(1) This Procedure is effective from 19 August 2024. (2) This Procedure sets out how the University ensures that all research involving human research participants, or their data or tissue is ethically designed, reviewed, and conducted. (3) This Procedure applies to all persons conducting University business who intend to conduct or review human research, including: (4) This Procedure is pursuant to the Research Conduct Policy. (5) Deakin upholds the principles of the National Statement on Ethical Conduct in Human Research (the National Statement) which help to shape a relationship of trust, mutual responsibility and ethical equality between researchers and participants. These principles are: (6) Deakin staff, students and external associates and visitors who intend to conduct human research must comply with the National Statement, all other relevant national guidelines, Commonwealth, State, and international Statutory Regulations and, where applicable, with any other specialised ethics guidelines and codes of practice. (7) Deakin staff and students who intend to conduct human research must undertake education and training and demonstrate their competency in accordance with Deakin’s human research ethics training requirements. (8) Deakin staff and students who intend to conduct human research must obtain ethics approval or an exemption from ethics approval at Deakin as outlined in this Procedure. No human research may commence, nor approved research be modified, without ethics approval or confirmation of exemption from ethics review. (9) Deakin staff and students who intend to conduct the research above must follow the approved processes and timelines and submit the appropriate forms described on the human research ethics website via ResearchPoint. (10) Under the authority of the Deputy Vice-Chancellor Research and Innovation, Deakin’s Human Research Ethics Committee (DUHREC) has been established and is constituted in accordance with the DUHREC Terms of Reference, responsible for ensuring human research complies with the National Statement and is ethically acceptable. (11) DUHREC is responsible for reviewing all higher risk human research and all human research involving: (12) Deakin staff and students who intend to conduct research described in clause 11 must submit an ethics application via ResearchPoint. (13) Deakin staff and students who intend to conduct research described in clause 11d will, in addition to the instruments described in clause 2, undertake consultation with Aboriginal and/or Torres Strait Islander communities prior to designing their projects as such consultation should inform project design. They should also consider and apply the values and ethics guidelines contained in: (14) Deakin has established Human Ethics Advisory Groups (HEAGs) which are responsible for the ethical review of lower risk human research projects in accordance with the National Statement and the HEAG Terms of Reference. (15) Deakin staff or students who intend to conduct lower risk human research must submit an ethics application via ResearchPoint to the HEAG. (16) Research may be eligible for an exemption from ethics review where it carries a lower risk to participants or the community and satisfies one or more conditions of the National Statement 5.1.17. (17) Deakin staff or students who intend to conduct human research that is eligible for exemption from ethics review must submit an application for exemption via ResearchPoint. Such research must not commence until formal acknowledgement of exemption is received. If the project receives such acknowledgement i.e. it meets National Statement 5.1.17a-d, the researchers will have four years to conduct their project. If the project project does not meet the eligibility criteria for exemption as per National Statement 5.1.17 a-d, a new ethics application will be required. (18) Deakin staff or students who have obtained approval to conduct research from the Human Research Ethics Committee (HREC) of another Australian institution, must submit an application via ResearchPoint to register the project. Work must not commence until notification from Deakin is received. (19) Prior to commencing human research projects that involve any Deakin staff or students and will be conducted in a country other than Australia (by any member of the research team including collaborators) must: (20) Applications to modify approved human research must be submitted to the Deakin ethics review body that approved the project originally i.e. DUHREC or a HEAG. (21) An application to modify a project must be submitted to DUHREC, even if a HEAG approved the original application, if the modification: (22) A project must not be modified until approval is obtained from DUHREC or a HEAG, or the external Australian HREC that has ethical oversight for the project (i.e. previously approved projects), has provided approval for the change. (23) An annual report must be submitted via ResearchPoint for each human research project approved by Deakin for noting or action as appropriate. (24) Annual Reports are not required for: (25) A final report must be submitted via ResearchPoint: (26) Quality assurance (QA), evaluation and research exist on a continuum of activity. In all cases, the activity must be conducted in a way that is ethical as described in Ethical Considerations in Quality Assurance and Evaluation Activities (2014). Such projects may be eligible for an exemption from ethics review as per National Statement 5.1.17 and may therefore be submitted via the Exemption for Ethics Review form in