CALVARY HEALTH CARE ACT (CHCACT)
HUMAN RESEARCH & ETHICS COMMITTEE (HREC)
GENERAL INFORMATION FOR RESEARCHERS
Calvary Health Care ACT has two HREC’s – one for the Public Hospital and one for the Private Hospital. They are constituted in accordance with the National Health and Medical Research Council (NHMRC) guidelines.
If you have received ethical approval from ACT Health HREC this does not allow you to undertake your research at Calvary Health Care ACT. You must supply a separate application to Calvary Health Care ACT.
The aim of the HRECs is to ensure that high ethical standards are maintained in research projects to protect the interests of research subjects, investigators and the institution. In carrying out these functions, Calvary Health Care ACT HREC at all times adheres to a number of ethical guidelines including NHMRC guidelines while taking into consideration local cultural and social attitudes.
Additional information can be obtained from our HREC intake contact on 6264 7162 or via email to
When is HREC approval necessary?
Ethics approval should be considered for any study, which involves humans (clients/patients, staff or volunteers) or personal information. Such studies may take many forms and be of either a quantitative or a qualitative nature. There are some exemptions for research involving laboratory samples. Contact the HREC () for details if your research is in this category.
How to apply to the HREC
To apply for Calvary HREC approval you must complete the National Ethics Application Form. Please visit the website at www.neaf.gov.au. NEAF is a dynamic, interactive, web-based tool for researchers of all disciplines to complete research ethics proposals for submission to Human Research Ethics Committees (HRECs). Follow the instructions on the website to complete a research proposal.
Ensure that you add all the attachments and documents listed by the NEAF and make sure that all pages (including the attachments) are numbered sequentially.
Please provide a covering letter detailing the documentation sent and whether you wish to apply to the Calvary Health Care ACT Public HREC or the Calvary Health Care ACT Public Private HREC, Calvary John James or Calvary Retirement Community. Prior to submitting an application for Calvary John James or Calvary Retirement Community, approval to conduct studies at these institutions must first be obtained from the Managers of these institutions and should be included with your ethics application.
All researchers involved in the research must provide their contact details and their signature on the application. Research applications that do not include all signatures will not be tabled for ethical review. This will delay your approval until the next HREC meeting.
Anticipated start dates must be following HREC approval. Applications with start dates prior to HREC approval will not be tabled nor approved. Calvary Health Care ACT does not provide retrospective approval for applications. Incorrectly dated application will not be tabled for ethical review. This will delay your approval until the next HREC meeting.
You should submit 1 electronic copy of your completed application to: prior to the closing date for the next HREC meetings.
Clinical Audit undertaken by Students
While all application should be submitted on a NEAF application, in some very defined areas Calvary Health Care ACT HREC has established a review process for students undertaking a retrospective medical records audit and there is a separate application process for those. Please contact the HREC () if you feel that your research is in this category.
How long does it take?
The HREC meets 6 times a year, generally every 2 months. The closing date for proposals is 3 weeks prior to each meeting. Dates of meetings and closing dates for applications are available on our website. No late applications will be presented for ethical review and instead they will be held over until the next HREC meeting. Following HREC approval, applications are forwarded to the Executive Management Group for operational and resource approval. Following Executive Management Group approval you will receive a formal letter by post informing you of the outcome of your application. If you have gained approval you will be send a formal letter informing you of your obligations to the Calvary Health Care ACT HREC. Failure to uphold your obligations could result in your HREC approval being withdrawn.
What are the charges?
Proposals submitted to the HREC for approval are subject to a Research Protocol Levy.
Calvary Health Care ACT staff Low-risk and research applications / $0Student low-risk projects unfunded / $0
Student low-risk studies funded / $110.00
Research projects funded/unfunded / $220.00
Clinical trials / $4,500
Clinical Trial sub-studies or extensions / $1,800
Amendments to approved projects (Clinical) / $660
Administrative changes and updated Investigator’s Brochure / $165
The levy is paid following the approval process.
If your application involves a clinical trial of a drug or device
It should be noted that all clinical trials require an additional approval process by the Calvary insurers. Following favourable consideration by the HREC, the trial proposal will be sent to the hospital’s insurers for further consideration and approval prior to formal approval from the Calvary Executive Management Group. Researchers should note that they should, therefore, allow extra time for approval of clinical trials.
Please note that no approval will be given for clinical trials in Calvary Private Hospital.
Use of Calvary Staff and/or Equipment
All applications must be accompanied by a completed Estimate of Costs Form, which can be downloaded from the Calvary website. This form is required for approval from the Calvary Executive Management Group. Failure to complete and submit this form will result in your application being delayed or rejected.
Length of Time of Research
Research applicants should be aware that all research is approved for a maximum 3 year period. If your research goes beyond this time period, you must reapply every 3 years in order to continue your study. Failure to do so will result in your ethics approval at Calvary Health Care ACT being cancelled. It is up to the researcher to ensure that their research continues and that their reapplication/s arrives by the due date.
Annual and Progress Reports
Researchers are required to provide annual progress reports and final reports. The submission dates for these reports should be noted in your calendar. CHCACT HREC should also be notified of any changes that occur to your research or researchers, such as, change of address or contact details. Failure to provide this information will result in cancellation of your ethics approval at Calvary Health Care ACT.
Check List
Prior to submitting an application for Calvary Health Care ACT HREC approval, please ensure that you have attached the checklist with the following documents where required:
Essential Documentation / Yes / NoYour fully completed application form
Participant Information Sheet
Participant Consent Form
Liability Insurance Certificate of Currency
Indemnity Cover between the sponsor and investigators
Indemnity Cover between the sponsor and CHCACT
Medicines Australia Form of Indemnity for clinical trials standard
Questionnaire, Surveys, etc
Study Protocol
Protocol Amendment
Subject Diary
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Poster
Visit Schedule
Visit Reminder Card
Physician Referral Card
Notification of intent to supply unapproved therapeutic goods under the clinical trial notification (CTN) Scheme
Copy of PI an Co-I Medical Registration Certificate and personal medical insurance cover
Evidence of Registration of the trial in a publicly accessible register
Other HREC approvals
Investigator Brochure
Any other participant/study documentation
Have you obtained and included all signatures where required?
Is your anticipated start date after HREC approval? (HREC approval will not be provided to retrospective studies)?
Have you provided an Estimate of Costs Form (Required for those intending to use Calvary Health Care ACT staff and/or equipment)
Please also note that the protocol levy is a cost that you will need to include on this form
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