur on the second Thursday of every month from Central

Office (Perth). In 2018 video-conferencing technology continued to be utilised for all

meetings that were held, with an average of nine members utilising this technology each

meeting, with the remaining members attending in person or via teleconference. The

average meeting lasting one hour and 30 minutes.

As per the WACHS HREC TOR, a quorum for meetings exists when at least six members

are present including one of each of the following categories: chair/deputy chair, researcher,

lawyer, layperson, professional care and either pastoral care or aboriginal representative. A

quorum was met for nine of the eleven meetings in 2018. In keeping with the WACHS

HREC Terms of Reference (2018), where a quorum was not met the meetings proceeded

with any decisions made by the HREC ratified following the meeting by the missing quorum-

required representative(s).

Researcher A/Prof Anne Whitworth (Curtin

University) 14 months Perth

Researcher Dr Paola Chivers (University of

Notre Dame) 21 months Perth

Researcher Dr Jennie Sharp (retired) 21 months South West

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5. WACHS Research (Ethics and Governance)

Unit

The WACHS Research (Ethics and Governance) Unit is comprised of three permanent

positions, each at 0.8FTE. These positions are as follows:

The Clinical Research Manager oversees the Research (Ethics and Governance) Unit and

is responsible for providing consultancy support, expert advice relating to ethics and

governance applications and the appropriate approval pathways, managing the research

budget, internal and external reporting, ensuring compliance with regulations and

legislation, development of networks, maintenance of the WACHS Research internet and

intranet webpage and executive support to the HREC.

The Ethics and QI Coordinator coordinates and provides administrative support to the

Ethics Review Function, including the WACHS HREC. This includes the administration of

the WACHS HREC meetings, development and maintenance of the research project

database and receiving and processing new applications, annual and final reports,

amendment requests, safety reports, complaints, conflicts of interests, breaches and/or

concerns, and education to internal and external stakeholders on the research ethics

processes.

The Research Governance Function is coordinated by the Research Governance

Coordinator whose responsibilities include conducting the preliminary and final review of

governance applications, administration of site authorisations, ongoing monitoring of active

research projects, including the review of reports and amendment requests, education to

internal and external stakeholders on the research governance processes, and supporting

the Research Governance Service IT System.

6. National Mutual Acceptance

The State/Territory governments of Australia signed a Memorandum of Understanding

(MoU) to implement a national approach to single ethical review for multi-centre human

research projects known as the National Mutual Acceptance (NMA). Western Australia

joined the NMA in August 2017. Under this process, all multi-centre human research

projects being conducted at sites (and participating in NMA) within Australia are ethically

and scientifically reviewed only once by an NHMRC NMA certified Lead HREC.

As a HREC registered with the NHMRC, WACHS HREC is an ‘accepting organisation’

under the NMA. This means that WACHS HREC accepts the ethical and scientific reviews

undertaken by NHMRC NMA Certified Lead HRECs as sufficient for the purposes of the

multi-centre projects involving WACHS.

Upon acceptance of a review by a Certified Lead HREC, the WACHS Research

Governance Function, like all other Western Australia Health Service Research Governance

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Functions, undertakes research governance review and institutional authorisation of those

research projects that are conducted at or involve WACHS sites.

In 2018, out of the 22 projects WACHS provided governance review and approval for, four

were NMA projects that had been granted ethical approval by a NHMRC NMA Certified

Lead HREC such as Townsville Hospital and Health Service HREC and the Gold Coast

Hospital and Health District HREC.

7. Research Governance Service From February 2017 all new research projects undertaken within WACHS sites or

accessing WACHS participants such as staff, patients or their carers (including their data

and/or tissue) have been submitted, reviewed and approved through the WA

Health Research Governance Service (RGS) information technology (IT) system.

The RGS is a centralised IT system for all WA Health research so that investigators,

research group members and sponsors can complete, submit, manage and track their

ethics and governance documentation through the life cycle of their human research project.

Stage 1 was rolled out in 2017 and included the approval and authorisation of research

projects. Stage 2 was released in late 2018, which comprised of monitoring, reporting and

publications of research projects.

