Introduction to human ethics

Understand the basics of the human ethics functions in Themis

The human ethics module of Themis facilitates applications for human ethics approval and progress it through to the required committee.

Researchers use the Themis human ethics module to register, submit and track ethics applications, and related annual reports.

The Human Ethics Advisory Group (HEAG) and Research Office administrators use the Themis human ethics module to administer ethics applications, initiate standard correspondence, and prepare reports for HEAGs or human ethics sub-committees (HESCs) to consider.

Themis human ethics application overview

Either a researcher or an HEAG administrator initiates the creation process. Once a human ethics application is submitted, the researcher is unable to make changes. Access to the application via the workbench will be in a ‘view only’ format.

The researcher creates or updates a human ethics application in Themis. They submit the application.
A HEAG administrator receives the application in the ‘items requiring action’ worklist. They change the status to ‘review by department’. They assign the application to a committee review. They generate the agenda reports.
The HEAG administrator enters the outcome of the committee review. They change the application status, based on the outcome. They advise the researcher if the application requires revision. Otherwise, they refer the application to the Research Office.
The Research Office assigns the application to the HESC committee review for review or ratification.
The HESC committee undertakes the committee review.
The Research Office enters the outcome of the committee review. They change the application status based on the outcomes.

Components of the Themis human ethics module

HEAG administrators use the Human Ethics Department responsibility. It contains three separate components: ethics, common modules and reporting. Each component contains links to discrete functions within the module.

Component	Link	Function Description
Ethics	Human ethics admin workbench	The administration component of Themis human ethics. This link allows HEAG admin or research office staff to receive human ethics applications and administer the application through the committee review process. Functions include: status management document review correspondence reporting
Ethics	Human ethics workbench	The primary researcher component of Themis human ethics. This link allows researchers (or HEAG admins/researcher office staff) to: create a human ethics application register or transfer an ethics application search and monitor existing applications update applications as required submit annual reports
Common modules	Committee management	The component of Themis human ethics, for administering human ethics committees. This link allows research office staff to create human ethics committees, assign departments, members, roles and end dates to these committees. HEAG admins use this sub-module to administer the HEAG committee on which they are named as ‘administrator’ or ‘alternate administrator’. This includes modifying member details, and assigning committee roles.
Common Modules	Meeting management	The component of Themis human ethics for administering human ethics committee meeting schedules. This link allows research office staff to create and modify meeting schedules for all human ethics committees. HEAG admins use this sub-module to create and maintain the meeting schedules for the HEAG committee where they are named as ‘administrator’ or ‘alternate administrator’.
Reporting	Reporting	The reporting component of Themis human ethics. Reports available include: correspondence agenda and outcome reports general reports (including by application status and document type)
Reporting	Annual report by status	Run reports relating to annual reports. Parameters include: annual report year HEAG department

Committee management

If you are intending to be absent from the University for a short period of time, an alternate administrator to the HEAG can receive notifications when new applications are lodged. There are two ways to achieve this. The first is that the alternate administrator may search for any human ethics application with an operational status of ‘lodged’.

However, if you with the alternate administrator to be able to view the applications via the ‘item requiring action’ screen and be notified by email each time a new application is lodged, you will need to give them the role of administrator while you are away.

To change the administrator:

Find the appropriate HEAG record. Navigate to the ‘member details’ screen.
Click ‘show’ next to your name and change your role from ‘administrator’ to ‘alternate administrator’.
Click ‘show’ the HEAG record and change their role to ‘administrator’.
Click ‘save’.

Data missing from the minimal risk approval letter

When a HEAG committee has approved a minimal risk project, you need to set the application status to ‘approved’. You can then print a minimal risk approval letter and send it to the researcher. This can be done via the ‘reporting’ tab.

Sometimes the letter does not contain the relevant data for the project. To make sure the letter has the required data:

Navigate to ‘application management’. Check the latest document review record for the following:
- It must be prepared for a committee meeting. If it hasn’t, prepare a new document review and set it to the scheduled meeting date. If the date has passed, the meeting should already have taken place as the HEAG has approved the project.
- The ‘document review outcome’ field should be set to ‘approved’.
Once you have checked the above factors, reselect the minimal risk approval letter in the ‘reporting’ tab.

Update the status of amendments or projects following a HEAG meeting

To prevent researchers chasing you regarding the outcome of amendments they have submitted for HEAG review, you should update the status of the record in Themis as early as possible following the HEAG meeting. Once the HEAG has agreed that an amendment is ready for a committee review, the administrator should change the status to ‘refer to research office’.

In the case of minimal risk applications, update the status to ‘approved HEAG’. Ensure a signed paper copy is sent to the Research Office, along with an approval letter.

Incomplete brief description displayed on the front page of the application

The brief description on the front page of an application summary report is limited to 100 words. However, researchers often exceed this word limit as the Themis field allows excess capacity. The extra text will not display on the application summary, so your description will be incomplete.

To update a description to display the full text:

Open two web browser windows.
In the first browser, locate the relevant application summary report in RTF format (Word). This is via the ‘reporting’ tab.
In the second browser, locate the relevant application via the ‘search’ function and navigate to the application summary screen. Copy the text in the brief description field.
Return to the browser that displays the summary.
Highlight the incomplete text. Paste the text from the full application.
Reprint the report. It will now display all the text on the front page.

Process a registration application

A registration is used when an external ethics committee has approved a project that includes University of Melbourne researchers. The external committee may also still maintain responsibility for the entire project. An appropriate HEAG must check the approval and ensure that the roles undertaken by local researchers are clear.

Refer to ‘create a registration of an external ethics clearance’ for further information.

Administer a registration on Themis

The process is the same as administering a standard project.

Progress the registration through the appropriate status levels.
Click ‘save’ when you reach ‘refer to Research Office’. This will save the status.
Send a hard copy of the application with HEAG signature to the Research Office.
The research office provides the researcher with a registration letter. This is not an approval letter.

Student access to Themis Human Ethics

Postgraduate student researchers should have access to Themis.

The Themis service desk can assist with access queries. Students can set up Themis accounts using the accounts registration system.

Human ethics policy

Human research has a broad definition. It includes research conducted with people, or about people. You need ethics approval if you are a University staff member or a postgraduate student and want to conduct research activities involving humans. This includes, but is not restricted to:

gathering information about human beings through interviewing, surveying, questionnaires, observation of human behaviour, audio/video recording, administering tests or stimuli, collecting or using human tissue/bone/blood or other bodily fluids
clinical trials
using archived data where individuals are identifiable
study or research in illegal activities

Human Ethics Advisory Groups (HEAGs)

The primary function of a HEAG is to provide preliminary assessment of human research projects. They are to advise the relevant human ethics sub-committee (HESC) and the central human research ethics committee (HREC) on issues pertaining to human research ethics in the department, school or faculty of application.