CHILDREN’S HEALTH QUEENSLAND
HOSPITAL AND HEALTH SERVICE				
HUMAN RESEARCH ETHICS COMMITTEE

Professor Alan Isles AM (Chair) 3069 7002
Mrs Amanda Smith (Co-ordinator)  3069 7002

Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street, South Brisbane  QLD  4101
Telephone (07) 3069 7002

3rd October 2017
Dr Clive Holloway
Audiologist
Allied Health Department
Caboolture Hospital
120 McKean St
Caboolture, QLD  4510

Dear Dr Holloway,

HREC Reference number: HREC/17/QRCH/164
Project title: Tympanometry in the Emergency Management of Children with Acute Otitis Media.

Many thanks for your letter received 15th September with responses to queries regarding the above project.  This has now been reviewed.

I am pleased to advise the proposal meets the requirements of the National Statement on Ethical Conduct in Human Research (2007) and the Committee is happy to give approval.  This HREC is constituted and operates in accordance with the National Health and Medical Research Council’s (NHMRC) National Statement on Ethical Conduct in Human Research (2007), and all subsequent updates, the Australian Code for the Responsible Conduct of Research (2007) and the CPMP/ICH Note for Guidance on Good Clinical Practice.

HREC Approval Date:	3 October 2017	
Please note the HREC does not issue pre-determined approval periods.  Ethical approval is ongoing, subject to the submission of an annual report on the anniversary of approval.

This project has Ethics approval for the following sites:

	Caboolture Hospital 

The documents reviewed and approved include:
 
Document   	Version   	Date   	 
Cover letter 		14 July 2017 	 
Letter of Support – Director of Emergency Caboolture Hospital 		17 July 2017	
Application 	AU/1/8D4F25	  	 
Emergency Department flowchart 	1.0 	22 June 2017 	 
Response to Request for Further Information 	 	Rec’d:  15 September 2017	 
Protocol 	1.1 	15 September 2017 	 
Parent/Guardian Information Sheet 	1.1 	14 September 2017 	 

	
Please note the following conditions of approval:

1.	We require an annual progress report (that covers all sites listed on approval) for the duration of the project.  This report is due on the anniversary of HREC approval.  Continuation of ethics approval is contingent on submission of an annual report.  Failure to comply with this requirement may result in suspension of the project by the HREC.
A comprehensive Final Report upon completion of the project.  (In accordance with National Statement 5.5.3)

2.	Please note if identifiable or potentially re-identifiable data for this research project is to be accessed without the written consent of the person to whom the data relates an application for disclosure of this data must be made under the Public Health Act.  Further information regarding the Public Health Act is available via this link:  http://www.health.qld.gov.au/ohmr/html/regu/aces_conf_hth_info.asp 

3.	Submit to the reviewing HREC for approval any proposed amendments to the project including any proposed changes to the Protocol, Participant Information and Consent Form/s and the Investigator Brochure.

4.	If the project does not proceed, the Committee must be informed as soon as possible. (In accordance with National Statement 5.5.6)

5.	The Committee must be informed of any potential or realised problem with bioethical implications, if such occurs during the conduct of the research project.  

6.	Any serious adverse event (SAE) that arises in the context of this research, or involving a researcher conducting this research, must be reported to the Ethics Committee within 72 hours and reported to the sponsor (if applicable) within the stipulated time frame.  

Serious Adverse Event Reports that are generated off-site may be (a) Serious Unexpected Adverse Reactions or (b) Serious Events which the Research Team believes cannot be related to the research intervention.  The Research team must report incidents of (a) during multi-centre trials.  Such are required to be submitted to the Chair of HREC on receipt by the researcher.  A summary of the SAE reports is to accompany the submission.  Information required includes; patient details (age & sex), adverse event, outcome and the likelihood of the event being related to the study drug/device/procedure.  

With respect to all SAEs, the researcher must provide his or her opinion as to whether the SAE is directly related to the research intervention.   A copy of the SAE Summary must be provided.  

8.	The HREC, authorising institution and/or their delegate/s may conduct an audit of the project at any time.

9.	Ethical approval to undertake this research project is given on the understanding that you have an intention to publish your findings in a refereed journal or similar peer-reviewed forum.  If you do not have this intention, it is an absolute requirement that you notify the Ethics Committee formally.  In this latter instance, approval for this research is not given at this time; and will require further negotiation.  Your work must be in accordance with the following:

	National Statement on Ethical Conduct in Human Research:
	https://www.nhmrc.gov.au/guidelines/publications/e72 
	Queensland Health Management Research Policy:
http://www.health.qld.gov.au/ohmr/html/regu/resrch_mge_policy.asp
		Declaration of Helsinki:  
		http://www.wma.net/en/30publications/10policies/b3/17c.pdf
	Guidelines under Section 95 of the Privacy Act1995 and Guidelines approved under Section 95A of the Privacy Act 1995.
http://www.health.qld.gov.au/ohmr/html/regu/aces_conf_hth_info.asp
		Queensland Health Privacy Guidelines IS42 & IS42A:
		http://www.health.qld.gov.au/privacy/IS42A.asp 

10.	Researchers should note, if not QLD Health employees, a Blue Card may be required for contact with children.

11.	The Researcher must send the ‘Notification of Commencement of Research Protocol’ as soon as research begins.  Status of the project will remain as ‘Not Started’ until this form is received.  

12.	In accordance with the National Statement (3.3.12), before beginning the clinical phase of the research, researchers should register clinical trials in a publicly accessible domain.

Should you have any queries about the HREC’s consideration of your project please contact Mrs Amanda Smith (Co-ordinator) or Professor Alan Isles (Chairperson).  The HREC terms of Reference, Standard Operating Procedures, membership and standard forms are available from:  http://www.health.qld.gov.au/ohmr/html/regu/regu_home.asp

You are reminded that this letter constitutes ethical approval only.  This project cannot proceed at any site until separate research governance authorisation has been obtained from the CEO or Delegate of the institution under whose auspices the research will be conducted at that site.

The HREC wishes you every success in your research.

Yours sincerely,

Professor Alan Isles AM
Chair
Children’s Health Queensland 
Hospital and Health Service
Human Research Ethics Committee

Cc:	Ethics Committee Files

Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC) 

NOTIFICATION OF COMMENCEMENT OF RESEARCH PROTOCOL

HREC No:		HREC/17/QRCH/164

PROTOCOL TITLE:	 

PRINCIPAL INVESTIGATOR:	 

This is to advise that the above research protocol commenced on:

				             /                        /            

Signature:--------------------------------------     Date: ---------/----------/-----------

Please forward to CHQ HREC:
Amanda Smith, Co-ordinator HREC
Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street, South Brisbane  QLD  4101