1. NAME

The name of the committee is The Royal Children's Hospital Human Research Ethics Committee (RCH HREC).

2. OBJECTIVES

The objectives of the RCH HREC are:

a) To assess the conduct of proposed human research against ethical principles as outlined in the National Health and Medical Research Council's (NHMRC) National Statement on Ethical Conduct in Human Research (2007) (and subsequent updates) (known as the National Statement) and advise on the ethical suitability of its commencement

b) To protect the welfare and rights of participants in research being mindful of the safety of individuals conducting the research; and

c) To facilitate research that is or will be of benefit to the wider community.

The RCH HREC has comprehensive expertise in the ethical review of research involving participants under the age of 18 years as well as in research involving adult participants.

The RCH HREC provides ethical review for research conducted on the Melbourne Children's campus or by Melbourne Children's researchers or research involving children referred to it for review..

3. ACCOUNTABILITY AND REPORTING

3.1. Accountability

Advice on the ethical conduct of proposed human research provided by the RCH HREC to the RCH CEO, the Director, Murdoch Childrens Research Institute and the Head of the Department of Paediatrics at the University of Melbourne (as Melbourne Children's campus partners) is an important step in enabling the governance authorisation of its commencement (delegated to the Director of Research Operations on their behalf).

An annual activity report is tabled at the RCH Board meeting by the Executive Director of Medical Services and Clinical Governance.

3.2. Reporting

The RCH and RCH HREC report annually to the NHMRC, through the Australian Health Ethics Committee (AHEC). The report format is determined by the NHMRC and may contain statistics of HREC activity and compliance with the National Statement.

In addition, an activity report may be given to:

• RCH Board of Directors 
• RCH Executive
• MCRI Executive or Board
• University of Melbourne representatives
• Victorian Health Services Commissioner 
• Victorian Privacy Commissioner
• Department of Health Human Services (DHHS), Radiation Safety Program
• Victorian Managed Insurance Authority (VMIA)
  at a frequency noted by the RCH HREC.

4. MEMBERSHIP OF THE COMMITTEE

4.1. Composition

The RCH HREC will have a minimum of eight members.

Membership is approved by the RCH Board.

The core membership of the RCH HREC will be in accordance with NHMRC National Statement comprising an even mix of men and women, internal and external, as follows:.

(a) a Chair with suitable experience
(b) at least 2 laypeople, 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
(d) at least one person who performs a pastoral care role in a community
(e) at least one lawyer, where possible one who is not engaged to advise the institution; and
(f) at least 2 people with current research experience that is relevant to research proposals to be considered at the meetings they attend. These two members may be selected, according to need, from an established pool of inducted members with relevant experience.

Additional Member roles appointed by the Board:

• Deputy Chair (s)
• Chair, Drug Trial subcommittee, RCH
• Chief Resident Medical Officer or nominee, RCH
• Clinical research fellow(s) meet category (f) requirements assigned for 6 month tenure
• Additional members as deemed necessary by the HREC Chair and in accordance with the NHMRC guidelines

In attendance:

• Director, Research Operations
• RCH Research Ethics Manager
• RCH Research Governance Manager, 
• HREC Secretariat, RCH
• HREC Plain Language Advisor, RCH
• Invitees of the Chair which may include researcher applicants or individuals with knowledge that may assist with RCH HREC decision making. All such invitees may be asked to leave the meeting during RCH HREC decision making and have no voting rights.

4.2. Role of Committee Members

The primary responsibility of each committee member is

a) to decide, independently, whether, in his or her opinion, the conduct of each research proposal submitted minimizes and manages the potential risks to participants, including voluntary and fully informed consent 
b) to meet the primary objectives listed in Section 2.

4.3. Appointment of committee members

All RCH HREC members will be appointed for their expertise and not as representatives of any group or organisation. All members (or member role/category) will be appointed by the RCH Board of Directors.

4.4. Tenure

RCH HREC members are appointed by the RCH Board for a minimum term of three years and may be eligible for re-appointment up to a maximum of nine consecutive years. This is consistent with the maximum tenure provisions in the Health Services Act for Directors of Victorian Public Health Services.

