Research Integrity and Compliance

Applying for Human Research Ethics Procedure

Policy Code: RS1922

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
Conditions of Approval
Reporting and Monitoring
Complaints and Appeals Procedure
Supporting Documents
Responsibility
Promulgation
Implementation
Forms/Record Keeping

Purpose

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.

Scope

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.

Legislative Context

National Statement on Ethical Conduct in Human Research (2007) incorporating all updates

Australian Code for the Responsible Conduct of Research

Definitions

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.
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.
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.

Actions

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.

HREC Standard and Expedited Application Process

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:

  • Plain Language Information Statement (PLIS)
  • Consent form
  • Recruitment advertisements
  • Data-gathering instruments e.g. survey
  • Interview schedules
  • Debriefing material
  • Evidence of approval from external agencies or other HRECs
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:

  • Principal Researcher
  • Research Team
  • Head of School
  • Deputy Head of School
  • Associate Dean of Research
  • Faculty Ethics Coordinator

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 hard copy of the application, including all attachments, to Research Services for presentation at the relevantHREC meeting: either Sub-Committee (expedited applications only) or Full Committee meeting (standard or expedited applications).

Email the application, including all attachments, (in word.doc format or pdf format) to  research.ethics@federation.edu.au by the required 'agenda items due' date.

Late submissions will be carried overto 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.

HREC Standard Bulk Application Process

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:

  • Lay description – incorporate all projects in the application in lay terms which are easy to understand.
  • Research Aims & Significance – incorporate all projects aims and significance in the application. Outline the point of the projects and their research significance.
  • Methodology – methods of all the methodology (you may have different ones listed separately in the methodology). Descriptions of what they are, example questions may be added.
  • Recruitment – generic description for recruitment incorporating all projects recruitment methods.
  • Risk – include risk management plans in place for all projects. Counselling services contact details for participants in the Plain Language Information Statements (PLIS).
Attach copies of any required supplementary documentation  The researchers involved with the project

Examples of documentation that may be required:

  • Plain Language Information Statement – sample PLIS for each methodology type in the application.
  • Consent form – sample of participant consent form for each methodology type in the application.
  • Permission request letter to School Principal – sample of letter to School Principal requesting permission to conduct research.
  • Recruitment advertisements – sample of recruitment advertisements (if any).
  • Survey/Interview questions – sample of questions for the projects.
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:

  • Researcher/s name and details.
  • Project title.
  • Information on which methodology method in bulk application will be used.
Attach copies of any required supplementary documentation  The researchers involved with the project

Documentation to be submitted:

  • PLIS – Matching methodology method chosen.
  • Consent form for participants to sign (if applicable) – Matching methodology method chosen.
  • External permissions – letter from Principal of Schools on official letterhead giving permission for research.
  • Survey/interview questions for project. 
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.

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 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.

HREC Request for Approval to use Existing Data Application Process

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:

  • Principal Researcher
  • Research Team
  • Head of School
  • Deputy Head of School
  • Associate Dean of Research
  • Faculty Ethics Cooridinator
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 ofOutcome Research Services Research Serviceswill contact the PrincipalResearcher advisingof the outcome of the meeting.

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

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

Federation University Australia Human ResearchEthics Committee recognises approvals from other Australian Human Research Ethics Committees and may endorse such approval in certain circumstances, such aswhen a researcher isinvolved in a collaborative project hosted by anotherinstitution. 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 projectsapproved 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.

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

  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.

Outcomes

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.

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 approvaland/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.

Reporting and Monitoring

Auditing
Suspension or Discontinuation of Research

The National Statement requires Human Research Ethics Committees (HREC) to monitor researchprojects for which they have given ethical approvalin order to ensure that they conform to the protocol approved.

The principalreason for monitoring research projects is to ensure that their conduct is not jeopardising the rights and interestsof 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:

  • 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 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 Principal Researcher submits a final report on 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 researchon participants which may have occurred;
  • any steps taken to deal with these;
  • changes in the researchprotocol;
  • any other problems relating to the conduct of the project.

Failure to completeand return a final report by the due date may lead to suspension or withdrawal ofethics approval.

Auditing

In line with the NationalStatement, theHREC has determined that all approved projects are subject to auditingas per the detailsoutlined in the National Statement.

Suspension or Discontinuation of Research

Where the Chair of the HREC issatisfied that circumstances have arisen such that a researchproject is not being or cannot be conductedin accordance with the approvedprotocol, including any conditions of approval, the HREC may withdraw approval and recommend that the researchproject be discontinued, suspended or that other necessaryaction be taken.

A researcher must not continue the researchif ethical approval has been withdrawn and must complywith any special conditions required by the HREC.

Complaints and Appeals Procedure

Complaints related to the ethical aspects of research
Complaints concerning ethics administration and committee decisions

Complaints related to the ethical aspects of research

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.

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 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.

Supporting Documents

  • Ethical Conduct of Research Policy
  • Research Integrity Policy
  • HREC Risk Assessment  Checklist
  • Appliaction 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

Responsibility

Researchers must ensure that:

  • no research is conducted which has not received approval by the HREC;
  • all relevant information hasbeen 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 approvedprojects;
  • 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 Human Research Ethics Procedure will be communicated throughout the University 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; and/or
  3. distribution of e-mails to Head of School / Head of Department / University staff; and/or
  4. documentation distribution, eg. posters, brochures.
  5. Other - please describe

Implementation

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

  1. Information Sessions; and/or
  2. Training Sessions; and/or
  3. Other - please describe

Forms/Record Keeping

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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Approval Authority: Deputy Vice-Chancellor (Research & Innovation) Original Issue 25/11/2015
Policy Sponsor: Director, Research Services Current Version: 25/11/2015
CRICOS Provider Number 00103D Review Date: 25/11/2020
Policy Code RS1922