Research Project Submissions

The Eastern Health Research and Ethics Committee is constituted and functions in accordance with the National Health and Medical Research Guidelines (NHMRC National Statement on Ethical Conduct in Human Research (2007)).

The Committee considers the following projects for Eastern Health - all drug trials, all trials involving devices, all trials involving genetic testing. Trials involving tissue storage or storage of body fluids, or projects where potentially contentious issues are explored.
All correspondence from researchers subsequent to trial application must include the Ethics Committee Reference Number.

SUBMISSION INSTRUCTIONS

Applications

Eastern Health HREC accepts the DHS Common Application Form. The most current version of the form must be submitted with each new project.

COPIES OF DOCUMENTS REQUIRED:

As of November 2007 printing services are no longer located on the Box Hill Hospital premises. The risk of document loss is low. However as a safeguard it is recommended that researchers now submit additional ELECTRONIC versions of study documents to the Research Office.

Additional electronic copies of the following documents are recommended:
- Cover letter
- Modules 1, 2, 3 and 4 (as required)
- Participant Information and Consent Forms
- Study Protocol & literature reviews
- Questionnaires, diaries and advertising materials
- Protocol amendments
- Final reports

Additional copies of the following documents are NOT REQUIRED:
- Investigator's brochures
- Safety reports
- Annual reports

RESEARCHERS WHO ARE UNABLE TO SUBMIT ELECTRONIC COPIES OF THEIR DOCUMENTS WILL NOT BE PENALISED. Submission will be processed as before. However in the unlikely event that documents are lost in transit it may necessitate a re-submission of documents. This may delay ethical review by the Committee. The Research and Ethics Office cannot be held responsible for these consequences.

Submitting amended documents - clean and tracked copies

- Example of Amended documents acceptable to Ethics Committee

- Why Using Bubbles in amended documents should be avoided?

Clinical Trials

Further documentation is required for Clinical Trials. The following must be submitted (if applicable):

• One (x1) copy of the Clinical Investigator's Brochure
• One (x1) copy of the CTN Form
• Three (x3) indemnities, signed by the sponsor
• One (x1) copy of the Insurance Certificate
• Three (x3) copies of the Clinical Trial Agreement, signed by the sponsor

Please note: ONLY ONE Clinical Trial Agreement will be accepted for ONE Institution which is Eastern Health - no matter how many sites or investigators. There is only ONE legal entity which is Eastern Health.

Please note: The indemnity must be in the Medicines Australia format. The “Indemnified Party” is Eastern Health, 16 Arnold Street, Box Hill, Victoria, 3128.

Eastern Health ABN 68 223 819 017

All Clinical Trial Agreements and Indemnity Forms should adhere to the Medicines Australia Format. Eastern Health is introducing additional fee      for the review of non-standard Medicines Australia format documents.

For the Medicines Australia Format Clinical Trial Agreement Template please use this link:
http://www.medicinesaustralia.com.au/pages/images/MA%20Medicines%20Australia%20Model%20Clinical%20Trial%20Research%20Agreement.pdf

For the Medicines Australia Format Indemnity Form Template please use this link:

Further information on requirements for indemnity forms, clinical trial agreements, certificates of insurance, etc. is available from the Victorian Managed Insurance Authority “Guidelines for Clinical Trials for Department of Human Services Victorian Public Hospital” on the following website www.vmia.vic.gov.au.

Guidelines in relation to ethical considerations relevant to research involving humans are available in the “National Statement on Ethical Conduct in Research Involving Humans” which are available on the NHMRC website http://www.nhmrc.gov.au/publications/synopses/e35syn.htm

If the study uses the services of a department(s) within Eastern Health, you must provide a letter of support from the head of department(s). This is a requirement for all new submissions.

Please send one copy only of each document. Please do not staple documents or place them in folders – documents should be secured with paper or foldback clips. Font used should be no smaller than 11 point Arial.
 

Nursing Research

Submissions for nursing research should be directed to the Senior Research Fellow for Nursing, Dr Trish Livingston, prior to submission to the Committee. Dr Livingston can be contacted by email at trish.livingston@deakin.edu.au.

Attendance by Researchers

This would not normally be required; however, from time to time the Committee may request researchers to attend to explain their project.

Legal Review

All Phase 1 and 2 trials, unsponsored drug trials and trials involving devices are referred for external legal review. This review takes approximately two weeks. All Clinical Trial Agreements and Indemnities are reviewed by Eastern Health corporate counsel.

Patient Information and Consent Forms

Patient Information and Consent Forms should be written in plain language avoiding the use of medical jargon and symbols such as “ ”. The form should include identification of the hospital site e.g. Box Hill Hospital. One document only should be used for multiple sites under the heading of Eastern Health.

All forms must note that, should participants wish to raise concerns or complain about the conduct of the research, Chairman, Eastern Health Research and Ethics Committee, Phone: 9895 3398, is the appropriate contact person.

VMIA recommended documents are preferred and can be found under Application Forms and Guidelines.

Protocol Deviations

Protocol deviations should be reported if:

• the deviation leads to a Serious Adverse Event in which case the deviation will be reported as part of the SAE;
• it involves a consent issue;
  
• it is considered to be a major violation, for example, a participant of child bearing potential is enrolled without a pregnancy test;
• it impacts on safety or patient care or study analysis;
  
• the Principal Investigator determines that the deviation should be submitted.
  

Payments to Participants in Research Projects

The Committee considers it appropriate to offer participants reimbursement for “out of pocket” expenses e.g. travel expenses. It is important that payments should not be seen as inducements to encourage participation in a study. Therefore, payments such as movie tickets, raffles or other “prizes” are not appropriate forms of reimbursement.

Site

Each application must clearly nominate every site within Eastern Health for which approval is being sought (e.g. Box Hill Hospital, Maroondah Hospital, Angliss Hospital, Peter James Centre).

EXPEDITED REVIEW

At the discretion of the Chairperson and where a researcher has pressing time constraints the Chairperson, with the agreement of at least two other members, may approve research involving minimal risks to participants.

Any projects approved by expedited review must be referred to the next meeting of the Committee for ratification.

Research with potential for physical or psychological harm should not be considered for expedited review. This includes drug trials, research involving invasive physical procedures and research exploring sensitive personal or cultural issues.

Ethics fees

A tax compliant invoice and payment must now accompany all ethics submissions that attract a fee. Please refer to current fee schedule.

Researchers who wish to pay fees from an Eastern Health special purpose fund may use an Authority to transfer fee form.

Researchers are reminded that all required documents, payment and tax compliant invoice must arrive at the Research and Ethics office by 5pm on the submission deadline for that month. Please adhere to these timelines to avoid disappointment."