Research Integrity and Compliance

Applying for Human Research Ethics Procedure

Policy code: RS1922
Policy owner: Director, Research Innovation and Enterprise
Approval authority: Deputy Vice-Chancellor (Research and Innovation)
Approval date: 25 November 2015
Next review date: 19 July 2025

Purpose

The purpose of the Applying for Human Research Ethics Approval Procedure is to guide researchers (including students undertaking research) through the Human Research Ethics Approval process.

This process will help researchers to meet their responsibilities to conduct ethical research involving humans in accordance with the National Statement on Ethical Conduct in Human Research.

Scope

This procedure applies to:

  • All staff, including sessional staff, employed by the University or any controlled entity;
  • All persons, including Adjunct and Honorary staff engaged in research under the auspices of the University or any controlled entity;
  • All students of the University who engage or have engaged in research and/or research related activities, related to their studies, while enrolled at the University.

Definitions

TERM DEFINITION
Amendment Any proposed modifications researchers might wish to make to an approved project. All amendments require approval from the Committee.
Application A request for approval from a Human Research Ethics Committee (HREC) to carry out a research project. An application may be for commencement of a project, or an amendment to an approved project.
Approval Withheld A review outcome for a project which requires that ethical issues be satisfactorily addressed and the application resubmitted to the relevant Committee before the project can commence.
Approved A review outcome for a project approved to commence.
Approved with comment A review outcome for a project that has been approved to commence, but with comment from the relevant Committee.
Chief Investigator The lead researcher on a project application for approval. This person must be a member of staff, and will hold responsibility for the project. Honorary and adjunct members may not be listed as Chief Investigator.  May also be referred to as Principal Researcher.
Compliance Acting in accordance with the Code, the National Statement and Conditions of Approval as listed on the Outcome Notification
Conditions of Approval Conditions outlined in the National Statement on Ethical Conduct in Human Research which must be adhered to, in order to ensure continued approval for projects involving human research.
Co-Investigator Person/s other than the Chief Investigator who make/s a significant contribution to the planning, design implementation or outputs of a research projects, including collection, analysis or interpretation of data. Also referred to as Co-Researcher.
HREC Full Committee Meetings The HREC above low risk, or standard, review human research applications.
Human Participant Research participants who are personally interacting with the investigator, subject to observation, and/or those whose records are being accessed. Also referred to as participants.
Human Research Ethics Committee (HREC) A University Committee established in accordance with the National Health and Medical Research Council requirements to oversee and approve research involving humans.
Incident/Adverse/Unexpected event Any outcome that may have a negative impact on a participant or the researcher, and was not foreseen in the approved project. It is one of the standard conditions of approval that any adverse unexpected incident be formally reported to the HREC.
Low Risk A category of risk determined according to the National Statement definitions of risk, that would permit an application to be reviewed by the Low Risk Human Research Ethics Committee.
Low Risk Human Research Ethics Committee A sub-committee of the University Human Research Ethics Committee. This Committee assesses and approves low risk human research applications in accordance with the National Statement.
Low Risk Review Review of low risk application by the Low Risk Human Research Ethics Committee.
Monitoring The process of verifying that the conduct of research conforms to the approved proposal.
National Statement National Statement on Ethical Conduct in Human Research.
NHMRC National Health and Medical Research Council
Non-Compliance Failure or refusal by researcher/s to act in accordance with the Standard Conditions of Approval for their project, respond to the directions of the Human Research Ethics Committee, or be in breach of the National Statement.
Not Approved A review outcome for a project that has not been given Committee approval to progress.
Principal Researcher The lead researcher on a project application for approval. This person must be a member of staff, and will hold responsibility for the project. Honorary and adjunct members may not be listed as Principal Researcher. May also be referred to as Chief Investigator.
Provisional Approval A review outcome for a project approved subject to particular issues being satisfactorily addressed as directed by the relevant Committee. The project must not commence until final approval is granted.
Quorum The minimum number of members of the HREC that must be present at any meeting to make the proceedings of that meeting valid in accordance with the Terms of Reference.
Risk Assessment The National Statement defines project risk level as either negligible, low or above low risk.  The risk level determines the application review pathway.
Terms of Reference Terms of Reference show how the scope of the Committees will be defined, developed, and verified. Generally referred to as ToR.
The Code National Statement of Ethical Conduct in Human Research.

