1. Background

1.1 The Australian Institute of Family Studies conducts research to improve policy and practice responses to the needs of families. It engages in a wide range of research activities including qualitative and quantitative methods involving interview, survey, and administrative data. Research participants include family members (adults and children) and professionals.

1.2 Compliance with the National Statement on Ethical Conduct in Human Research (2007, updated 2018, NHMRC) (the National Statement) and the Australian Code for the Responsible Conduct of Research (Code of Conduct) is integral to AIFS operations.

1.3 The AIFS Human Research Ethics Committee (HREC) provides independent review and monitoring of research and evaluation activities, in accordance with the principles of the National Statement.

1.4 The AIFS HREC is a social sciences HREC with expertise in a range of social science subject matter and methods.

2. Purpose of these Terms of Reference

2.1 These Terms of Reference (ToR) for the AIFS HREC guide the committee in meeting its obligations under the National Statement and the Code of Conduct.

3. Accountability and scope

3.1 The accountable authority (Director of the Institute) of the Australian Institute of Family Studies (the Institute) has established the Human Research Ethics Committee in compliance with the requirements of the National Statement on Ethical Conduct in Human Research.

3.2 All human research involving 'greater than low risk' and 'low risk' will be reviewed by the HREC. Negligible or low risk research will be considered by an AIFS Research Director (see Appendix A for the definition of 'low risk' and 'negligible risk'). These approvals will be reported to the HREC.

4. Functions of the AIFS Human Research Ethics Committee

4.1 The role of the AIFS Human Research Ethics Committee is to:

a) provide independent, competent and timely ethical review in accordance with the values and principles set out in the National Statement guidelines pertaining to research and ethical review, the Australian Code for Responsible Conduct to Research (2018), and all relevant State and Commonwealth legislation;

b) provide oversight, monitoring and advice on ethical aspects of human research;

c) on ethical grounds, the Committee may: provide, withhold, suspend, or withdraw approval for human research.

4.2 In carrying out its task the HREC will apply the principles described in the National Statement (S1) of research merit and integrity; justice; beneficence; and respect.

5. The responsibilities of the HREC, Chair, Deputy Chair, individual members, and secretariat

5.1 The HREC operates in accordance with these terms of reference, in order to:

a) assess all research proposals and amendment applications in relation to the values and principles outlined in the National Statement on Ethical Conduct in Human Research 2007 (updated 2018) and the Code of Conduct;

b) identify potential risks and burdens to participants of all research activities;

c) ensure the research design minimises risks, taking into account the balance of potential benefits to participants;

d) specifically review research procedures for informed consent, to ensure compliance with the National Statement;

e) specifically review confidentiality of data storage, and in the dissemination of results and findings;

f) inform each unsuccessful research applicant of the grounds for declining to approve the application with reference to the National Statement. Applicants should be provided with guidance on how the application should be improved to achieve compliance with the National Statement;

g) monitor all approved research activities to ensure adherence to the relevant values and principles, through receiving and considering end of project reports and reports in relation to breaches of ethical protocols;

h) withdraw or suspend approval of any project where non-compliance has been identified or the safety of participants has been adversely impacted;

i) receive and respond to ethical complaints from research participants and other parties.

5.2 Role of the Chair and Deputy Chair

5.2.1 The role of the Chair is to

a) approve committee membership;

b) preside over the meetings in accordance with the Terms of Reference;

c) ensure that minutes represent a true record of the Committee's decision and a summary of its deliberations;

d) provide advice to the Research Director as required;

e) determine when an out of session review of an application may take place;

f) in the absence of the nominated Chair, the formally appointed Deputy Chair will be acting as the Chairperson. The Acting Chair will be appointed on ongoing basis from one of the current members of the HREC.

5.3 Members of the HREC are individually responsible for:

a) becoming familiar with the National Statement and other relevant codes and guidelines;

b) preparing for and making all reasonable efforts to attend scheduled meetings, or submitting comments via email if unavailable.

c) participating in out of session activities on a needs basis as determined by the Chair;

d) sending apologies when unable to attend meetings;

e) keeping all information that comes to the committee confidential; destroying any hard copies, and ensuring that materials are secure at all times.

f) declaring any conflicts of interest and withdrawing from meetings when decisions about relevant projects are being made;

g) respecting the expression of a diversity of viewpoints and allowing time to consider all members' concerns;

h) participating in training on research ethics provided by AIFS at least every three years.

