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Human Research Ethics Committee (HREC)

The Royal Brisbane & Women’s Hospital Human Research Ethics Committee (HREC) is one of two HRECs in the Metro North Hospital and Health Service.

The RBWH HREC is registered with the National Health and Medical Research Council (NHMRC) (Registration No: EC00172) and is certified by the NHMRC as a lead HREC under the National Approach to Single Ethical Review of Multi-Centre Research.

Researchers requiring information about single ethical review for multi-centre research should refer to the Central Coordinating Service and MOU for Single Ethical Review of Clinical Trials (NSW Health, Qld Health & Vic Dept of Health) for further information and access the MOU Checklist for Coordinating Principal Investigators to submit with HREC applications.

Multi-centre research is research that is conducted at more than one site or conducted by researchers who are affiliated with more than one Institution (University and Hospital) or student research (University and Hospital). Student research includes undergraduate, postgraduate and PhD research for the purpose of a higher degree.

At the conclusion of its deliberations the Committee recommends ethical approval / or not dependent upon scientific validity and ethical viability. Researchers are also required to complete a site specific assessment for research governance purposes to gain District Executive Director authorisation to commence the research. 

Please contact the Research Governance Office for further information about this process.  Guidance for researchers can be found at Queensland Health Information for Researchers.

The Committee is constituted in accordance with the National Health and Medical Research Council's National Statement on Ethical Conduct in Human Research 2007 (updated in 2009)

HREC Terms of Reference (TOR) + Appendix - Ssc TOR   (PDF,  765 KB)

Research Governance Office

Research Governance Office
Phone: (07) 3646 8579
Location:  University of Queensland Centre for Clinical Research (UQCCR), Level 4, RBWH 
Email:  anitha_dinesh@health.qld.gov.au

Checklist for Site Specific Assessment - please refer to page 4 in Site Requirements located at:
Queensland Health - Human Research Ethics Committees - Contacts

RBWH HREC Guidelines

Please refer to Queensland Health Information for Researchers

For other site specific RBWH HREC information that does not appear on this site please contact the Research Ethics Coordinator on (07) 364 65490.

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Low Risk Research Applications

Single Site or Multi Site

If you are conducting single site low risk research at the Royal Brisbane & Women's Hospital, please complete the application form at the Online Forms website.  The Online Forms website has been updated to include the Qld Low & Negligible Risk (LNR) Form and LNR SSA Forms.  For enquiries regarding submission, please contact the Research Governance Office, Centre for the Advancement of Clinical Research, Level 4, UQCCR (telephone 07 3646 8579).

If you are conducting multi-centre low risk research at the Royal Brisbane & Women's Hospital, this research must first be registered by the Central Coordinating Service.  The Online Forms website has been updated to include the Qld Low & Negligible Risk (LNR) Form and LNR SSA Forms.  For enquiries regarding submission, please contact the HREC Office, Level 7 Block 7, Royal Brisbane & Women's Hospital (telephone: 07 3646 5490).

Application for Exemption from full HREC review

In accordance with the National Statement on Ethical Conduct in Human Research 2007 (updated in 2009) the definition of research appears on page 7. Please carefully review this when considering whether you are conducting research.

In addition, some research may be exempt from full HREC review. Please refer to page 79 in the National Statement.

Checklist for Exemption from full HREC review

Should you wish to submit a project for consideration of exemption, a) because it is not research or b) because it may be exempt research:

1. Letter to the HREC Chairperson, describing what you wish to do, how, why, expected outcome or benefit
2. Include copies of any tools that you may use to complete your project (for example, data collection spreadsheet, standards against which you are measuring your data)
3. Please justify your request in accordance with the National Statement
4. Please send one hard copy to the HREC office at the Royal Brisbane & Women's Hospital, Level 7, Block 7, Butterfield Street Herston 4029.



Forms

Links and Downloadable versions

Useful Information

  • Please send the Commencement Form as soon as the study commences.  (Start up date rather than the date the first participant is successfully recruited). 
  • Please send the Annual Report form twelve months from the date of HREC approval of the study.
  • Please send the Final Report form when the study is complete.  (A copy of the final results and any publications should be sent as soon as they are available).
  • Please send the Local Serious Adverse Event Report as soon as an event is reported.  (See the form for information required)
  • Please send Safety and SUSAR Reports periodically as directed by your sponsor e.g. 6 monthly.  SAE / Safety / SUSAR Reporting to the RBWH (PDF,165KB)
  • Remember that HREC approval is required for any amendments to the Protocol, Participant Information & Consent Form, Advertisements, Radio Scripts, Questionnaires, Patient Cards, etc.  (Please refer to the amendment checklist and forward one set of papers with a covering letter from the Principal Investigator explaining the amendment rationale and whether/how it will affect the study).  RBWH-Human Research Ethics Committee Amendment Checklist (PDF,170KB)
  • Please ensure that all documents submitted for approval contain document identifiers, version numbers, dates and page numbers ... of ...
  • Amended documents also need to have the changes highlighted (use the Microsoft Word 'Track Changes' feature for this)
  • Please do not hesitate to contact the Coordinator (07) 3646 5490, Assistant Coordinator (07) 3646 6132 or Chairperson (07) 3646 0331 of the HREC for further assistance. Alternatively email: RBWH-Ethics@health.qld.gov.au

Complaints

Should you wish to discuss the study in relation to your rights as a participant, or should you wish to make an independent complaint, you may contact the Coordinator or Chairperson, Human Research Ethics Committee, Royal Brisbane & Women's Hospital, Herston, Qld, 4029 or telephone (07) 3646 5490, email: RBWH-Ethics@health.qld.gov.au or the Royal Brisbane & Women's Hospital Patient Liaison Officer on 07 3646 8216.

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Location:
Human Research Ethics Office
Level 7, Block 7
Royal Brisbane and Women's Hospital
Metro North Health Service District

Telephone: (07) 3646 5490

Facsimile:   (07) 3646 5849

Email: RBWH-Ethics@health.qld.gov.au
(with the subject "HREC")


Last Updated: 12 September 2013
Last Reviewed: 27 June 2013