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 (ethics@calvary-act.com.au) 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:

Delivered Postal Address
Dr Suzanne Smallbane
Chairman
CPHB HREC
Cnr Haydon Dr and Belconnen Way
Bruce ACT 2614
Dr Suzanne Smallbane
Chairman
CPHB HREC
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.

  • Sampledoc.pdf
  • Sampledoc.pdf
  • Sampledoc.pdf

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 ethics@calvary-act.com.au 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 ethics@calvary-act.com.au 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 trials $4,500
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:

Non-Student HREC application low risk

The following application must be completed by any student seeking approval to undertake a clinical audit of medical records at Calvary Health Care ACT:

Student HREC application low risk

The following Estimate of Cost must be completed for any research application:

Estimate of cost form final

The Following Interim or Final Report template must be completed for any research project:

Interim or Final report template

The following form must be used for any complaints relating to Research and Ethics issues at Calvary Public Hospital Bruce:

Complaints form

Essential Documentation Yes No
Covering letter
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
Study Protocol
Protocol Amendment
Subject Diary
Advertisement
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
pdf Format
Sequential numbering of files