• Section 1 - Purpose
• Section 2 - Authority
• Section 3 - Scope
• Section 4 - Procedure
• Human Research Ethics at RMIT
• Gaining Human Research Ethics Approval at RMIT
• Registering or Transferring an External Human Research Ethics Approval
• Research with Aboriginal and Torres Strait Islander Peoples
• Ethics Review and Approval
• Maintaining Ethics Approval
• Reporting
• Adverse Events
• Monitoring of human research
• Withdrawal/Suspension of Ethics Approval
• Complaints
• Section 5 - Definitions

Section 1 - Purpose

(1) This procedure ensures that human research conducted at RMIT is ethical, responsible and consistent with relevant legislation, regulations, guidelines and institutional policies and procedures.

Section 2 - Authority

(2) Authority for this document is established by the Research Policy.

Section 3 - Scope

(3) This procedure applies to all staff, students, visiting researchers and honorary and adjunct appointees undertaking or supporting research across the RMIT Group and external research locations and all human research activities or projects conducted at or reasonably considered to be the responsibility of RMIT. Human research is defined broadly and includes research that involves people, and/or their data, and/or their biospecimens. RMIT recognises that some activities, such as quality assurance, evaluation, teaching and learning, and activities undertaken as part of work integrated learning and internships, fall outside this definition and that some human research activities are exempt from the requirement to gain and maintain ethics approval (see below).

Section 4 - Procedure

Human Research Ethics at RMIT

(4) Human research will only be undertaken at RMIT when conducted ethically and responsibly. All risks involved in human research will be assessed, minimised and managed to ensure that the welfare and interests of the participants, researchers and institutions are adequately protected throughout the research process.

(5) Appropriate ethics approval will be gained and maintained for all human research conducted at RMIT by RMIT staff, students, visiting researchers and honorary and adjunct appointees across the RMIT Group, with established human research ethics review pathways at RMIT as follows:

1. Exempt human research: with Human Research Ethics exemption applications at RMIT governance reviewed via the Research Ethics, Integrity and Governance (REIG) Team.
2. Lower risk research: with lower risk Human Research Ethics applications at RMIT ethics reviewed by the appropriate College Human Ethics Advisory Network (CHEAN).
3. Higher risk research: with higher risk Human Research Ethics applications at RMIT ethics reviewed by the RMIT University Human Research Ethics Committee (HREC).

(6) RMIT will provide professional development, resources, processes and infrastructure to support researchers’ understanding of human research ethics and the gaining and maintaining of human research ethics approval, as well as the ethical and responsible conduct of research in compliance with relevant legislation, regulations, guidelines and RMIT policy.

(7) RMIT Australia researchers must always adhere to the requirements of the National Statement, including when researching overseas. RMIT Europe and Vietnam researchers should adhere to the National Statement where possible, except where this would be inconsistent with applicable local laws, regulations, or ethics requirements. In these circumstances, researchers should meet the higher ethics standard and seek appropriate ethics or other reviews and approvals, as necessary.

(8) All human research ethics applications, including new applications, amendments, registrations, and reports are managed via the RMIT Research Ethics Platform (REP), with additional instructions, guidance and or/schedule of dates provided on the Researcher Portal.

(9) Researchers will not collect data, commence recruitment activities, or implement amendments without first receiving formal notification of ethics approval. Noting, some scoping and other pre-research planning activities may proceed prior to approval. If clarification is needed, contact the Research Ethics, Integrity and Governance team (REIG) and/or HREC or CHEAN.

Gaining Human Research Ethics Approval at RMIT

Risk Assessment

(10) Researchers will consider the risks and benefits of proposed human research and complete a risk assessment as part of any application for ethics approval before starting any research activities involving human participants. This risk assessment assists researchers to determine the level of risk (lower risk or higher risk) and the appropriate ethics review pathway. However, the final determination of risk level and review pathway rests with the relevant ethics review body (CHEAN or HREC), which may confirm or revise the researchers’ assessment, consistent with the risk assessment criteria outlined in the National Statement and as informed by other related legislation, regulations, guidelines, and institutional policies and procedures.

