The Melbourne Clinic Research Ethics Committee (TMC REC) has a commitment to excellence in clinical research leading to improved patient outcomes.

The role of the TMC REC is to provide leadership for Healthscope facilities in relation to the conduct of medical research in mental health. The main research interests include: psychopharmacology; psychiatry, psychology, cognitive neuropsychiatry; old age psychiatry; youth mental health; service evaluation; and psychosocial research.

The office coordinates the administration of research and ethics activities, and provides advice, assistance and encouragement to all staff wishing to pursue clinical research activities.

It has close partnerships, with a number of Universities primarily with The University of Melbourne; Department of Psychiatry and liaises with external organisations and governing bodies such as the NHMRC.

The main objectives of the TMC REC are to ensure that standards of patient care are not compromised, secondly that investigators and the institution are properly protected and thirdly, to optimise the opportunity for research to be translated in practice.

By seeking ethics approval from TMC REC you are agreeing to conduct the study in accordance with the NHMRC National Statement on Ethics Conduct in Human Research (2007) and as a basic standard agreeing to comply with the Australian Code for the Responsible Conduct of Research (2007) and the ICH Guidelines for Good Clinical Practice (GCP).

The committee also acts as a committee of appeal against decisions and will hear complaints on projects within its purview.

The TMC REC uses as a reference, the NHMRC National Statement in Ethical Conduct in Human Research (2007) in addition, it is expected that all researchers will comply with the Australian Code for the Responsible Conduct of Research (2007) and the ICH Guidelines for Good Clinical Practice (GCP).

These guidelines apply to all persons conducting research within a Healthscope facility.

It is also expected that all researchers are familiar with, and will conform to, the Healthscope Corporate Policy and Procedures in conjunction with the State and Commonwealth laws and principals concerning, privacy, health records, guardianship and their respective administrations.

Further, it is a requirement that the nature of the research is such that it can be integrated with ongoing patient care in a way that complements existing clinical programs.

As Healthscope Hospitals are private hospitals, in addition to the usual Patient Informed Consent, it is required that the researcher first approach the patients treating Consultant Psychiatrist or doctor to grant permission for the involvement of their individual patients in a project; if permission is given then the patient may be approached.

The TMC REC accepts applications for research projects involving clinical work at TMC and other Melbourne based Healthscope Hospitals such as Victoria Clinic and Northpark Hospital in the speciality of psychiatry, mental health and the behavioural sciences.

TMC REC reviews clinical trials of psychiatric and psychological treatment, which may include medication, physical, psychosocial treatments and program evaluation.

TMC REC does not review research projects for Healthscope facilities in a state other than Victoria, nor does it review research projects with a primary Surgical or Medical focus. In these circumstances, it is suggested that you approach the nearest Human Research Ethics Committee registered with the National Health & Medical Research Council in your area.

Such committees are likely to be found at your nearest teaching hospital or university.

Please note that if you do fall under these latter categories once you have received Ethics Approval it is the Principal Investigator (PIs’) responsibility to make the General Manager and the Medical Advisory Committee of the Healthscope facility in which you intend to carry out your project aware of the fact.

Whether collecting data directly or indirectly from a patient it is sometimes difficult to decide whether a project that falls under the banner of Quality Assurance, Program Evaluation or Research. Quality Assurance, Peer Review, and Audit are all terms used interchangeably and fall on a continuum within research.

What matters is that those staff who undertake any of these activities are compliant with the relevant ethical, institutional, State and Commonwealth laws and principals as outlined in the National Statement in Ethical Conduct in Human Research (2007) which deals with this issue – for further information please see the NHMRC website.

If your project is likely to impinge on any of these areas outlined in the statement then the wisest solution is to seek Ethics Approval.

Additionally, be aware that if you intend to publish your Audit or Quality Assurance project that some journal editors insist that a Research Ethics Committee has reviewed the project.

An application for approval of a research proposal should be lodged using the forms obtainable from this web site or they can be obtained by contacting:

Secretariat
The Melbourne Clinic Research Ethics Committee
Professorial Unit
The Melbourne Clinic130 Church StRichmond Vic 3121
Ph: 9420 9353
Email: tmc.research@healthscope.com.au

Documents you need to submit

Cover letter

A formal cover letter to the Chair of the TMC REC requesting a review of the application. This cover letter is to note the study name, Principal Investigator, affiliated institute, and dot point all accompanying documentation for review).

The TMC REC application form.

This form found on this web-site is a summary of the Research Proposal. Please ensure that all contact details for the Principal Investigator and any additional investigators including postal addresses, email and mobile phone number are included on this form.

