The Avenue Hospital

Human Research & Ethics Committee

The Avenue Private Hospital actively encourages and supports clinical research as part of its role as a private hospital.

The focus on research provides an environment in which The Avenue’s accredited clinicians can maintain their knowledge and expertise at the forefront of clinical practice.

The HREC Coordinator can provide information and advice on research at The Avenue. The Coordinator can be contacted via email: BaldwinMonique@ramsayhealth.com.au.

The Avenue's Research Ethics Committee is constituted in accordance with the National Statement on Ethical Conduct in Research Involving Humans 2007 (and its Amendments) and reports annually to both the NHMRC & Health Services Commissioner.

This committee has wide representation, encompassing medical practitioners, researchers, a lawyer, a clergyman and community representatives.

Meetings are held every two months. All research involving human participants undertaken at The Avenue must be reviewed by The Avenue's Research Ethics Committee.

Ethics approval is granted when the committee is satisfied that the conduct of the proposed research is ethical and lawful.

The HREC is constituted to review research proposals for properly credentialed staff of The Avenue Hospital or other Ramsay Hospitals in Victoria where there is no affiliation with another properly constituted HREC. The aim is to ensure that Ramsay Hospitals are only engaged in research projects that maintain high ethical standards to protect the interests of research subjects, investigators and the institution.

Six Meetings are held yearly on the 3rd Tuesday of each second month starting in February.

(Dates may change depending upon availability of both Members and Venue.)

 

Meeting Date

Study Closure Dates**

First Meeting

21 February 2017

24 January 2017

Second Meeting

18 April 2017

21 March 2017

Third Meeting

27 June 2017

30 May 2017

Forth Meeting

15 August 2017

18 July 2017

Fifth Meeting

17 October 2017

19 September 2017

Sixth Meeting

28 November 2017

1 November 2017

**All new research proposals and updates should be in hand one month prior to the meeting date to allow proposals to be checked for errors / omissions and for Committee Members to have adequate reading and preparation time.

As stated on the CCHRE (Consultative Council for Human Research Ethics) Website "The purpose of a clinical trial is to evaluate new approaches to treat particular conditions or diseases. This involves doing research under controlled conditions to find how people respond and what side effects may occur as a result of a treatment."

All research projects involving human subjects to be conducted at The Avenue Private Hospital must be submitted through the Ethics Coordinator who will forward the protocol to the Ethics Committee for ethical approval. Ethical approval must be obtained before any research projects may commence.

Investigators who only want to modify routine diagnostic or therapeutic procedures and are unsure whether to submit a full proposal are encouraged to submit such proposals for the Committee’s opinion. The Ethics Committee considers that each case should be judged individually.

Patient related projects that involve control subjects or compare two or more alternative treatments, are considered research and must be submitted for approval.
Whether a study is deemed to be a quality improvement activity or a research project depends on the intent of the researcher. The same data collected from the same subjects in the same way could equally constitute an audit or a research project depending on the intention of the person collecting it. The “intent” and what constitutes research should be considered with the following points:

  • Purpose of the study (whether it is to evaluate a service versus acquisition of knowledge about mechanisms or relationships);
  • Dissemination (limited to a department or (at most) the hospital versus the broader scientific community) - any project that is intended to be published outside the institution is research and must be considered;
  • Data analysis (simple tabulation or frequency distributions versus statistical analysis);
  • Hypothesis formulation (aim is simply to evaluate or measure efficacy or worth versus to confirm or refute one or more prior hypotheses);
  • Likely action as a result of the findings (modification to service delivery within a circumscribed geographic setting versus implications for action of potential impact on the broader community).
  • The remuneration if any that the researcher is receiving for the research. If it is based on recruitment or activity through a trial please specify.
  • Any financial remuneration that the subjects may receive. Include any reimbursement of costs such as travel etc.

The Ethics Committee encourages researchers to submit proposals for the Committees’ opinion where there is doubt as to whether the project constitutes research or quality improvement.

For studies associated with interventional clinical trials and ongoing activities relating to clinical trials it may be appropriate to submit a Low and Negligible Risk Form for ethics approval. Such research could include observational research and evaluation of a trial, developing a registry and other post-marketing surveillance activities.