(11) In line with the National Statement, and recognising that risk in research exists on a continuum, the following categories and sub-categories of risk apply to human research activities and projects at RMIT:

1. Lower Risk
   1. Low: No risk of harm; risk of discomfort.
   2. Minimal: No risk of harm or discomfort; potential for minor burden or inconvenience.
2. Higher risk
   1. Greater than low risk: research presenting a risk of harm. The forms of harm include physical, psychological, social, cultural, economic, legal, or devaluation of personal worth.
   2. High: research presenting a significant risk of harm.

(12) Research that is lower risk, and which meets the National Statement requirements for exempt research, is exempt from the requirement to gain and maintain ethics approval. For any exempt human research activities or projects, researchers will submit an Exemption Assessment form via REP for governance review by the REIG Team, with the following outcomes possible:

1. Where the activity or project aligns to exemption criteria, it is confirmed as exempt from ethics review.
2. Where the activity or project does not align to the exemption criteria, it is confirmed as not exempt from ethics review and referred to the appropriate ethics review process.

(13) Where it is unclear whether the activity or project aligns with the exemption criteria, further information and/or clarification will be sought from the researchers. Records of Exemption Assessments and outcomes will be retained by the institution and should also be retained by the researchers.

Standard Applications

(14) Researchers will complete and submit the appropriate ethics application form, inclusive of Risk Assessment, in REP.

(15) The Principal Investigator on the application will be an RMIT staff member. For honours, postgraduate or higher degree by research (HDR) projects, the Supervisor will be named as Principal Investigator on the application form.

(16) All relevant supporting documentation intended for use in the conduct of a research project will be submitted with the ethics application form (uploaded to the e-form), including but not limited to:

1. Research protocols or project descriptions,
2. recruitment materials (i.e. advertisements, posters, flyers, brochures etc.),
3. participant information and consent form/s,
4. research instruments (i.e. questionnaire/s, survey/s, and/or proposed interview/focus group script/s or outlines),
5. Research Data Management Plan, and
6. other supporting documents or materials required as part of the ethics and governance processes.

(17) Submission dates for applications and meeting dates (as applicable) for the HREC and CHEANs are published on the Researcher Portal, with new applications generally reviewed in-session.

(18) All applications will be governance reviewed by REIG for completeness and compliance with governance requirements. Incomplete, insufficient and/or unauthorised applications will not be accepted for ethics review.  

(19) Relevant ethics training must be completed before applicants apply for ethics approval. Proof of completion may be requested.

Coursework or Lab Work Applications

(20) RMIT staff can apply for coursework or lab work human research ethics approval for common and clearly defined human research activities undertaken:

1. by multiple students in a coursework context (either undergraduate, postgraduate or vocational), or
2.  by multiple members (staff or students) in a lab work context.

(21) Coursework and lab work research ethics approvals will generally only be appropriate for lower risk human research activities. Where coursework or lab work related research activities are assessed as higher risk, the HREC will be consulted regarding the provision of human research ethics approval.

(22) Coursework applications will be prepared and submitted by the relevant Course Coordinator, convenor or person responsible for the conduct of the course or program. This person will be named as the Principal Investigator on the application form.

(23) Lab work applications will be prepared and submitted by the relevant Lab Group Leader responsible for the conduct of the related human research ethics activities. This person will be named as the Principal Investigator on the application form.

(24) The completed application form will be ethics reviewed by the relevant CHEAN, most closely aligned with the course or lab group, for review and approval.

(25) For coursework, this human research ethics approval covers all students enrolled in the relevant course or program to carry out the common and defined research activities for the designated approval period.

(26) For lab work, this human research ethics approval covers all students or staff named in the lab group to carry out the common and defined research activities for the designated approval period.

(27) Changes to Course Coordinators or Lab Group Leaders will require an amendment to the ethics approval.

