* Ethics Committee

• About the Albury Wodonga Human Research Ethics Committee
• Contact Details
• Application Form
• Meeting dates
• Fees
• Approval Conditions
• Complaints
• Terms of Reference

About the Albury Wodonga Human Research Ethics Committee

The Albury Wodonga Human Research Ethics Committee (AWHREC) is constituted and operates in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007).

The AWHREC primary role is to protect the welfare and the rights of participants in research.

The AWHREC receives and considers for approval clinical research projects or any research project involving humans undertaken at Albury Wodonga Health (both Albury & Wodonga Campuses), Murray Valley Private Hospital, Albury and Wodonga Private Hospital, Mercy Health Service, and various other Albury / Wodonga Community organisations.

Contact Details:

Felicity Fox
Research Governance Officer
Albury Wodonga Human Research Ethics Committee
Albury Wodonga Health - Wodonga Campus
Phone: (02) 6051 7649
E-mail:  felicity.fox@awh.org.au 

Application form:

Applications for ethics approval should be made via the ‘Online Forms for Research' website (https://www.ethicsform.org/au/SignIn.aspx) using the National Ethics Application Form (NEAF).  Further information about the NEAD is available for public use through the independent NEAF website at www.neaf.gov.au.

Meeting dates:

ALBURY WODONGA HUMAN RESEARCH ETHICS COMMITTEE

MEETING DATES AND DEADLINES 2012

 

Submissions to the Albury Wodonga Human Research Ethics committee must be made to:

Felicity Fox
Research Governance Officer
Albury Wodonga Human Research Ethics Committee
Albury Wodonga Health - Wodonga Campus
Phone: (02) 6051 7649
E-mail: felicity.fox@awh.org.au

By the dates listed above to be considered at the corresponding meeting. 

Fees:

The fees for the submission of research applications have been determined as follows, and are inclusive of GST:

	Ethics Review1	Governance Review2
Commercially Sponsored Clinical Trails	$3,300	$1,650
Unsponsored Clinical Trials	$660	$330
Collaborative Group Sponsored Trials	$330	$165
Non Clinical Trials (non student / employee)	$220	$110
Employee Initiated Trials	$55	$0
Amendments - Commercially Sponsored	$550	$275
Additional Sub Studies – Commercially Sponsored	$1,100	$550

Notes:

1. All new trails requesting single-site ethics review will be required to submit a National Ethics Application Form via the on-line forms website (https://www.ethicsform.org/au/SignIn.aspx) and will incur fees associated with ethics review only.

2. Research projects that have already received ethics approval from one of the accredited Human Research Ethics Committees (HREC) in either Victoria or New South Wales will be required to submit a Site Specific Assessment and incur fees associated with governance review only.

These fees have been determined on advice from the National Health and Medical Research Council, local researchers and fees charged by other HRECs.  They cover costs involved in undertaking either ethics or governance review and include such items as staff salaries, administration, and training.  All revenue raised through the application of this policy is used by the Albury Wodonga HREC and Albury Wodonga Health to support research governance functions.

An invoice will be generated once the applicant's submission has been considered by the appropriate body.

Cheques are to be made payable to Albury Wodonga Health.

Click here to see our Fees Policy

Approval Conditions:

Albury Wodonga Human Research Ethics Committee Approval Conditions Applying to all Approved Submissions:

In order to comply with the National Statement on Ethical Conduct in Human Research (2007), Guidelines for Good Clinical Research Practice and the Committee's internal policies and procedures you are required to:

• Submit a progress report to the HREC six months after the commencement of the study and each six months thereafter until the conclusion of the study.
• Submit a final report to the HREC at the completion of the study.
• Submit to the HREC for approval any proposed amendments to the project including any proposed changes to the protocol, participant information and consent form/s and the investigators brochure.
• Submit to the HREC details of any published material eventuating from the project.
• Maintain appropriate records of research data (including electronic data) for 15 years after the research has been completed or after the last contact, whichever is the later.  Data must be recorded in a durable and appropriately referenced form and comply with relevant privacy protocols.
• Notify the HREC immediately of any adverse events that have a material impact on the conduct of the research in accordance with the NHMRC Position Statement: Monitoring and reporting of safety for clinical trials involving therapeutic products May 2009.
• Notify the HREC immediately of any unforseen events that might affect continued ethical acceptability of the project.
• Notify the HREC of any changes in research personnel involved in the project.
• Notify the HREC if a decision is made to end the study prior to the expected date of completion or failure to commence the study within 12 months of the HREC approval date.
• Notify the HREC of any other matters which may impact the conduct of the project.

Complaints:

All research related complaints whether they are from Research Participants, Researchers, AWHREC Members and other Interested Persons should be directed in the first instance to:

Felicity Fox
Research Governance Officer
Albury Wodonga Human Research Ethics Committee
Albury Wodonga Health - Wodonga Campus
Phone: (02) 6051 7649
E-mail: felicity.fox@awh.org.au

All complaints will be handled in accordance with the Committee's Complaints Policy and Procedure.

Click here to see our Complaints Policy

Click here see our Complaints Procedure

Terms of Reference:

Albury Wodonga Human Research Ethics Committee

Terms Of Reference

TITLE

The Albury Wodonga Human Research Ethics Committee (AWHREC)

FUNCTIONS & OBJECTIVES:

• The AWHREC primary role is to protect the welfare and the rights of participants in research in compliance with the National Statement on Ethical Conduct of Research involving Humans and Section 95 of the Privacy Act.
• The AWHREC receives and considers for approval clinical research projects or any research project involving humans undertaken at Albury Wodonga Health (both Albury & Wodonga Campuses), Murray Valley Private Hospital, Albury Wodonga Private Hospital, and Mercy Health Service.

