Concord Hospital Concord Hospital
The Concord Research Office

Terms of Reference

July 2014

1.  OBJECTIVES
The objectives of the Human Research Ethics Committee (HREC) are:
1.1      To protect the mental and physical welfare, rights, dignity and safety of participants in  research.                    
1.2      To facilitate ethical research through efficient and effective review processes.                         
1.3      To promote ethical principles in human research.               
1.4      To review research in accordance with the National Health and Medical Research Council National
Statement on Ethical Conduct in Human Research (2007), incorporating all updates. 

2.  FUNCTIONS
The functions of the Human Research Ethics Committee (HREC) are:
2.1      To provide independent oversight of human research projects; and
2.2      To provide competent, timely review and monitoring of human research projects in respect of their
ethical and scientific acceptability for as long as the projects are active; and
2.3      To determine the compliance of a human research project with the National Statement and grant, withhold or withdraw ethical approval; and
2.4      To provide advice on strategies to promote awareness of the ethical conduct of human research.

3. SCOPE OF RESPONSIBILITY
The responsibilities of the Human Research Ethics Committee (HREC) are to:
3.1      Review human research applications where the research takes place at:

  • Concord Repatriation General Hospital; and/or
  • Any institutions governed by NSW Public Health Organisations for multi-centre studies; and/or 
  • Organisations and individuals external to the public health system where an agreement has been made between the organisation or individual and the Sydney Local Health District.  This form of agreement is to be found in the NSW Health Proforma Agreement to Undertake Ethical Review for an External Entity (NSW Health Policy Directive PD2008_046); and/or 
  • Interstate institutions or organisations within the scope of a scheme of mutual acceptance of ethical and scientific review entered into by NSW Ministry of Health on behalf of the HREC.

The Executive Ethical Review Panel
3.2      The HREC has an Executive Ethical Review Panel (EERP) whose minimum membership is
the Chairperson, or a member of the HREC delegated by the Chairperson, and the Executive Officer, or their delegate.
3.3      The Executive Ethical Review Panel (EERP) is delegated to undertake expedited review
and approval of business that does not require full HREC review, including:

  • Research applications which meet the definitions of low and negligible risk research given in the NHMRC National Statement on Ethical Conduct in Human Research;
  • Amendments to current HREC approved research projects;
  • Responses to HREC queries, as approved by the full HREC for EERP review and approval; and
  • Annual progress reports and final reports.

3.4      The Executive Ethical Review Panel (EERP) will usually meet at least once per month, but more frequently if required.
3.5      The minutes and decisions of the Executive Ethical Review Panel (EERP) are noted at the
next HREC meeting.

The Scientific Sub-committee of the Human Research Ethics Committee
3.6     The HREC may delegate scientific review of applications to the Scientific sub-committee.
3.7     The Scientific sub-committee will make recommendations on scientific acceptability to the
HREC.
3.8     The HREC or the Scientific sub-committee may obtain additional expert scientific/technical
advice, as required.
3.9     The minutes and recommendations of the Scientific sub-committee are noted at the next
HREC meeting.

4.  STATUS OF THE HUMAN RESERCH ETHICS COMMITTEE (HREC) WITHIN THE LOCAL HEALTH DISTRICT

4.1     The HREC is a committee of the Sydney Local Health District Board (reporting to the Education and Research Committee) with responsibility for granting, withholding, suspending and withdrawing ethical approval.

5.  ACCOUNTABILITY OF THE HUMAN RESERCH ETHICS COMMITTEE (HREC)

5.1    The HREC is accountable to the Chief Executive in the conduct of its business. The minutes of each HREC meeting shall be signed by the Chairperson and forwarded to the Chief Executive, following confirmation.

5.2     A copy of the minutes shall be forwarded to the Medical Director, Concord Hospital.

5.3     The HREC shall provide an annual report to the Chief Executive at the end of each calendar year, which will include information on membership and the number of proposals reviewed. A copy of this report shall also be forwarded to the General Manager, Concord Hospital.