Actions

Research requiring review by the Human Research Ethics Committee

A project requires Human Research Ethics approval prior to commencement if it involves the collection or use of human data, i.e. human participation.  As per the National Statement Human participation may include:

  • taking part in surveys, interviews or focus groups;
  • undergoing psychological, physiological or medical testing or treatment;
  • being observed by researchers;
  • researchers having access to their personal documents or other materials;
  • the collection and use of their body organs, tissues or fluids (eg skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath;
  • access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.

Ethical considerations in the Design, Development, Review and Conduct of Research

All those involved in Human Research must be aware of the National Statement. 

Researchers designing a research project should read the National Statement on Ethical Conduct in Human Research, noting in particular Chapter 3.1, The Elements of Research Design, and other sections relevant to their project.

Chapter 3.1 of the National Statement on Ethical Conduct in Human Research outlines seven elements that provide guidance on the ethical considerations that are relevant to the way that research is designed, reviewed and conducted.

These Elements are:

Element 1 Research Scope, Aims, Themes, Questions and Methods

Element 2 Recruitment

Element 3 Consent

Element 4 Collection, Use and Management of Data and Information

Element 5 Communication of Research Findings or Results to Participants

Element 6 Dissemination of Research Outputs and Outcomes

Element 7 After the Project

Researchers planning to do any type of research involving Aboriginal and Torres Strait islander peoples must consult and follow the advice in the most contemporary versions of:

  • Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders and Keeping research on track 11
  • AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research produced by the Australian Institute of Aboriginal and Torres Strait Islander Studies.

These guidelines embody the best standards of ethical research and human rights and seek to ensure that research with and about Aboriginal and Torres Strait Islander peoples, and research which draws on their traditional knowledge, follows a process of meaningful engagement and reciprocity between the researcher and the individuals and/or communities involved in the research.

HREC Application Process

Researchers must review the list of meeting dates to determine the most appropriate due date for their application.   

Researchers (both staff and students) should complete the following steps to gain HREC approval:

  STEPS WHO IS RESPONSIBLE? COMMENTS
1. Assess the project for ethics application risk category

Chief Investigator

Co-Researchers

Assess the project’s level of ethical risk by reviewing the definition of risk outlined in the National Statement.

Supervisors will, in consultation with HDR candidates, Masters by Coursework and Honours students, ensure that the appropriate category of risk is identified.

2. Download and complete the application form.  The form can be found on the Research Ethics website. 

Chief Investigator

Co-Researchers

Select and complete the Human Research Ethics Application Form.

Ensure the application form is fully completed and authorised by the Chief Investigator and any other researchers listed on the application.

The Ethics Office can be consulted in regards to administrative aspects of an application and queries related to risk assessment.

Supervisors will mentor research students throughout the development of the ethics application and will provide guidance throughout the process.

3. Supplementary documentation

Chief Investigator

Co-Researchers

Attach copies of any required supplementary documentation

Examples of documentation that may be required:

  • Recruitment material, including advertisements, emails, phone scripts, etc.
  • Plain Language Information Statement (PLIS)
  • Consent form
  • Data collection tools such as questionnaires, interview schedules, focus group guides
  • Debriefing material
  • Other required approvals or supporting documentation.
4. Approval by Institute/Centre

Chief Investigator

Co-Researchers

Applications must be signed by the:

  • Chief Investigator, and the
  • Co-Researchers

And then be reviewed, and approved for submission to the HREC by one of the authorised personnel listed on the form and/or Federation University Research Ethics website.

