Human research ethics policy process

Purpose

To ensure that human research at RMIT is ethical, responsible and consistent with institutional policy, legislation and guidelines.

Scope

This process includes all human research that is reasonably considered the responsibility of RMIT.

It excludes activities not considered human research, or exempt from ethical review according to the National Statement, such as quality assurance activities, and some work integrated learning and internships.

Process steps

1. Human research ethics at RMIT

1.1. Research that involves people, their data and/or bio-specimens will only be undertaken where it is ethical and conducted responsibly. All risks involved in research will be minimised and managed to ensure that the interests of the participants, researchers and institutions are adequately protected throughout the research process.

1.2. All human research at RMIT involving people, their data and/or bio-specimens requires prior ethics review and approval according to the steps outlined in this process.

1.3. RMIT provides professional development, resources, processes and infrastructure that inform researchers about gaining and maintaining ethics approval, and conducting research that complies with relevant codes, legislation and RMIT policy.

1.4. In Australia, RMIT researchers will remain compliant with the National Statement at all times, including when at other institutions. While outside Australia, RMIT staff members will remain compliant with the National Statement where possible. For advice on compliance for research outside Australia, contact the RMIT HREC.

2. Gaining human research ethics approval at RMIT

2.1. Risk assessment:

2.1.1. Researchers will complete a risk assessment before applying for ethics approval and before starting any research activities involving human participants. The risk assessment is contained in the RMIT Human Research Ethics application form and will assist researchers in determining the level of risk.

2.1.2. In line with the National Statement, human research is categorised by the level of risk. There are four categories:

    a) Exempt from review (research involving secondary analysis of non-identifiable data);

    b) Negligible risk (research in which there is no foreseeable risk of harm or discomfort);

    c) Low risk (research in which the only foreseeable risk is one of discomfort);

    d) More than low risk (research that may lead to harm, including physical harm, anxiety, pain, psychological disturbance, devaluation of personal worth and social disadvantage).

2.1.3. Projects that are exempt from review will not require ethics review and/or approval by a CHEAN/VREC or HREC. However, researchers will retain evidence that they have assessed their research project as exempt from review i.e. keep a copy of the completed RMIT human research ethics risk assessment.

2.1.4. Submit ethics applications for research projects that are negligible or low risk to the College Human Ethics Advisory Network (CHEAN) most closely aligned with the area of research, or to the Vietnam Research Ethics Committee (VREC) where the researchers are based at RMIT Vietnam.

2.1.5. Submit ethics applications for research activities that are more than low risk to the RMIT HREC.

2.1.6. A CHEAN/VREC or HREC, or CHEAN/VREC or HREC Chairperson, and/or research governance staff may recommend a new risk assessment where they determine that the original assessment is inappropriate.

2.2. Application:

2.2.1. The Chief Investigator will complete the appropriate ethics application form and submit it to the appropriate ethics committee, using the forms and instructions provided on the RMIT website and in this process.

2.2.2. For honours, postgraduate or higher degrees by research (HDR) projects, the Supervisor will be named as Chief Investigator/Senior Supervisor on the application form.

2.2.3. Relevant accompanying and supporting documentation will be submitted with the ethics application form including copies, if applicable, of:

    a) Recruitment materials (advertisements, posters, flyers, brochures etc.);

    b) Participant information and consent form;

    c) Research instruments (questionnaire(s), survey/s and/or proposed interview/focus group outline;

    d) Other material required as part of the application process.

2.2.4. Submission dates for applications and meeting dates for RMIT Australia ethics committees will be published on the RMIT website. Submission dates for applications and meeting dates for RMIT Vietnam VREC will be published on the RMIT Vietnam Research Office website. Applications that do not meet relevant submission dates or other governance requirements will be held over to a following meeting.

2.2.5. All applications will be vetted by research governance and/or other appropriate administrative staff for completeness and compliance with governance requirements. Incomplete, insufficient and/or unauthorised applications will not be accepted for review;

2.2.6. Relevant ethics training will be completed before applicants apply for ethics approval.

2.3. Coursework research activities:

2.3.1. RMIT staff can apply for coursework human ethics approval for common and clearly defined human research activities that are being undertaken by multiple students in a coursework context (either undergraduate, postgraduate or vocational).

2.3.2. Coursework research ethics approvals apply to only negligible or low risk human research. If the coursework or programme-related research activities are assessed as more than low risk then the applicant will consult the HREC regarding the provision of coursework human ethics approval.

2.3.3. Coursework applications will be prepared and submitted by the relevant Course Co-ordinator, convenor or person responsible for the conduct of the course or programme. This person will be named as the Chief Investigator on the coursework human ethics application form.

2.3.4. Submit coursework human ethics applications to the relevant CHEAN or VREC, most closely aligned with the course, for review and approval.

