HREC TERMS OF REFERENCE AND OPERATING PROCEDURES

Anne McDonald Centre Human Research Ethics Committee

TERMS OF REFERENCE AND OPERATING PROCEDURES

Definitions and Acronyms

NHMRC – National Health and Medical Research Council. Australia’s peak body for supporting health and medical research; for developing health advice for the Australian community, health professionals and governments; and for providing advice on ethical behaviour in health care and in the conduct of health and medical research.

 

The National Statement – The National Statement on Ethical Conduct in Human Research (2007 – as updated from time to time).

The National Statement consists of a series of Guidelines made in accordance with the National Health and Medical Research Council Act 1992. It is intended for use by researchers conducting research with human participants, HREC members reviewing that research, those involved in research governance, and potential research participants.

The National Statement is developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia.

 

The Code – The Australian Code for the Responsible Conduct of Research (2007) guides institutions and researchers in responsible research practices and promotes integrity in research for researchers.

The Code details how to manage breaches and allegations of research misconduct, how to manage research data and materials, how to publish and disseminate research findings, including proper attribution of authorship, how to conduct effective peer review and how to manage conflicts of interest. It also explains the responsibilities and rights of researchers if they witness research misconduct.

The Code is developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia and has broad relevance across all research disciplines.

 

 

1. Preamble

1.1 The National Statement on Ethical Conduct in Human Research (2007 – Updated May 2015) (The National Statement) sets out that institutions must ensure that all research involving human participants is designed and conducted in accordance with Australian Code for the Responsible Conduct of Research (2007) (The Code) and ethically reviewed and monitored in accordance with the National Statement[1].

Organisations that regularly undertake research involving humans may establish a Human Research Ethics Committee (HREC) to review this research.

2. Objectives

2.1 To protect the rights and welfare of research participants by ensuring all research projects involving human participants and conducted under the auspices of the Anne McDonald Centre are designed in accordance with the following values:

a. Respect for human beings

b. Research merit and integrity

c. Justice

d. Beneficence

2.2 To facilitate ethically good research through efficient and thorough review processes developed in accordance with the National Statement.

2.3 To minimise the risk of harm arising from research studies involving humans.

2.4 To monitor ethically approved research in accordance with the National Statement.

3. Functions

3.1 To provide independent ethical review of research projects in accordance with the National Statement.

3.2 To ensure that researchers comply with the relevant guidelines on the conduct of human research, including the National Statement and The Code, and other appropriate guidelines and legislation as the HREC requires.

3.3 To conduct regular monitoring processes in accordance with the National Statement to ensure that ethical standards are maintained.

3.4 To provide advice to researchers and other personnel involved in the conduct of research.

3.6 To receive complaints from research participants, researchers or others regarding the conduct of human research projects and to deal with these in accordance with the Centre’s policies and procedures.

3.7 To protect the privacy and confidentiality of research participants by ensuring that researchers appropriately manage the storage, security and disposal of confidential data collected during the conduct of research involving humans.

3.8 To promote an understanding of human research ethics within the Centre and the broader community.

4. Scope of Responsibility

The HREC will be responsible for reviewing, approving and monitoring research involving human participants and carried out by researchers approved by the Centre.

It is mandated to:

a. Approve human research on ethical and scientific grounds

b. Withhold human research approval on ethical and scientific grounds

c. Suspend human research approval on ethical and scientific grounds

d. Withdraw human research approval on ethical and scientific grounds

5. Accountability

The HREC is accountable to the Committee of Management of the Centre.

Where a complaint alleges research misconduct, the HREC shall report these matters to the Director to be handled under the Centre’s policies.

6. Membership

6.1 In accordance with the National Statement, the HRECs will have a minimum membership of eight. As far as possible, this will include:

a. Equal numbers of men and women

b. A least one third of the members from outside of the institution

6.2 In accordance with the National Statement, the membership of the HRECs will constitute the following:

a. A Chairperson, with suitable experience and whose other responsibilities will not impair the HREC’s capacity to carry out its obligations under the National Statement.

b. At least two lay people, one man and one woman, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work.

c. At least one person with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, an allied health professional.

d. At least one person who performs a pastoral care role in the community.

e. At least one lawyer, where possible who is not engaged to advise the institution.

f. At least two people with current research experience that is relevant to research proposals to be considered at the meetings they attend.

6.3 No member may be appointed in more than one of the above categories.

6.4 Wherever possible one or more of the members listed in 6.2 should be experienced in ethical decision-making.

7. Appointment of Members

7.1 Committee members are recruited by direct approach from the Director.

7.2 Members are appointed for their expertise and not in a representative capacity.

7.3 All members including the Chairperson and Deputy Chairs will receive a letter of appointment. The letter of appointment will include the date of appointment, length of tenure, indemnity and termination. Members will also be provided with an orientation package and will be asked to sign a confidentiality agreement which indicates that all matters of which the member becomes aware during the course of their work on the HREC will be kept confidential and that any conflicts of interest will be declared.

