PMH ETHICS COMMITTEE

About the Committee

Contact

Meetings and Submission Deadlines

Approval Process

Forms

Submission Fees

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:

• Princess Margaret Hospital for Children (PMH)
• Institute for Child Health Research
• Where Hospital patients are recruited as subjects for studies undertaken externally.

Scientific content and clinical implications of projects are also considered.

CONTACT

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 a 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 2008

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 monthly at PMH on the first Thursday of the month;
• 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 PMH Ethics Committee (PEC) agenda for the same month;
• if the SASC requires extensive changes to be made the study may have to be resubmitted for review at the following month’s SASC meeting before proceeding to the EC;

• the study is reviewed at the EC meeting and is either:
  • approved with no changes,
  • approved subject to certain minor amendments being made,
  • asked to resubmit after certain changes are made or
  • rejected.

The ECs meet monthly on the third Thursday of the month;

• 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 requested to submit a progress report to the EC annually which is reviewed by the SASC and a summary sent to the EC;
• if any amendments or extension of time are required for the study, a request 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

Ethics Cover Sheet

Declaration of Interest

Information Sheet

Information Sheet Child

Form of Consent

Funding and Budgetary Information

DNA Consent Form for Gene studies

Ethics Application Checklist

Instruction Sheet for TICHR

TICHR New Research Studies Privacy Information spreadsheet

Recruitment Letter

Annual Progress 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):

1. National Statement on Ethical Conduct in Research Involving Humans (1999).
   
   
2. Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies (effective 1 January 2000).
   
   
3. Guidelines for Genetic Registers and Associated Genetic Material (effective from 1 January 2000).
   
   
4. Ethical Guidelines on assisted reproductive technology (1996).
   
   
5. Ethical aspects of qualitative research methods in health research (1995).
   
   
6. Recommendations for limiting exposure to ionizing radiation (1995).
   
   
7. 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.