CHILDREN, YOUTH & WOMEN'S HEALTH SERVICE (CYWHS)

HUMAN RESEARCH ETHICS COMMITTEE (HREC)

PROTOCOL FORMAT

12 copies of this form, or equivalent application form addressing all the points listed below in the Protocol Format form, should be submitted to theCYWHS HREC. For those projects involving therapeutic substances 6 copies of this form or an equivalent should also be submitted to the Drug and Therapeutics Committee (DTC) Clinical Trials Group.

Protocol pages should be numbered (1 of 12 etc), and include protocol version and date.

Please note: All applications to the CYWHS HREC and DTC Clinical Trials Group should be accompanied by 12 copies and 6 copies respectively of the Application Form to Accompany all Protocolsform.

1.TITLE

2.INVESTIGATORS & QUALIFICATIONS. Include previous experience of investigators in this field of investigation.

3.PURPOSE OF STUDY (including hypothesis to be tested)

4.BACKGROUND (including references)

5.PRELIMINARY STUDY (if any)

6.PARTICIPANTS - a full and detailed description of procedures to be used on patient subjects. Patient groups and numbers and any randomisation should also be outlined.

7.SELECTION and EXCLUSION CRITERIA (specific). Also withdrawal criteria, if applicable.

8.PLAN & STUDY DESIGN (including methodology, statistical analysis)

9.THERAPEUTIC SUBSTANCES

-Dose, route(s) of administration, formulation.

-Source (commercial, manufactured).

-Time and cost implications (during trial, after trial)

-Withdrawal criteria

-Monitoring - therapeutic response

-Monitoring - potential adverse effects, reporting of adverse effects

-Discussed with ADON Clinical/Director of Pharmacy/Department Head (as appropriate)

10.SAFETY & ECOLOGICAL CONSIDERATIONS (e.g. radiation, toxicity, bio-degradability)

If radiation exposure is an aspect of the research plan, the following should be detailed:

-Why the subjects are exposed to ionizing radiation

-The number of subjects to be exposed

-The accumulated effective dose equivalent per subject

-The steps to be taken to monitor levels of exposure

-The precautions to be taken to keep exposure to a minimum

11.ETHICAL CONSIDERATIONS

All ethical issues need to be considered and should include possible risks, pain or discomfort, and an indication of whether the procedure is part of standard diagnosis and treatment.

12.A specific Consent Form and Information Sheet should be included.

Notes:

  • For participants who are under 18, parental/guardian consent must be obtained. If parents/guardians have consented to their child’s participation, then consent should also be obtained from those children/young persons deemed sufficiently mature.
  • Research involving children or people with a mental illness or intellectual disability which would preclude consent, should only be conducted when it is in their best interests.
  • Parents must be aware that can withdraw their child from the study at any stage and that this will not affect the medical care or any other aspects of their child’s relationship with the relevant healthcare services.

13.CONFIDENTIALITY AND DATA SECURITY.

A description of the information to be collected, the sources used, and the safeguards to preserve the confidentiality of the data should be listed. This should include the means of data storage (e.g. computer files).

14.OTHER RELEVANT INFORMATION

15.OTHER ETHICS COMMITTEES TO WHICH PROTOCOL HAS BEEN SUBMITTED

10/10/20071