(28) Data collected under a coursework or lab work approval may be used as part of research but will require a separate standard application (see ‘Standard Application’). If it is intended to use data in research, then the Course Coordinators/Lab Group Leaders must advise the student participants of this likelihood at the start of the course in writing.

Registering or Transferring an External Human Research Ethics Approval

(29) Where an RMIT staff member or student has ethics approval for a research project or activity from an external (non-RMIT) ethics review body, the REIG team and relevant HREC or CHEAN must be notified.

(30) RMIT will seek to avoid duplication of ethics review where possible and in line with the National Statement. Noting, RMIT will generally recognise and register human research ethics approvals issued by other NHMRC accredited ethics review bodies in Australia, with human research ethics approvals issued by other ethics review bodies outside Australia to be assessed on a case-by-case basis.

(31) Transfer of a previously approved application occurs when a staff (or student) researcher transfers their employment or enrolment to RMIT. The transfer arrangement moves ethics responsibility to the appropriate RMIT University ethics review body.

(32) Researchers will use REP to apply to register or transfer an externally approved project.

(33) Applications to register an externally approved project will include:

1. copies of the application and all associated documentation approved by the external committee
2. verification of the approval, including the terms and conditions.

(34) Applications to transfer an externally approved project will include:

1. copies of the application and supporting documentation approved by the external committee
2. verification of the approval, including the terms and conditions
3. revised copies of relevant documentation (e.g. Participant Information and Consent Forms) using RMIT templates or formats
4. copies of any progress or adverse event reports and/or requested and approved amendments
5. copies of any related correspondence, reports and amendments submitted via REP application
6. information on the status of any data that was collected under the external approval included current storage arrangements.

(35) Applications to register or transfer an approval will be governance reviewed by REIG before being considered by the HREC or CHEAN.

(36) As part of the governance review, the status of the external review body will be considered as follows:

1. Confirmation will be sought to establish the external committee’s registration and compliance with the NHMRC.
2. Where external review has been conducted by a non-Australian human research ethics committee or process, information will be sought on the committee and process of review and whether an appropriate level of review has been undertaken.

(37) Following governance review, the HREC or CHEAN will consider a recommendation to accept or not accept the review and approval of the external review body.

(38) In the case of transfers, a new review will be undertaken by the appropriate RMIT ethics review body where it is recommended not to accept the external review and approval.

(39) Where an RMIT staff member exits RMIT and takes up employment at another institution, any existing human research ethics approvals for which they are Principal Investigator, along with RMIT’s administrative responsibilities, will cease as of their departure date. In this circumstance and where the project will continue, there are two options:

1. where the staff member is transferring to another institution and will remain Principal Investigator, they will make advance arrangements for an appropriate ethics approval to be put in place at their new institution and which avoids any gap between approvals, or
2. where the staff member is transferring to another institution and they will not remain Principal Investigator, the Principal Investigator role will be transferred to another RMIT staff member. This transfer will be made by way of a Request for Amendment to change the Principal Investigator.

Research with Aboriginal and Torres Strait Islander Peoples

(40) Research involving Aboriginal and Torres Strait Islander peoples will be reviewed and approved by the appropriate ethics review body (HREC or CHEAN) informed by the risk level.

(41) Research with Aboriginal and Torres Strait Islander Peoples, is research which/for which:

1. is focused on a topic identified as being of specific benefit for or identified as a priority by Aboriginal and Torres Strait Islander people and communities and/or
2. involves a research cohort (either through targeted, likely/foreseeable or incidental recruitment) that has a significant proportion of Aboriginal and Torres Strait Islander people and/or
3. the geographic location or recruitment strategy of the research which will mean a significant number or proportion of the population is likely to be Aboriginal and Torres Strait Islander people and communities and/or
4. the data gathered in the research includes analysis that specifically identifies Aboriginal and Torres Strait Islander people and communities and/or
5. the research outcomes will have a specific impact on Aboriginal and Torres Strait Islander people and communities.