Additional members serving in an ex officio or  membership role (e.g. Chair, Drug Trial subcommittee) will serve for the duration of their time respectively in those roles.

4.5. Liability Coverage

The Royal Children's Hospital accepts legal responsibility for all decisions and advice received from the RCH HREC members.  The Royal Children's Hospital will provide legal protection in respect of any liabilities that may arise in the course of bona fide conduct of their duties as committee members.

4.6. Remuneration

The RCH HREC Chair will be remunerated, on an agreed sessional basis, for carrying out duties in addition to chairing the scheduled monthly meetings.

All other members of the RCH HREC, and its subcommittees, are not offered remuneration.

4.7. Secretariat

Secretariat services for the RCH HREC will be provided by Research Ethics and Governance Office, RCH.

5. MEETINGS

5.1. Frequency of Meetings

The RCH HREC will meet at least monthly, with at least 12 meetings per year. The Chair has the option to call additional meetings of the RCH HREC more frequently as required.

5.2. Meeting Agenda

The finalised agenda (not including late and urgent items) will be distributed by the Secretariat to all members and attendees at least 5 days before the next scheduled meeting.

5.3. Quorum

A quorum shall consist of the eight (8) members required to fulfil the minimum membership requirements as outlined in the National Statement (Sections 5.1.29-5.1.30). 

If the eight core members are not present the chairperson must be satisfied that these members have received all the relevant papers and have had the opportunity to contribute their views and that these have been received and considered before a final decision is made (as per Section 5.2.30 of the National Statement).

5.4. Conflict of Interest

Any member of the RCH HREC who has an interest, financial or otherwise, in a proposal or other related matter considered by the RCH HREC, should as soon as practicable declare such an interest. The member will withdraw from the discussion of any issues relating to the proposal, unless invited to attend by the RCH HREC. All declarations of interest and the absence of the member concerned must be minuted.

5.5. Decision Making

Decisions of the RCH HREC will only be made after members from each of the member categories has had an opportunity to contribute their views during or prior to the decision making process. Members unable to attend the meeting will be asked to forward comments to the Secretariat prior to the meeting.

The RCH HREC will endeavour to reach a decision concerning the ethical acceptability of a proposal by general agreement.The decision need not be unanimous.
 
In the absence of general agreement, the Chair will ask the core members to vote on a recommendation of the RCH HREC on how to proceed.

Minutes of the RCH HREC meeting are ratified as a true record of proceedings and decisions taken (or amended) by the RCH HREC at its subsequent meeting. The HREC Chair will consider and authorise actions arising from a draft record of a meeting in advance of this ratification to enable timely communication with researchers.

5.6. Records

The Secretariat will prepare and maintain records of the RCH HREC's activities including agendas and minutes of all meetings of the RCH HREC.

5.7. Confidentiality

Members of the RCH HREC will treat as, and keep confidential, all information and documents which relate to the business considered by the RCH HREC. RCH HREC members who are not RCH employees will complete a declaration of confidentiality upon their appointment and at such frequency as required under RCH policy.

6. METHOD OF OPERATION

6.1. Procedures

The RCH HREC will perform its functions according to standard operating procedures and relevant RCH policies (as agreed by the RCH Board or Executive). These procedures will be reviewed periodically and amended and updated as necessary. All RCH HREC members and researchers will have access to these procedures.

In carrying out its functions the RCH HREC shall at all times:

a) ensure their enquiries of the researcher will be made in a spirit of courtesy and support, so as to develop mutual respect and a sense of partnership in the development of sound ethical practice.

b) provide the decisions of the RCH HREC in writing and within a reasonable timeframe to the persons nominated in the submission.

c) determine the method of monitoring appropriate to each project. Projects that have received ethical approval will be monitored and may be audited in order to ensure that they conform to the protocol approved. The RCH HREC shall request that any amendments to approved protocols be presented to it for approval.

6.2. Establishment of RCH HREC Subcommittees

The RCH HREC may establish subcommittees to assist it in its decision making including, but not limited to, a subcommittee to provide technical and/or scientific advice. Such subcommittees may act under Terms of Reference or at the specific direction of the RCH HREC.