5.4    The HREC may from time to time bring to the attention of the Chief Executive issues of significant concern.

5.5    The HREC will provide the following annual reports:

  • Report to the NSW Privacy Commissioner in accordance with the requirements of the Health Records and Information Privacy Act 2002 (NSW);
  • HREC Annual Report to the  National Health and Medical Research Council (NH&MRC);
  • Certified Institution Annual Report to the National Health and Medical Research Council (NHMRC); and
  • Any other reports as required.

5.6     The HREC Terms of Reference, Standard Operating Procedures and membership will be available upon request to the general public and will be posted on the Concord Hospital Research Office website.
5.7     Monitoring Measures: The HREC will undertake its review in a timely and efficient manner and have mechanisms to monitor and evaluate its performance.

6.  MEMBERSHIP
6.1         Composition of the HREC
6.1.1 The composition of the HREC is in accordance with the National Statement and includes at least:     

a)  A Chairperson with suitable experience whose other responsibilities will not impair the HREC capacity to carry out its obligations under the National Statement;

b)  At least two members who are lay people, one man and one woman, with no affiliation with the institution or organisation and not currently involved in medical, scientific, legal or academic work;

c)  At least one member with knowledge of, and current experience in, the professional care, counselling or treatment of people;

d)  At least one member who performs a pastoral care role in the community, for example, an Aboriginal elder or a minister of religion;

e)  At least one member who is a lawyer, where possible one who is not engaged to advise the institution for which the HREC is reviewing research; and

f)    At least two members with knowledge of and current research experience that is relevant to the applications to be considered at the meetings they attend.

6.1.2 To ensure the membership will equip the HREC to address all relevant considerations arising from the categories      of research likely to be submitted, some or all of the above categories may be represented by more than one person.

6.1.3 No member will be appointed in more than one of the membership categories.

6.2      Appointment to the HREC
6.2.1 Prospective members may be recruited by direct approach, nomination or by advertisement. The minister of religion may be nominated by the retiring or former member in this category or by the Concord Hospital Pastoral Care service or by other means as deemed appropriate.
6.2.2  Prospective members may be invited to observe meetings of the HREC.
6.2.3  Prospective members are asked to provide a copy of their curriculum vitae to a selection committee comprising the Chairperson, Executive Officer and at least one other HREC member. The selection committee interviews prospective members, consults with HREC members and makes a recommendation on new appointments to the Chief Executive.
6.2.4  Members are appointed as individuals for their knowledge, qualities and experience and not as representatives of any organisation, group or opinion.
6.2.5  Membership of the HREC is made publicly available.
6.2.6  All members including the Chairperson, Deputy Chairperson(s) and Chairperson of any subcommittee are appointed by the Chief Executive.
The letter of appointment includes the date of appointment, length of tenure and information about indemnity and termination.
6.2.7  Members are appointed for a period of up to 3 years and may serve a total of 6 years (two consecutive terms), unless otherwise approved by the Chief Executive or delegate.
6.2.8  The Chairperson, Deputy Chairperson and Chairperson of any subcommittee may serve longer terms with the approval of the Chief Executive or delegate.
6.2.9  Members are advised when their term is due to expire. Reappointment will be by application to the Chairperson of the HREC who then makes a recommendation to the Chief Executive or delegate.
6.2.10   Sydney Local Health District will review membership at least every three years. New and renewed appointments allow for continuity, development of expertise within the HREC, and regular input of fresh ideas and approaches.

