Introduction:
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/Wodonga Private Hospital, and Mercy Health Service.
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 using the National Ethics Application Form (NEAF) which 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 2011
|
Meeting Date |
Time |
Submission Deadline |
|
Wednesday February 16th |
1 – 2.30 pm |
February 2nd |
|
Wednesday April 13th |
1 – 2.30 pm |
March 30th |
|
Wednesday June 15th |
1 – 2.30 pm |
June 1st |
|
Wednesday August 17th |
1 – 2.30 pm |
August 3rd |
|
Wednesday October 19th |
1 – 2.30 pm |
October 5th |
|
Wednesday December 14th |
1 – 2.30 pm |
November 30th |
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.
Approval Conditions:
Albury Wodonga Human Research Ethics Committee Approval Conditions
Conditions Applying To All Approved Submissions:
1. A report is to be forwarded to the Committee six (6) months after the commencement of the study and six (6) monthly thereafter until conclusion.
2. A report is to be forwarded to the Committee at the conclusion of the study.
3. Any adverse reports/outcomes are to be notified to the Committee as the study progresses.
4. Changes and/or amendments require the approval of the Ethics Committee.
5. Details of any published material are to be provided to the Committee - not necessarily the actual publications.
6. The Therapeutic Goods Administration's Guidelines for Good Clinical Research Practice states that both the principal investigator and the sponsor of a clinical trial should keep records and data from the study for at least fifteen years. As a participant in this study you are asked to comply with any directive from the aforementioned.
7. Appropriate and sufficient insurance cover for you as a research/trial participant, as mentioned in the NHMRC Report on Compensation, Insurance and Indemnity Arrangements for Institutional Ethics Committees, is to be provided in accordance with these guidelines.
Additional information regarding company-sponsored trials, not NHMRC guidelines, is to be found in the Australian Pharmaceutical Manufacturers Association's Form of indemnity for clinical trials and Guidelines for compensation for injury resulting from participation in a company-sponsored clinical trial.
8. NHMRC Guidelines for the protection of privacy in the conduct of medical
research are to apply – refer Guidelines Under Section 95 of the Privacy Act 1988 and Guidelines approved under Section 95A of the Privacy Act 1988
9. The approval granted by this committee relates to submission content. No authority to proceed without site specific approval by the relevant authority is implied.
10. The Joint Hospitals' Ethics Committee reference to be quoted in all correspondence.
(Pt. 5 - also applies to the JHEC record retention - 15 years minimum !)
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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