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Research Governance Service (RGS)

Stage I: Human Research Ethics Committee

Training Manual

Version 1.0

November 2016

© Department of Health 2016

Copyright to this material is vested in the State of Western Australia unless otherwise indicated. Apart from any fair dealing for the purposes of private study, research, criticism or review, as permitted under the provisions of the Copyright Act 1968, no part may be reproduced or re-used for any purposes whatsoever without written permission of the State of Western Australia.

Suggested Citation

Department of Health. (2016). Research Governance Service (RGS) Stage 1: Human Research Ethics Committee Training Manual, Research Development Unit, Department of Health, Perth.

Important Disclaimer

All information and content in this Material is provided in good faith by the Department of Health, Western Australia and is based on sources believed to be reliable and accurate at the time of development. The State of Western Australia, the Department of Health, Western Australia and their respective officers, employees and agents, do not accept legal liability or responsibility for the Material, or any consequences arising from its use.

Research Governance Service (RGS) Stage I: HREC Training Manual November 2016 v1.0 of 18

Contents

1. Introduction 4

1.1 Research Governance Service (RGS) 4

1.2 24/7 Access 4

1.3 Secure collaborative workspace 4

1.4 Centralised data repository, generate reports on-demand 4

1.5 Using Help Wiki 5

1.6 Technical Assistance 5

2. Review Agenda and Associated Documents 6

2.1 Access the Agenda from an Invitation Email 6

2.2 Access the Agenda from Tasks 6

2.3 Access the Agenda from the Calendar 8

3. Agenda Overview 9

4. Review Projects on the Agenda 11

4.1 Access Forms and Documents through View 12

4.2 Access Project through PRN 13

5. Reviewing Other Agenda Items 14

6. Minutes of the Meeting 14

7. Contribute to a Discussion Board 15


1. Introduction

Single ethical review of multi-site human research within WA Health was introduced in 2013, as a forerunner for the introduction the National Mutual Acceptance (NMA) process. This has allowed administrative processes involved in authorising research projects at multiple sites with one ethical review to be established prior to legally joining the National Mutual Acceptance (NMA). The NMA will provide WA Health sites the ability to accept ethical approval from a Human Research Ethics Committee (HREC) sponsored by a public sector Australian institution and Certified by the National Health and Medical Research Council (NHMRC) to act as a Lead HREC.

Members of the NMA are required to have the capability of a web-based research governance platform to submit, track and report on applications. WA Health has been developing the Research Governance Service (RGS) information technology (IT) platform to meet the NMA requirements and sign the Memorandum of Understanding in 2017. This will be achieved by the release of Stage 1 of the RGS in November 2016 and extra capabilities to support the NMA will be released over 2017.

1.1 Research Governance Service (RGS)

RGS is an IT system which supports the research governance framework for conducting WA Health human research projects.

The RGS is a centralised system for investigators, research group members and sponsors to complete, submit, manage and track their ethics and governance documentation through the lifecycle of their human research project. This includes approval/authorisation, monitoring and publication.

In addition, the RGS provides for Ethics, Research Governance and Hospital Administrators, Human Research Ethics Committees (and Subcommittees) to administer and report on all human research conducted within WA Health or accessing WA Health participants, their tissue or data.

1.2 24/7 Access

RGS is a web-based application that can be accessed 24/7 anywhere in the world as long as you have access to the internet and either your primary or alternate email.

1.3 Secure collaborative workspace

Signing in to the RGS requires two factor authentication. Each time a user logs in, they are provided with a security code to gain access. The audit logs retain the traceable activity of all users, so researchers can be assured that the confidentiality and integrity of their research is being protected.

Each research project also has its own security, as access is by invitation only. It is a collaborative workspace that allows easy interaction between the research group members with the ability to create forms, upload documents, post comments, and create and action group and individual tasks. The history and timeline give a clear and concise picture of the project's progress.

For both the ethics and research governance, it means that reviews can be conducted within the RGS, giving greater access sooner. Committees have their own collaborative meeting space to enable discussion prior to meetings.

1.4 Centralised data repository, generate reports on-demand

In Stage 2 there will be a comprehensive list of reports available, with access based on the individual user's security. The investigator speciality list and the recruitment search are just two


of the reports which will be available to the public that the RGS is able to generate in real-time. For RGS users, there is a comprehensive search criteria that can be used to search for both projects and related publications. RGS is also able to produce both state and national reports with the ability to update these as requirements change.

1.5 Using Help Wiki

The Help Wiki has been created to assist users of the RGS. The public pages of the help gives instructions on how to sign up, and the rest of the help is dedicated to providing researchers with information on how to create and manage their projects within the RGS.

The screens in the RGS also have tooltips. Click on them to read more information about the section or field to be completed.

1.6 Technical Assistance

If you require further assistance, contact our RGS Support:

Email: [email protected]

mailto:[email protected]


2. Review Agenda and Associated Documents

Committee Members of either the Human Research Ethics Committee (HREC) or its subcommittees will be invited to an ethics meeting by the Ethics Executive Officer (EEO). Once the invitation has been sent Committee Members can access the agenda. The agenda contains links to all research projects and other items that are to be reviewed at that meeting.

The agenda can be accessed through the invitation email, Tasks or the Meeting Calendar.