NB. In the case of an application for a student research project, the Principal Supervisor must sign off as the Chief Investigator. The Principal Supervisor takes on all responsibility entailed as Chief Investigator.

5. Application submission

Chief Investigator

Co-Researchers

Submit one completed and fully authorised copy of the application, including all attachments, (in word.doc format or pdf format) as per the submission method and deadlines detailed on the Research Ethics website for presentation at the relevant HREC meeting.

Researchers are responsible for follow-up with an email or phone call prior to the Agenda Due Date to obtain the Project Number & Meeting Number if they have not otherwise been advised by the Ethics office that the application has been accepted.

Late submissions will be carried over to the next appropriate meeting without exception.

6. Notification of Outcome Ethics Office The Ethics Office will contact the Chief Investigator advising of the outcome of the meeting. Possible outcomes are detailed below.

HREC Bulk Application Process

This application type is used for a cluster of class-based student projects. Researchers should complete the following steps to gain HREC approval for Standard Bulk Applications:

  STEPS WHO IS RESPONSIBLE? COMMENTS
1 Download and complete application form.  The form can be found on the Research Ethics website. Chief Investigator Ensure the form is fully completed.
2 Attach copies of any required supplementary documentation Chief Investigator

Examples of documentation that may be required:

  • Recruitment material - sample recruitment material for each project in the application.
  • Plain Language Information Statement – sample PLIS for each project in the application.
  • Consent form – sample of participant consent form for each project in the application.
  • Data collection tools such as questionnaires, interview schedules, focus group guides - sample material for each project in the application.
  • Other required approvals, permission request letters or supporting documentation as appropriate for each project in the application.
3 Submit application for review and signature, by the relevant staff member, prior to the due date and submission of application to the Ethics Office. Chief Investigator

Applications must be signed by the:

  • Chief Investigator; and the
  • Co-Researchers

And then be reviewed, and approved for submission to the HREC by one of the authorised personnel listed on the form and/or Federation University Research Ethics website.

NB. In the case of an application for a student research project, the Principal Supervisor must sign off as the Chief Investigator. The Principal Supervisor takes on all responsibility that this entails.

4 Submit completed and fully authorised copy of the application, including all attachments, (in word.doc format or pdf format) to the Ethics Office as per the submission method detailed on the Research Ethics website for presentation at the relevant HREC meeting. The researchers involved with the project

Ensure the application has been reviewed and signed by all the required people.

Ensure the application is submitted to the Ethics Office by the agenda items due date and time for the HREC meeting you would like your application reviewed at. Late submissions are not accepted and will be carried over to the next HREC meeting.

After the Initial Bulk Application has been submitted and approved, individual student researchers should complete the following steps to gain HREC approval for their component of the project:

  STEPS

WHO IS RESPONSIBLE?

 

COMMENTS
1 Download and complete the Bulk Request for Amendments form.  The form can be found on the Research Ethics website. Chief Investigator, along with other researchers involved in the project(s).

Ensure the form is fully completed.

Amendment form should include:

  • Researcher/s name and details. Note, in the case of student projects, this may include a list of all involved students.
  • Project title.

Information on which methodology method in bulk application will be used.

2 Attach copies of any required supplementary documentation. Chief Investigator, along with other researchers involved in the project(s).

Documentation to be submitted:

  • Specific recruitment material, if required, for each distinct project.
  • Specific PLIS for each distinct project – Matching methodology method chosen.
  • Specific consent form each distinct project – Matching methodology method chosen.
  • Specific data collection tools – such as questionnaires, interview schedules, focus group guides – for each distinct project.
  • Specific other required approvals, permission request letters or supporting documentation as appropriate for each distinct project in the application.
3 Submit amendment All researchers involved with the project(s). Submit amendment for review and signature by the Chief Investigator of the Bulk project.
4 Submit one completed and fully authorised copy of the application, including all attachments, (in word.doc format or pdf format) to the Ethics Office as per the submission method detailed on the Research Ethics website. Chief Investigator The Bulk Request for Amendments application will be reviewed by the HREC Chair and the researchers will be notified by the Ethics Office of the outcome.

