Princess Margaret Hospital
Ethics
NEW CAHS RESEARCH REQUIREMENTS FOR 2010
These new requirements are mandatory from 6 April 2010 -
until then their use is optional
Meetings and Submission Deadlines
National Health and Medical Research Council (NHMRC) Publications
About the Committee
The primary function of the Ethics Committee is to consider the ethical implications of all proposed research projects involving human subjects to be carried out within:
- Consider the ethical implications of all proposed research projects involving humans submitted to the Ethics Committee for approval (Research Projects)
- Involving the staff, patients or resources of the Child and Adolescent Health Service (CAHS)
- Involving the staff, patients or resources of the Institute of Child Health Research
Scientific content and clinical implications of projects are considered by the Scientific Advisory Sub-Committee (SASC)
Contact
| Name | Marlene Clayton |
| Position | Ethics Committee Secretary |
| Location | Level 1 |
| Postal address | GPO Box D184 Perth WA 6840 |
| Telephone | (08) 9340 8221 |
| pmhethics@health.wa.gov.au |
Meetings and Submission Deadlines
The PMH Committee meets on the third Thursday of the month. (There are some exceptions so please refer to the schedule for specific dates).
The current membership of the PMH Committee is 13, 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 include 5 members from outside the Health Service.
Schedule for Dates of Meetings and Deadlines for Submissions for 2009
Schedule for Dates of Meetings and Deadlines for Submissions for 2010
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 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 PMH 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,
- resubmit to EC for further review following receipt of requested amendments; or
- rejected.
The EC meets monthly as per listed schedule
- after the recommendations of the EC are ratified by the Chief Executive, a formal letter of approval (valid for 3 years) is sent to the investigators of approved studies;
- the investigator is required to submit a progress report to the EC 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.
Forms
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 SUBMISSIONS. SUBMISSIONS SUBMITTED NOT USING THESE FORMS WILL NOT BE ACCEPTED.
Written Guidelines for Research Submission to the Ethics Committee of PMH
Funding and Budgetary Information
DNA Consent Form for Gene studies
TICHR New Research Studies Privacy Information spreadsheet
Initial Serious Adverse Event Report
Reporting of Serious Adverse Events
Follow Up Serious Adverse Event Report
Submission Fees
Applications for projects which are fully sponsored by external agencies (eg. pharmaceutical companies or other commercial bodies) will attract a submission fee of $2,500 (plus GST), payable on submission. Further fees of $100 - $250 may be charged for amendments.
Applications by individual researchers for non-sponsored projects or for competitive grant applications will not attract a fee. However, for those that include a CTN a fee of $2,000 may be payable.
NHMRC Publications
The following NHMRC publications may be of interest to researchers and are available at the NHMRC website (http://www.nhmrc.gov.au):
National Statement on Ethical Conduct in Research Involving Humans (2007)
The Australian Clinical Trial Handbook 2006
Australian Code for the Responsible conduct of Research 2007
The Note for Guidance for Good Clinical Practice 2000
The Guidelines under Section 95 of the Privacy Act 1988
When does quality assurance in health care require independent ethical review?
