Research

Frequently Asked Questions (FAQ's)

Can I get one on one help? Office for Research Ethics and Governance 'Drop In' Service

The Office for Research has a  'Drop In' Service for researchers seeking advice, clarification or assistance with ethics and governance.

Days:  Tuesday and Friday

Time: 12pm to 1pm

Location: Harold Stokes Building

                 Level 8

                 Office for Research

                 Meeting Table

 

To serve you better and process your submissions in a timely manner, it is appreciated if all appointments outside this time be made via ethics@austin.org.au 

Contracts and all other documents can be submitted in the in-tray at the front desk outside these times following completion of the supplied cover sheet.

Do I need to record participation in research in the patient's medical record?

 

The participant's scanned medical record should include documentation of the participant's consent to research. It should include an outline of what was discussed, including risks. The amount of recording necessary depends on the circumstances of the consent and the amount of information provided on a consent form. It is not necessary to repeat information already documented on the consent form.

 

The signed consent form in its entirety should be sent to Health Information Services (HIS) to be scanned into the participants scanned medical record (SMR). A copy of the signed consent form should be given to the participant for their personal records.

 

Can I use the HREA form instead of the NEAF?

The NHMRC is developing a new form called the HREA (Human Research Ethics Application), which will eventually replace the National Ethics Application Form. However, the HREA is not currently compatible with multi-site applications involving study sites in Victoria.

The NHMRC are closing down the NHMRC NEAF website effective from the 30 June 2017. Please note: This is NOT the same form required for Austin Health submission's please continue to use the online forms site to access the correct form.

 

As such, all multi-site and single site studies must be submitted using the NEAF through Online Forms. The HREA will not be accepted at this time. 

Do I have to book in Governance Submissions to a meeting?

No, Governance submissions can be submitted at any time.

How do I submit Correspondence? eg. Dear Investigator Letters (DIL's)?

Please submit a cover letter providing HREC number and Study Title along with the correspondence document/s to the Office for Research for acknowledgment.

What if my Contract/Agreement is not on a Standard Template?

Any Contract/Agreement submitted to the Office for Research that deviates from the Standard Template must be reviewed by Corporate Counsel following submission to our office for processing.

This may delay the approval/authorisation of a project by several weeks.

What are the differences between identifiable, re-identifiable and non-identifiable data?

 

·         Identifiable: the identity of a specific individual can be determined

·         Re-identifiable: data from which identifiers have been removed and replaced by a code; however it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets

·         Non-identifiable: data that have never been labelled with individual identifiers or from which the identifier has been permanently removed and therefore no specific individual can be identified

 

 

Please refer Chapter 3.2 of the National Statement located at NHMRC National Statement for Ethical Conduct in Human Research

Are you including Radiation in your study?

If your study includes radiation please follow the Radiation Submission Process Flowchart to assist with your project submission requirements.

Please complete the Medical Physicist Report Request Form

and forward the:

to the Radiation Safety Officer prior to submitting your ethics package.

How do I lodge a Clinical Trial Notification (CTN) to the TGA?

As of 01 July 2015, the Therapeutic Goods Administration (TGA) no longer accepts the Clinical Trial Notification (CTN) Form in hard copy. The system is now solely online.

This is a welcome initiative and will enhance the efficiency of governance aspects of clinical trials in Australia.  This is the first in a series of developments to improve and streamline the administrative processes of the clinical trials schemes.  Guidance material for the online CTN form is available at: http://www.tga.gov.au/form/ctn-scheme-forms

 Please note that Austin Health (AH) has adopted the following approach to the e-CTN online system.

 

For EXTERNALLY sponsored CTN clinical trials (NOTE: an external sponsor can be commercial, eg pharmaceutical company, or non-commercial, eg a collaborative group or another hospital)

Upon receipt of the Ethics Approval Letter from AH, the external sponsor will be able to lodge the CTN directly with the TGA, online. 

 

It is requested that the AH principal investigator forward the email confirmation from the TGA and a PDF copy of the lodged CTN to the Office for Research (ethics@austin.org.au) as soon as this is available (This should be provided to investigators by the sponsor). The Office for Research will audit its records regularly to verify compliance with this requirement.

Site details can be found here.

 

For Austin Health sponsored CTN clinical trials (ie Investigator initiated trials where there is no external sponsor)


Upon receipt of the Ethics Approval  Letter from AH , researchers are asked to fill in the CTN template form and CTN fee form and send to Lisa Pedro HREC Manager  for drug trials, lisa.pedro@austin.org.au  or to Kristina Zlatic HREC manager for non-drug trials Kristina.zlatic@austin.org.au  for all device trials requiring notification to the TGA. We have made this arrangement to ensure that a consistent approach is used for trials where AH, through the investigator, assumes responsibility for the trial.  This is an essential risk management activity and will ensure that our institution and our investigators are protected and fully compliant with TGA and insurance requirements. The fees associated with CTN submission for such trials will be processed by AH accounts payable with costs set against the applicable research cost centre.

 

Please direct any questions or concerns about the new e-CTN system to Lisa Pedro, HREC Manager - Drug Trials via email (Lisa.Pedro@austin.org.au) or call on 9496 4035.

 

How do I know if a device is a therapeutic device?

Refer to the Therapeutic Goods Administration (TGA) website for full details.  However in short, a therapeutic device is one that is used in or connected with:

 

  • Preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or
  • Influencing, inhibiting or modifying a physiological process in persons or animals; or
  • Testing the susceptibility of persons or animals to a disease or ailment; or
  • Influencing, controlling or preventing conception in persons; or
  • Testing for pregnancy in persons; or
  • The replacement or modification of parts of the anatomy in persons or animals.

If you are using a therapeutic device outside of its approved indication, you must submit an eCTN.

I have completed my study and I have a CTN/CTX - Do I need to do anything?

The Australian Government Department of Health Therapeutic Goods Administration (TGA) require notification of completion from the Sponsor, this should be made only after the trial has been completed at all sites.   It is not necessary to notify completion dates for individual sites.  

This online form should be used by sponsors of clinical trials to notify the TGA of completion of trials of medicines, biologicals and medical devices conducted under the CTN and CTX Schemes.

For information regarding the role of a sponsor, please see: http://www.tga.gov.au/industry/basics-role-of-sponsor.htm

Please also e-mail a copy of the notification to ethics@austin.org.au (refer to the HREC/Local Reference Number).

Do case reports require HREC approval?

Case reports in medical journals describe and explain the way in which a patient has experienced a particular medical condition. The Consent Form required is to be used for a patient consenting to publication of information about them in a medical journal. In some cases journals may require their own consent form to be signed, for others you may use the Austin Health site specific Consent Form.

Austin Health site specific Consent Form (updated June 2013)

What if my study is a First time in Human Clinical Trial?

In the event that the HREC is presented with a first time in humans phase 1 clinical trial to be reviewed under the CTN scheme, the HREC follows the Protocol for review of First Time in Human Research Proposals under the CTN Scheme developed by the Victorian Managed Insurance Authority (VMIA), insurer of all public hospitals in Victoria.

 

This protocol is designed to assist HRECs to meet their obligations under the National Statement (2007) and the Therapeutic Goods Administration’s Guidelines, Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (2004), by providing a rigorous, standardised protocol for the review of first time in humans trials, which includes access to a comprehensive database of independent experts with extensive expertise in evaluating preclinical data.

 

Please ensure you contact the office for research to discuss arrangements prior to booking the study in for HREC review.