6.3         Conditions of appointment
6.3.1  Members must agree to their name and category of membership being made available to the public, including being published on the Concord Hospital Research Office website.
6.3.2  Members are not offered remuneration. However, reimbursement for legitimate transport expenses incurred in attending HREC meetings (eg taxi vouchers) will be considered after discussion with the Chairman.
6.3.3  Members will be required to sign a statement undertaking:
·         that all matters of which he/she becomes aware during the course of his/her work on the HREC will be kept confidential;
·         that any conflicts of interest, which exist or may arise during his/her tenure on the HREC will be declared; and
·         that he/she has not been subject to any criminal conviction or disciplinary action which may prejudice his/her standing as a HREC member.
6.3.4  Membership lapses if a member fails to attend:
·         three consecutive meetings without reasonable excuse/apology or exceptional circumstances; and
·         at least two thirds of all scheduled HREC meetings in each year, barring exceptional circumstances.
6.3.5  The Chairperson notifies the member of a lapse of membership in writing. Steps are taken to fill the vacancy.
6.3.6  A member may resign from the HREC at any time upon giving notice in writing to the Chairperson. Steps will be taken to fill the vacancy of the former member.
6.3.7  The Chief Executive may terminate the appointment of any member of the
          HREC if the Chief Executive is of the opinion that:
·         it is necessary for the proper and effective functioning of the HREC;
·         the person is not a fit and proper person to serve on an HREC;
·         the person has failed to carry out their duties as an HREC member.
6.3.8  There is an expectation that members will have read the meeting papers and will, therefore, be in a position to contribute to the discussion of each agenda item. Members are expected to remain for a substantial proportion of each meeting they attend. Where members who have received the meeting papers are unable to attend in person, they will be encouraged to provide comments to the Executive Officer either verbally or in writing.
6.3.9  Members are expected to participate in relevant specialized working groups as required.
6.3.10   The Chairperson is expected to be available between meetings to participate in HREC Executive Committee meetings where required.

6.4         Education for HREC members
6.4.1  Newly appointed members shall be provided with adequate orientation.
6.4.2  Throughout their tenure, members shall be given the opportunity to attend conferences and workshops relevant to the work and responsibilities of the HREC, at the expense of the Sydney Local Health District, where possible.

6.5         Sub-committees
6.5.1  The HREC may appoint such sub-committees as it sees fit to carry out a scientific or technical review of a research proposal or ethical review of minimal risk research submitted to the HREC. The Chair of any such sub-committee will be appointed by the Chief Executive. Members of the sub-committee need not be members of the HREC.  Minutes of the Scientific Sub-Committee and the Executive Ethical Review Panel are tabled for comment at the next HREC meeting.

6.6         Liability coverage
6.6.1  The Local Health District provides indemnity for members of the HREC for any liabilities that arise as a result of the member exercising his or her duties as a member in good faith.  Details of the indemnity are provided in the member’s letter of appointment.   Such indemnity is provided through the NSW Treasury Managed Fund.

7.  CONDUCT OF BUISNESS

7.1         Procedures

7.1.1 The HREC conducts its business in accordance with the Terms of Reference and the Standard Operating Procedures.
7.1.2  The HREC Terms of Reference and Standard Operating Procedures will be reviewed at least every three years and amended and updated as necessary.  All HREC members will be consulted with regard to any proposed changes.
7.1.3 The HREC Terms of Reference and Standard Operating Procedures are made publicly available.

7.2         Expert reviewers

7.2.1 The HREC and/or its sub-committees will be free to consult any person(s) considered to be qualified to provide advice and assistance in the review of any research proposal submitted to it, subject to that person having no conflict of interest and providing an undertaking of confidentiality. Such person(s) shall not be entitled to vote on any matter.

7.3         Meetings

7.3.1 The HREC meets on a regular basis which normally would be at monthly intervals. No meeting is held in January.
7.3.2 Meeting dates and agenda closing dates will be published on the Concord Hospital Research Office website
7.3.3 A quorum is required at each meeting for the HREC to reach a final decision on any agenda item. A quorum exists when a representative of each of the categories listed in 6.1 is in attendance, whether in person or via videoconference.
7.3.4 Members may make prior submissions of written comments so that where there is less than a full attendance of the minimum membership the meeting may still proceed if the Chairperson is satisfied that the views of those absent who belong to the minimum membership have been received and considered.