8. Review of Ethics Applications

Table 2: Number and status of ethics applications considered by the WACHS HREC

for 2018

Total ethics applications processed in 2018 20

Approved applications 13

Withdrawn 1

Ethics not approved 1

Reviewed and awaiting further clarification from researchers 5

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The WACHS HREC received 20 new applications during the reporting period. As shown in

table 2, 13 of the 20 applications were approved, five were awaiting further clarification from

researchers, one withdrew following HREC review and one project was reviewed but denied

ethical approval because the risks of the project outweighed any potential benefit. The total

number of new applications received by WACHS HREC during 2018 equates to an average

of two new applications reviewed by the HREC each month. The titles of the approved

applications are shown in Appendix H. Appendices A, B and C provide a breakdown of

projects approved by WACHS HREC by organisation, region and research theme.

The number of new applications has significantly decreased since 2016. This may be

attributable to the WACHS HREC accepting reviews by another WA Health Lead HREC or

by an NHMRC Certified Lead HREC pursuant to the NMA. The introduction of the RGS IT

system and the period of time needed for all users to transition to the new system may be

another reason for the decrease in applications. Due to the high level of stakeholder

feedback since the launch of RGS, a Research Governance Service Business User Group

(RGS BUG) was formed in late 2017. The purpose of the RGS BUG is to provide strategic

advice on the roll out of RGS and coordinate user feedback to ensure optimal operation and

improvement of the RGS IT system.

Graph 1: Number of new ethics applications considered by the WACHS HREC by

calendar year from 2010 to 2018

2010 2011 2012 2013 2014 2015 2016 2017 2018

Applications 38 31 46 37 28 40 31 19 20

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The NHMRC have specific categories of vulnerable populations which require additional

ethical considerations. If a research project focuses on one or more of these vulnerable

participant groups it is deemed to be more than low risk. Below is a list of the total number

of ethics applications approved which focused on vulnerable populations.

Table 3: Number of ethics applications involving vulnerable participants in 2018

Total ethics applications approved by WACHS HREC in 2018 6*

Women who are pregnant and the human fetus 0

Children and young people 1

People in dependent or unequal relationships 1

People highly dependent on medical care 1

People with a cognitive impairment, intellectual disability or mental illness 1

People who may be involved in illegal activities 0

Aboriginal and Torres Strait Islander peoples 3

People in other countries 0

*Projects with vulnerable participants may fall under more than one category e.g. Aboriginal and Torres Strait

Islander peoples AND pregnant women

9. Review of Governance Applications

Governance review of the research protocol is required to confirm the suitability of single or

multi-centre research to be conducted at site(s), assessment and management of site risk

and identification of institutional resources required to conduct and complete the project. All

human research projects must undergo governance review before commencement of the

research.

The number of governance applications reviewed by the Research Governance

Coordinator, encompassing research projects ethically approved by WACHS HREC and

other WA Health Lead HRECs in 2018 and the status of these applications are tabulated

below. The titles of the approved applications are shown in Appendices I and J.

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Table 4: Number and status of new governance applications from 1 January to

31 December 2018

The WACHS Research Governance Function received 33 new governance applications

during the reporting period. As shown in table 4, 22 were approved, eight were still under

review at the end of the reporting period, two were withdrawn and one was not granted

research governance approval. The project that was not granted approval was due to the

study requesting access to specific data from the Patient Assisted Travel Scheme database.

The data variables were not available through the database or those that were, were highly

contentious and placed the organisation and its patients at increased risk.

The number of governance applications in 2018 has remained consistent with the same

total received in 2017. This corresponds to the consistency of the number of ethics

applications between 2017 and 2018.

Out of the 22 approved governance applications, 12 projects were ethically approved by

WACHS HREC and six projects received ethical approval by another WA Health Lead

HREC. The other four approvals were for projects ethically approved under the NMA.

Appendices D, E and F show the breakdown of the governance approved projects by

organisation, region and research theme. Appendix G outlines the in-kind support provided

in 2018.

At the end of the reporting period there were three projects with ethical approval that had

not yet submitted a governance application. This is a decrease from the eight at the end of

2017 and nine at the end of the 2016 reporting period. The Research Governance Unit has

notified the researchers of the projects and awaits the governance application submissions.

Total governance applications processed in 2018 33

Approved applications 22

Withdrawn 2

Research governance approval not granted 1

Under review (at the end of reporting period) 8

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10. Duration of Ethics and Governance Review Process

10.1 Ethical Review Process

A WA Health Lead HREC must conduct its ethical and scientific review of a project within 60

calendar days. The timeframe is measured from the HREC application closing date

(associated with the meeting at which the application is reviewed) until written notification of

the final ethical opinion is sent to the Coordinating Principal Investigator. The 60 day

measurement applies to the HREC review only and does not include site authorisation

(governance review).