Membership of RCH HREC subcommittees may comprise RCH HREC members or non members invited or appointed by the RCH HREC (or the RCH HREC Chair) to the subcommittee for a specified period.

6.3. Delegations

The RCH HREC may delegate any or all of its decision making power to the Chair to enable expedited review and decision making through:

• specifying the situation where this occurs on a case by case basis or
• in relation to a category of types of decisions.

When enacting the delegation, the Chair must act in a way consistent with the principle that HREC decision making encompasses the diversity of perspectives provided by the composition of the RCH HREC and in accordance with the guidance of the National Statement.

The delegation may include signing relevant documentation on behalf of the RCH HREC.

Decisions made by the Chair under delegated authority are ratified by the RCH HREC at the subsequent meeting.

The Chair may authorise the Director, Research Ethics and Governance, or, with the agreement of the Director, another member of the Research Ethics and Governance team, to carry out administrative tasks and make decisions on behalf of the RCH HREC providing the granting of such an authority is registered in a permanent record. Any limitations or conditions of the authority must be noted.

6.4 Expedited Review

The review of research proposals defined as Low or Negligible risk to participants, as defined by the National Statement and through the standard operating procedures, may be through an expedited review process between scheduled meetings at the discretion of the Chair.

The Chair may seek advice from other HREC members, as appropriate, before reaching a decision. If approval is granted, such approval shall be considered for ratification at the subsequent HREC meeting.

The review of modifications and renewals of approved research protocols may be through an expedited review process between scheduled meetings at the discretion of the Chair or delegate. The Chair or delegate may seek advice from other RCH HREC members or a person with relevant expertise, as appropriate, before reaching a decision. If approval is granted, such approval shall be considered for ratification at the next meeting.

6.5 Suspension or withdrawal of ethical approval

The RCH HREC may suspend or withdraw ethical approval if a project is not being, or cannot be conducted in accordance with the approved protocol.

The RCH HREC will inform the investigator(s) and the relevant institution(s) or organisation(s) of such a withdrawal, and recommend to the institution(s) or organisation(s) that the project be discontinued, suspended, or that other necessary steps be taken.

 7.References and Links:

• RCH HREC SOPs 
• DTS Terms of Reference
• NHMRC National Statement on Ethical Conduct in Human Research

1. NAME

The name of the sub-committee is The Royal Children’s Hospital Human Research Ethics Committee (RCH HREC) expedited review subcommittee.  

2. OBJECTIVES

The objectives of the RCH HREC expedited review subcommittee are:

• To act in line with all objectives outlined in the terms of reference for the RCH HREC.
• To provide expedited review of research ethics applications where the requirement for review is urgent (with proven time criticality) and requires consideration before the next scheduled HREC meeting.
  

3. ACCOUNTABILITY AND REPORTING

All activity and reporting to be in line with that described in the RCH HREC terms and conditions document.  

4. MEMBERSHIP OF THE COMMITTEE

4.1. Composition

The RCH HREC expedited review subcommittee will have a minimum of four members.

Membership is approved by the RCH Board and in accordance with NHMRC National Statement.

Composition could include any of the following:

• a Chair with suitable experience
• at least 2 laypeople, one man and one woman, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work
• at least one person with knowledge of, and current experience in, the professional care, counselling or treatment of people
• at least one person who performs a pastoral care role in a community
• at least one lawyer, where possible one who is not engaged to advise the institution; and
• at least 2 people with current research experience that is relevant to research proposals to be considered at the meetings they attend. These two members may be selected, according to need, from an established pool of inducted members with relevant experience.  

Additional Member roles appointed by the HREC Chair:

• Deputy Chair(s)
• Chair, Drug Trial Subcommittee, RCH
• Chief Resident Medical Officer or nominee, RCH
• Additional members as deemed necessary by the HREC Chair and in accordance with the NHMRC guidelines   

In attendance:

• Director, Research Operations (or delegate),
• RCH Research Ethics Manager and/or HREC Secretariat (delegated Research Ethics and Governance officer), RCH   

4.2. Role of Committee Members

 In accordance with RCH HREC Terms of Reference.   