7.4         Conflict of Interest

7.4.1 Any member of the HREC who has a conflict of  interest in a proposal or other related matter(s) considered by the HREC, should as soon as practicable declare such interest.  Conflict of interest includes financial interests, personal, professional or institutional benefits or advantages that depend significantly on the research outcomes.

7.4.2 If the member is present at a meeting at which the project is the subject of consideration, the member will be asked to withdraw from the meeting until the HREC’s consideration of the relevant matter has been completed.  The member will not participate in discussions.  If the Chairperson has a potential conflict of interest as described above, the Deputy Chairperson will take over the conduct of the meeting for the proposal in question. 

7.4.3 The minutes will record all declarations of interest and the procedures to be followed.

7.5         Confidentiality

HREC meetings are held in private. The agenda and minutes of meetings, applications, supporting documentation and correspondences are all treated confidentially.

7.6         Decision Making

7.6.1 The HREC, after consideration of an application at a meeting, will make one of the following decisions:

  • It will approve the project as being ethically acceptable, with or without conditions; or
  • It will defer making a decision on the project until the clarification of information or the provision of further information to the HREC; or
  • It will request modification of the project; or
  • It will reject the project. 

7.6.2  The HREC will endeavour to reach a decision concerning the ethical acceptability of a proposal by unanimous agreement.  Members present will be allowed reasonable opportunity to express relevant views on matters on the agenda. 
7.6.3  Where a unanimous decision cannot be reached, 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.
7.6.4  Any significant minority view will be noted in the minutes.

7.7         Minutes

7.7.1  To encourage free and open discussion and to emphasise the collegiate character of the HREC, particular views will not be attributed to particular individuals in the minutes except where a member wishes to have their opinion or objection recorded.
7.7.2  Minutes of the meeting shall be taken by the Executive Officer, or their delegate. A copy of the minutes is to be distributed to all committee members prior to the next meeting. A clean copy of the minutes is to be signed by the chairperson and filed as a true record of that meeting. A copy of the minutes shall be forwarded to the Chief Executive, Sydney Local Health District and the Medical Director, Concord Hospital.

7.8         Records

7.8.1  The Executive Officer, or delegate, will prepare and maintain written records of the HREC’s activities including agendas and minutes of all meetings of the Human Research Ethics Committee and the Executive Ethical Review Panel.
7.8.2  The Executive Officer, or delegate, will prepare and maintain a file for each application received including a copy of the application, and any relevant correspondence including that between the applicant and the HREC.
7.8.3  Files shall be kept securely and confidentially in accordance with the requirements of the State Records Act 1998. 
7.8.4  The HREC will maintain a register of all the applications received and reviewed in accordance with the National Statement.

7.9     Fees

7.9.1  A fee will be charged for applications submitted for assessment by the HREC in the case of commercially-sponsored research.  These fees will comply with the NSW Health Fee Policy for Review of Commercially Sponsored Research (PD2008_030).

8.  MONITORING RESEARCH PROJECTS

8.1      The HREC monitors approved projects to ensure compliance with the conditions of approval and to protect the rights, safety and welfare of participants. In doing so it may request and discuss information on any relevant aspects of the project with the investigators at any time.
8.2     The HREC will, as a condition of approval of each project, require that investigators immediately report anything which might warrant review of ethical approval of the project including:

  • proposed changes in the research protocol or conduct
  • unforeseen events that might affect continued ethical acceptability of the project;
  • serious or unexpected adverse events; and
  • if the project is abandoned for any reason.

8.3     The HREC may adopt any additional appropriate mechanisms for monitoring as deemed necessary, depending on the complexity, design and risk perceived. These include:

  • Discussion of relevant aspects of the project with the investigators at any time;
  • Random inspection of research sites, data or consent documentation;
  • Interview with research participants or other forms of feedback from them; and
  • Request and review reports from independent agencies such as Data & Safety Monitoring Boards.

