About the WNHS Ethics Committee
Quality Improvement or research?
Meetings and Submission Deadlines
Ethics Committee Terms of Reference
The WNHS Ethics Committee operates under the Guidelines of the NHMRC National Statement on Ethical Conduct in Research Involving Humans (2007). The primary function of the Ethics Committee is to advise upon and carry out the ethical review of all research involving the staff, patients or resources of the Women and Newborn Health Service (WNHS), primarily encompassing research conducted at KEMH and affiliated organisations. Research cannot commence without formal approval from the WNHS Ethics Committee.
Assessment of scientific content & quality, clinical implications, and adverse events monitoring is performed by the Scientific Advisory Sub-Committee (SASC), a sub-committee of the WNHS Ethics Committee.
The Research Governance Office (RGO) provides an independent systematic evaluation of research applications, which ensures the safety and minimises the risk for the patient, the researcher and the institution.
The RGO reviews matters relating to research staff qualifications, Intellectual Property, insurance, indemnity, study agreements and monitoring of research project to ensure the research projects comply with the Guidelines set down by the National Statement on Ethical Conduct in Research Involving Humans (2007)
Assistance in determining whether your project is "quality improvement" or "research" is available on page 5 & 6 of the WNHS Research Governance Investigator Guidelines. Projects deemed to be quality improvement or audit should be entered into the QI database via the GEKO website for approval. Advice regarding this process can be obtained from the GEKO website, or from the Performance Review and Audit Coordinator on extension 1540.
| Ethics Office | Research Governance Office | |
| Name | Karen Taylor | Dianne Hodge |
| Position | Ethics Committee Secretary | Research Governance Officer |
| Location | Level 1, Children's Clinical |
Level 1, Children's Clinical Research Facility (CCRF) Princess Margaret Hospital |
| Postal address | GPO Box D184 Perth WA 6840 |
GPO Box D184 Perth WA 6840 |
| Telephone | (08) 9340 7845 | (08) 9340 7846 |
| kemhethics@health.wa.gov.au | kemh.rgo@health.wa.gov.au | |
| Availability | Mon, Tues, Wed and Friday 9am - 2.30pm |
Tues, Thurs, 9.00 - 5.00 pm |
| On other days please leave a telephone message, and we will return your call as soon as possible. | ||
The WNHS Ethics Committee meets on the first Tuesday of the month, February to December (there is no meeting in January).
The WNHS Ethics Committee currently consists of 12 members, together with an Ethics Committee Secretary. The membership conforms to the requirements set out in the NHMRC National Statement on Ethical Conduct in Research Involving Humans and includes 5 members from outside the Health Service.
Schedule for Dates of Meetings and Deadlines for Submissions for 2013
The approval process for a research proposal can be outlined as follows:
All Adverse Events (AE) and Serious Adverse Events (SAE) must be reported to the Ethics Committee within 24 hours.
The following forms are to be used to lodge reports:
Initial Serious Adverse Event Report
Reporting of Serious Adverse Events
Follow Up Serious Adverse Event Report
To assist researchers with their submissions, written guidelines and the required forms are available here in electronic form. PLEASE NOTE THESE FORMS MUST BE USED FOR ALL APPLICATIONS SUBMITTED FROM 3rd AUGUST 2010.
Written Guidelines for Research Submission to the KEMH Ethics Committee
Application form for all Research Project for Submission to WNHS Ethics Committee (Form 1B)
NEAF forms will be accepted in place of Form 1B for multicentre studies ONLY.
WNHS Research Ethics Committee Governance Form (Form 2B)
Scientific Protocol for Clinical Trials (Form 4C)
Scientific Protocol Form for Non Clinical Trials (Form 4D)
DNA Consent Form for Gene Studies (Form 6)
Annual Progress/Final Report Form
Form of Indemnity (Medicines Australia)
TICHR New Research Studies Privacy Information spreadsheet
Applications should be sent to Ethics Secretary as follows:
Applications by individual researchers for non-sponsored projects or for competitive grant applications will not attract a fee.
Application for projects which are sponsored by commercial agencies (e.g. Pharmaceutical companies or other industry bodies) will attract a submission fee. Fees are payable on submission; further fees may be charged for amendments:
| List of new application fees (from 3rd August 2010) | |
| New application fee | $5500 |
| Administrative amendments | No fee |
| Minor protocol amendments | $640 |
| Major protocol amendments or introduction of a sub-study within an existing approval | $2750 |
Major protocol amendments are substantial amendments that introduce major new aims (i.e. a new primary or secondary objective) or which introduce major new safety considerations and which require extended scientific and/or ethical review.
Industry and non-industry submission of incomplete applications requiring significant additional administrative workload may be subject to additional fees both for sponsored and non sponsored studies.
Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95)
Annotated with TGA comments.
National Statement on Ethical Conduct in Research Involving Humans (2007)
Australian Code for the Responsible conduct of Research 2007
The following NHMRC publications may be of interest to researchers and are available at the NHMRC website (http://www.nhmrc.gov.au):