4.3. Appointment of committee members

Members will be representatives of the RCH HREC. Members will be appointed to the subcommittee on a rolling adhoc basis, where the additional meeting is scheduled. Members will be appointed on a rotating basis from the HREC according to availability.   

4.4. Tenure

In accordance with RCH HREC Terms of Reference   

4.5. Liability Coverage

In accordance with RCH HREC Terms of Reference   

4.6. Remuneration   

In accordance with RCH HREC Terms of Reference  

4.7. Secretariat

Secretariat services for the RCH HREC will be provided by Research Ethics and Governance Office, RCH.  

5. MEETINGS

5.1. Frequency of Meetings

The RCH HREC Expedited review subcommittee will meet on a needs basis, where determined and approved by the HREC Chair.  

5.2. Meeting Agenda

The agenda will be distributed by the Secretariat to all members and attendees at least 3 working days before the meeting is scheduled.  

5.3. Quorum

A quorum shall consist of four (4) members required to fulfil the minimum membership category representation as outlined in the National Statement (Sections 5.1.29-5.1.30).

If the four core members are not present at the meeting the chairperson must be satisfied that these members have received all the relevant papers and have had the opportunity to contribute their views and that these have been received and considered before a final decision is made (as per Section 5.2.30 of the National Statement).   

5.4. Conflict of Interest

In accordance with RCH HREC Terms of Reference  

5.5. Decision Making

Decisions of the RCH HREC Expedited review subcommittee will only be made after members from each of the member categories has had an opportunity to contribute their views during or prior to the decision making process. Members unable to attend the meeting will be asked to forward comments to the Secretariat prior to the meeting.   

The RCH HREC Expedited review subcommittee will endeavour to reach a decision concerning the ethical acceptability of a proposal by general agreement; the decision need not be unanimous.  

In the absence of general agreement, the Chair will ask the core members to vote on a recommendation of the RCH HREC Expedited review subcommittee on how to proceed.   

Minutes of the RCH HREC Expedited review subcommittee meeting are ratified as a true record of proceedings and decisions taken (or amended) by the RCH HREC at its subsequent meeting. The HREC Chair will consider and authorise actions arising from a draft record of a meeting in advance of this ratification to enable timely communication with researchers.   

5.6. Records

The Secretariat will prepare and maintain records of the RCH HREC Expedited review subcommittee’s activities including agendas and minutes of all meetings of the RCH HREC Expedited review subcommittee.   

5.7. Confidentiality

In accordance with RCH HREC Terms of Reference     

6. METHOD OF OPERATION 

6.1. Procedures

In accordance with the RCH HREC Standard Operating Procedures and RCH HREC Terms of Reference   

6.2. Delegations

The RCH HREC Expedited review subcommittee may delegate any or all of its decision making power to the Chair to enable expedited review and decision making through:

• specifying the situation where this occurs on a case by case basis or 
• in relation to a category of types of decisions.

When enacting the delegation, the Chair must act in a way consistent with the principle that HREC decision making encompasses the diversity of perspectives provided by the composition of the RCH HREC Expedited review subcommittee and in accordance with the guidance of the National Statement.   

The delegation may include signing relevant documentation on behalf of the RCH HREC Expedited review subcommittee.   

Decisions made by the Chair under delegated authority are ratified by the RCH HREC at the subsequent meeting.   

The Chair may authorise the Director, Research Operations, or, with the agreement of the Director, another member of the Research Ethics and Governance team, to carry out administrative tasks and make decisions on behalf of the RCH HREC Expedited review subcommittee providing the granting of such an authority is registered in a permanent record. Any limitations or conditions of the authority must be noted.   

6.3. Expedited Review

The Chair may seek advice from other HREC members or other relevant representatives of the RCH (e.g. legal), as appropriate, before reaching a decision on an application considered at a sub-committee meeting. If approval is granted, such approval shall be considered for ratification at the subsequent HREC meeting.   

6.4. Related documents

TGA/CTPRG COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors