Applications for single site ethical review by the Barwon Health Human Research Ethics Committee

 Project Number | Application (low/negligible risk) | Application (standard) 

Forms | External Applicants | Minimising Duplication | FeesHow to Submit | Dates

Legal and Regulatory Requirements | Dangerous Goods Courses |Section 19(5)

 

Project Number

All projects are identified with a unique number that remains for the life of the project.

Internal applicants: please register on the Activity Register .

External applicants : Please request a project number by emailing hrec@barwonhealth.org.au   before submission stating:

  • Principal investigator
  • Research team
  • Full Title
  • Project type ( eg audit, clinical trial , clinical research)  

If you have any queries, please contact the Research and Ethics Office on (03) 5226 7978.   

Application for low/negligible risk 

If the project involves negligible or low risk ,  that is where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience, full ethical review may not be required.

Please complete the following 

o       Module 6

o         Low risk application

   

  

This might also apply to any projects which while not strictly research also require ethics approval (for example if you intend to publish).   

Application for greater than low risk 

If the project is greater than negligible or low risk , full ethical review is required.

You may use:

·         Module 6

·         Module one from the Common Application Form (CAF)

·         Any other modules relevant to your project

                   http://www.health.vic.gov.au/ethics/single/common_app_form.htm

 OR

·         Module 6

·         NEAF

                    https://www.neaf.gov.au/Default.aspx   

Participant Information and Consent forms

Please note that it  is expected that information and consent forms comply to the proformas provided on the DHS website

http://www.health.vic.gov.au/ethics/single/common_app_form.htm#download

 Participant Information and Consent Form - Health and/or social science (79kb, MS Word)  Participant Information and Consent Form - Clinical drug/device (152kb, MS Word)

Participant Information and Consent Form - Clinical non drug/device (115kb, MS Word)

 External Applicants

  If you are an applicant who is not a staff member of Barwon Health you must include at least one senior member of staff on the research team whose role is to be the  ‘organisational sponsor’ of the project. Although this  person should be a senior staff member, their role should not prevent them from having a close working relationship with the project. It is preferred that this person is a co- researcher but at minimum must have a working knowledge  of the project.  This person acts as a resource and provides oversight of the external researcher’s activities in relation to Barwon Health (eg which services should be contacted regarding the application, managing the confidentiality agreement, determining  whether or not a police check in required, or the type of badge required.

Fees

Fees apply for certain categories of applications 

Committees

CMH Research Governance Committee for Community & Mental Health projects only)

 All projects involving Community and Mental Health sectors must be approved by this committee, which has been established to monitor research, quality assurance and audit projects proposed and conducted within Community & Mental Health.

Research Review Committee (RRC)

All research are  reviewed by the RRC, which has been established to review projects from a technical, scientific and governance perspective and make recommendations to the HREC. The RRC may approve low or negligible risk projects.

Human Research Ethics Committee (HREC)

The Barwon Health HREC  is constituted and operates in accordance with the NHMRC Statement on Ethical Conduct in Research Involving Humans (2007). All projects of greater than low risk or those involving ethical issues must be reviewed by the HREC

Submitting your application to the Ethics Committee

To submit an application, download the appropriate form and complete.  

You will then need to submit one  complete signed paper original and one complete electronic copy

to the Research and Ethics Office. The same application is used by all reviewing Committees.

 

The application  includes items such as completed indemnity statements, CVs, CTN forms and clinical trial research agreements (CTRAs) which are to be signed and placed with the original, paper application. The submission will be checked for completeness by the office and any omissions or changes requested will be conveyed to you by email.

Responding  to the Ethics Committee

Ethics review may involve one or more committees.  We endeavour to make this as transparent  as possible therefore please submit your response to queries and amended documents only. Do not resubmit a new application

 Minimizing the Duplication of Review

 The National Statement on Ethical Conduct in Human Research (2007) requires that organizations minimize the duplication of ethical review of research proposals (National Statement 5.3). Research which has received ethics approval by a Human Research Ethics Committee constituted in accordance with the National Statement (Sections 5.1.26 – 5.1.37), may not require additional ethical review. However application must be made to the RRC for consideration prior to commencement. The RRC determines if further review is required.

Dates

The RRC and HREC meetings are held monthly with agenda closing two weeks prior. Please note that due to administrative pressures, it may be impossible to accept late submissions.

Legal and Regulatory requirements

Commercially sponsored applications are usually accompanied by an indemnity statement, a current insurance certificate and a Clinical Trial Research Agreement.

Guidelines for compensation for injury resulting from participation in a company-sponsored clinical trial    Medicines Australia - Guidelines for Compensation (85kb, PDF)

Clinical Trials Research Agreement - Medicines Australia

Form of indemnity for clinical trials

Form of Indemnity for Clinical Trials (76kb, MS Word)

Form of Indemnity: HREC review only

Clinical Trial Notification (CTN) Scheme Form

CTN Form (55kb, PDF)

Registration of Clinical Trials 

The International Committee of Medical Journal Editors (ICMJE) has adopted a policy that the member journals will only consider publication of clinical trials if the trial has been registered in a World Health Organisation (WHO)-accredited clinical trial registry. Click on the links below for more information.

Trials can be registered with:

The ClinicalTrials.gov registry of the US National Institutes of Health and developed by the National Library of Medicine: http://www.clinicaltrials.gov.

The NHMRC–developed, Australian Clinical Trials Registry (ACTR): http://www.actr.org.au 

Dangerous Goods Courses

Who should do a dangerous goods course?  

Shippers: people employed to send dangerous goods by air must do an approved course. This covers employees who do any of the following:

  • enclose the goods in packaging 
  • mark or label the consignment 
  • prepare a shipper's declaration

Training Requirement

 Readers should note that Part 92-120 of Civil Aviation Safety Regulations 1998 requires that shippers of ALL dangerous goods be trained. This includes UN3373 prepared in accordance with Packing Instruction 650, whether or not it is packed with a medium or another substance that is dangerous goods. Training is also required for shippers who ship “exempt” material on or with a medium or substance that is dangerous goods; these include dry-ice, formaldehyde, alcohol etc. For further information contact a CASA Dangerous Goods specialist on 131 757.

 

Authorisation under Subsection 19(5)  Therapeutic Goods Act 1989

  • Subsection 19(5) authorisations allow a doctor to prescribe drugs that are not marketed in Australia, but are available from a supplier under the Special Access Scheme (SAS).  It saves the inconvenience of applying on behalf of individual patients.
  • Subsection 19(5) authorisations are available to practitioners who have the expertise and information to judge whether treatment with an SAS drug is appropriate for individual patients, and who see numbers of such patients.
  • An independent body has to endorse the practitioner (ie, attest that he/she has the special expertise required) before TGA will consider the application.  The TGA accepts that the ethics committee of a teaching hospital can provide this endorsement for “a medical practitioner who is engaged in clinical practice at (the) hospital”.  At Barwon Health , the Head of Pharmacy evaluates applications from clinical staff and makes recommendation to  the Human Research Ethics Committee regarding endorsement.

 

Application and report details

 

 

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