Full Research Proposal which should cover:

a) An Introduction to the research question, a literature review and key findings, the theoretical underpinnings of the proposed question and the significance of the project.

b) The aims and hypothesis.

c) The methodology, describing the subjects to be recruited and procedures to be used. The method should be fully described and justified. The subjects age range should be described – in particular the use of minors under the age of 18 years, elderly, persons whose capacity to give informed consent may be compromised, persons who may be involved in illegal activities or persons from cultural backgrounds who may require special consideration. All procedures to be used in the study should also be fully described and justified. In particular, access to patient’s records, the administration of any active agents, control substances, therapeutic approaches, placebo or the use of medical devices must be described and justified.

For qualitative research and research using observational methods such as the use of audio tape, video tape and photographs these need to be described and fully justified. A separate Consent Form for these types of recordings should be considered. Likewise, the collection of any medical data such as MRI scans, body fluids or samples must be fully justified. Note that there specific rules governing the collection of DNA samples and a separate Consent Form should be considered for this (refer to the NHMRC National Statement, 2007).

d) You should include details on the estimated time commitment to complete research related tasks for each patient or subject. Any payment or incentives to participants must be described.

e) In the methodology section you should include the proposed statistical analysis. Power analyses should be considered.

f) The plan for disseminating the results.

g) The budget.

h) A reference list.

i) Appendices – the appendices should include all questionnaires, scales, cognitive measures and interviews to be used in the conduct of the study.

PICF is an integral part of the application. The PICF consists of two parts, the Patient Information Form and the Consent Form.

The Patient Information Form should explain clearly for the research subject the purpose of the research, who is undertaking it, why they, the participant have been asked to participate, what their involvement in the study means and each of the tasks they will be required to perform – it may be necessary to do this on a step-by-step basis, the time commitment expected, and all the benefits and risks of the project beyond what they would expect in everyday life.

The Patient Information Form should include all possible side-effects if new investigational interventions are used.

If the study is a randomised clinical trial, explain from the outset what some of the more unfamiliar terms and study procedures are (e.g. placebo, randomization, or blinding). Please do not use medical jargon and abbreviations. General guidelines are found in the web-site below to help researchers ensure they are properly consenting their participants, particularly those with low literacy and intellectual skills.

The participants should also be told what chance they have of getting which drug/intervention (i.e. one in four chances of getting the investigational drug).

You should explain too that placebo means the use of an inactive drug that has no medicinal properties.

If blood samples are to be taken you should explain how many times the samples will be taken during the course of the study and what volume that will be drawn each time, (in mls).

The Patient Information Form must also explain to the participant that their participation is voluntary and that they are free to withdraw from the project at any time without prejudice to their normal treatment.

Explain too how the research team will maintain the confidentiality of their data, especially with respect to the information about the participant which would otherwise be known only to the treating physician but would now be available to the entire research team. When conducting studies which include DNA samples you should be aware that the NHMRC National Statement, (2007) is very specific about the rules governing confidentiality.

The PICF should also provide the name and contact information of someone who is involved, informed and accessible if the participant has any further concerns or questions during the conduct of the study. State also that the proposal has been approved by the ethics committee.

Further, the PICF must detail for the study participant whom to contact if he or she has any complaints about the project – Professor Bruce Singh, Chairman, The Melbourne Clinic Research Ethics Committee. Ph: 9420 9353.

The logo of all participating institutions involved in the study should be on the top of the Consent Form and Patient Information Form. If appropriate, The Melbourne Clinic and Healthscope logos can be requested from The Melbourne Clinic's Business Development Manager, Olga Anthony (Olga.Anthony@healthscope.com.au).

Lastly, if you intend to recruit normal control subjects or staff as subjects they too are afforded the same rights as patients and therefore you are required to obtain written consent from all staff, normal controls and patients who participate in a study.

A template for the Consent Form can be found on this web-site.

The Consultant Psychiatrist Consent Form

The TMC REC requires that researchers first seek permission of the patients treating Consultant Psychiatrist or doctor prior to the patient giving Informed Consent to participate in a project. A template for this is available on this web-site.

Regulatory Documents

If the proposed study is an industry sponsored clinical trial of medication or a physical device then indemnity, insurance and CTN documents should be attached to the submission.

Advertising

If you intend to advertise for research subjects then a copy of the advertising material and the wording to be used in the advertisement must be submitted to TMC REC for review. Whether it is planned to display the advertisement on a noticeboard, or communicated via the radio, or in newspapers or via electronic media etc. – all should be submitted for review.

Curriculum Vitae

If this the application is a first ever application to TMC REC from a Principal Investigator; then a brief Curriculum Vitae for the Principal Investigator (PI) should be attached to the application giving details of research experience and expertise, including grants and publications. The PI is the individual who is ultimately responsible for the conduct of the research. In the case of a student researcher the student’s academic supervisor is the person who is regarded as the PI.