5.4 The role of the Secretariat is to:

a) determine the schedule of meetings in liaison with the Chair;

b) develop and circulate meeting agendas, papers and minutes. Meeting papers will be circulated at least seven days in advance of the meeting date;

c) conduct an initial quality and compliance review of applications;

d) maintain records of all decisions and correspondence (see section 13);

e) communicate decisions to researchers;

f) provide information on HREC processes to researchers;

g) co-ordinate the provision of applications, breach reports and end of project reports (section 12) to the HREC;

h) draft the Committee's annual report to the NHMRC;

i) monitor and organise appointments and re-appointments to the Committee;

j) ensure that members are informed of issues and information relevant to the Committee's work.

6. Conflict of interest

6.1 A conflict of interest exists when 'an independent observer might reasonably conclude that the professional actions of a person are or may be unduly influenced by other interests. This refers to a financial or non-financial interest which may be a perceived, potential or actual conflict of interest' (Australian Code for the Responsible Conduct of Research 2018 p5).

6.2 No member of the committee is entitled to adjudicate research in which they have, or could be seen to have, a conflict of interest. A committee member in this position should not discuss the project with other members, nor attempt to influence the committee in any way.

6.3 Members must declare any conflicts of interest prior to joining the committee and in relation to each ethics application.

6.4 Conflict of interest will be a standing item on the committee agenda.

7. Composition

7.1 The HREC must include at least 8 members in the following indicative categories:

a) a chairperson (mandatory);

b) at least 2 lay members (male and female) who have no affiliation to AIFS and are not currently involved in medical, scientific or legal work;

c) at least 1 professional with knowledge and experience in professional care, counselling or treatment of people;

d) at least 1 person who performs a pastoral care role in the community;

e) at least 1 lawyer, who is not engaged to advise or represent AIFS;

f) at least 2 people with current research experience that is relevant to the research proposals being considered;

g) every effort should be made to have First Nations representative on the Committee.

7.2 Appointment and termination of members.

a) members will be appointed through an open and transparent process including advertising for members and applying a merit selection process.

b) members will be appointed for a term of three years with the possibility of renewal for not more than three further terms.

c) A member may resign at any time upon giving notice in writing to the Chair and the Ethics Secretariat.

d) The Chair of the HREC may be recruited by direct approach from the Research Director and formally nominated by the Director of AIFS.

7.3 The HREC must strive for:

a) equal male/female representation;

b) one third of members to come from outside the institutions for which the HREC is reviewing proposals.

7.4 Quorum

7.4.1 A quorum is constituted by a simple majority.

7.4.2 As far as possible at least one member in each category should be involved in deliberations for decisions to be made.

7.4.3 Participation in meetings may be in person or virtually. Participation in deliberations may occur through communication via email where attendance at meetings is not possible.

7.4.4 The committee may delegate minor decisions for follow up or action, in between meetings.

8. Remuneration

8.1 Remuneration for HREC members will be according to the Remuneration and Allowances for Holders of Part-time Public Office Determination.

9. Maintenance of Research Ethics Knowledge

9.1 All new members will be expected to undertake training in human research ethics prior to commencement provided by AIFS.

9.2 Ongoing members are invited to request additional training by informing the ethics secretariat as needed, and once annually. Ongoing members will receive training every 3 years that will be organised by AIFS. HREC members will be provided with privacy training once a year.

10. Structure and procedures of the HREC

10.1 Meetings will be held between four and five times a year at intervals determined by project needs. Members will be informed of scheduled dates well in advance. All members will receive the agenda and copies of research proposals/protocols at least one week prior to the meeting.

10.2 Formal minutes will be taken at each meeting to record deliberations in brief; decisions; and actions.

10.3 Minutes will be approved by the Chair prior to circulating decisions to researchers. Minutes will be ratified at the next meeting of the Committee.

10.4 Ordinarily, applications will be considered in session. Applications may be considered out of session at the discretion of the Chair having regard to the urgency of the application and the interval between meetings.

10.5 If research project involves First Nations People participants, the HREC review process should include assessment or advice from an Aboriginal person (noting it is not requirement for Aboriginal representative to be on the Committee).

10.6 The Committee may invite researchers to meetings to clarify matters in relation to their applications.

11. Ethics applications for consideration

11.1 Applications are to be submitted on the Human Research Ethics Application form (HREA).

11.2 The HREC will ordinarily not consider applications from researchers with no affiliation to AIFS. The committee reviews AIFS research or research where AIFS is a research partner and consider ethical review of research from external agencies where there is a strategic relationship with fees charged for cost recovery.

11.3 Where primary ethics approval is required to be obtained from another HREC, the AIFS HREC will be informed of this approval, and this will be registered to minimise duplication of ethical review (National Statement Chapter 5.3).

11.4 Where additional approval is required to be obtained from another HREC, the AIFS HREC will be informed of this.

11.5 All applications must be accompanied by copies of proposed advertising material, questionnaires, interview schedules, information sheets, consent forms, observational criteria, surveys, approval letters from other ethics committees, and letters of support.

12. Decision-making

12.1 The committee should endeavour to reach decisions by agreement. The Chair will need to facilitate the expression of opinion from all members, identify points of agreement and of disagreement and judge when a sufficient degree of general agreement has been reached. Where there is significant disagreement, the Chair has the discretion to extend the deliberation process and to seek further information.

12.2 Approval will be granted to a proposal when the committee determines:

a) the study has clear aims, research questions and scope;

b) the study has sound methodology that will achieve the research aims;

c) the researchers have an appropriate level of competence, qualifications and experience;

d) research procedures facilitate a process of informed consent;

e) the benefits of the research balance the risks and burdens to participants;

f) the rights and welfare of the participants will be protected throughout the study;

g) measures for ensuring confidentiality of data during and after the study are clear and sufficient;

h) strategies for communication of findings adhere to the principles of research merit and integrity; justice; beneficence; and respect.

12.3 A written statement of approval signed by the chairperson or nominee will be issued to the researcher/s clearly indicating the conditions and the duration for which this approval is given.

12.4 Conditional approval may be granted when amendments are required. Research will not be approved for commencement before all necessary amendments occur. Proposals may also be rejected, at any stage of the review process.

13. Records and reporting to AIFS

13.1 A copy of each research ethics application including consent forms, information sheets and relevant correspondence will be kept for a minimum period of 7 years and then destroyed in a confidential manner.

13.2 Minutes of HREC meetings will be kept for a minimum of 7 years and then destroyed in a confidential manner.

13.3 The HREC is accountable to the Director of AIFS. The reporting mechanism from the HREC to the Director is the HREC meeting minutes, maintained by the Secretariat.

13.4 The Director of AIFS may solicit advice from the Chair as needed.

14. Monitoring of research projects and withdrawal of approval

14.1 The Human Research Ethics Committee has responsibility for monitoring approved research projects to determine they are being carried out according to the terms of approval.

14.2 As a condition of approval the HREC requires researchers to immediately report anything that is contrary to the approved protocol, and any serious adverse events that might warrant the project's review (such as any sort of unexpected harm to participants; and complaints of research misconduct' as defined in the Code of Conduct).

14.3 A final report is required at the closure of all research projects. For longitudinal studies, this means the closure of the relevant fieldwork period.

14.4 The Committee requires an annual report from primary researchers on matters including:

a) the progress to date or outcome of the project;

b) the maintenance and security of records;

c) compliance with the approved protocol;

d) compliance with the conditions of approval.

14.4.1. This report will be sent to the HREC on anniversary of the Committee approval for AIFS longitudinal projects.

14.5 If the HREC has any concern about the manner in which the research project is being conducted, it may consider additional means of monitoring progress including project updates at defined intervals.

14.6 If the HREC is satisfied that circumstances are such that the project cannot be conducted in accordance with the approved protocol, the HREC may withdraw its approval. The researcher/s will be informed that the project is to be discontinued, suspended or other necessary steps taken.

15. Complaints

15.1 Research participant information should outline complaints procedures and state that complaints may be lodged with the chairperson of the HREC. The chairperson must follow the guidelines for handling complaints outlined in the National Statement and the Code of Conduct.

16. Annual report to the NHMRC

16.1 The HREC (via the secretariat) shall report annually to the National Health and Medical Research Council on all aspects of its procedures including: membership and membership changes, number of meetings, the number of protocols considered, approved and rejected, monitoring of projects and complaints handled.

Appendix A: Terminology summary of national statement definitions

Human Research is research conducted with or about people, or their data or tissue ((see: the National Statement on Ethical Conduct in Human Research (2007, updated 2018, NHMRC) page 7).

Negligible Risk Research describes research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience (see: the National Statement on Ethical Conduct in Human Research (2007, updated 2018, NHMRC) section 2, page 13).

Low Risk Research Low describes research in which the only foreseeable risk is one of discomfort. Research in which the risk for participants is more serious than discomfort is not low risk (see: the National Statement on Ethical Conduct in Human Research (2007, updated 2018, NHMRC) section 2, page 13).