HREC Out of Session Application Process

Researchers should complete the following steps to gain HREC approval for Out of Session Reviews:

  STEPS WHO IS RESPONSIBLE? COMMENTS
1. Out of Session application review

Chief Investigator

Co-Researchers

Consideration of an ethics application with an urgent deadline is available under exceptional circumstances. Out of Session reviews are not standard practice, and will not be considered for applicants who have missed a prior meeting deadline.

In the case of exceptional or extenuating circumstances, requests for Out of Session reviews should be directed in the first instance to the Ethics Office.

2. Request is considered HREC Chair

The Chair HREC will determine if the application will be considered for an Out of Session review.

For above low risk projects, quorum for the HREC Out of Session review must be achieved to finalise the review of the application.

HREC Projects Approved by another Australian Human Research Ethics Committee (HREC) Application Process

As per the National Statement, Federation University has a responsibility to reduce or eliminate duplication of ethical review.  As such Federation University Australia Human Research Ethics Committee recognises approvals from other Australian Human Research Ethics Committees and may endorse such approval in certain circumstances, such as when a researcher is involved in a collaborative project hosted by another institution. The HREC will also consider the approval of projects transferred from another institution by a new staff member.

Researchers should complete the following steps to apply for HREC endorsement for projects approved by another Australian Human Research Ethics Committee.

Projects where the Federation University staff member is part of a collaborative project hosted by another institution:

  STEPS WHO IS RESPONSIBLE? COMMENTS
1. Complete and submit the Externally Approved Application form, selecting ‘externally approved’, and submit it to the Ethics Office as per the submission method detailed on the Research Ethics website. Federation University Chief Investigator (note, the overall project lead/Chief Investigator may be a different person based at a different institution). A copy of the original application (including attachments) and notice of approval from the external HREC must be submitted to the Ethics Office.
2. Consideration of application HREC Chair The Ethics Office will review the application and advise the Chair of any potential issues.
3. Chair Approval HREC Chair The Chair, HREC signs off on the endorsement of external approval.
4. Notification of outcome Ethics Office The Ethics Office will advise the applicant of the outcome.

Projects transferred from another institution by the Chief Investigator, who is a new member of staff:

  STEPS WHO IS RESPONSIBLE? COMMENTS
1. Complete and submit the Externally Approved Application form, selecting ‘transfer’, and submit it to the Ethics Office as per the submission method detailed on the Research Ethics website.

Chief Investigator

Co-Researchers

A copy of the original application (including attachments) and notice of approval from the external HREC must be submitted to the Ethics Office, Research Services.
2. Consideration of application HREC Chair The Chair of the HREC will review the application and advise whether the approval is endorsed by the University, or the project requires new approval, requiring submission of a completed application.
3. Notification of outcome Ethics Office The Ethics Office will advise the applicant of the outcome.

Outcomes

Research projects involving human participants cannot proceed without official written approval from the HREC.

After submission, the application will be assessed with one of the following outcomes:

OUTCOME EXPLANATION
Approved No further action required.  Full approval allows the researcher/s to commence the project on the commencement date outlined in the notification.
Approved with Comment No further action required, however the researcher/s should note the comments made by the Committee. Approved with comment is deemed as Full approval and allows the researcher/s to commence the project on the commencement date outlined in the notification.
Provisional Approval

The researcher/s must address the provisions outlined in the notification.

PROTOCOL:

Return to the Ethics Office a copy of the Provisional Approval as a response-sheet with your rejoinder underneath each issue raised, point by point.

Explain clearly how each of the matters raised has been addressed within the application and/or supporting documents.

