Research Integrity and Compliance
- Ethical Conduct of Research Policy
- Applying for Human Research Ethics Procedure
- Applying for Animal Research Ethics Procedure
- Institutional Biosafety Procedure
- Authorship Procedure
- Research Integrity Policy
- Research Integrity & Misconduct Procedure
- Research Data Management Procedure
- Research Data Management Policy
- Intellectual Property Policy
- Disclosing and Exploiting Intellectual Property Procedure
- Disbursement of Net Revenue from Intellectual Property Commercialisation Procedure
- Forms
- Printable PDF Version
- Purpose
- Scope
- Legislative Context
- Definitions
- Actions
- HREC Standard and Expedited Application Process
- HREC Standard Bulk Application Process
- HREC Out of Session Application Process
- HREC Request for Approval to use Existing Data Application Process
- HREC Projects Approved by another Australian Human Research Ethics Committee (HREC) Application Process
- Outcomes
- Timeline for resubmission of reviewed applications
- Conditions of Approval
- Reporting and Monitoring
- Complaints and Appeals Procedure
- Supporting Documents
- Responsibility
- Promulgation
- Implementation
- Forms/Record Keeping
The purpose of the Applying for Human Research Ethics Approval Procedure is to guide researchers 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 National Statement on Ethical Conduct in Human Research.
This procedure applies to:
- All staff, including sessional staff, employed by the University or any controlled entity;
- All persons, including adjunct staff 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.
National Statement on Ethical Conduct in Human Research (2007) incorporating all updates
| Term | Definition |
|---|---|
| Approved | A category review outcome for a project approved to commence |
| Approved with comment | A category review outcome for a project that has been approved to commence, but with comment from the relevant Committee |
| Approval Withheld | A category review outcome for a project application which requires that ethical issues be satisfactorily addressed and the application resubmitted to the relevant Committee before the project can commence. |
| Co-Researcher/s | One or more participants (or a particular sub-group of participants) who make/s a significant contribution to the planning, design implementation or outputs of a research projects, including collection, analysis or interpretation of data. |
| 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 |
| Expedited Review | A special category of low risk application fast tracked by review only by the HREC Sub-committee |
| Human Participants | Are research participants who are personally interacting with the investigator, subject to observation, and/or those whose personal and confidential records are being accessed |
| 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 |
| HREC Full Committee Meetings | The HREC review Standard Applications and Expedited Applications at Full Committee meetings |
| HREC Sub-Committee Meetings | A Sub-committee of the University Human Research Ethics Committee established in accordance with the National Health and Medical Research Council requirements to oversee and approve research involving humans. This Committee only assesses Expedited Applications |
| 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 |
| Low Risk | A category of risk determined after completion of the Risk Assessment Checklist, that would permit an application to be 'fast-tracked' for review by the HRE Sub-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 |
| Not Approved | A category review outcome for a project that has not been given Committee approval to progress |
| Participant | Anyone who has given informed consent to participate |
| 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. |
| Provisional Approval | A category review outcome for a project approved subject to particular issues being satisfactorily addressed as directed by the relevant Committee |
| 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 | The function of the magnitude of harm and the probability that it will occur |
| Risk Assessment Checklist | The mandatory assessment of the project to determine if it can be assessed as low risk (expedited application) |
| Standard Application | Standard application process for ethics approval |
| Terms of Reference | Terms of Reference show how the scope of the Committees will be defined, developed, and verified |
| The Code | National Statement of Ethical Conduct in Human Research |
| Variation | Any proposed amendment or modifications researchers might wish to make to an approved project. All variations require approval from the Committee. |
Research requiring review by the Human Research Ethics Committee
A project requires ethical consideration by the HREC if:
- it involves a direct approach to human participants;
- consent is to be sought;
- medical or electronic records are to be accessed;
- identifying information is to be collected or used;
- personal or culturally sensitive information is to be collected or used;
- individuals (or groups) could be disadvantaged as a result of participation;
- information collected could have ethical, legal or commercial implications;
- the results might be submitted for publication.
