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Research

Human Research and Ethics Committee

Human Research and Ethics Committee

The Human Research Ethics Committee (HREC) is a multi-disciplinary committee established in accordance to the National Health and Medical Research Council (NHMRC) requirements, specifically the National Statement on Ethical Conduct in Human Research (2007). The committee’s objective is to consider applications and to ensure that research conducted within the hospital complies to the NHMRC principles and any issues arising from these projects are administered by a properly constituted committee.

The Human Research Ethics Committee (HREC) consists of as far as possible equal numbers of men and women, at least one third of whom are not emplyees of The Royal Victorian Eye and Ear Hospital. The committee shall include the core members;

  • The Chair
  • At least two members who are lay people, one man and one woman with no affiliation with the hospital and not involved in medical or legal work
  • At least one member with knowledge of, and current experience in, the professional care, counselling or treatment of people, for example a nurse or allied health professional
  • At least one member who performs a pastoral care role in a community, for example a Minister of Religion or an Aboriginal Elder
  • At least one member who us a lawyer, where possible one who is not engaged to advise the instituition
  • At least two people with current research experience that is relevant to the type of research to be considered at the meetings they attend

Please refer to the Forms and Documentation section for the latest version of template forms. If you would like further information in relation to how the Human Research and Ethics Committee works and the reporting process, please refer to the General Information document.

Clinical Trials Information

A project is considered a drug/device trial if it involves allocating participants to an intervention that is a medical device, medicine or other therapeutic good, whether or not the product is approved for the particular use under investigation.

For all clinical trials which are conducted under the Therapeutic Goods Association (TGA) Clinical Trial Notification (CTN) Scheme, the application will need to be submitted to the Hospital’s Insurers (VMIA) prior to approval being granted. VMIS has specific guidelines for applications which are found here.

Commercially sponsored applications are usually accompanied by an indemnity statement, an insurance certificate and a Clinical Trial Research Agreement (CTRA). There are certain requirements regarding the wording of these documents and applicants and commercial sponsors should be familiar with these. Any agreement that is not submitted using one of these templates will not be accepted by the Eye and Ear Hospital. Please ensure that the documents are signed by sponsor and researcher prior to submitting to the Research and Ethics Office.

Clinical Trial Research Agreements

The Victorian Managed Insurance Authority (VMIA) in collaboration with interstate health departments and industry agencies, have approved Medicine's Australia Standard Clinical Trial Research Agreements (CTRA's), as listed below. In addition, the VMIA in collaboration with the Medical Technology Association of Australia have approved a Clinical Trial Research Agreement for clinical trials involving devices.

Indemnity

The Eye and Ear accepts the Medicine’s Australia Standard Form of Indemnity for clinical drug trials and for studies involving a device accepts the Medical Technology Association of Australia Standard Form of Indemnity. The Institution or Indemnified Party for the purposes of any legal documents (i.e. Indemnity or CTRA) is to be named as ‘Royal Victorian Eye and Ear Hospital, ABN 81 863 814 677, 32 Gisborne Street, East Melbourne, VIC 3002'.

Certificate of Insurance

A Certificate of Insurance is to be included with the application submitted to the Human Research Ethics Committee (HREC). The certificate of insurance must contain:

(i) Evidence that the policy will be current throughout the entire period in which the clinical trial is conducted; and

(ii) Contain insurance coverage for a minimum amount AUD$10 million for any one occurrence and in the annual aggregate. The Insurance Policy must not contain an excess/deductible greater than AUD$10,000 for each and every claim or series of claims arising out of one originating cause.

VMIA may exercise its discretion by approving insurance arrangements for less than $10 million and/or a deductible greater than $10,000. This consideration may include such matters as the following:

  • The level of clinical risk associated with the trial
  • The financial strength of the insurer
  • The financial strength of the commercial clinical trial sponsor

The Pharmacy Department also have requirements relating to the conduct of clinical trials. If you require the services of the Pharmacy Department, please ensure that you have liaised with the them prior to submitting the application.