* Ethics Committee

• Contact Details
• Application Form
• Meeting dates
• Approval Conditions
• Terms of Reference

      Introduction:

The Joint Hospitals' Ethic Committee (JHEC) is constituted and operates in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007).

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

The JHEC 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:

Sharon Williams
Administration Officer
Joint Hospitals' Ethics Committee
Albury Wodonga Health - Wodonga Campus
Phone: (02) 60517546
Fax: (02) 60517477

E-mail: sharon.williams@wrhs.org.au

Meeting dates:

JOINT HOSPITALS' ETHICS COMMITTEE MEETING DATES AND DEADLINES 2008

Meeting Date	Time	Submission Deadline
Wednesday February 18th	1 - 2.30 pm	February 4th
Wednesday April 15th	1 - 2.30 pm	April 1st
Wednesday June 17th	1 - 2.30 pm	June 3rd
Wednesday August 19th	1 - 2.30 pm	August 5th
Wednesday October 21st	1 - 2.30 pm	October 7th
Wednesday December 16th	1 - 2.30 pm	December 2nd

Submissions to the Joint Hospital's Ethics committee must be made to:

Sharon Williams
Administration Officer
Joint Hospitals' Ethics Committee
Albury Wodonga Health - Wodonga Campus
Phone: (02) 60517546
Fax: (02) 60517477
e-mail: sharon.williams@wrhs.org.au

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

Approval Conditions:

Joint Hospitals' 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:

Joint Hospitals' Ethics Committee

Terms Of Reference

TITLE

· The Joint Hospitals' Ethics Committee (JHEC)

FUNCTIONS & OBJECTIVES:

· The JHEC 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 JHEC 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 JHEC 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.

· JHEC 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 JHEC will provide legal protection in respect of liabilities that may arise in the course of bona fide conduct of the duties of committee members.

· JHEC 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 JHEC 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 JHEC 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 JHEC 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 JHEC 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 JHEC 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 JHEC 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 JHEC by the relevant closing date, in writing, in the format specified by the by the JHEC and should include documentation as the JHEC 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 JHEC to have the fee waived.

· All documents and other materials used to inform participants of the research must be approved by the JHEC.

· All approved submissions will be required to follow terms and conditions.

· Applications maybe submitted to the JHEC for expedited review.  Review of such applications will be made at the discretion of the Committee and Chair.

MEETINGS

· JHEC 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 JHEC 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 JHEC.

· The JHEC can approve, require amendment of or reject a research submission.

· Decisions by the JHEC should be reached by general agreement. An extension of time may be required for reconsideration of the proposal and its possible amendment.

· The JHEC 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 JHEC should not communicate directly with a research sponsor except in regard to insurance, administration and indemnity.

· The JHEC 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 JHEC 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 JHEC will be acknowledged in writing within two weeks of receipt of the complaint.

· Complaints against the JHEC or researcher will be handled according to the complaints procedure.

SUSPENSION OR DISCONTINUATION OF RESEARCH

· The JHEC 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 JHEC.

· 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. 

 

Top of Page