Include in this response sheet, all amended text included in the revised application and/or supporting documents.

A response merely stating that the relevant issues have been addressed in the application/documentation is not acceptable.

Include a copy of any amended document. e.g. Application, Plain Language Statements, Consent forms or advertisements. Highlight changes made in the documents.

The Ethics Office will assess the researcher’s response. Where necessary, the Ethics Office will confer with the HREC Chair before issuing the researcher with an updated notification of the outcome.

Approval Withheld

The applicant/s must address the issues outlined in the notification and resubmit the amended application to a subsequent HREC meeting.

Instructions to applicants:

  • Use the ‘Withheld Notification’ as a response sheet for your revised application.
  • Provide your response underneath each issue raised, point by point
  • Explain clearly how each of the matters raised has been addressed within the new application.
  • Include in this response sheet, all amended text included in the revised application and/or supporting documents.
  • A response merely stating that the relevant issues have been addressed in the application/documentation is not acceptable.
  • Highlight all amended text within the revised application and supporting documents, for easy visual reference for the committee.
  • The re-submission must be a complete application:
  • Include all supporting documents whether they required amendment or not, and authorised by all required signatories.
  • Provide a clean copy of the PLIS and Consent forms, and any other document to be presented to potential participants, in addition to the copy where amendments have been made and highlighted.

Resubmitted applications that do not meet these instructions will not be reviewed by the HREC.

Be aware that review of the revised application may result in new concerns and new queries being raised by the Committee. Should this occur, they will be listed on the new Outcome Notification.

The Committee will assess the researcher’s response/s at a subsequent meeting.  A new Notification Outcome will be issued after review.

Not Approved

The HREC has identified major issues regarding the project that are of such significance that, the project cannot proceed in its current form.

If required, the Chair or one of the Committee members will meet with the researcher/s to explain the outcome and discuss ways of re-designing the project from an HREC standpoint.

The researcher/s will then be required to submit a new application. The Committee will assess the new application as per the standard process.

Timeline for resubmission of reviewed applications

For each project submitted to the HREC, a notification of outcome will be received by the researchers.  For those projects provisionally approved or with approval withheld, researchers must respond or resubmit their application within a 6 month period after receipt of the outcome.

A new application will be required if the submission is not within this timeframe.

If extenuating circumstances prevent resubmission within the stipulated timeframe, the Chief Investigator must submit a request to the Committee for approval of a resubmission delay.

If this request is not approved, the researchers must respond or resubmit on time, or a new application will be required.

Conditions of Approval

Each approved project must comply with the Conditions of Approval as summarised on the Outcome Notification (Approval Document). Failure to abide by these conditions may result in suspension or discontinuation of approval and/or disciplinary action.

Failure to comply with the National Statement on Ethical Conduct in Human Research (2007) and with the conditions of approval will result in suspension or withdrawal of approval.

Approved applicants who fail to comply with the Conditions of Approval will be subject to disciplinary action under the Research Integrity Policy.

Amendments to Approved Applications

Researchers should complete the following steps to gain HREC approval for proposed Project Amendments:

 

  STEPS

WHO IS RESPONSIBLE?

 

COMMENTS
1. Download and complete the Request for Amendments form.  The form can be found on the Research Ethics website.  Researchers involved with the project

This form is to be used for:

  • Any proposed change(s) to an existing project
  • An extension request for an existing project
  • A change of personnel for an existing project

 Amendment Request forms should include:

  • Researcher/s name and details.
  • Project title.
  • Detailed information in relation to the proposed amendments.
2. Attach copies of any supplementary documentation required for this amendment. Researchers involved with the project

Any documents that have been amended should be attached to the Amendment Request.  These may include, but are not limited to:

  • Recruitment material
  • PLIS
  • Consent form
  • Data collection tools
  • External permissions
  • Amended documents should be clearly marked with highlighting or tracked changes.
3. Review Amendment Request Chief Investigator Amendment must be reviewed and approved by the Chief Investigator of the project.
4. Submit completed and signed Request for Amendments to the Ethics Office as per the submission method detailed on the Research Ethics website. Researchers involved with the project The Request for Amendments application will be reviewed by the HREC Chair and the researchers will be notified by the Ethics Office of the outcome.