In 2018, the average duration of the WACHS HREC ethical review process was 40 days.

This duration is 10 days less compared to 2017, where the average length of ethical review

was 50 days. This reduction in review duration may be attributed to the development of

submission guidelines and recommendations by the Ethics Coordinator who, where

possible, provides these to investigators prior to their submission.

10.2 Governance Review Process

The Research Governance Coordinator must conduct governance review (including

validation) within 60 calendar days and recommend to the EDMS whether to authorise or

not authorise the project. The timeframe is measured from the submission date until written

notification of authorisation is sent to the site Principal Investigator. The review timeline for

this reporting period has been reported in conjunction with the use of the RGS overall

review stop clock.

In 2018, the average duration of the WACHS governance review process was 29 days.

Governance applications can be submitted to the Research Governance Coordinator at any

time via the RGS IT system. Following this review, the Regional Director(s)’ review and

EDMS’ review occurs electronically outside of the RGS system. The average review

duration period is fairly consistent with the 30 day average in 2017.

Both 60 day measurements allow for a stop clock capability (i.e. the timing stops when

additional input is required by the HREC or Research Governance Coordinator from an

investigator). The clock is stopped on the day the request is sent and is recommenced when

all the required information is received.

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11. Ongoing Governance and Monitoring of Projects

In accordance with chapter 5.5 of the National Statement, WACHS HREC is required to

monitor the progress of all approved projects until completion. This ensures the research

conducted conforms to the approved ethical standards. It is also a requirement that the

Research Governance Function of each institution where the research is taking place

monitors the conduct of research. WACHS complies with the monitoring requirements by

requiring researchers to complete annual progress and final reports as well as timely

adverse event reporting and amendment requests. With the increase in resources, the

Research Governance Unit continued to review active projects to ascertain researchers

non-compliant with these monitoring requirements and notified them of the overdue reports

and reporting obligations.

Chapter 5.5.3 of the National Statement states researchers have a significant responsibility

in monitoring their research. In addition to any amendment requests as well as annual

progress reports, researchers must also report any serious unexpected, adverse or

unforeseen events that might affect the continued ethical acceptability of the project, as

soon as possible to the appropriate HREC and Research Governance Office.

11.1 Safety Reporting (Serious adverse events, protocol deviations and violations)

It is the researcher’s responsibility to submit timely safety reporting of serious adverse

events or protocol deviations/violations that might affect the continued ethical responsibility

of the project and/or the institutional risk.

Serious adverse events are any untoward medical occurrences that result in death, or an

event which is life-threatening, requires inpatient hospitalisation or prolongation of existing

hospitalisation, results in persistent or significant disability/incapacity, is a congenital

anomaly/birth defect, or is an important medical event or reaction.

Protocol deviations are minor or administrative departures from HREC approved protocol

procedures whereby data is unusable or not available, but which do not affect the scientific

soundness of the research plan or the rights, safety, or welfare of research participants.

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Protocol violations are major departures from the HREC approved protocol procedures

and/or regulatory guidelines which compromises the ethical acceptability of the project, and

are generally more serious in nature than protocol deviations. Protocol violations are

considered to potentially affect the scientific soundness of the research plan and/or the

rights, safety, or welfare of research participants.

Table 5: Number of safety reports received for 2018

WACHS HREC

Serious adverse events 0

Protocol deviations 0

Protocol violations 1

Research Governance only projects

Serious adverse events 4

Protocol deviations 2

Protocol violations 1

In 2018, there was one protocol violation concerning a WACHS HREC approved project.

This violation was initially raised in the form of a complaint, and the conclusion was that the

investigators did not follow the approved protocol in regards to analysis of data, approved

project members, specialised HREC approvals, and publication of data. The outcome was

to rectify the administrative violations and increased monitoring of the project and all other

projects the principal investigator was leading. Further information can be found at section

11.4 Complaints.

In regards to the research governance only projects, all safety reports (excluding one

protocol deviation) concerned one project which had ethical approval from North

Metropolitan Health Service - Mental Health HREC (NMHS MH HREC). Upon investigating

the safety reports, in conjunction with NMHS MH HREC, it was determined that there was

no risk to study participants and the series of reported safety issues were the result of

quality assurance monitoring conducted by auditors on behalf of the study sponsors. This

quality assurance procedure reflected high auditing standards rather than a general failure

in quality systems or ethical breaches. The cluster of reports stemmed from the

investigators promptly addressing the reporting requirements.