(42) Researchers and ethics review bodies will consider and apply the values and ethics guidelines contained in the National Statement, AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research 2020 (the AIATSIS Code) and A Guide to Applying the AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research 2020 (the AIATSIS Guide) and other relevant guidance documents, including:

1. Ethical conduct in research with Aboriginal and Torres Strait Islander peoples and communities: Guidelines for researchers and stakeholders NHMRC 2018, including the six core values of: Spirit and integrity, Cultural continuity, Equity, Reciprocity, Respect and Responsibility.
2. Keeping research on track II NHMRC 2018.

(43) Where HREC review is required, it will include advice from:

1. HRECs that have specialist expertise in reviewing ethics proposals for research with Aboriginal and Torres Strait Islander people and communities and/or
2. people who are culturally capable and competent, and aware of considerations specific to the Aboriginal and Torres Strait Islander people and communities with whom the research will be taking place to ensure cultural safety and/or
3. people with networks with Aboriginal and Torres Strait Islander people and communities and/or knowledge of research with Aboriginal and Torres Strait Islander people and communities.

Ethics Review and Approval

(44) The HREC or CHEAN will ethics review all applications for human research ethics at RMIT on behalf of the institution and in line with relevant codes, guidelines, legislation and RMIT policy and procedures, and with the ethics review focused on the ethical acceptability of the proposed research activities consistent with the core values and ethics guidelines outlined in the National Statement and other related legislation, regulations, guidelines and institutional policies and procedures.

(45) Potential outcomes of ethics review are:

1. Approved: the application is approved and data collection may commence subject to any conditions described in the outcome letter.
2. Revisions required: the application must be resubmitted for review after being revised in accordance with the concerns in the outcome letter.
3. Not approved: the application will not be approved, including in revised form.

(46) The HREC or CHEAN will inform the Principal Investigator of the outcome of the review in a timely manner.

(47) Applications will be approved for a maximum of three years, although extensions can be requested beyond the initial three-year approval period up to a maximum of five (5) years.

(48) Where revision is required, the applicant will resubmit their revised application, addressing the specific concerns outlined in their outcome letter via REP within six weeks. The revised application will be subject to the normal application pathway, closing dates, and governance review by the Ethics Coordinator of the HREC or CHEAN.

1. Where the HREC or CHEAN recommends that an application requires further revision, the applicants are requested to submit a further response and/or resubmit the application within six weeks.
2. If a response is not received within six weeks, the applicant will be advised that the application will be withdrawn from consideration. The applicant will have the opportunity to provide an explanation and/or request an extension of time within five (5) working days.
3. Explanations and/or requests for extensions of time will be considered by the relevant ethics review body Chair, who may approve or not approve such requests. The maximum period available for any revision and/or resubmission of an application is six months from the date at which the application was last ethics reviewed.

(49) The HREC or CHEAN may determine that compliance with the requirements of the National Statement cannot be achieved through further revisions to an application. Where this is the case, the applicant will be notified that the application is not approved.

(50) The HREC or CHEAN will be notified of any applications which have undergone ethics review but are later withdrawn from consideration.

Maintaining Ethics Approval

Amending a Human Research Ethics Approval

(51) Amendments are required where researchers plan to vary any aspect of their approved project. It is the responsibility of the Principal Investigator named on the project to request the amendment and receive approval prior to implementing any amendment.

(52) Amendments to a project in this context include, but are not limited to, amendments that (i) are proposed or undertaken in order to eliminate immediate risks to participants, and/or (ii) may increase the risks to participants, and/or (iii) significantly affect the conduct of the research or (iv) change the scope of the project. The below list is a non-exhaustive list of amendments

1. changes to any of the investigators (i.e. addition, removal or change of role), including the Principal Investigator, Primary Supervisor, or HDR candidate
2. an HDR candidate or student taking a leave of absence from their program
3. request for extension of the ethics approval
4. changes to participant population, recruitment methods, or consent process
5. changes to research methodology, sites/location, or data management.

(53) Researchers will gain approval for an amendment prior to implementing the change.