- Research must cease if approval from the HREC has expired, is suspended or is withdrawn.
- All those involved in Human Research must be aware of the National Statement.
Researchers who are designing a research project should read Chapter 3.1 of the National Statement on Ethical Conduct in Human Research, noting which parts of the guidance are relevant for their project.
Ethical considerations in the Design, Development, Review and Conduct of Research
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 as well as the Guidelines for Ethical Research in Australian Indigenous Studies (GERAIS) 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 follows a process of meaningful engagement and reciprocity between the researcher and the individuals and/or communities involved in the research.
Researchers (both staff and students) should complete the following steps to gain HREC approval for Standard and Expedited Applications:
| STEPS | WHO IS RESPONSIBLE? | COMMENTS | |
|---|---|---|---|
| 1. | Assess the Ethics Application for risk category |
Principal Researcher Research team |
Assess the project’s level of ethical risk by completing the ‘Risk Assessment Checklist”. Low risk (e.g. All ‘no’ boxes ticked): Use the Expedited Application for HREC Approval Other than low risk (e.g. One or more ‘yes’ boxes ticked): Use the Standard Application for HREC Approval. If an applicant has ticked one yes box, but feels they can make a case for their application to be considered in the expedited category, they should tick the Special Case Applicant box. The Chair will advise whether the application should be expedited. If an application is submitted as an Expedited Application and the HREC deem the project to be a higher risk, the researchers may be requested to resubmit the project as a Standard Application. Supervisors will, in consultation with HDR candidates, Masters by Coursework and Honours students, ensure that the appropriate category of application is identified. |
| 2. | Complete appropriate application form |
Principal Researcher Research team |
Select and complete the appropriate application form, based on the checklist assessment. Ensure the application form is fully completed and authorised by the Principal researcher and any other researchers listed on the application. Research Services can be consulted in regards to administrative aspects of an application. Supervisors will mentor research students throughout the development of the ethics application and will provide guidance throughout the process. |
| 3. | Supplementary documentation |
Principal Researcher Research team |
Attach copies of any required supplementary documentation Examples of documentation that may be required:
|
| 4. | Approval by Faculty/Centre delegate |
Principal Researcher Research Team Head of School Deputy Head of School Associate Dean of Research Faculty Ethics Coordinator |
Applications must be reviewed, signed and approved for submission to the HREC. Authorised Personnel are:
NB. In the case of an application for a student research project, the Principal Supervisor must sign off as the Principal Researcher. The Principal Supervisor takes on all of the responsibility that this entails. |
| 5. | Application submission |
Principal Researcher Research team |
Submit one completed and fully authorised copy of the application electronically via email, including all attachments, (in word.doc format or pdf format) to research.ethics@federation.edu.au for presentation at the relevant HREC meeting: either Sub-Committee (expedited applications only) or Full Committee meeting (standard or expedited applications). 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 you have not been advised by the Ethics office that your application has been accepted. Late submissions will be carried over to the next HREC meeting without exception. |
| 6. | Notification of Outcome | Research Services | Research Services will contact the Principal Researcher advising of the outcome of the meeting. |
Researchers should complete the following steps to gain HREC approval for Standard Bulk Applications:
| STEPS | WHO IS RESPONSIBLE? | COMMENTS |
|---|---|---|
| Download Standard Bulk Application from Federation University Australia website. | The researchers involved with the project | |
| Complete application form. | The researchers involved with the project |
Ensure the form is fully completed. Areas with specific requirements include:
|
| Attach copies of any required supplementary documentation | The researchers involved with the project |
Examples of documentation that may be required:
|
| Submit application for review and signature, by the relevant staff member, prior to the due date and submission of application to the Ethics Officer | The researchers involved with the project |
Applications can be reviewed and signed by the following relevant to your school staff members: ADR Head of School Deputy Head of School Faculty Ethics Coordinator |
| Submit completed and signed hard copy of the application to the Ethics Officer for presentation at a HREC full committee meeting. Submit the application electronically. | 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 Officer 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. |
Researchers should complete the following steps to gain HREC approval for Standard Bulk Project Amendments:
| STEPS |
WHO IS RESPONSIBLE?