The remaining protocol deviation relates to a participant information and consent form used

to enrol WACHS participants, in that it was not WACHS site specific and did not include

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WACHS’ Research Governance contact information. It was concluded there was no risk to

participants and this administrative deviation has been rectified.

11.2 Annual Reports Submitted by Researchers

Annual reports require researchers to provide the following information about the project:

1. Progress to date;

2. Maintenance and security of records and data;

3. Compliance with the approved protocol;

4. Compliance with the conditions of approval;

5. Changes to the protocol or conduct of the research;

6. Changes to the personnel or contact details of the principal investigator; and

7. Adverse events or complaints relating to the project.

A total of 28 annual reports were approved by the WACHS HREC and reviewed by the

Research Governance Coordinator in 2018. An additional 13 annual reports were reviewed

by the Research Governance Coordinator in conjunction with other WA Lead HRECs.

Audits of previously approved projects are regularly conducted to identify researchers that

are non-compliant with their reporting responsibilities. In 2018 the RGS IT system also

included the function of an automated tracking system which contacts researchers when

they are due to submit a report.

Annual progress reports are reviewed by the Research Governance Coordinator in

conjunction with the WACHS HREC’s review or another Lead HREC’s review and approval

to ensure the projects are in keeping with the original governance submission and no site or

ethical issues have arisen regarding finances, risk management, legal, credentialing or

intellectual property.

Graph 2: Total number of annual progress reports approved by WACHS HREC and

reviewed by Research Governance Coordinator from 2012 to 2018

2012 2013 2014 2015 2016 2017 2018

Annual Progress Reports 19 28 32 13 21 19 28

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11.3 Amendments

Researchers are required to complete the standardised amendment request form when

seeking approval for changes to the research protocol including methodology, change in

sites, duration of the project and changes to the approved data storage arrangements. A

total of 24 amendment requests were approved by the WACHS HREC and reviewed by the

Research Governance Coordinator in 2018, which is less than the two previous years of

amendments where there were 39 approved amendment requests in 2017 and 34 approved

amendment requests in 2016. An additional 14 amendment requests were reviewed by the

Research Governance Coordinator in conjunction with other WA Lead HRECs.

Amendment requests concerning governance issues are reviewed by the Research

Governance Coordinator to assess any site implications. Examples include amendments to

the WACHS sites involved in the study, project budget, site recruitment that may impact on

in-kind support requirements and changes to site research personnel.

Graph 3: Total number of amendment requests approved by WACHS HREC and

reviewed by Research Governance Coordinator from 2012 to 2018

2012 2013 2014 2015 2016 2017 2018

Amendments 14 25 23 24 34 39 24

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11.4 Complaints

There were two complaints received for the 2018 reporting period. Both complaints were

managed in accordance with the WACHS HREC Procedures (2018).

One complaint was lodged regarding the HREC’s review and the submission procedure,

and the HREC Chair and Clinical Research Manager further investigated each issue and

then provided a response:

The HREC complaint concerned the HREC’s request for written information to be

sent by letter to participants from the health care providers before the researcher

contacted patients by telephone. The researcher regarded this as unnecessary and

time consuming. Following the complaint, the chair and deputy chair met with the

researcher to discuss the importance of maintaining trust in the confidentiality of

patient information. The project methodology proposed by the researcher required a

waiver of consent under section 95A of the Privacy Act, as it would have involved

access to identifiable information such as the patient’s contact details and medical

history held by a private health care provider in addition to information held at

WACHS sites.

The procedural complaint was in regards to delays in the project being reviewed and

re-reviewed by the HREC, and incorrect advice provided regarding the submission

process. Following an investigation it was found the delay was due to a lack of formal

response made by the researcher via the RGS system as requested, as well as

technical difficulties the researcher experienced with the RGS system. The incorrect

advice provided by this office was based on NMA certified accepting HRECs rather

than NMA Lead certified HRECs. This error was acknowledged to the researcher,

however, it did not contribute to any significant delays in reviewing the application.

The second complaint was raised by the WACHS Executive, who discovered a published

article of an approved project which contained identifying information which was not

consistent with the project’s approved protocol and participant information and consent

form. The project also listed investigators in the publication that were not approved project

members as per the protocol. An Incident Review Committee was established to investigate

the complaint. It was also found that specialised HREC review by the WA Aboriginal Health

Ethics Committee did not cover this project and that data analysis discussed in the

publication was also inconsistent with the approved protocol. The outcome of the review

was that these issues were considered a protocol violation. Increased monitoring was

imposed on the project and on all other projects the CPI was coordinating. Administrative

violations were also required to be rectified immediately.