2.3.5. A coursework human ethics approval covers all students enrolled in the relevant course or programme, to carry out the common and defined research activities for the designated approval period.

2.4. Externally approved human research ethics:

2.4.1. Where an RMIT staff member or student has an external approval for a research project the relevant RMIT HREC or CHEAN/VREC will be notified.

2.4.2. The RMIT researcher will submit the notification according to the directions on the website of the relevant RMIT HREC or CHEAN/VREC.

2.4.3. Following submission of a notification, a formal acknowledgement will be issued to the researcher by the relevant RMIT HREC or CHEAN/VREC.

2.5. Multi-centre research and minimising duplication of review:

2.5.1. RMIT University seeks to avoid duplication of ethics review, in line with the National Statement.

2.5.2. RMIT University accepts human research ethics approvals from HRECs registered with the NHMRC, and accepts multi-centre research proposals where RMIT University researchers are involved, but the Chief Investigator is from another institution. All such projects will be registered with the respective HREC or CHEAN/VREC (see section 2.4).

2.6. Aboriginal and Torres Strait Islander research:

2.6.1. Research involving Aboriginal and Torres Strait Islander Peoples will be reviewed and approved by the RMIT HREC.

2.6.2. In determining whether research involves Aboriginal and Torres Strait Islander Peoples consider:

    a) the scope of the project; and/or

    b) the demographics of participants; and/or

    c) the research topic, social phenomena and/or the illness or health burden being studied; and/or

    d) their historical, social and cultural context and connections.

2.6.3. Researchers and ethics review bodies will consider and apply the values and ethics guidelines contained in the National Statement and other relevant guidance documents (such as the Guidelines for Ethical Research in Indigenous Studies [AITSIS] and Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research [NHRMC] and Keeping research on track: A guide for Aboriginal and Torres Strait Islander peoples about health research ethics [NHMRC]), including the six core values of: reciprocity; respect; equality; responsibility; survival and protection; and spirit and integrity.

2.6.4. HREC review of research involving Aboriginal and Torres Strait Islander Peoples will include assessment by and/or advice from:

    a) People who have networks with Aboriginal and Torres Strait Islander Peoples and/or knowledge of research Aboriginal and Torres Strait Islander Peoples; and

    b) People familiar with the culture and practices of the Aboriginal and Torres Strait Islander Peoples with whom participation in the research will be discussed.

2.6.5. For further advice, consult the Research Ethics Coordinator.

2.7. Researchers will not collect data or commence recruitment activities without first receiving formal notification of ethics approval. Scoping and other pre-research planning activities may proceed prior to approval.

3. Ethics review and approval

3.1. The HREC and CHEAN/VREC will 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 processes.

3.2. The HREC or CHEAN/VREC will inform the Chief Investigator of the outcome of the review in a timely manner.

3.3. Applications will be approved for a minimum of six months and for a maximum of three years, although extensions can be requested for beyond the initial three year approval period up to a maximum of 5 years.

4. Amendment to an approved application

4.1. Amendments are required where researchers plan to vary any aspect of their approved project, including changes to the Chief Investigator or other investigators (including student investigators taking a leave of absence from their program), participants, recruitment methods, research methods, research sites/locations, or an extension of approval.

4.2. Researchers will gain approval for an amendment prior to implementing the change.

4.3. 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.

4.4. For amendments to projects approved by an RMIT ethics review body:

4.4.1. The Chief Investigator will submit an application for an amendment electronically, in line with the forms and any applicable instructions and/or schedule of dates provided on the HREC or relevant CHEAN or VREC website. Applications which fail to meet any applicable submission dates will be held over to a future meeting

4.4.2. Requested amendments to an approved project will not be implemented by the Chief Investigator until the request is approved by the relevant CHEAN/VREC or HREC.

4.4.3. The CHEAN/VREC or HREC Executive may review and approve amendments out-of-session. During the review they may seek additional advice from the Chief Investigator. Any amendments approved out-of-session will be ratified at the next regular CHEAN/VREC or HREC meeting.

4.5. For amendments to projects approved externally:

4.5.1. The Chief Investigator will submit an application for an amendment electronically, in line with the requirements of the external ethics committee that approved the project.

4.5.2. Requested amendments to an approved project will not be implemented by the Chief Investigator until the request is approved by the relevant external ethics committee.

4.5.3. Once approved the Chief Investigator will forward a copy of the amendment and the approval to the relevant RMIT CHEAN/VREC or HREC for noting.

5. Reporting

5.1. The Chief Investigator will submit an annual report by the anniversary date of ethics approval for the duration of approval period.

5.2. The annual reports will detail the project progress over the past 12 months including any progress made towards the objectives of the study and any adverse events or incidents over the reporting period.