MEMBERSHIP OF THE COMMITTEE:

The AWHREC will have a minimum of seven members and composed according to the National Statement on Ethical Conduct of Research involving Humans.

The core membership comprises of:

a)  a chairperson;

b)  at least two members who are lay people, one man and one woman, who have no affiliation with the institution or organisation, are not currently involved in medical, scientific, or legal work, and who are preferably  from the community in which the institution or organisation is located;

c)  at least one member with knowledge of, and current experience in, the areas of research that are regularly considered by the HREC (e.g. health, medical, social, psychological, epidemiological, as appropriate)

d)  at least one member with knowledge of, and current experience in , the professional care, counselling or treatment of people (e.g. medical practitioner, clinical psychologist, social worker, nurse, as appropriate);

e)  at least one member who is a minister of religion, or such a person who performs a similar role in the community such as an Aboriginal elder;

f) At least one member who is a lawyer.

• AWHREC members are appointed for a period of up to three years and limitation is not set on the number of terms a member may remain appointed.
• The AWHREC will provide legal protection in respect of liabilities that may arise in the course of bona fide conduct of the duties of committee members.
• AWHREC membership is a volunteer appointment and remuneration will not be considered.
• The Chairperson will be appointed by the committee.  In the absence of the Chairperson, the alternate Chairperson will perform the roles and duties of the Chairperson.
• Administrative duties will be arranged by Albury Wodonga Health - Wodonga Campus.

ACCOUNTABILITY & REPORTING:

The activities of the AWHREC will be audited by the National Health and Medical Research Council (NHMRC), through the Australian Health Ethics Committee (AHEC), to ensure compliance with the National Statement on Ethical Conduct in Research Involving Humans.

The AWHREC will report annually to the NHMRC information relevant to its procedures including:

a)  membership/membership changes;

b)  number of meetings;

c)  confirmation of participation by required categories of members;

d)  the number of protocols presented, the number approved, and the number rejected;

e)  monitoring procedures in place and any problems encountered; and

f) complaints procedures and the number of complaints handled.

 The AWHREC will maintain records or applications including:

a)  name of responsible organisation;

b)  project identification numbers;

c)  principal researcher;

d)  title of project;

e)  ethical approval and non approval and date;

f) terms and conditions of any approval;

g)  whether approval was by expedited review;

h)  whether the opinion of another HREC was considered;

i)  action taken by the AWHREC to monitor conduct of the research;

j)  the relevance, if any, of the Guidelines for the Protection of Privacy in the Conduct of Medical Research.

The AWHREC will also retain in file a copy of each proposal and application for approval including any information sheets and consent forms or relevant correspondence

MODE OF OPERATION:

The AWHREC will perform its functions according to its Terms of Reference and any other written policies and procedures.  The procedures will be reviewed periodically and amended and updated as necessary.  All committee members will have access to/or be provided with copies of the procedures

APPLICATIONS:

• All applications to the committee must be submitted to the AWHREC by the relevant closing date, in writing, in the format specified by the by the AWHREC and should include documentation as the AWHREC may specify
• A levy for all sponsored and unsponsored drug trials will apply.
• Local researchers will be charged a fee; however they may apply to the AWHREC to have the fee waived.
• All documents and other materials used to inform participants of the research must be approved by the AWHREC.
• All approved submissions will be required to follow terms and conditions.
• Applications maybe submitted to the AWHREC for expedited review.  Review of such applications will be made at the discretion of the Committee and Chair.

MEETINGS

• AWHREC meetings will be held at least five (5) times annually.
• Agendas and minutes and associated papers to the next meeting, will be circulated at least one week prior to the scheduled date of the meeting.
• A quorum must be present in order for the AWHREC to reach any final decision.  A quorum shall be seven members.  Where there is less than a full attendance at a meeting, the Chairperson must be satisfied, before a decision is reached that the minimum membership have received all papers and have had the opportunity to contribute their views.  These views are to be recorded and considered.
• A researcher maybe invited to present their proposals to the AWHREC.
• The AWHREC can approve, require amendment of or reject a research submission.
• Decisions by the AWHREC should be reached by general agreement. An extension of time may be required for reconsideration of the proposal and its possible amendment.
• The AWHREC may request advice and assistance from experts to assist with consideration of a research submission.  The Chairperson must be satisfied that experts assisting in the manner have no conflict of interest in the research.
• The Chairperson must be satisfied that no member of the committee adjudicated on the research in which that member has a conflict of interest.
• The AWHREC should not communicate directly with a research sponsor except in regard to insurance, administration and indemnity.
• The AWHREC will endeavour to reach a decision concerning the scientific/technical acceptability of a proposal by unanimous agreement.  Any significant minority view will be noted in the minutes.
• The AWHREC will issue its review in writing to the applicant.

POST ASSESSMENT RESPONSIBILITIES

It is the responsibility of the applicant to adhere to the conditions applying to approved submissions.  Details of these conditions will be provided with approval letter.

COMPLAINTS

• Complaints directed to the AWHREC will be acknowledged in writing within two weeks of receipt of the complaint.
• Complaints against the AWHREC or researcher will be handled according to the complaints procedure.

SUSPENSION OR DISCONTINUATION OF RESEARCH

• The AWHREC may withdraw approval for research at anytime if it believes the approved protocol is not being followed.
• Withdrawal of approval will be in writing to the researcher, clearly stating the reason for withdrawal of approval and the research will be suspended or discontinued immediately. 
• Researchers have 14 days to appeal the decision of the AWHREC.
• The appeal will be referred to the Ethics committee of another comparable institution for adjudication.  Both the committee and the researcher will approve the choice of the arbitrating institution. 

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