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11.5 Declarations of Interest

Nine declarations of interests were made by HREC members over the 11 meetings in 2018,

however, only three were deemed a conflict of interest. These conflicts of interest were due

to committee members being involved in a research project that was being considered at

the meeting. As per the WACHS HREC Terms of Reference, when a conflict of interests

was determined the member excluded themselves from any discussion or decision making

regarding the project. This was recorded in the meeting minutes.

12. Project Completion Compliance

12.1 Final Reports

A final report is required to be submitted at the completion of the research project. The

report includes the outcomes of the research, a copy of the results and any publications. A

total of 11 final reports were submitted and approved by WACHS HREC and reviewed by

the Research Governance Coordinator in 2018. This was significantly less compared to the

number of final reports submitted and approved in 2017. This was due to the audits we

conducted on all projects in 2017 to identify non-compliant projects which had been

completed and required closure.

Graph 4: Number of final reports approved by WACHS HREC and reviewed by

Research Governance Coordinator from 2012 to 2018

In 2018, following the HREC and Research Governance Coordinator’s review and approval

of final reports, the Research Governance Coordinator commenced distributing results from

final reports to the Regional Directors to disseminate to their relevant departments and

2012 2013 2014 2015 2016 2017 2018

Final Reports 10 11 10 11 7 46 11

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disciplines. This ensures findings are available rapidly and can be translated into practice

immediately resulting in stronger evidence based practice and improved patient care.

13. Other Reporting 13.1 NHMRC Annual Report

All registered HRECs are required to complete and submit an annual report to the NHMRC.

This report is completed by the Clinical Research Manager in conjunction with the HREC

Chair and includes a questionnaire capturing information on the HREC’s composition,

meeting arrangements, new submissions, monitoring requirements and any applications

that requested a waiver of consent under section 95 or 95A of the Privacy Act 1988.

13.2 WACHS Annual Report

This is the fourth annual report for WACHS outlining the ethical and governance activity for

2018. This report is developed annually by the Clinical Research Manager for endorsement

by the WACHS Executive Committee.

13.3 WACHS Summaries of Approved Projects Report

To avoid duplication of research projects and to increase awareness of predominant

research themes, primary participant groups and WACHS sites, the Clinical Research

Manager develops bi-annual publications of approved projects’ summaries. Publications of

the summaries commenced in 2015 and are available on the WACHS Research internet

webpage: http://www.wacountry.health.wa.gov.au/research

13.4 WACHS Quarterly Reports

Quarterly reports are provided to the WACHS Executive Committee on key activity for the

HREC and Research Governance Function.

14. Reference List Medical Services, WA Country Health Service (2018) Human Research Ethics Committee

Terms of Reference. WA Country Health Service, Perth.

Medical Services, WA Country Health Service (2018) Human Research Ethics Committee

Procedures. WA Country Health Service, Perth.

Medical Services, WA Country Health Service (2018) Human Research Ethics Committee

Appointment Policy. WA Country Health Service, Perth.

National Health and Medical Research Council (2018). National Statement on Ethical

Conduct in Human Research. Australian Government, Canberra.

22

National Health and Medical Research Council (2011). Research Governance Handbook:

Guidance for the national approach to single ethical review. Australian Government,

Canberra.

Research Development Unit, Office of the Chief Medical Officer (2012). WA Health

Research Governance Policy and Procedures. Department of Health WA, Perth.

Research Development Unit, Office of the Chief Medical Officer (2013). WA Health

Research Governance and Single Ethical Review Standard Operating Procedures.

Department of Health WA, Perth.

23

Appendix A – WACHS HREC Approved Projects by Organisations

In 2018, universities formed the largest group of organisations that submitted ethics

applications (54%) with the majority of these applications submitted by researchers at

various WA universities and one from an eastern state university. The total amount of

university applications has increased from 2017 where universities accounted for 23% of

initiated projects. Interestingly, nearly half of the 2018 university applications approved were

WACHS staff undertaking higher education studies.

WACHS formed the second largest organisation that submitted ethics applications in 2018

(30%). This was a slight decrease from 2017 when 38% of WACHS based applications

were approved. Of the 2018 WACHS applications approved, all were service improvement

projects in the areas of oncology, orthopaedics, patient safety and spinal injury care.

Graph 5: Breakdown of ethically approved projects by organisation for 2018

Graph 6: Breakdown of ethically approved projects by organisation for 2017

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24

Appendix B – WACHS HREC Approved Projects by WACHS Region

Ethically approved projects in 2018 were evenly distributed throughout the regions with the exception of Goldfields and Pilbara as both reported no activity. In 2017, the Kimberley region hosted the majority of research with seven projects accessing the region alone. This region has consistently been the most researched as seen in both 2016 and 2015. Although the Kimberley region did not have the most projects approved by 2018, the current number of active projects initiated in previous years continues to remain high.

Graph 7: Ethically approved projects by WACHS region for 2018

Graph 8: Ethically approved projects by WACHS region for 2017

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Wheatbelt

South West

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25

Appendix C – WACHS HREC Approved Projects by Research Theme

The ethically approved projects for 2018 were predominately focused on service delivery,

which is a consistent theme for the last four years. Of the 53% of service focused projects,

over half were evaluations of WACHS established programs and service delivery models in

the areas of chronic disease management, oncology and clinical safety. The remaining

projects investigated advances to access health services or cost effective alternatives in the

areas of Aboriginal health, orthopaedics and emergency spinal care.

Interestingly, in 2018 only one ethically approved project targeted Aboriginal health. There

were no projects targeting alcohol and other drugs which was also the case in 2017. This is

a noteworthy reduction compared to 11 alcohol and drug related projects (21%) in 2015

where the majority of these projects were concerning fetal alcohol spectrum disorder.

Although this is not the focus of new research there are still many active projects within

WACHS focussing on these research themes at present.

Graph 9: Ethics approvals by research theme for 2018

Graph 10: Ethics approvals by research theme for 2017

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Theme

By Theme Aboriginal Health

Nutrition

Environment

Alcohol and other Drugs

Infectious Disease

Service

General Medicine

Paediatric Care

Cardiovascular

Mental Health

Cancer

Pregnancy

Aged Care

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By Theme 2017 Aboriginal Health

Nutrition

Environment

Alcohol and other Drugs

Infectious Disease

Service

General Medicine

Paediatric Care

Cardiovascular

Mental Health

Cancer

Pregnancy

Aged Care

26

Appendix D – WACHS Research Governance Approved Projects by Organisations

In 2018, the majority of research governance applications submitted for review by the

Research Governance Coordinator were universities and collaborative projects. Of the

applications from universities, the University of Western Australia submitted five. New

applications were also received from universities from the eastern states, including Monash

University and James Cook University.

Importantly, WACHS played a significant role in the majority of collaborative projects and in

private research involving Telethon Kids Institute. The outcomes for WACHS as a result of

these collaborations can be demonstrated through one example; The Lighthouse Hospital

Project (LHP) coordinated by the Heart Foundation, in collaboration with Australian

Hospitals. The project has three phases; the aim of the LHP Phase 3 - Project Evaluation, is

to validate the impact of the project and toolkit on the health outcomes of Aboriginal and

Torres Strait Islander people diagnosed with ACS, and complete an economic analysis of

the project to determine the costs and benefits of the project.

Graph 11: Institutionally approved projects by organisation for 2018

Graph 12: Institutionally approved projects by organisation for 2017

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Collaboration WACHS PrivateOrganisations

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Other WA Health Service

Collaboration

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Private Organisations

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University

Other WA Health Service

Collaboration

WACHS

Private Organisations

27

Appendix E – WACHS Research Governance Approved Projects by WACHS Region

In 2018 all regions participated in research activities, although the Goldfields and the

Wheatbelt regions were not the targeted focus of a project that received governance

approval. Similarly to the 2017 graph the Wheatbelt and the Midwest were not the sole

focus of a research project. In 2018 and 2017, the Kimberly region hosted the majority of

singular regional research for 2018, with six projects accessing this region alone in 2018.

Graph 13: Institutionally approved projects by WACHS region for 2018

Graph 14: Institutionally approved projects by WACHS region for 2017

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Goldfields

South West

Pilbara

Kimberely

Great Southern

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Midwest

Multiple

All Regions

28

Appendix F – WACHS Research Governance Approved Projects by Research Theme

In keeping with the statistics for 2017, in 2018 the majority of focus for institutionally

approved projects was service, which is consistent with the previous year’s submissions.

Service has been a primary focus for the last three years. Aboriginal health also continued

to be a main focus within WACHS as did infectious disease.

Graph 15: Institutionally approved projects by research theme for 2018

Graph 16: Institutionally approved projects by research theme for 2017

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Nutrition

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Alcohol and other Drugs

Infectious Disease

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Paediatric Care

Cardiovascular

Mental Health

Cancer

Pregnancy

Aged Care

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Mental Health

Cancer

Pregnancy

Aged Care

29

Appendix G – WACHS In-Kind Support approved in 2018 Research

Projects

Many research projects require in-kind support from WACHS at no charge to the

researchers in order for studies to be conducted. The main source of in-kind support for

projects approved in 2018 was staff time in either assisting with research (such as

distributing recruitment materials or identifying potential participants on the researcher’s

behalf) or participating in research (as research subjects). Other examples of in-kind

support include administrative costs, lost productivity costs and equipment. This information

is captured in research governance applications.

The total in-kind support for projects approved in 2018 is estimated at $459,871.36. This is

a reduction of over half the total amount compared to 2017 total estimate of $1,167,558.93.

The reason for this reduction is that in 2017 one project alone that involved the Kimberley

and Pilbara regions had an estimated in-kind support amount of over $500,000.

WACHS Central Office has been added to the in kind costs for Research Governance in

2018. This is due to the commencement in 2018 of the allocation of in kind costing to

conduct ethics and research governance review at a rate agreed upon across all WA Health

Services; $3,500 per review.

WACHS provided the majority of in kind costs in 2018 to university led projects, and

collaborative projects that involved WACHS and other institutions. WACHS provided the

greatest in-kind supporting costs for two projects in 2018.

The first project is conducted by the Telethon Kids Institute with support from WACHS

Kimberley. Skin health has been identified as one of the health priorities by communities

and health services in the Kimberley. This project aims to strengthen and build on existing

practices implemented by WACHS Kimberley and other health services operating in the

Kimberley to improve the awareness, detection, and treatment of skin infections (including

impetigo, scabies and crusted scabies). The SToP trial study will implement several

activities aimed at Seeing (S), Treating (T), and preventing (P) skin infections. This includes

training WACHS staff to administer Ivermectin as a first line treatment against classical

scabies because it has demonstrated superior efficacy in a number of clinical trials. WACHS

is contributing an estimated $259,928.60 in in-kind support through the WACHS Kimberley

office for the estimated three year lifespan of the project. This support includes the provision

of a WACHS staff member to facilitate trial related activities at remote WACHS Kimberley

sites and WACHS staff providing screening, treating and preventative activities to the local

communities.

The second project is a collaborative project between Murdoch University and WACHS, with

investigators from University of Notre Dame, Mercy Hospital, The University of Melbourne,

Murdoch Children’s Research Institute, Erasmus Medical Centre and Leiden University in

the Netherlands. The project was awarded funding from WACHS Mental Health under the

Shark Tank Research initiative to the amount of $243,016.80. The project aims to conduct a

comprehensive investigation to understand how exposure to maternal mental illness

impacts the subsequent development of children, and role that treatment plays in reducing

30

this risk. WACHS is contributing an estimated $77,906.00 in in-kind support over the

estimated four year lifespan of this project. The support committed by WACHS includes the

provision of identified WACHS staff as co-investigators who are providing oversight of the

research in WACHS. The findings of this project will provide evidence based information to

inform WACHS of potential high risk areas which can then inform service delivery needs.

Table 6: WACHS in-kind support for internal and external research projects for 2018

*The costs considered in this table do not include costs for projects that obtained ethics approval in 2018 only those that were authorised to commence in WACHS in 2018.

Table 7: WACHS in-kind support for internal and external research projects for 2017

Wheatbelt Kimberley Goldfields Great Southern

Midwest Pilbara South West

Central Office

WACHS initiated or collaborated

$ 0.00 $265,014.27 $24,731.90 $12,236.01 $24,802.00 $7,202.75 $36,908.13 $19,426.00

External to WACHS

$474.00 $916.30 $274.00 $1,024.00 $10,039.00 $274.00 $474.00 $56,075.00

Total $474.00 $265,930.57 $25,005.90 $13,260.01 $34,841.00 $7,476.75 $37,382.13 $75,501.00

GRAND TOTAL

$459,871.36

Wheatbelt Kimberley Goldfields Great

Southern

Midwest Pilbara South West

WACHS

initiated or

collaborated

$2,785.14

$537,299.64 $38,696.14 $2,335.14

$37,796.14 $527,099.64 $2,785.14

External to

WACHS

$1,082.73 $4,591.94 $948.70 $8,508.22 $1,163.32 $1,387.60 $1,079.44

Total $3,867.87 $541,891.58 $39,644.84 $10,843.36 $38,959.46 $528,487.24 $3,864.58

GRAND

TOTAL

$1,167,558.93

31

Appendix H – Approved ethics applications in 2018

HREC Number Project title

RGS 915 Exploring the role of remote art centres in supporting older Aboriginal people and those

living with dementia – Phase one and two

RGS 770 Evaluation of the Integrated Chronic Disease Care Program in rural Western Australia

RGS 742 Evaluation of the combined model haematology service in WA Country Health Service –

Great Southern

RGS 831 Factors affecting outcomes following unicompartmental knee replacement surgery

RGS 1039 A study investigating x-ray operators’ perception of competence and issues experienced

in general radiography practice in Western Australia

RGS 1130 Exploring the choice to pursue rural work amongst early career doctors

RGS 1155 How do partners support extended breastfeeding?

RGS 977 Clinical Yarning Education Program: Preliminary evaluation

RGS 695 Evaluating the outcomes of the introduction of the Safety II Clinical Review Program in

WACHS Wheatbelt

RGS 1336 A clinical audit of pharmacotherapy in Schizophrenia: WA Country Health Service

Midwest area

RGS 1312 Spinal precaution adherence in a rural setting

RGS 1374 The prevalence of chronic wet cough in young Aboriginal children in the Kimberley

RGS 1395 An alternative pathway for the National Bowel Cancer Screening Program (NBCSP) for

Indigenous Australians: A cluster randomised trial of implementation models

32

Appendix I – Approved governance applications in 2018

WACHS HREC approved projects

HREC Number Project title

RGS 270 An audit of dermatological diagnoses referred to and managed by the visiting

dermatologist to the Kimberley from 2012 - 2017

RGS 229 From isolation to inclusion: Embracing local perspectives in examining the treatment

model of Tuberculosis and Leprosy in Kimberley Aboriginal peoples

RGS 398 Improving recognition and management of chronic moist cough in young Aboriginal

children by caregivers and health care workers in the Kimberley

RGS 357

The MADE Paediatric Safety Audit - A retrospective clinical audit following introduction of

an Injury, Burns & Toxicological Risk Proforma in the Hedland Health Campus

Emergency Department

RGS 642 Lighthouse hospital project phase 3 - Project evaluation

RGS 915 Exploring the role of remote art centres in supporting older Aboriginal people and those living with dementia - Phase one and two

RGS 770 Evaluation of the Integrated Chronic Disease Care Program in rural Western Australia

RGS 742 Evaluation of the combined model Haematology service in WA Country Health Service –

Great Southern

RGS 831 Factors affecting outcomes following unicompartmental knee replacement surgery

RGS 1039 A study investigating x-ray operators' perception of competence and issues experienced

in general radiography practice in Western Australia

RGS 1130 Exploring the choice to pursue rural work amongst early career doctors

RGS 977 Clinical Yarning Education Program: Preliminary evaluation

33

Appendix J – Approved governance applications in 2018

Other WA Health Lead HREC (other than WACHS HREC) approved projects

HREC

Number Project title

RGS 584 The SToP (See, Treat, Prevent) Skin Sores and Scabies Trial: A cluster randomised,

stepped-wedge trial for skin disease control in remote Western Australia

RGS 2594 Australasian paediatric head injury rule study

RGS 1784 Prophylactic administration of Melatonin for the prevention of delirium in intensive care

units – a randomized placebo controlled trial (Pro-MEDIC study)

RGS 852 The success of research implementation strategies on evidence based decision making by

allied health managers: A randomised controlled trial

RGS 2296 South Metropolitan pregnancy and emotional wellbeing study (SMPEWS)

RGS 1046 A resource utilisation classification study to inform reform of residential aged care funding

RGS 1071 The contribution of home language exposure to intergenerational transmission of inequality

RGS 849 WA Trauma Training and Education Unit - Training needs analysis 2018

RGS 739 Allied Health Rural Generalist Education Program (AHRGEP) evaluation

RGS 1181 The Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency

department sepsis observational study