ResearchPoint as per clause 16. However, ethics approval may be required in some instances, depending on the nature of the ethical issues involved. (27) Where ethics approval is required, an application must be submitted to DUHREC or a HEAG via ResearchPoint. (28) Researchers are responsible for taking immediate action to ensure the welfare of participant/s who experience adverse events, incidents or reactions. The principal investigator should be contacted by research team members to assist in assessing and determining the immediate actions required. (29) As soon as practical after the participant/s immediate welfare needs and any other risks are addressed, the researchers must notify Research Ethics and Integrity. (30) Where the research is a clinical trial, only serious adverse events, incidents, or reactions caused by the research must be reported to Research Ethics and Integrity. (31) Clinical trials involving therapeutic goods must adhere to the specific safety monitoring and reporting requirements of the NHMRC Guidance Safety reporting and monitoring in clinical trials involving therapeutic goods. (32) Upon receipt of a notification, DUHREC may immediately suspend ethics approval for the research where there is reason to believe that the continuance of the project will compromise the participant welfare. (33) The principal investigator must promptly complete an Adverse Event Form and submit the report, via ResearchPoint. (34) DUHREC will review the Adverse Event Form and may determine additional actions for the project. Actions may include but are not limited to: (35) DUHREC will notify the principal investigator of the outcome and any recommended actions. (36) Where ethics approval for a research project has been withdrawn: (37) Allegations of research integrity breaches will be managed in accordance with the Deakin Human Research Ethics Breach process and the Research Integrity Breaches Procedure. (38) As per Deakin’s website, researchers can put forward an alternative view on the outcome of their ethics application, making reference to the National Statement principles and any other relevant guidelines. If the researcher is unsatisfied with the final decision of either DUHREC or a HEAG, the researcher can make a formal complaint to the Pro Vice-Chancellor Research Planning and Governance. The Pro Vice-Chancellor Research Planning and Governance will review the complaint and provide the complainant with written notification of the resolution of the matter and reason(s) for the decision. (39) If a complainant remains dissatisfied with the resolution of their complaint about a decision made by DUHREC or the HEAG, they may make a further complaint to the Victorian Ombudsman. (40) Complaints about the conduct of a Deakin human research project may be made in writing by a research participant or any other interested party to Research Ethics and Integrity as per the Human Research Ethics public webpage. (41) Complaints will be managed in accordance with the complaints handling process published on Deakin’s Human Research Ethics public webpage. (42) Organisational consent for research involving Deakin University staff and students as participants must be obtained prior to seeking human research ethics approval. Approval will only be given where staff and student participation is appropriate and necessary for the research and other options are not available. Such research will minimise the number of Deakin University staff and students involved. Where the research is by an external party it must also be of benefit to the University and relevant results provided to the staff or students involved. (43) Organisational consent must be obtained from one of the following: (44) Where the proposed research is changed as a result of the ethics approval process, approval for any amendments affecting staff or student experience, including the plain language statement and consent form, must be reconfirmed by the responsible person/s in clause 43. (45) Where more than 200 students are to be surveyed, researcher(s) will also consult with Institutional Research and Surveys prior to scheduling the research. While consultation with Institutional Research and Surveys may occur prior to or after ethics approval is obtained, the research may not be scheduled until after ethics approval is provided. (46) Researchers who conscientiously object to being involved in conducting research with human embryos, foetuses, embryonic or foetal tissue will not be obliged to participate in such research, nor will they be put at a disadvantage because of their objection. (47) For the purpose of this procedure:Human Research Ethics Procedure
Section 1 - Preamble
Section 2 - Purpose
Section 3 - Scope
Top of PageSection 4 - Policy
Top of PageSection 5 - Procedure
Human research ethics
Deakin University Human Research Ethics Committee (DUHREC)
Human Ethics Advisory Groups (HEAGs)
Exemption from ethics review
Previous approval from external ethics committees within Australia
Human research projects conducted in a country other than Australia
Modifying an approved project
Annual and final reporting
Quality assurance or evaluation activities
Adverse events, incidents, or reactions
Allegations of research integrity breaches
Complaints concerning DUHREC or HEAG processes or decisions
Complaints concerning a Deakin human research project
Organisational consent
Conscientious objection
Section 6 - Definitions
Which has a possible, probable or definite causal relationship with the research project.
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