(54) Researchers will seek approval for an amendment to extend ethics approval before the approval period has expired. Research activities that require ethics approval will not continue when such approval has expired.

(55) For amendments to projects approved by an RMIT ethics review body:

1. The Principal Investigator must submit an application for an amendment. Applications which fail to meet applicable submission dates will be held over to a future meeting.
2. Requested amendments to an approved project will not be implemented by the Principal Investigator until the request is approved by the relevant CHEAN or HREC.
3. The CHEAN or HREC Executive may review and approve amendments out–of-session. During the review they may seek additional advice from the Principal Investigator. Any amendments approved out–of-session will be ratified at the next regular CHEAN or HREC meeting.

(56) For amendments to projects approved externally, the Principal Investigator will submit an application for an amendment in line with the requirements of the external ethics review body that approved the project.

Reporting

(57) In accordance with monitoring requirements of the National Statement, the Principal Investigator will submit an Annual Report outlining: the progress to date; management, maintenance and security of research data and records; any adverse events or other issues with ethics considerations; compliance with the approved protocol; and compliance with any conditions of the ethics approval for the reporting period.

(58) The annual report will be submitted on the anniversary date of approval for the life of the project or program (regardless of the duration of human research ethics approval). The Principal Investigator is responsible for providing timely progress reports.

(59) Ongoing approval of a project is conditional upon the timely submission of annual reports.

(60) In the final year of ethics approval, the Principal Investigator will submit a final report within six months of the end of the approval period.

(61) The final report will include a summary statement of the outcomes of the project or activities and should also outline any publications (either submitted or in progress) and any further avenues of research resulting from the project or activities. Final reports will be submitted within six months of the end of the approval of the project or as soon as possible after a research project has concluded.

(62) Annual and/or Final Reports are required even where an approved project has not yet commenced or has been abandoned.

(63) The HREC/CHEAN may decide not to review new applications from a Principal Investigator whilst annual and final reports for previous projects remain outstanding.

Adverse Events

(64) Any adverse event must be reported promptly by the Principal Investigator to the approving ethics review body at RMIT (HREC/CHEAN) within 24 hours of it being identified or coming to the attention of the researcher/s, via REP.

(65) Adverse events will be ethics reviewed by the relevant HREC/CHEAN with support from REIG.

(66) The Principal Investigator, line manager and any other appropriate persons/bodies will be notified of the outcome of this review, including any related findings and/or recommendations.

Monitoring of human research

(67) Monitoring of ethically approved research is a requirement under the National Statement, with monitoring responsibilities shared between researchers, institutions, ethics review bodies and sponsors and extending across the research lifecycle.

(68) Monitoring requirements for individual projects will be commensurate with the risk, size, and complexity of the research being conducted. However, at a minimum, all RMIT projects will be monitored via governance review, annual progress reporting, and final reporting.

(69) In accordance with the National Statement, researchers are responsible for providing annual reports, including:

1. reports from researchers
2. reports from independent agencies
3. review of adverse events
4. audits or inspections of research sites, data, or documentation
5. interviews with research participants or other forms of feedback.

(70) The HREC/CHEAN may request an audit of research projects with human research ethics approval. Results of any audits will be reported back to the relevant HREC or CHEAN.

(71) The HREC/CHEAN may withdraw approval for any project, before or after an audit, when they have reason to believe that the continuation of the research project would compromise the welfare of participants, researchers or others.

(72) Where a HREC/CHEAN withdraws approval for a project, the HREC/CHEAN will notify the researcher/s, as well as the relevant line manager and/or Head of school/college/centre, and may also notify other parties, including participants, as possible and appropriate.

(73) Where the HREC/CHEAN considers that urgent suspension of approval for a research project is necessary before the complaints process described in this procedure is undertaken, they may stop the research.

(74) In reviewing cases of non-compliance or situations in which participant welfare has been compromised, the HREC/CHEAN may refer the matter to the institution (the Designated Person at RMIT), for consideration under the Research Integrity Breach Management Procedure.

