HREC Lodgement Information for Research Applications 2023

 

HREC Meeting Dates 2023 Application Closing Dates 2023
February 15 January 25
April 26 March 24
June 21 June 1
August 16 July 26
October 18 September 27
December 6 November 13

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 members ensure 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.

 

Ethics approval should be considered for any study which will involve patients, staff, volunteers, personal information, historical information and records access. Such studies can take many forms and be of either a quantitative or a qualitative nature.

Contact ethics@calvary-act.com.au for further information.

To apply for Calvary HREC approval an Application Form is required, the links can be found at the end of this document.

CPHB HREC accepts

  • HREA forms with an accompanying letter for any study greater than low risk
  • ACT Health applications with changes to addressee and site specific changes for low risk applications.

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.

All applications need to be accompanied by a covering letter addressing the following points and emailed with the application to: ethics@calvary-act.com.au

In plain English (without jargon) the covering letter should include the following information:

  • Name of the project
  • An outline of the project
  • name of the Principal Investigator (P.I)
  • the risk level
  • the anticipated length of time the study will take
  • contact details of the P.I. including email address and names and email addresses of other contacts who will need to receive correspondence from Calvary

The letter should also include details of the documents sent and name the hospital you wish to apply to: Calvary Public Hospital Bruce, Calvary Hospital Private Bruce, Calvary John James Hospital, Clare Holland House or Calvary Retirement Community. P.I. contact details including email address should be included.

Prior to submitting an application for Calvary Bruce Private, Calvary John James, Clare Holland House 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.

Ensure that all pages (including the attachments) are numbered sequentially.

Anticipated start dates need to be following the HREC meeting approval date. CPHB HREC are 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 by the application cut-off date (above), at least three weeks prior to the next HREC meeting.

Calvary has two HREC’s – one for the Public Hospital and one for the Private Hospitals and Retirement Villages. 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 and staff undertaking a retrospective medical records audit or quality assurance program for which there is a separate application process. Please contact ethics@calvary-act.com.au if your research meets 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 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. A site specific application (SSA) will be completed by the Head of Department approving the application within Calvary. The SSA will also be forwarded to the P.I. requesting information associated with resources that will required for the research program.  Following this approval process the P.I. will receive correspondence informing them of the outcome of the application. The approval letter sets out the P.I.’s obligations to CPHB. Failure to uphold these obligations could result in 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

 

 

Clinical trials conducted in Australia are subject to various regulatory controls to ensure the safety of participants.  Applications involving medication or medical devices must be accompanied by relevant Therapeutic Goods Australia (TGA) appropriate approvals.  Refer to the TGA website for further information.

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. Note, approval of clinical trials takes extra approval time.

All Clinical Trials need to be registered with the ANZCT registry and the application number needs to accompany the application.

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 an application being delayed or rejected.

All research is approved for a maximum 3 year period. If a research program extends beyond this time period, a new application is required. Failure to comply may result in ethics approval being cancelled. It is up to the P.I. to ensure their research continues and a new or updated application is tabled at the HREC by the due date.

P.Is are required to provide annual progress reports and final reports. Where annual reports are not up to date, further requests for amendments cannot be considered by CPHB HREC.

To remain compliant with NHMRC guidelines, P.I’s are required to notify CPHB HREC of any changes that occur to research programs 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 cancellation of your ethics approval at Calvary Health Care ACT. The Interim or Final Report Template is the correct format for notification of changes.

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
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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
pdf Format
Sequential numbering of files