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.

RESEARCH GOVERNANCE

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)

QUALITY IMPROVEMENT OR RESEARCH?

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.

CONTACT DETAILS

	Ethics Office	Research Governance Office
Name	Karen Taylor	Dianne Hodge
Position	Ethics Committee Secretary	Research Governance Officer
Location	Level 1, Children's Clinical Research Facility (CCRF) Princess Margaret Hospital	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
Email	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.

MEETINGS AND SUBMISSION DEADLINES

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

APPROVAL PROCESS

The approval process for a research proposal can be outlined as follows:

A study is submitted to the Committee Secretary and, provided all the necessary documentation has been included, it is registered;
The study is included on the agenda for the Scientific Advisory Sub-Committee (SASC) meeting where the scientific content is reviewed. These meetings are held as per listed schedule;
The SASC gives feedback to the investigators as to any amendments required;
If approved by the SASC, the study, together with any amendments following SASC recommendations, is included in the next WNHS Ethics Committee (EC) agenda;
If the SASC requires extensive changes to be made the study may have to be resubmitted for further review by SASC before proceeding to the EC;
The study is reviewed at the EC meeting and is either:
- approved with no changes,
- approved subject to specific amendments being made;
- resubmitted to EC for further review following receipt of requested amendments;
- rejected.

While ethical review takes place, the Research Governance Office (RGO) reviews all applications to ensure they comply with the RGO Guidelines and that the Research Ethics Committee Governance Form has been fully completed.
The RGO will liaise with the investigators if it receives inadequate or insufficient documentation regarding the proposed study.
All research governance requirements must be met before the application receives final approval from WNHS Chief Executive for the project to proceed.
Upon ratification of the recommendations of the Ethics Committee and Research Governance Office by the Chief Executive, a formal letter of approval (valid for up to 3 years) is sent to the investigators of approved studies.
The investigator is required to submit a progress report to the EC & RGO annually which is reviewed by the SASC and a summary sent to the EC.
All amendments/changes or request for extension of time must be submitted to the EC for approval.

POST APPROVAL MONITORING

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

FORMS FOR APPROVAL OF RESEARCH PROJECTS

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)

Information Sheet (Form 3)

Scientific Protocol for Clinical Trials (Form 4C)

Scientific Protocol Form for Non Clinical Trials (Form 4D)

Consent Form (Form 5)

DNA Consent Form for Gene Studies (Form 6)

Annual Progress/Final Report Form

Form of Indemnity (Medicines Australia)

Instruction Sheet for TICHR

TICHR New Research Studies Privacy Information spreadsheet

Recruitment Letter (TICHR)

RESEARCH SUBMISSION INSTRUCTIONS

Applications should be sent to Ethics Secretary as follows:

ONE SIGNED HARD COPY of:
1. Application form for all WNHS Research Projects (Form 1B)
2. WNHS Governance Form (Form 2B)
ONE HARD COPY of:
1. WNHS Scientific Protocol for Clinical Trials or/Non clinical Trials Form 4C OR 4D (whichever is applicable)
2. Any "Additional Attachments" (signed if appropriate) as listed on Page 2 of Form 2B
One Non Re-writable CD containing:
1. a copy of completed Form 1B
2. a copy of completed Form 2B
3. a copy of Form 4C OR 4D (whichever is applicable
4. a copy of any forms from "Additional Attachments" (Pg 2 of Form 2B)

If a receipt is required please ensure that the submission is handed IN PERSON to an Ethics Committee administration staff member.

SUBMISSION FEES

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 3^rd 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.

IMPORTANT PUBLICATIONS FOR RESEARCHERS

The following NHMRC publications may be of interest to researchers and are available at the NHMRC website (http://www.nhmrc.gov.au):

Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies (effective 1 January 2000).
Guidelines for Genetic Registers and Associated Genetic Material (effective from 1 January 2000).
Ethical Guidelines on assisted reproductive technology (1996).
Ethical aspects of qualitative research methods in health research (1995).
Recommendations for limiting exposure to ionizing radiation (1995).
Ethical issues in organ donation (1997) - 4 discussion papers:
- Paper 1 - Donating organs after death: ethical issues.
- Paper 2 - Ethical issues in donation of organs or tissues by living donors.
- Paper 3 - Ethical issues raised by allocation of transplant resources.
- Paper 4 - Certifying death: the brain function criterion.

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