|
COMMENTS |
|---|---|---|
| Download Bulk Request for Amendments form from Federation University Australia website. | The researchers involved with the project | Submit Amendment Request documentation when bulk application has been approved. |
| Complete the Bulk Request for Amendments form. | The researchers involved with the project |
Ensure the form is fully completed. Amendment form should include:
|
| Attach copies of any required supplementary documentation | The researchers involved with the project |
Documentation to be submitted:
|
| Submit amendment for review and signature by the Principal Researcher of the Bulk project. | The researchers involved with the project | |
|
Submit completed and signed hard copy of the Bulk Request for Amendments application to the Ethics Officer. Submit the amendment request electronically. |
The researchers involved with the project | The Bulk Request for Amendments application will be reviewed by the HREC Chair and the researchers will be notified by the Ethics officer of the outcome. |
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 | Principal Researcher Research team |
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 Officer, Research Services.
The Chair HREC will determine if the application will be considered for an Out of Session review.
Quorum for the HREC Out of Session review must be achieved to finalise the review of the application. |
Researchers should complete the following steps to gain HREC approval for Request for Approval to use Existing Data Applications:
| STEPS | WHO IS RESPONSIBLE? | COMMENTS | |
|---|---|---|---|
| 1 | Complete the appropriate application form | Principal Researcher Research team | Applicants complete the document titled ‘Request for Approval to use Existing Data’ |
| 2 | Complete Supplementary documentation | Principal Researcher Research team |
Attach copies of any required supplementary documentation
E.g. a letter of approval from the providers of the data, if applicable. |
| 3 | Approval by Faculty/Centre review |
Principal Researcher Research Team Head of School Deputy Head of School Associate Dean of Research Faculty Ethics Coordinator |
Applications must be reviewed, signed and approved for submission to the HREC by the relevant staff within your Faculty:
|
| 4 | Application submission | Principal Researcher Research team |
Submit one completed and fully authorised hard copy of the application, including all attachments, to Research Services for presentation to the HREC Chair.
Email the application, including all attachments, (in word.doc or pdf format)to research.ethics@federation.edu.au
These applications are reviewed by the HREC Chair. |
| 5 | Notification of Outcome | Research Services | Research Services will contact the Principal Researcher advising of the outcome of the meeting. |
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. | Application for Federation University endorsement of a project that has been granted approval by another HREC | Principal Researcher Research team | A copy of the original application (including attachments) and notice of approval from the external HREC must be submitted to the Ethics Officer, Research Services. |
| 2. | Consideration of application | Ethics Officer Chair | The Ethics Officer will review the application and advise the Chair of any potential issues. |
| 3. | Chair Approval | Chair | The Chair, HREC signs off on the endorsement of external approval. |
| 4. | Notification of outcome | Ethics Officer | The Ethics Officer will advise the applicant of the outcome. |
| STEPS | WHO IS RESPONSIBLE? | COMMENTS | |
|---|---|---|---|
| 1. | Application for Federation University endorsement of a project that has been granted approval by another HREC | Principal Researcher Research team | A copy of the original application (including attachments) and notice of approval from the external HREC must be submitted to the Ethics Officer, Research Services. |
| 2. | Consideration of application | 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 Officer | The Ethics Officer will advise the applicant of the outcome. |
No Research projects involving human participants can 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 in the form of an email, letter or memo listing the project reference number and including a response to each of the issues raised, clearly explaining how each of the matters has been addressed. A hard copy of any amended document, eg. Plain Language Information Statement (PLIS), Consent form or advertisements must be provided to Research Services. Research Services will assess the researcher’s response to addressing the provisions. Where necessary, Research Services will confer with the HREC Chair before issuing the researcher with a notification of the outcome. |
| Approval Withheld |
The researcher/s must address the issues outlined in the notification and resubmit the amended application to a subsequent HREC meeting. The issues must be addressed,point by point, in the form of an email, letter or memo listing the project reference number and including a response to each of the issues raised, clearly explaining how each of the matters has been addressed. A hard copy of any amended document; eg. Plain Language Information Statement (PLIS), Consent form or advertisements must be provided to Research Services. 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. |
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 for any reason a researcher is experiencing extenuating circumstances which prevents them from responding or resubmitting within this timeframe, they 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.
