HREC Lodgement Information for Research Applications 2021
|HREC Meeting Dates 2021||Application Closing Dates 2021|
|February 17||January 29|
|April 14||March 26|
|June 23||May 21|
|August 18||July 23|
|October 13||September 24|
|December 15||November 26|
The purpose of the Calvary Public Hospital Human Research and Ethics Committee (HREC) is to ensure the principles of ethically good human research is practised when research is being conducted in this hospital.
CPHB HREC ensures that consistently high ethical standards are maintained and that research undertaken within the hospital protects the interests of research participants, investigators and the institution. In carrying out these functions, Calvary HREC at all times adheres to the ethical guidelines detailed in the NHMRC National Statement while also respecting our local cultural and social attitudes.
Whilst Calvary Public Hospital Bruce (CPHB) work closely with ACT Health we are an independent organisation that is part of the Little Company of Mary.
We accept the same applications that are submitted to ACT Health, however, researchers looking to carry out research at CPHB are required to lodge a separate submission with CPHB HREC. Submissions that are not low risk need to be lodged with a covering letter in plain English outlining a description of the project along with the Protocol, HREA, PICF and all docs related to the project. If the research is low-risk please download the online form to complete.
Ethics approval should be considered for any study which will involve patients, staff, volunteers, personal information, historical information and records access. Such studies may take many forms and be of either a quantitative or qualitative nature.
Contact the HREC (firstname.lastname@example.org) for details if your research is in this category.
To apply for Calvary HREC approval you need complete an Application Form, the links can be found at the end of this document.
CPHB HREC accepts:
- HREA forms with an accompanying letter.
- ACT Health applications with changes to addressee and site specific changes
CPHB HREC will accept REGIS applications once REGIS comes online for CPHB HREC. Information for lodging applications will be updated on this website when REGIS is available to this site.
When lodging an application you need to include a covering letter addressed to:
|Dr Suzanne Smallbane
Cnr Haydon Dr and Belconnen Way
Bruce ACT 2614
|Dr Suzanne Smallbane
P.O. Box 254
Jamison Centre ACT 2614
In plain English (without jargon) the letter should include the following information:
- Name of the project
- An outline of the project
- Name of the head P.I
- The risk level
- The anticipated length of time the study will take
The letter should also include details of the documents sent and name the hospital you wish to apply to: Calvary Public Hospital Bruce HREC, Calvary Hospital Private Bruce HREC, Calvary John James Hospital or Calvary Retirement Community. Please make sure you include contact details.
Prior to submitting an application for Calvary John James or Calvary Retirement Community, approval to conduct studies at these campus’ needs to be obtained.
Include all documents that are relevant. They must be in PDF format and numbered according to the sequence they need to be represented for submission to the HREC e.g.
Please ensure that all pages (including the attachments) are numbered sequentially.
Anticipated start dates need to be following the HREC meeting approval date. Applications with start dates prior to HREC approval cannot be tabled. CPHB HREC is unable to provide retrospective approval for applications and incorrectly dated applications may delay your approval until the next HREC meeting. For consideration of your application please submit an electronic copy of your completed application to email@example.com prior to the closing date for the next HREC.
Calvary has two HREC’s – one for the Public Hospital and one for the Private Hospitals. They are constituted in accordance with the NHMRC guidelines and HREC practice ensures compliance. Both HRECs meet on the same date and work concurrently.
In some defined areas CPHB HREC has established a review process for students undertaking a retrospective medical records audit for which there is a separate application process. Please contact HREC at firstname.lastname@example.org if you feel that your research is in this category.
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 above. Late applications won’t be presented for ethical review and 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 or email informing you of the outcome of your application. The approval letter sets out your obligations to the CPHB HREC. Failure to uphold your obligations could result in your HREC approval being withdrawn.
Proposals submitted to the HREC for approval are subject to a Research Protocol Levy.
|Type of project||Levy|
|Calvary Health Care ACT staff Low-risk and research applications without funding||$0
If funded $125
|Student low-risk projects unfunded||$0|
|Student low-risk studies funded||$110|
|Research projects funded/unfunded||$220|
|Clinical Trial sub-studies or extensions||$2,000|
|Amendments to approved projects (Clinical)||$660|
|Administrative changes and updated Investigator’s Brochure||$165|
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.
Applications need to be accompanied by a completed Estimate of Costs Form, which can be downloaded from this website. This form is required for approval from the Calvary Executive Management Group. Failure to complete and submit this form may result in your application being delayed or rejected.
Please be aware that all research is approved for a maximum 3 year period. If your research extends beyond this time period, you need to reapply to continue your study. Failure to comply may result in your ethics approval being cancelled. It is up to the researcher to ensure that their research continues and that their reapplication/s arrives by the due date.
Researchers are required to provide annual progress reports and final reports. The submission dates for these reports should be noted in your calendar. CPHB HREC needs to be notified of any changes that occur to your research or researchers, such as, change of address or contact details. Staff changes including CVs need to be supplied as ‘Amendments’ to CPHB HREC for noting. Failure to provide this information may result in the cancellation of your ethics approval at Calvary Health Care ACT.
Any application for research involving humans must seek an ethics review from the National Health and Medical Research Council through The Human Research Ethics Application (HREA). Click here to commence that process.
The following application must be completed by any person or organisation other than a student seeking approval to undertake low risk research at Calvary Public Hospital Bruce:
The following application must be completed by any student seeking approval to undertake a clinical audit of medical records at Calvary Health Care ACT:
The following Estimate of Cost must be completed for any research application:
The Following Interim or Final Report template must be completed for any research project:
The following form must be used for any complaints relating to Research and Ethics issues at Calvary Public Hospital Bruce:
|Your 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|
|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|
|Sequential numbering of files|