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

HUMAN RESEARCH ETHICS COMMITTEE (HREC)

APPLICATION FORM TO ACCOMPANY ALL PROTOCOLS

Notes

  • Insurance, Indemnity and Risk Approval must be provided
  • The required number of copies must be provided; please see General Information.
  • Please see Meeting Datesfor closing dates for receipt of applications.
  • Ensure that each page of the protocol is numbered and includes the version and date.
  • Please type all answers.

1.GENERAL INFORMATION

1.1

Title of the proposed project

1.2

Name(s) and position(s) of the Investigators

Notes

  • Please include the address and direct phone numberof the Chief Investigator; non availability may impede the process of review.

1.3

Give a brief summary of the proposed project.

1.4

Specify the likely duration of the project, the proposed commencement date, and where the research will be undertaken.

2.ETHICAL/SAFETY CONSIDERATIONS

2.1TRIALS INVOLVING DRUGS

a) Is a drug (therapeutic substance) to be administered to participants in this study? Yes/No

b) Have you attached theClinical Trial Application FormCheck List to the original copy?Yes/No

c) Is the drug (therapeutic substance) approved and marketed in Australia for the use and the category of patientbeing researched in this project? Yes/No

d) Is this a CTN/CTX application (cross out as applicable)? Yes/No

Notes

  • If unsure contact Mr Kingsley Coulthard, Secretary of the Drug & Therapeutics Committee: extn 18350.
  • If CTN, a CTN form needs to be attached to original application. Attached? Yes/No

e)PHARMACY CONSIDERATIONS
Is the Pharmacy Department required for any of the following

PackagingY/N

Manufacturing/preparationY/N

DispensingY/N

StorageY/N

OrderingY/N

Stock accountabilityY/N

If yes, you are required to discussed with Director Pharmacy prior to the Pharmacy Department signing off.

2.2INFECTION CONTROL CONSIDERATIONS

a) Do you intend to use therapeutic devices which will enter a critical or semi critical body site? Yes/No

Notes:

  • A critical body site is a normally sterile body site; a semi critical body site is intact mucosa or non intact skin.

b) Is it designated by the manufacturer as Reusable? Yes/No

c) If yes have you consulted with the Infection Control Coordinator (extn 16388) or the CSSD Manager (extn 16552) regarding appropriate decontamination? Yes/No

Notes:

  • Items which enter critical or semi critical body sites and are designated by the manufacturer as single-use are not to be reused, unless in extraordinary circumstances. See Reprocessing and Re-use of Single Use Medical Devices.
  • Other institutionalpolicies which may require your consideration are:
  • 18/98 Ward/Unit management of multiple-use sterile fluid for injection or irrigation of a normally sterile site.
  • 02/01 Standard and Additional Precautions.
  • 9/00 Hand hygiene and handcare for staff who have hands-on patient contact.

2.3

a) As part of this study, will participants be exposed to ionizing irradiation, such as nuclear medicine, CT or other x-ray examination in additional to what the patient would receive as part of his/her normal clinical management? Yes/No

Notes:

  • If yes, a dosimetry report MUST be obtained from the CYWH's Radiation Safety Officer before ethical approval will be given(Dr G. Bibbo Ext. 16640).

b) Is a dosimetry report attached? Yes/No

Notes:

  • Following ethical approval, approval MUST be obtained from the Radiation Protection Branch (Environment Protection Authority) before you proceed with the study. A copy of the dosimetry report, HREC approval letter, Information Sheet and Consent Form should be attached to your application to the Radiation Protection Branch.
  • Refer to the NHMRC guidelines on Exposure to Humans to Ionizing Radiation for Research Purposes 2005 and Radiation Protection and Control (Ionising Radiation) Regulations 2000.

2.4

Has this project ever been scientifically assessed? Yes/No

Notes:

  • If "yes", please enclose a copy of the scientific assessment.

2.5

If two or more methods of treatment are being compared, is any one of them believed tobe superior to any of the others? Yes/No

Notes:

  • Please provide an explanation.

2.6

Specify the number of participants and the investigator's relationship to them.

2.7

Specify inclusion criteria (or page number of protocol where this information is given).

2.8

Specify exclusion criteria (or page number of protocol where this information is given).

2.9

Summarise involvement of participants, e.g. how much extra blood, additional visits beyond clinical requirements, or time to complete questionnaires.

2.10

Summarise procedures which may cause discomfort, distress or pain to the participant; assess their degree and their likely duration.

2.11

State the manner in which the parents’/guardians' or participants' consent will be obtained.What is the recruitment process, e.g. how will potential participants be contacted? Who will be responsible for obtaining consent?

2.12

Privacy considerations:

a) Are you requesting personal information from a source other than the participants themselves , e.g. medical records from a hospital/service or medical practitioner? Yes/No

b) If yes to (a) which sources?

c) Are you requesting personal information from a state-based register or records from a state department? Yes/No

d) If yes to (c), which source/s.

e) If yes to (c) and how many records?

f) Are you requesting information from a Commonwealth agency? Yes/No

g) If yes to (f), which Commonwealth agency?

f) If yes to (f) how many records do you wish to access?

g) Summarise your reasons for requesting access.