Withdrawal/Suspension of Ethics Approval

(75) In accordance with National Statement, the HREC or CHEAN may withdraw approval for any project (before or after an audit) when they have reason to believe that the continuation of the research project would compromise the welfare of participants, researchers, or others.

(76) Where a HREC/CHEAN withdraws approval for a project, they will notify the researcher/s, as well as the relevant line manager and/or Head of school/college/centre, and may also notify other parties, including participants, as appropriate and where possible.

(77) Where the HREC/CHEAN considers that urgent suspension of approval for a research project is necessary before the complaints process is undertaken, they will suspend approval.

(78) In reviewing cases of non-compliance or situations in which participant welfare has been compromised, the HREC/CHEAN may refer the matter to the institution (the Designated Person at RMIT), for consideration under the Research Integrity Breach Management Procedure.

Complaints

(79) Staff, students, members of the public, or any other concerned persons may make a complaint concerning human research projects or activities at RMIT.

Complaints about an RMIT Human Research Project

(80) The complaint will be submitted in writing to REIG via email ( humanethics@rmit.edu.au), who will acknowledge receipt of the complaint and inform the Chair of the HREC or CHEAN, the Senior Manager, Ethics Integrity and Governance and others as appropriate.

(81) Where there is an apparent ongoing impact to a participant’s welfare extending beyond those described in the approved ethics application, the institution may require that researchers cease activities, and the HREC or CHEAN may suspend or withdraw approval as follows:

1. Where the complaint relates to activities that would normally require HREC or CHEAN ethics approval, the complaint will be considered by the Senior Manager, Ethics Integrity and Governance, and the Chair of the relevant HREC/CHEAN, who will determine the level of investigation required in accordance with the National Statement. Where further investigation is called for, REIG will undertake investigation via additional monitoring mechanisms as outlined in this procedure, and prepare a report for the relevant HREC/CHEAN.
2. The report will detail the investigation and any findings and recommendations for further action.
3. The HREC/CHEAN will decide on any required actions and inform the relevant parties of these.
4. Where investigation finds that the complaint involves a breach of the National Statement, the working party will work with the relevant CHEAN and/or school/college/centre to avoid a recurrence.
5. Where the review or investigation finds that the breach of the National Statement may also represent a breach of the Australian Code or research misconduct, the working party will refer it to the Designated Officer who will handle it in line with the Research Integrity Breach Management Procedure.
6. Where the review or investigation determines the complaint to be unfounded or unsupported, the HREC Chair will dismiss the complaint and the reason/s for dismissal will be provided to the complainant and to the HREC/CHEAN.
7. Where the review or investigation finds that the complaint should be managed under other institutional pathways, as established in the RMIT Complaints Framework, the HREC/CHEAN Chair will refer it on as appropriate.

Complaints Regarding the Conduct of the HREC or CHEAN

(82) Where appropriate and possible, the complainant and the HREC or CHEAN shall engage in dialogue to resolve the complaint. Noting, complaints regarding the conduct of staff as established by the RMIT Code of Conduct will be referred to the Central Complaints and Investigation team.

(83) Where the complaint cannot be readily resolved by communication between the complainant and the HREC or CHEAN, the complaint may be submitted to the Director, Research Services in writing.

(84) Following receipt of a complaint, the Director, Research Services or nominee shall seek further information from the relevant HREC/CHEAN Chair, REIG, and relevant staff as necessary to establish the veracity of the complaint, and whether any RMIT policies or processes have been compromised.

(85) The Director, Research Services or nominee will provide a report to the relevant committee and the complainant on the outcome of the investigation of the complaint, and include a recommendation for any further actions.

(86) The Director, Research Services or nominee may choose to refer the complaint to an independent assessor if deemed appropriate.

(87) As per the National Statement, researchers cannot appeal an ethics review body’s decision to reject an application.

(88) A summary of complaints will be included in the HREC quarterly report to the Research Committee.

Section 5 - Definitions