Before completing the Victorian LNR Application Form, discuss the research project with the HREC Coordinator who will provide advice regarding whether a VIC LNR Application Form or National Ethics Application Form (NEAF) is appropriate for your research.

PROPOSAL FORMAT

We adhere to minimal paper use and therefore require you to provide:

  • One completed / signed hard copy –ensure identifying trial number and version numbers are in the footer with each application / modification / amendment. Please contact the HREC coordinator prior to submission who will provide you with a trial reference.
  • One soft copy of the same document –ensure identifying trial number and version numbers are in the footer with each application / modification / amendment. Please contact the HREC coordinator prior to submission who will provide you with a trial reference.
Deliver documents to – The Avenue Ethics Coordinator
40 The Avenue
WINDSOR VIC 3181
Email to:

BaldwinMonique@ramsayhealth.com.au or

hrec.tah@ramsayhealth.com.au

Note - Please be aware that as per DHHS Vic Health reporting guidelines, unless valid reasons are given, trials must commence within 12 months of approval.

If the project is not commenced within 12 months of approval then the approval becomes void and a new proposal will need to be submitted.

In all cases sufficient detail should be given to allow a valid assessment of the ethical issues involved.

PROTOCOL
All research studies, including low and negligible risk studies, require a protocol. It is also advisable that all clinical audits should have a formal written project plan.

FULL APPLICATION
The Avenue's Research Ethics Committee will accept research applications submitted on the latest NEAF version which is available through Online Forms (au.ethicsform.org/SignIn.aspx). Email a copy of the completed NEAF to The Avenue Ethics Coordinator.

Or - (www.health.vic.gov.au/clinicaltrials/application-instructions.htm).

Alternatively, research applications can be submitted using the HREA (Human Research Ethics Application) available at hrea.gov.au. Email a copy of the completed NEAF to The Avenue Ethics Coordinator. Please note, researchers need only complete the NEAF or the HREA, not both.

The application should also include the Victorian Specific Module – (docs.health.vic.gov.au/docs/doc/Victorian-Specific-Module)

Please read the Guidelines for the Victorian Specific Module to assist in completing the form.
docs.health.vic.gov.au/docs/doc/Victorian-Specific-Module-Guidelines

LOW AND NEGLIGIBLE RISK APPLICATION
For Low & Negligible Risk applications the standard forms and guidelines are available from (www.health.vic.gov.au/clinicaltrials/application-instructions.htm) or through Online Forms (au.ethicsform.org/SignIn.aspxwww.neaf.gov.au). Email a copy of the completed LNR VIC, together with all other supporting documentation, to The Avenue Ethics Coordinator.

PARTICIPANT INFORMATION SHEET
A Patient information sheet must accompany each consent form. It must be written in simple language and contain minimal or neither technical terms nor jargon. It is also to be given to, and remain the property of, the patient or volunteer. A copy of the Patient Information Sheet should accompany the proposal when it is submitted to the Committee. The Committee also requires the Patient Information Sheet to include the version number and the date it was prepared/amended.

CONSENT FORMS
An adequate consent procedure is necessary to ensure that the interests of the subjects, the researcher and the institution are properly protected. The Ethics Committee requires all applicants to submit for approval a consent form for each study or else to justify why this is considered unnecessary. The Committee also requires the consent form to include the version number and the date it was prepared/amended.

Participant Information and Consent Forms (PICF) are available via –

  • All research studies, including low and negligible risk studies, require a protocol. It is also advisable that all clinical audits should have a formal written project plan.
  • Applications should also contain any recruitment letters, questionnaires, advertisements, diaries that will be used during the trial.
  • New Researchers must provide a copy of their recent C.V.
  • If a researcher is a student we require confirmation from the educational institution in question that students are both adequately experienced and qualified, or will be supervised.

Whenever a patient is involved in a drug trial they should be provided with a card to carry on their person identifying the name of the study as well as containing relevant information on the drug, the study and appropriate contact numbers in case of an emergency. Details about this should be included in the proposal.

Where a full NEAF Application is required the researcher must be prepared to meet with the Committee to present their research proposal and answer any questions raised. If the researcher is a student we require their supervisor to also attend.

Individual presentation times will be notified and 15-20 minutes only are allowed for presentation and question time combined.

Committee response / decision will be notified to the researcher as soon as practicable following the Committee meeting. Should amendments be required the approval times will be dependent upon researcher response.