2.1 Access the Agenda from an Invitation Email

Committee Members will receive an email to let them know that they have been invited to a meeting. If the user is logged into RGS the link in the email will launch the ‘Committee Meeting’ screen for the meeting, otherwise it will launch the RGS Home page. Once the user logs in, the ‘Committee Meeting’ screen will launch.

2.2 Access the Agenda from Tasks

To access the agenda from the task menu click on Tasks in the left-hand side menu.


The invitation to the meeting will be listed under My Tasks on the Tasks menu screen. Click on the invite to meeting task.

The Task Form will appear. Click ‘Action’ and the agenda will launch. Click ‘Cancel to return to the Tasks menu screen.


2.3 Access the Agenda from the Calendar

Once logged into RGS the agenda can be accessed from the calendar.

A filter can be applied to the calendar. Select ‘My Meetings’ and the calendar will only show the meetings you are invited to (example below). Click on the relevant meeting to open the agenda.


3. Agenda Overview

The upper part of the ‘Committee Meeting’ screen provides the meeting details and the lower part contains a series of tabs. 'Venue' tab provides the location of the meeting.

The ‘Invitation to Meeting’ tab lists all Committee Members invited to the meeting.


The 'Agenda & Minutes' tab provides a condensed view of the agenda. This can be expanded by clicking the plus sign (+) next to the agenda item.

The ‘Discussion Board’ tab provides the ability for Committee Members to have a discussion about the meeting agenda items. Committee Members can add a discussion item to the agenda, view the discussions already created and add to discussions started by other members.


4. Review Projects on the Agenda

To view the agenda access the ‘Committee Meeting’ screen via the email invitation, Tasks or the Meeting Calendar. Click on the Agenda & Minutes tab. The agenda content can be expanded by clicking on the plus sign (+) next to a heading.

Expand ‘Items for Review’ and ‘New Applications’, to review new projects. To review the forms and documents attached to the new application click on ‘View’. To go to the project workspace of the new application, click on the Project Reference Number (PRN).


4.1 Access Forms and Documents through View

Click ‘View’ and the ‘View List of Attached Form(s) & Documents(s)’ screen will launch.

Click on either the form or document name to open them. The link will be purple if you have previously selected it. Forms will open in a separate tab. Documents will be downloaded to your computer before opening. To close the screen click 'OK', this will take you back to the agenda.

To access the project workspace from the application forms, click on 'Back to Forms & Documents' on the top right-hand corner of the form.


4.2 Access Project through PRN

Click on the PRN to access the project workspace. Click on any of the tabs to review any part of the project, including:

Sites – to review sites involved in the project.

Members – to review project members and their roles.

Forms & Documents – to review the ethics application forms and documents submitted to the committee.

Declarations – to review who has signed a Declaration of Confidentiality and any Conflict of Interest Forms.

Summary – to review a high level summary of the project.

User tip:

When accessing the project workspace, use the back arrow at the top of the screen to navigate back to the agenda.

To have the agenda, a project's form and the project workspace open at the same time. Open the form first from 'View' and right click the 'Back to Forms & Document' link to open a new tab for the project workspace. Go to the 'Discussion Board' tab on the agenda to add a discussion item for the project. Close the tabs when finished.


5. Reviewing Other Agenda Items

Agenda items not related to a specific project will be listed in Other Business under either Other Business for Discussion or Other Business for Information. If the item has an attachment it will be attached to the agenda under Attachments (Non Project Specific). Click on the Document Name of the attachment to open it. This will download it to your computer.

6. Minutes of the Meeting

Following a meeting the EEO will create the Minutes of the Meeting by entering the minutes for each item in to the agenda. The draft minutes can be reviewed and edited by the committee Chair. The minutes can be printed and attached to the agenda of the next meeting. Committee Members can view the minutes of any committee meeting they are associated with through the Meeting Calendar, whether they have attended the meeting or not.


7. Contribute to a Discussion Board

The discussion board within the committee meeting is intended to be a collaboration tool among Committee Members. This aims to facilitate the sharing of comments and ideas with the committee, especially prior to the meeting.

The discussion board allows Committee Members to leave a comment against an agenda item which other members and the EEO can review and comment on. If members are unable to attend a meeting this forum allows them to leave a comment against any agenda item.

Go to Calendar found in the upper menu or ribbon of RGS.

In the Calendar, click on an existing calendar event that is type 'MTG'.


The Calendar Meeting screen will be shown. Click on the 'Discussion Board' tab.

Once you are in the Discussion Board tab, click 'Add new discussion' to start a new discussion topic.


Complete the fields on the 'Add Discussion' screen. All mandatory fields have a red asterisk (*) next to them. In the Subject field enter the projects PRN (listed in the agenda) or another topic for discussion. Click ‘Save’ to add a discussion topic, or ‘Cancel’ to discard your changes.

Once a topic has been added, other users who have access to the meeting (e.g. Committee Members, EEOs) will be able to reply to the topic created. They may do so by clicking the embedded link of the desired 'Subject'.


In the 'Add/Remove Discussion Replies' screen, a user may provide their comments in the text box and click 'Add'.

The most recent reply will be added on top of the list. Any Committee Members can add additional comments to the discussion stream.

Note that users, other than the RGS Administrator, will NOT be able to remove any comments or discussion replies posted. The RGS Administrator will have to be contacted if a discussion item needs to be removed.