Reporting and Monitoring

The National Statement requires Human Research Ethics Committees (HREC) to monitor research projects for which they have given ethical approval to ensure that they conform to the approved protocol.  Any changes to the approved project will require Committee approval.

Submission of the following reports is required for all approved projects:

  STEPS WHO IS RESPONSIBLE? COMMENTS
1. Incidents and adverse or unforeseen effects (if applicable) Chief Investigator

Incidents, adverse effects and unforeseen events must be reported immediately to the Ethics Team. For example: Serious or unexpected adverse effects on participants and unforeseen events that might affect continued ethical acceptability of the project.

Failure to do so will result in a review of the ethics approval and may lead to discontinuation of approval and/or disciplinary action.

Chief Investigator must provide details of steps, (proposed or taken) to deal with any such incidents.

2. Annual reports Chief Investigator

It is a condition of approval that the Chief Investigator submits an annual report, which is to be submitted to the Coordinator, Research Ethics. The report must be made on the appropriate form, signed by all investigators and provide the following information:

  • details of progress to date;
  • maintenance and security of records;
  • compliance with the approved protocol;
  • compliance with any conditions of approval;
  • details of any serious or unexpected adverse effects of the research on participants which may have occurred;
  • steps taken to deal with these;
  • changes in the research protocol; and
  • any other problems relating to the conduct of the project.

It is the Chief Investigator’s responsibility to submit the report within 12 months of the project commencing and annually thereafter. Failure to complete and return an annual report by the due date may lead to suspension or withdrawal of ethics approval.

3. Final reports Chief Investigator

It is a condition of approval that the Chief Investigator submits a final report upon completion/discontinuation of a project.

This final report will include:

  1. a summary of the results of the project;
  2. whether the aims of the project were achieved;
  3. maintenance and security of records;
  4. compliance with the approved protocol; and
  5. compliance with any conditions of approval.

The final report must also contain:

  • details of any serious or unexpected adverse effects of the research on participants which may have occurred (as previously reported on Adverse Incident report form);
  • any steps taken to deal with these (as previously reported on Adverse Incident report form);
  • changes in the research protocol (as previously reported on Amendment form);
  • any other problems relating to the conduct of the project.

Failure to complete and return a final report by the due date may lead to suspension or withdrawal of ethics approval.

Auditing

In line with the National Statement, the HREC has determined that all approved projects are subject to auditing as per the details outlined in the National Statement.

Suspension or Discontinuation of Research

Where the Chair of the HREC is satisfied that circumstances have arisen such that a research project is not being or cannot be conducted in accordance with the approved protocol, including any conditions of approval, the HREC may withdraw approval and recommend that the research project be discontinued, suspended or other necessary action be taken.

A researcher must not continue the research if ethical approval has been withdrawn and must comply with any special conditions required by the HREC.

Complaints and Appeals Procedure

Complaints related to the ethical aspects of research

Complaints or concerns relating to the ethical aspects of a research activity should be directed to Ethics Office in the first instance. The procedure for investigation would normally be:

  ACTION RESPONSIBLE COMMENTS
1. Submission of complaint Aggrieved person Complainant submits their complaint or concern in writing to the Ethics Office.
2. Lodgement of complaint with Chair Ethics Office The Ethics Office lodges the complaint or concern with the Chair of the HREC and notifies the DVC(RI) of the complaint.
3. Chair considers complaint Chair The Chair (or a delegate of the Chair) considers the complaint, including, where necessary, reference to original approved protocol.
4. Chair reports to the DVC(RI) Chair The Chair reports their finding to the DVC(RI)
5. Investigation of complaint DVC(RI) The DVC(RI) orders the investigation of the complaint, if required, under the Staff Conduct Policy and/or the Code for the Responsible Conduct of Research procedures.
6. Notification to the HREC DVC(RI) The DVC(RI) will report on the status of an investigation to the HREC, as required.