All protocols must be submitted to the Ethics Committee Coordinator no less than four (4) weeks prior to the meeting. Any protocols submitted after this time will not be considered until the next meeting. Closing Dates for the year are available on the Ethics Committee Meetings Calendar or available from the Coordinator upon request. BaldwinMonique@ramsayhealth.com.au

It is the responsibility of the Researcher to notify the Ethics Committee of: -

  • Any adverse events
  • Any safety updates
  • Any amendments required to the protocol as originally approved. All amendments will require further approval by the Committee. Version numbers and date must be displayed on new material. Please supply a clean and tracked version of the amendments.
  • Changes to researchers / contact details
  • Failure to commence the trial within 12 months of approval (amendment)

Please use the templates found ‘Monitoring and reporting‘ on the following website – www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/monitoring-reporting.

  • As a condition of approval The Avenue Private Hospital Ethics Committee requires the submission of a Progress Report on an annual basis. The template link will be sent to the chief investigator each year and the form should be completed and forwarded back to the Secretary by the requested date.
  • The Committee also request a list / copy of any publications that have arisen from the research be forwarded at this time.
  • All trials being performed within a Ramsay Health Care facility are required to be acknowledged by the site CEO or Medical Advisory Committee (if outside The Avenue / Masada PH). This is to ensure the facility has the capacity and willingness to support the trial / project to its conclusion.
  • Once documents are in hand the HREC Coordinator checks your proposal for obvious errors / omissions prior to presentation to enable early amendment / correction.
  • Once study material is checked for completeness, you will be notified of a presentation date and time.
  • All trial materials are forwarded to Committee 3 weeks before each meeting.
  • Trial materials are also sent to Ramsay Health Care Legal Counsel to be checked for risk and liabilities. (Acknowledgment from the Legal Department is required before a trial may commence).
  • A presentation to the HREC is requested for all NEAF trials and at presentation you are allowed time to give a 10 minute overview of the study, which will be followed by Q&A time with the HREC members (10mins approximately). Presentation style is of your own choice. Please notify us of any IT requirements.
  • Following your presentation you will receive approval / notification of any amendments / changes required by the HREC. Once any amendments are returned they will be sent to HREC members for comment / approval. (This is usually achieved via E-mail however if further discussion is required it may be held over until the next HREC meeting date.)

No trials can proceed until all approvals are in hand i.e. HREC members / Ramsay Legal Department & in the case of Ionising Radiation possibly that of the Radiation Advisory Committee

  • LNR Trials are usually dealt with outside of the meetings and no presentation is normally required. If clarification is required at all, this would normally be done via e-mail or phone.
  • Trials will be considered as current provided that, for the duration of the trial (four years maximum) you provide satisfactory ongoing information to the Committee in the form of the annual Progress Report. You will receive a reminder and appropriate form when due.
  • If the project has run for four (4) years and is still ongoing you will need to complete and submit a final report and submit a new application for the project. The four year limit on renewal of approvals allows the Committee to fully review research in an environment where legislation, guidelines and requirements are continually changing.
  • A Final Report and a copy of any published data are required at the end of the trial.
  • Failure to provide an annual Progress Report may result in withdrawal of ongoing approval and may jeopardise future trial approvals unless valid reasons can be given.
  • If the project is not commenced within 12 months of approval then the approval becomes void and a new proposal will need to be submitted unless valid reasons are received.

Note - All reports should be submitted using the forms as specified on the CCHRE Website (‘Monitoring and reporting‘ ) – (www.health.vic.gov.au/clinicaltrials/application-instructions.htm)

There are no fees for non-sponsored trials.

A flat fee of $4,400.00 (inclusive of GST*) will be charged to all commercial companies submitting research proposals. This fee is common to all ethics committees and is to cover costs of assessment.

This is a once-off upfront fee (non-refundable) for commercially sponsored drug and device trials. This covers all amendments throughout the period of the trial.
If the sponsor is an overseas company a local contact must be given.

To allow the sponsor sufficient time to raise a cheque so that it may be submitted with the initial application, the Principal Investigator must advise the HREC Coordinator of the following information as soon as possible so that a complying tax invoice can be generated as required by law:

  • clinical protocol number version & date
  • sponsor's company name
  • local contact name
  • address & phone number

Researchers should ensure that this fee is included in the budget/contract with the sponsoring company.