7.4 Members will be provided with appropriate induction and support. Members will receive a copy of the National Statement and any other relevant policies, guidelines and legislation.

7.5 Members will be appointed for a period of three years with an opportunity to renew at the end of this period.

7.6 Members are expected to be familiar with the National Statement and other guidelines and legislation as required.

7.7 Membership will lapse if a member fails, without providing reason, to attend three consecutive meetings. The Chair will notify the member in writing prior to any lapse in membership. Termination of a member’s appointment will be in writing.

7.8 A member may resign from the HREC at any time upon giving notice in writing to the Chair.

7.9 The Committee of Management may terminate the appointment of any member of the HREC if of the opinion that:

a. It is necessary for the proper and effective functioning of the HREC

b. The person is not a fit and proper person to serve on the HREC

c. The person has failed to carry out their duties as a HREC member.

8. Liability and Coverage

8.1 The Centre will provide indemnity for members of the HRECs for any liabilities that may arise as a result of the member exercising their duties as a member in good faith.

9. Applications, Review and Approvals

9.1 Applications are to be submitted for review by the HREC.

9.2 The HREC will check applications for completeness and may request additional information or corrections.

9.3 The HRECs may request an applicant attend a Committee meeting for the purpose of providing information to, and answering questions from, HREC members.

9.4 The meeting agenda, previous meeting minutes and associated documents and any new applications will be circulated to all HREC members prior to the meeting.

10. Meetings

10.1 HREC meetings will be conducted when applications need to be processed and at least once a year.

10.2 As set out in the National Statement Sec 5.1.29, HREC meetings will require a minimum attendance of eight members, with at least one third of these members from outside the institution, in order to have a quorum.

10.3 Any HREC member who has a conflict of interest associated with a proposal or other related matter being considered should declare such an interest at the earliest opportunity. The member shall absent themselves from the meeting when the project is the subject of consideration, and any related documentation regarding the project will be distributed to other members of the HREC separately. Once the HREC has considered the matter and a decision has been reached, the member will be asked to return to the meeting. A permanent item will be added to the meeting agenda whereby members can declare a conflict of interest. All declarations of interest and absences of members will be minuted.

10.3 The HREC will endeavour to reach a unanimous decision concerning the ethical acceptability of a research protocol. Where a unanimous decision is not reached, the decision will be considered to be carried by a majority vote of two-thirds of members who examined the proposal, providing the majority includes at least one layperson. Minority views will be recorded in the minutes.

10.4 Meetings will be conducted in such a way to encourage discussion, debate and the exchange of ideas.

11. Records

11.1 The Secretary will prepare and retain records of the HRECs’ activities, including agendas and minutes of all meetings of the HRECs and the Committee Executives.

13.2 Files will remain confidential and will be kept securely.

13.3 Records will be held for sufficient time to allow for future reference.

13.4 The Ethics Secretariat will maintain a record of all complaints received regarding the activities of the Committee. This record will include the complaint, the outcome of the complaint, and any related investigations. A record of complaints received regarding HRECapproved research will also be maintained. This will include the complaint, the outcome of the complaint and any related investigations.

12. Monitoring and Reporting Requirements

14.1 The HREC will monitor approved projects in accordance with the National Statement Ch. 5.5 in order to verify that the conduct of the research conforms to the approved proposal.

14.2 Unless otherwise decided by the HREC, the mechanism for reporting will be annual progress reports from researchers. If a project is deemed to be of considerable risk to participants researchers may be requested to provide more frequent progress reports.

15. Complaints regarding HREC–approved research

15.1 Complaints about the conduct of a HREC-approved research project, whether from the research participants, the general public or university staff or students, should be directed in writing in the first instance to the HREC Chair.

15.2 If a complainant provides their consent, the complainant’s contact details will be recorded in the Complaints file maintained by the HREC so that the outcome of the investigation can be reported to the complainant.

15.3 The complaints procedure will be made clear to research participants on the participant information and consent form.

15.4 The Ethics Secretariat will notify the HREC Chairs of the complaint immediately after it has been received.

15.5 The Chair will decide on the appropriate course of action in consultation with the Ethics Secretariat, Director Research Ethics and Integrity and relevant personnel as required.

16. Complaints regarding the HREC review processes

16.1 Complaints regarding the process of review should be directed in writing in the first instance to the Director. If this is not successfully resolved, the complaint should be managed in accordance with Centre policies and procedures.

 

[1] Australian Government, National Health and Medical Research Council (NHMRC), The National Statement on Ethical Conduct in Human Research (National Statement) s 5.1.1 <

Anne McDonald Centre. 538 Dandenong Road, Caulfield 3162 Victoria, Australia Ph: 03 9509 6324, Fax: 03 9509 6321
 
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