Two (2) hard copies and one electronic copy of the completed Application Form, Proposal and all appendix & attachments, the PICF and the Consultants Consent Form should be forwarded to

Secretariat
TMC Research Ethics Committee Professorial Unit
130 Church St
RICHMOND 3121
tmc.research@healthscope.com.au

The documents should be received at least three weeks prior to the date of the meeting. The hard copies should be double sided on A4 paper. Please do not use folders or inserts that exceed the dimensions of a sheet of A4 paper.

If further information regarding your application is required, please contact the Secretariat.

In the event that the research is to be based in another hospital or institution in addition to a Healthscope facility, evidence will be required that the proposal has been accepted by the ethics committee of that hospital or institution.

The evidence is usually in the form of a copy of the Letter of Approval from that institutions’ HREC.

Non-Healthscope staff wishing to carry out research project in a Healthscope facility must have a Healthscope staff member as a Supervisor or collaborator to act as clinical cover on the project.

If you do not know a Healthscope staff member to approach for this purpose please contact the Secretariat via 9420 9353 or tmc.research@healthscope.com.au

The Committee meets bi-monthly between 2.00pm and 3:30 pm in the Isaac Schweitzer Conference Room at The Melbourne Clinic, 130 Church Street Richmond. The main entrance to the clinic is located in Tweedie Place.

Prior to the meeting the TMC REC Secretariat will advise you of your appointment time by email.

Parking is available at the rear of the Clinic adjacent to the main entrance.

The principal researcher of the research group will be requested to attend the meeting of The Melbourne Clinic Research Ethics Committee to present a brief outline of the study and answer any questions the Committee may have. Other investigators may also attend.

If the project is a student research project, the Committee invites the student to attend in addition to the supervisor.

Following approval by the Research Ethics Committee, the applicant will be notified in writing. A written undertaking will then be sought from the researcher/s.

By signing the agreement you agree to comply with the stated requirements of The Melbourne Clinic Research Ethics Committee. Projects will be granted approval for three years with the option to reapply at the end date for an extension.

If no extension is applied for then approval for the project will be terminated.

Once your project has been approved you will be allocated a Project Number please use that number to identify your study in all future communications with the Ethics Committee.

Submission Dates

• 27 January
• 7 April
• 26 May
• 28 July
• 29 September
• 1 December

Meeting dates

• 10 February
• 21 April
• 9 June
• 11 August
• 13 October
• 15 December

All clinical trials of investigational products, such as devices and randomised controlled trials of medications and or psychosocial interventions should be registered prospectively on a publically accessible Clinical Trials Registry website. An example is the Australian New Zealand Clinical Trials Registry (ANZCTR). The purpose of registration is to promote access to information about all clinical trials. Registration is a requirement of the National Statement on Ethical Conduct in Human Research (2007) and the Australian Code for the Responsible Conduct of Research (2007). The number allocated by the registry should be forwarded to the Secretariat.

Please note that the submission of most projects and all industry-sponsored projects will incur a fee.

Please contact the Secretariat for information regarding fees.

Fees are payable before submission.

Amendments

All changes to the conduct of an approved project are to be submitted in writing with a covering letter to the Chair briefly outlining the reason for the proposed change. This applies to changes in all study documents including, Protocols, Patient Information and Consent Forms, study Advertising, safety information such as Investigators Brochures, or any changes to study staff or study sites. It is the responsibility of the study staff to ensure that insurance, indemnity and CTN documents are updated on or prior to their expiry date throughout the study and the updated documents are forwarded to the Committee for approval.Changes in updated documents are to be provided in both track changes and clean copies. In the footer the updated version should be given a new date, version number and all pages should be numbered.The committee requires that two hard and one electronic copy of the amended documents are forwarded to the Secretariat.

Safety & Adverse Events Reporting

For investigator initiated studies - the TMC REC requires written notification of all serious and non-serious adverse events at the next committee meeting date following the event.

A serious adverse event is any undesirable experience associated with a research project.

The general rule of when to report an event is when the event does not fit the expected outcomes for all subjects enrolled in the study or the event jeopardizes the subject so that he/she requires medical or surgical intervention or prolonged hospitalisation.

Death of a subject must be reported within 24 hours.

For industry sponsored studies - six monthly line listings of SUSARS are acceptable.

Change of PI Contact Details

Any changes to the PI contact details must forwarded to the Secretariat as soon as possible.

Annual Reports

Progress reports on the research are required annually, usually prior to the last meeting date in December.

You will be sent a form for completion in advance of the December meeting.

It is expected that completed research projects will be submitted for publication, and the participation of The Melbourne Clinic Research Ethics Committee should be appropriately acknowledged.

At the time of the Annual Report a copy of published papers should be provided to the Secretariat for the Research Ethics file.

Ethical complaints or any complaints about the conduct of a research study should be forwarded in writing to the Chair. Information about the method for making a complaint is to be available to research participants via the Patient/Subject Information Form. To obtain an address for the Chair please phone the Secretariat on 9420 9353.