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 Staff Misconduct Policy and the Research Integrity Policy.
The National Statement requires Human Research Ethics Committees (HREC) to monitor research projects for which they have given ethical approval in order to ensure that they conform to the protocol approved.
The principal reason for monitoring research projects is to ensure that their conduct is not jeopardising the rights and interests of those who have consented to participate and/or approved use of their personal information.
| STEPS | WHO IS RESPONSIBLE? | COMMENTS | |
|---|---|---|---|
| 1. | Variations to Project Reporting | Principal Researcher | The Ethics Committee must be formally notified of any proposed variations or modifications researchers might wish to make to an approved project. These require approval from the Committee. |
| 2. | Incidents and adverse or unforeseen effects | Principal Researcher |
Incidents, adverse effects and unforeseen event s must be reported immediately to Research Services, 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. Principal Researchers must provide details of steps, proposed or taken, to deal with any such incidents. |
| 3. | Annual reports | Principal Researcher |
It is a condition of approval that the Principal Researcher submits an annual report. The report must be made on the appropriate form, signed by all investigators and provide the following information:
It is the Principal 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. |
| 4. | Final reports | Principal Researcher |
It is a condition of approval that;
The final report must also contain:
Failure to complete and return a final report by the due date may lead to suspension or withdrawal of ethics approval. |
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.
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 that 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 or concerns relating to the ethical aspects of a research activity should be directed to Research Services in the first instance. The procedure for investigation would normally be:
| Action | Responsible | Comments | |
|---|---|---|---|
| 1. | Submission of complaint | Staff member Student General Public | Complainant submits their complaint or concern in writing to the Ethics Officer in Research Services. |
| 2. | Lodgement of complaint with Chair | Ethics Officer | Ethics Officer 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. |
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 Officer in Research Services. |
| 2. | Consideration of complaint |
Chair Ethics Officer Associate Dean Research |
The Chair and the Ethics Officer consider the complaint. The relevant Associate Dean of Research 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 Officer |
The Ethics Officer 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. |
- Ethical Conduct of Research Policy
- Research Integrity Policy
- HREC Risk Assessment Checklist
- Application for HREC Approval (Bulk)
- Application for HREC Approval (Expedited)
- Application for HREC Approval (Standard)
- Approval to Use Existing Data
- HREC Request for Amendments
- HREC Request for Extension
- Changes to Personnel – Existing Project
- Informed Consent Form
- Plain Language Information Statement
- HREC Annual Report
- HREC Final Report
- Declaration of Confidentiality
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.
Research services are 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.
The Human Research Ethics Procedure will be communicated throughout the University via:
- 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;
- inclusion on the University Policy, Procedure and Forms website; and/or
- distribution of e-mails to Head of School / Head of Department / University staff; and/or
- documentation distribution, eg. posters, brochures.
- Other - please describe
The Human Research Ethics Procedure will be implemented throughout the University via:
- Information Sessions; and/or
- Training Sessions; and/or
- Other - please describe
| Title | Location | Responsible Officer | Minimum Retention Period |
|---|---|---|---|
| HREC Application Forms | Research Services | Director, Research Services | 7 years |
| HREC Approval Notification Forms | Research Services | Director, Research Services | 7 years |
| HREC Amendment Request Forms | Research Services | Director, Research Services | 7 years |
| HREC Change to Personnel Request Forms | Research Services | Director, Research Services | 7 years |
| HREC Project Extension Request Forms | Research Services | Director, Research Services | 7 years |
| Annual Project Report Forms | Research Services | Director, Research Services | 7 years |
| Final Project Report Forms | Research Services | Director, Research Services | 7 years |
| Project Incident Report Forms | Research Services | Director, Research Services | 7 years |
| Misconduct Report Forms | Research Services | Director, Research Services | 7 years |
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