Cheques are to be made out to Australian Hospital Care (The Avenue) Pty. Ltd.

Alternately the Hospital ABN is 12 072 759 338

* GST is not payable if the sponsor is an overseas company and does not have an Australian subsidiary and there is no Australian-based contract research organisation supporting the sponsor for the study. As a rule, the same applies if the sponsor is an overseas company and the agreement is between the sponsor and the Principal Investigator and data are sent directly to the sponsor even if support is being provided by an Australian-based contract research organisation.

External Agencies and Pharmaceutical companies sponsoring trials must indemnify the Committee and the institution at which the study is to be undertaken. The investigator should identify in the application what indemnity is provided for the study.

External Agencies and Pharmaceutical companies sponsoring trials must provide evidence of insurance to the Committee to support the indemnity provided.

The Committee can resolve to take applications from other Victorian Ramsay hospitals. In such a case the sponsoring companies or entities will have to ensure that the host institution is indemnified in accordance with the Ramsay Modified indemnity, a copy of which can be sent by the Ethics Coordinator.

In circumstances where the commercial sponsor of the study is an international sponsor, a local sponsor must be appointed. It is the local sponsor in such cases that must provide the indemnity to the Committee and the host institution.

No study may commence at a Ramsay institution until such time as the Committee and the relevant Ramsay institution has received the appropriate indemnity from the sponsor.

In addition to the indemnity mentioned above, any commercially sponsored trials will not be able to be undertaken in a Ramsay facility until such time as a Clinical Trial Agreement is executed between the sponsor, the investigator and the Ramsay facility at which the trial will be conducted.

Note - A copy of the Ramsay approved Clinical Trial Agreement can be obtained from the Coordinator of the Ethics Committee on request.

Guidelines for the Protection of Privacy in the conduct of medical research have been approved by the Commonwealth Privacy Commissioner under Section 95A of the Privacy Act 1988 and the Privacy Amendment (Private Sector) Act 2000. Health and research ethics guidelines links can be accessed at the National Health and Medical Research Council (NHMRC) web site – www.nhmrc.gov.au/guidelines-publications/e72

If a proposal breaches or might breach an APP (Australian Privacy Principle) then the researcher is required under the Privacy Guidelines to provide a written statement in the protocol stating the reason for believing that the public interest in the research outweighs the public interest in adhering to the particular privacy principle(s).

Aspects of privacy and confidentiality that require special consideration include:

  • For research requiring access to records of personal information, including the medical record, consent should generally be obtained. In certain circumstances the Ethics Committee may approve the granting of access to records without consent.
  • Identifying information must be physically separated from the study data at the earliest possible time. The study data and code dictionary must be stored securely in a locked filing cabinet and there should be password access for computer data storage systems. The mechanisms to be used to safeguard the security of the research records must be included in the protocol.

Information obtained for research that is confidential or personal, must not be used for purposes other than that specified in a written research protocol. If the information is to be used for new research, a new protocol is to be submitted to the Ethics Committee.

Specific consent from participants should be sought if any information which could identify subjects is to be published.

When submitting a study protocol to the Committee, researchers should disclose all affiliation with, or financial involvement (actual or potential or remuneration from) in any organisation or entity, which has a direct commercial interest in the proposed research.

The National Health & Medical Research Council requires original data to be kept at least

  • 7 years for clinical research
  • 15 years for clinical trials (device / drugs)
  • 23 years for clinical trials involving children.

This may require researchers keeping tissue sections if this information is required to validate the results if questioned in the future.

The Ethics Committee will generally maintain their records of studies for at least seven (7) years and longer as necessary.

Complaints by researchers or study subjects should be directed initially to Monique Baldwin, Ethics Coordinator/Secretary via email BaldwinMonique@ramsayhealth.com.au. Complaints will then be communicated to the Chairperson. The Ethics Coordinator/Secretary and the Chairperson will then arrange to meet with the complainant in order to resolve any issues.

CURRENT CHAIRAssociate Professor Wendy Brown

Any problems / cancellations or for further information regarding any of the above please contact –

Monique Baldwin, HREC Coordinator via E-mail – hrec.tah@ramsayhealth.com.au Or BaldwinMonique@ramsayhealth.com.au

Or call 03 9526 5396