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Human Research Ethics procedure

Section 1 - Preamble

(1) This Procedure is effective from 2 March 2021.

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Section 2 - Purpose

(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.

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Section 3 - Scope

(3) This Procedure applies to all persons conducting University business that intend to conduct human research, including:

  1. Deakin staff and students, regardless of where the research is carried out, and
  2. Research collaborators and visitors listed on a Deakin human research ethics application.
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Section 4 - Policy

(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:

  1. Research Merit and Integrity
  2. Justice
  3. Beneficence and
  4. Respect.
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Section 5 - Procedure

Human research ethics

(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.

Deakin University Human Research Ethics Committee (DUHREC)

(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:

  1. Women who are pregnant and the human foetus
  2. People highly dependent on medical care who may be unable to give informed consent
  3. People with a cognitive impairment, an intellectual disability, or a mental illness
  4. Aboriginal and Torres Strait Islander peoples or issues
  5. People who may be involved in illegal activities, where the research is designed to expose the illegal activity, or likely to discover it
  6. Clinical trials
  7. Human genomics except where no information that can identify an individual is used, no linkage of data is planned, and the research is otherwise ‘low risk’
  8. Human biospecimens including any derivative of human biospecimens, such as human cell lines (see the Low Risk Human Research Ethics Application Form for further details)
  9. Overseas travel to regions classified as Levels 2, 3 or 4 by the Department of Foreign Affairs and Trade (DFAT) (except where researchers live in the region, their research only involves travel to areas they would normally visit and the project does not involve sensitivities that elevate the normal risks associated with living and working in that region)
  10. Active concealment or planned deception of participants
  11. Collection of identifiable health or sensitive data or information, without permission from the person identified
  12. Opt-out consent in relation to the collection of identifiable health or sensitive data or information from participants
  13. Animal to human xenotransplantation or
  14. Exposure to ionising radiation.

(12) Deakin staff and students who intend to conduct research described in clause 11 must submit an ethics application to DUHREC for review.

Human Ethics Advisory Groups (HEAGs)

(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.

Exemption from ethics review

(15) Research is exempt from ethics review where both of the following conditions are met:

  1. there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience; and
  2. the project involves only the use of existing collections of data or records that contain only non-identifiable data about human beings.

(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 the Human Research Ethics Office.

(17) Research that is exempt from ethics review must not commence until a formal acknowledgement of exemption from ethics review is obtained from the Human Research Ethics Office.

(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.

Previous approval from external ethics committees within Australia

(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.

Human research projects conducted in a country other than Australia

(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:

  1. comply with the National Statement
  2. comply with any required local ethics review processes and other legal and/or cultural requirements and
  3. obtain ethics approval from DUHREC or another Australian HREC. If approval was obtained from another Australian HREC, DUHREC will note this according to clause 18.

(21) Research must not commence oversees until approval is obtained from DUHREC or a HEAG, or DUHREC notes the approval of another Australian HREC.

Modifying an approved project

(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:

  1. involves a request to waive the requirement for consent for access to potentially identifiable health or sensitive data or information
  2. involves an opt-out consent process for access to potentially identifiable health or sensitive data or information or
  3. is higher than low risk or meets any of the criteria listed in clause 11 a) to n).

(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.

Annual and final reporting

(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:

  1. human research projects exempted from ethics review by DUHREC or
  2. human research projects approved by another Australian HREC and noted by DUHREC

(28) A final report must be submitted to DUHREC or a HEAG:

  1. at the conclusion of data collection, or when a final report is submitted to the original approving Australian HREC or
  2. if the project is discontinued prior to the expected completion date.

Quality assurance or evaluation activities

(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.

Adverse events, incidents, or reactions

(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 the Deakin Human Research Ethics Office.

(33) Where the research is a clinical trial, only serious adverse events, incidents, or reactions caused by the research must be reported to the Deakin Human Research Ethics Office.

(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 to the Deakin Human Research Ethics Office.

(37) DUHREC will review the Adverse Event Form and may determine additional actions for the project. Actions may include but are not limited to:

  1. modifying the project
  2. withdrawing approval for the project or activity.

(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:

  1. the researcher, the University, and where possible, the participants should be informed of the withdrawal
  2. the researcher must promptly suspend the research and make arrangements to meet the needs of participants, and
  3. the research may only resume upon approval by DUHREC.

Allegations of research integrity breaches

(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.

Complaints concerning DUHREC or HEAG processes or decisions

(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.

Complaints concerning a Deakin human research project

(46) Complaints about the conduct of a Deakin human research project may be made by a research participant or any other interested party to the Deakin Human Research Ethics Office.

(47) Complaints will be managed in accordance with the complaints handling process published on Deakin’s Research Integrity Human Ethics public website.

Organisational consent

(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:

  1. the Head of Academic Unit for staff and students enrolled in an Academic Unit (including participants in combined courses where the research relates to their enrolment in that Academic Unit)
  2. the Faculty Executive Dean or Institute Director for staff and students in more than one Academic Unit
  3. the Dean of Students for students in two or more Faculties or Institutes.
  4. the Deputy Vice-Chancellor Research and Innovation or delegate/nominee for staff in two or more Faculties, Institutes or Portfolios.

(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 the Strategic Intelligence and Planning Unit (SIPU) prior to scheduling the research. While consultation with SIPU may occur prior to, or after ethics approval is obtained, the research may not be scheduled until after ethics approval is provided.

Conscientious objection

(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.

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Section 6 - Definitions

(53) For the purpose of this procedure:

  1. Adverse incident:
    1. Any unexpected adverse occurrence for which there was no mitigation plan in place, or
    2. An expected adverse occurrence that was more severe than anticipated and/or for which the mitigation plan proved ineffective

      Which has a possible, probable or definite causal relationship with the research project.
  2. Adverse event: any untoward medical occurrence in a research participant with a possible, probable or definite causal relationship with the research project.
  3. Clinical trial: any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
  4. Clinical trials involving a therapeutic good: clinical trials involving investigational medicinal products and investigational medical devices for trials conducted under the Clinical Trial Exemption (CTX) or Clinical Trial Notification (CTN) schemes.
  5. Human Ethics Advisory Group (HEAG): A faculty committee of peers responsible for reviewing and approving low risk human research.
  6. Higher than low risk: research with the potential risk of harm to research participants, researchers, or others. Harms may include (but are not limited to) psychological harms, social harms, economic harms, and legal harms.
  7. Life-threatening: refers to an event in which the participant was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe.
  8. Low risk research: research where the only foreseeable risk is one of discomfort. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk.
  9. Principal investigator: A paid Deakin staff member who is responsible for obtaining ethics and other approvals prior to the commencement of research and ensuring that all conditions of any approvals are adhered to during the course of the research.
  10. Researcher: Any person conducting research including but not limited to staff and students.
  11. Serious adverse event or reaction: an event that results in death, is life-threatening, requires inpatient hospitalisation or results in prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a medically important event or reaction that may require medical or surgical intervention to prevent one of the other outcomes.