(1) This Procedure is effective from 25 July 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 that intend to conduct 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 (2007 – updated 2018) (the National Statement) which help to shape a relationship of trust, mutual responsibility and ethical equality between researchers and participants. They 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, or commence following modification, without ethics approval or an exemption. (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 will establish a Deakin University Human Research Ethics Committee (DUHREC) 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 than low 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 to DUHREC for review. (13) HEAGs are responsible for reviewing and approving all low risk human research in accordance with the National Statement and the HEAG Terms of Reference. (14) Deakin staff or students who intend to conduct ‘low risk’ human research must submit an ethics application to their Faculty HEAG or, with the permission of the relevant HEAG Chair, to the HEAG with the required disciplinary expertise most closely aligned to the proposed research. (15) Research is exempt from ethics review where both of the following conditions are met: (16) Deakin staff or students who intend to conduct human research that is eligible for exemption from ethics review must submit an application for exemption from ethics review to Research Ethics and Integrity. (17) Research that is exempt from ethics review must not commence until a formal acknowledgement of exemption from ethics review is obtained from Research Ethics and Integrity. (18) In some instances, human data that is in the public domain may be exempt from ethics review. Where this is the case, no application for exemption from ethics review is required. Further information can be found in section 25 of the Deakin Human Ethics Guidelines. (19) Deakin staff or students who have obtained approval to conduct research from the HREC of another Australian institution, must submit a Previously Approved Application to DUHREC for noting. Work must not commence until notification from DUHREC is received. (20) 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: (21) Research must not commence oversees until approval is obtained from DUHREC or a HEAG, or DUHREC notes the approval of another Australian HREC. (22) Applications to modify Deakin approved human research must be submitted to DUHREC or a HEAG. (23) An application to modify a project must be submitted to DUHREC even if a HEAG approved the original application if the modification: (24) Applications to modify projects originally approved by another Australian HRECs must be submitted to the original approving Australian HREC. When the modification relates to the composition of the research team, a previously approved application must be submitted to DUHREC for noting once approval has been received from the external HREC. (25) A project must not commence in its modified form until approval is obtained from DUHREC, a HEAG or an external Australian HREC’s approval is noted by DURHEC. (26) An annual report must be submitted to DUHREC or a HEAG for each human research project approved by Deakin for noting or action as appropriate. (27) Annual Reports are not required for: (28) A final report must be submitted to DUHREC or a HEAG: (29) 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). Ethics approval may be required to conduct QA and evaluation activities in some instances depending on the nature of the ethical issues involved. (30) Where ethics approval is required, an application must be submitted to DUHREC or a HEAG as appropriate. (31) 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. (32) 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. (33) 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. (34) 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. (35) 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 participants’ welfare. (36) The principal investigator must promptly complete an Adverse Event Form and submit the report, via ResearchPoint to Research Ethics and Integrity. (37) DUHREC will review the Adverse Event Form and may determine additional actions for the project. Actions may include but are not limited to: (38) DUHREC will notify the principal investigator of the outcome and any recommended actions. (39) Where ethics approval for a research project has been withdrawn: (40) Allegations of research integrity breaches will be managed in accordance with the Deakin Human Research Ethics Breach process and the Research Integrity Breaches Procedure. (41) Complaints concerning DUHREC or HEAG processes or decisions must be made in writing to the Human Ethics Research Office, and where applicable, cite relevant National Statement principles and guidelines. (42) The complaint will be referred to DUHREC or the HEAG to review and attempt to resolve the matter with the complainant. (43) If the matter is not resolved, it will be referred to the Pro Vice-Chancellor Researcher Development. The Pro Vice-Chancellor Researcher Development will review the complaint and make recommendations to DUHREC. The ultimate decision regarding the ethical acceptability of any human research lies with DUHREC or the HEAG and cannot be overridden. (44) The complainant will receive a written notification outlining the decision and the reasons for the decision. (45) If a complainant remains dissatisfied with the resolution of their complaint, they may make a further complaint to the Victorian Ombudsman. (46) Complaints about the conduct of a Deakin human research project may be made by a research participant or any other interested party to Research Ethics and Integrity. (47) Complaints will be managed in accordance with the complaints handling process published on Deakin’s Human Research Ethics public webpage. (48) 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. (49) Organisational consent must be obtained from one of the following: (50) 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 49. (51) 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. (52) 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. (53) 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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