8.4     The HREC also has the discretion to recommend in the letter of approval that the site co-ordinates onsite monitoring at recommended intervals or randomly throughout the project.

9.     COMPLAINTS AND REVIEW

9.1         Complaints about the conduct of an approved research project

9.1.1  Any concern or complaint from a participant or any other person about the conduct of a project should be directed to the attention of the HREC Executive Officer, or their delegate, who will notify the Chairperson as soon as possible. The Chairperson of the HREC will instigate an investigation of the complaint and make a recommendation on the appropriate course of action. The complainant will receive a written response, if appropriate, from the HREC. If the complainant is not satisfied with the outcome of the Chairperson’s investigation, then he/she can refer the complaint to the Chief Executive or his/her nominee, or request the Chairperson to do so.

9.1.2 A concern or complaint about the conduct of a research project which involves allegations of research misconduct, is managed in accordance with the Sydney Local Health District local procedures (Responding to allegations of Research Misconduct SLHD_PD2012_004).

9.2         Complaints about the HREC’s review process

9.2.1  Any concern or complaint about the HREC’s review process should be directed to the attention of the Chairperson of the HREC, detailing it in writing.  Complaints may also be made to the Chief Executive.  The Chairperson will notify the Chief Executive of any complaints received by him/her.  The Chief Executive will inform the Chairperson of any complaints received by him/her as soon as possible. 

9.2.2  The Chairperson will instigate an investigation of the complaint and its validity and make a recommendation to the HREC on the appropriate course of action. The complainant will receive a written response, if appropriate, from the HREC. If the complainant is not satisfied with the outcome of the Chairperson’s investigation, then he/she can refer the complaint to the Chief Executive or his/her nominee or request the Chairperson to do so.

9.3         Complaints about the HREC’s rejection of an application

9.3.1  A person with a complaint about the HREC’s rejection of their application should bring the complaint to the attention of the Chairperson of the HREC detailing the grounds of the complaint. Complaints may also be made to the Chief Executive.  The Chairperson will notify the Chief Executive of the complaint.  The Chief Executive will notify the Chairperson of any complaints received by him/her as soon as possible.

9.3.2  The Chairperson will instigate an investigation of the complaint and its validity and make a recommendation to the HREC on the appropriate course of action. The complainant will receive a written response, if appropriate, from the HREC. If the complainant is not satisfied with the action taken by the HREC, then he/she can refer the complaint to the Chief Executive or his/her nominee or request the Chairperson to do so. 

9.3.3  Should the HREC be requested to review its decision, then the outcome of this review by the HREC will be final. 

9.4         Complaints about the HREC’s approval of an application

9.4.1 Where the HREC has given a favourable decision on an application and an ethical or scientific issue is subsequently identified by any party or it has become apparent that the decision was based on inconsistent application of policy and guidelines, a written appeal is lodged with the Chairperson in the first instance.

9.5         Complaints about the conduct of HREC members

9.5.1 Complaints about the conduct of an HREC member are managed by the Chief Executive, or their delegate who informs the Chairperson of the complaint.

10.              REVIEW/AMENDMENT TO THE TERMS OF REFERENCE

10.1       These Terms of Reference will be reviewed every three years and may be amended in consultation with the HREC.

10.2       Revised Terms of Reference will be sent to the Chief Executive and the Sydney Local Health District Board for approval.

11.              TERMINATION OF HREC RESPONSIBILITY

11.1 Where the HREC is to be merged, closed or has ceased to function, Sydney Local Health District will notify the NHMRC and will determine the appropriate course of action, such as the status of its registration and/or status as a certified institution with the NHMRC and the monitoring of previously approved research. Sydney Local Health District will also notify the NSW Ministry of Health.

For review July 2017