5.3. Ongoing approval of a project is conditional upon the submission of annual reports.

5.4. In the final year, the Chief Investigator will submit a final report within six months of the end of the approval period.

5.5. The final report will provide a conclusion statement of the outcomes of the project, and outline any publications (either submitted or in progress) resulting from the project. Final reports must be submitted within six months of the end of the approval of the project and/or as soon as possible after a research project has concluded.

5.6. Annual and final reports will be submitted using the RMIT HREC/CHEAN/VREC approved forms, and the instructions, provided on the RMIT website.

5.7. Reports are still required even where an approved project has not commenced or has been abandoned.

5.8. The HREC/CHEAN/VREC may decide not to review new applications from a Chief Investigator, whilst annual and final reports for previous projects remain outstanding.

6. Adverse events

6.1. Any adverse event will be reported promptly by the Chief Investigator to the Secretary of the HREC/CHEAN/VREC which approved the original application within 24 hours of it being identified or coming to the attention of the researcher/s. Notifications can be submitted in writing or in person, via phone, letter or email.

6.2. Following notification, researchers will be issued an Adverse Event Report Form to complete, which will include details of the incident and any action taken or that will be taken. Complete this form and return it to the HREC/CHEAN/VREC Secretary.

6.3. When notified about an adverse event the HREC/CHEAN/VREC Secretary will advise the HREC Chairperson immediately and report it to the next HREC meeting.

6.4. The Chairperson reviews the adverse event report form, and provides a report to the HREC detailing the event, and any findings and recommendations. The HREC will notify the Chief Investigator, line manager and any other appropriate persons/bodies, as required. Where a response is time critical the Chairperson may provide a response and recommendations direct to the Chief Investigator, and report to the HREC at a later date.

7. Monitoring and withdrawal of approval

7.1. Monitoring and auditing ethically approved research is the responsibility of the institution.

7.2. As per the National Statement guidelines monitoring is conducted through various mechanisms including:

7.2.1. Reports from researchers;

7.2.2. Reports from independent agencies;

7.2.3. Review of adverse events;

7.2.4. Random inspections of research sites, data, or documentation;

7.2.5. Interviews with research participants or other forms of feedback.

7.3. The HREC/CHEAN/VREC may request an audit of research projects that have human research ethics approval. Results of any audits will be reported back to the relevant HREC or CHEAN/VREC.

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

7.5. Where a HREC/CHEAN/VREC withdraws approval for a project, the HREC/CHEAN/VREC 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.

7.6. Where the HREC/CHEAN/VREC considers that urgent suspension of approval for a research project/s is necessary before the complaints process described in Section 8 is undertaken, they may stop the research.

7.7. In reviewing cases of non-compliance or situations in which participant welfare has been compromised, the HREC/CHEAN/VREC may refer the matter to the institution (the Designated Person at RMIT), for consideration under the Research misconduct policy process.

8. Complaints

8.1. Complaints about an RMIT human research project:

8.1.1. The complaint will be forwarded to the HREC Secretary.

8.1.2. The HREC Secretary will acknowledge receipt of the complaint and inform the HREC Chairperson and the Research Office.

8.1.3. The HREC Chairperson will dismiss the complaint or refer it onto the appropriate institutional process (this includes the Research misconduct policy process) or form a working party to investigate the complaint and report to the HREC.

8.1.4. The working party will consist of the Chairperson (or delegate) and two members of the committee, and may include others. Where the complaint relates to a project approved by a CHEAN or VREC, the relevant CHEAN or VREC Chairperson (or delegate) will join the working party.

8.1.5. The report will detail the investigation and any findings and recommendations for further action.

8.1.6. The HREC decides on any required actions and informs the relevant parties.

8.1.7. Where investigation finds that the complaint involves a breach of the National Statement, the working party will work with the relevant CHEAN/VREC and/or School/College/Centre to avoid a recurrence.

8.1.8. Where the 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 Person who will handle it in line with the RMIT Research misconduct policy process.

8.1.9. Where the working party or the HREC Chairperson dismisses a complaint, they will provide reasons for dismissal to the complainant and to the HREC.

8.1.10. Where the working party or the HREC Chairperson finds that the complaint should be dealt with under other institutional provisions they will refer it on as appropriate.

8.2. Complaints regarding the conduct of the HREC, CHEAN or VREC:

8.2.1. Where the complaint cannot be readily resolved by communication between the complainant and the review body, the complaint may be submitted to the Director of Research Integrity, Governance and Systems in writing or may be made in line with RMIT University’s established Complaints process for staff and students.

8.2.2. Following receipt of a complaint, the Director of Research Integrity or nominee shall seek further information from the relevant HREC/CHEAN/VREC Chairperson, and other staff as necessary to establish the veracity of the complaint, and whether any RMIT policies or processes have been compromised.

8.2.3. The Director 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.

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

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