Skip links and keyboard navigation

Research

Ethics Frequently Asked Questions (FAQs)

See below answers to some of the frequently asked questions in regards to Ethics approval and applications.

How long will it take to get ethical approval?

Queensland Health Human Research Ethics Committees (HREC) work on a 60-day clock for approval of your research.  This is from closing date until you are advised if your application has been approved.

On average, our standard risk applications are approved within 27 days and low and negligible risk applications seven days.  This does not include site specific assessment authorisation.

What is the length of ethical approval?

A maximum five years with a recommended minimum period of 18 months.

Do I need to upload supporting documents onto the online forms?

Yes, this ensures all documentation is automatically uploaded into the HREC database. Supporting documents can be uploaded after the ethics application has been submitted.  These can include progress reports, participant information and consent forms (PICF), annual reports and study amendments.

Tips for applications?
  • Choose an achievable start and finish date, allowing time for HREC and RGO processing. We recommend a minimum of one year for a project
  • Research data must comply with the Australian Code for the Responsible Conduct of Research, section 2.5
  • Include version numbers and dates on your supporting documents
  • Head of Department sign off and/or letters of support must be signed by the appropriate Head of Department, who cannot be on the research team
  • Include key references to support the study
  • Get someone to review your submission for errors you may have missed. Do a spelling and grammar check
  • Regardless of level of risk, you must have a protocol. The NEAF or LNR Form is not your protocol or study plan.
Which supporting documents are recommended for an ethics application?
  • Cover letter outlining your application and which sites are seeking approval. Include a list of attachments for the submission.
  • Study protocol  is essential for all projects
  • Participant information and consent forms
  • Data collection tools
  • For low risk, letter of support from appropriate Heads of Department.
  • All researchers must submit a signed and dated current curriculum vitae if they haven’t submitted one during the past two years.
  • Investigator’s brochure
  • Questionnaires/surveys/anything given to the participant
  • Letters of invitation
  • Advertising materials including transcript for advertisement, brochure, webpage or poster
  • Peer review, expert independent review (highly recommended for all projects).Signature pages from the application form with “wet ink” signatures.
Why do I need to have a study protocol or study plan?

A research protocol is your complete study design. It includes: 

  • methodology
  • statistics
  • data analysis
  • risks
  • management of risks
  • Data safety monitoring committee
  • addendums (participant information, questionnaires, other tools)
  • Standard operating procedures
  • day to day guidance for conducting a survey

The ethics application, asks relevant ethical questions, but its format is not conducive to your study.  You probably won’t refer to this document again.  The protocol forms the basis for your final study publication. Amendments and changes to your study will be made in the study protocol, not the NEAF or LNR.

Tips for participant information sheets?
  • Write for a reading age of 12, in simple language and for a non-expert
  • Include contact details for researchers and reviewing HREC
  • State if the consent will be for “future use of data and tissue in research”
  • Refer to National Statement sections 2.2, 3.2, 3.4 and 3.5 for details on specific consent requirements
  • We suggest you use our PICF template. While not needing to be a duplicate of the GCHHS form, it should contain all elements.
Do I need to submit an annual report?

You will be required to submit a report for each research project on the annual anniversary of ethics approval, unless otherwise specified. Based on information in the progress report, the HREC or RGO may decide to undertake a monitoring visit.

 

How do I amend my research project after submission and/or approval?

Amendments to approved research protocols must be submitted to the HREC Coordinator for HREC review. You do not need to submit a new ethics application form.

Email the amendment to HREC Coordinator at GCHEthics@health.qld.gov.au  and include:

  • A signed covering letter
  •  Relevant, clean and tracked versions of updated supporting documents such as Participant Information and Consent Forms or Study Protocols

If the risk is low, amendments may be approved by the HREC Chair between meetings. Otherwise the Chair will refer the amendment to the next meeting. Amendments must be submitted to each relevant RGO for approval after HREC review.

What is an adverse event?

An adverse event can be any unfavourable or unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product, irrespective of whether or not it is related to the product.

How do I report an adverse event?
  • Notify the HREC as soon as possible
  • Provide a summary of the adverse event in specified format including reference to suspected causality
  • Advise if changes are required to the patient information and consent form.
What do I do if there has been a serious adverse event at a local site?

A report is required from the Principal Investigator, including duration of treatment and the outcome of the event. Adverse event reporting templates are under our amendments and reporting section.

For more detailed information, please refer to the Researcher User Guide.


Last updated 21 Sep 2017