Complaints concerning ethics administration and committee decisions

The National Statement requires that an institution establish procedures for receiving and promptly handling concerns or complaints from researchers about the consideration of their research protocol by an HREC. If a researcher wishes to appeal the decision of the HREC about their research project or express concerns about the ethics administration process, the following action would normally be taken.

  ACTION RESPONSIBLE COMMENTS
1. Submission of complaint Applicant Complainant submits their complaint or concern in writing to the Ethics Office.
2. Consideration of complaint

Chair

Ethics Office

Associate Dean Research

The Chair and the Ethics Office consider the complaint.

The relevant Research Advisor, Centre Director or delegate may be consulted, if required.

The Chair may refer the matter to the full Committee, should they deem this appropriate.

3 Applicant advised of outcome Ethics Office

The Ethics Office will advise the applicant of the outcome of the consideration of their complaint.

If the complainant is not satisfied with the result, the matter will be referred to the DVC(RI) for consideration.

Complaints related to Non-Compliance with relevant Codes

Complaints or concerns relating to Research Integrity/Misconduct should be submitted in accordance with the:

Responsibility

Researchers must ensure that:

  • no research is conducted which has not received approval by the HREC;
  • all relevant information has been provided to the Ethics Committee;
  • all relevant guidelines and legal requirements are complied with;
  • monitoring requirements are complied with;
  • proposed protocol modifications and amendments are submitted to the Ethics Committee for approval;
  • adverse events are promptly notified.

Researchers are expected to declare:  

  • sources of funding;
  • commercial sponsorship and/or involvement;
  • relevant personal and/or competing interests, including consultancies, paid travel, shareholdings, patents or patent applications, etc.;
  • any payments, inducements or rewards offered to research participants.

The Ethics Office is responsible for:

  • Liaising with researchers, the HREC Chair and the HREC and Sub-committees;
  • Providing executive support to the HREC;
  • Informing researchers of the outcome of their application;
  • Coordinating the annual and final reporting for approved projects;
  • Collating annual reports for various Government departments;
  • Reporting to Federation University Australia governing bodies, as required.

HREC is responsible for:

  • Assessing and approving all applications in accordance with the relevant governing document;
  • Monitoring approved applications throughout their lifecycle;
  • Operating in accordance with the National Statement;
  • Notifying the DVC(RI) of any potential issues relating to ethics in research in a timely manner.

Promulgation

The Applying for Human Research Ethics Procedure will be communicated throughout the University community via:

  1. an Announcement Notice under ‘FedNews’ website and through the University Policy - ‘Recently Approved Documents’ webpage to alert the University-wide community of the approved Policy;
  2. inclusion on the University Policy, Procedure and Forms website.

Implementation

The Human Research Ethics Procedure will be implemented throughout the University via:

  1. Information Sessions; and/or
  2. Training Sessions

Records Management

TITLE LOCATION RESPONSIBLE OFFICER MINIMUM RETENTION PERIOD
HREC Application Forms Ethics Office Director, Research Innovation & Enterprise 7 years
HREC Approval Notification Forms Ethics Office Director, Research Innovation & Enterprise 7 years
HREC Amendment Request Forms Ethics Office Director, Research Innovation & Enterprise 7 years
Annual Project Report Forms Ethics Office Director, Research Innovation & Enterprise 7 years
Final Project Report Forms Ethics Office Director, Research Innovation & Enterprise 7 years
Project Incident Report Forms Ethics Office Director, Research Innovation & Enterprise 7 years
Misconduct Report Forms Ethics Office Director, Research Innovation & Enterprise 7 years