Notes:

  • Include how the public interest in the proposed research outweighs to a substantial degree the public interest in the protection of privacy. For guidance in making a public interest case see the section Weighing the Public Interestin the Guidelines for the preparation of audit submissions.

2.13

Specify any other ethical considerations of relevance to the study, e.g. data storage and disposal.

2.14

Specify the monitoring processes for adverse events.

2.15

Does the protocol stipulate reporting of adverse events with drug protocols to the REC, Therapeutic Goods Administration and DTC? Yes/No

2.16

Does the protocol involve ART (Artificial reproductive technology)? Yes/No

3.ADMINISTRATIVE CONSIDERATIONS

3.1

Have you obtained verification of indemnification from John Markic (Dept of Health )? Yes/No/To follow

3.2

Has a Confidentiality Agreement been signed for researchers who are not employeed by the CYWHS?……………………………Yes/No/Not Applicable

3.3

Describe the involvement of staff who are not part of the investigative team; indicating the time involved and the type of instruction they will be given.

3.4

Designate which divisions within the CYWHS will be affected, including which areas/departments within the division.

3.5

What are the resource implications for each division and the proposed funding source?

3.5.1

Divisional certification

In providing certification you are ensuring that all involved departments and areas have been made aware of and can accommodate the project. Certification does not relate to the scientific or ethical considerations of the project. Where there are resource implications, this section must also be endorsed by the Divisional Chief or delegate.

Division :Signature(s)

Printed name(s)

Comments:

Division :Signature(s)

Printed name(s)

Comments:

Division :Signature(s)

Printed name(s)

Comments:

3.6

a) Is the study supported by a sponsor (e.g. pharmaceutical company)? Yes/No

b) If yes to (a), please provide details of both the assistance and expenditure to justify the amount of sponsorship.

Notes:

  • If the study is being sponsored, all parties in the research (sponsor, investigator/s, institution/s) must be covered by the appropriate liability indemnification, before the study commences.
  • The provision of cover is the responsibility of the sponsor and proof must be attached to the application; a standard Indemnity for Clinical Trials form can be obtained from
  • The Ethics Committee will obtain confirmation that the cover is legally acceptable BEFORE ethical approval will be given.

c) Have you attached a copy of the indemnification cover? Yes / No / Not applicable as not sponsored.

Notes:

  • If the study involves a therapeutic substance, and is supported by a sponsor, the payment of a fee will be required to offset the costs of meeting the demands of appropriate ethical review; please see Application Fee for Review of Clinical Trials Involving Therapeutic Substances.

GENERAL NOTES:

  • Formal notification will usually be forwarded to researchers within three weeks of the meeting.
  • Research cannot occur until approval has been received by the CYWHS HREC and all provisos complied with.
  • Investigators are required to inform the Committee of any adverse or unforeseen circumstances arising out of this study, or of any change in the study design.
  • Brief annual reports on the progress of the study are required and a copy of any publication/s of the findings of the study should be sent to the Committee.

Signature of Investigator(s)

______

______

______

______

Date: / / 20 .

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

HUMAN RESEARCH ETHICS COMMITTEE (HREC)

CLINICAL TRIAL APPLICATION FORM CHECK LIST

TO BE ATTACHED TO ALL PROTOCOLS INVOLVING DRUGS & THERAPEUTIC SUBSTANCES

Tick
Contact phone number(s) of Chief Investigator
......
Each page of the protocol numbered, dated and version stated
(e.g. 23/3/99 Version 1)
20 complete, collated setsof REC application form, protocol, information sheet and consent form are provided
If thestudy involves a new drug, 2 copies of investigational drug brochure are provided
Consent Form and patient/parent Information Sheet attached (as above)
If a CTN protocol, 1 completed CTN form attached to original application
If study is sponsored, indemnification statement and certificate of insurance attached

Signature of investigator...... date:...... /...... /

It is the responsibility of the Chief Investigator to ensure completion of this checklist. Failure to submit all relevant information to the REC Secretariat may impede the approval process.

Appendix A (DO NOT INCLUDE WITH YOUR APPLICATION)

The Research Secretariat is responsible for the receipt and forwarding of protocols to the Research Ethics Committee (REC) and, where appropriate, the Drug & Therapeutics Committee (DTC) and Risk Manager:

  • All protocols involving the use of a therapeutic substance (section 2.1 of the application form) must first be considered by the DTC.
  • If the study is supported by a sponsor (section 3.4 of the application form) the indemnification cover provided by the sponsor must be approved by the CYWHS’s Risk Manager. A standard ‘Form of Indemnity for Clinical Trials’ may be obtained from the Research Secretariat.
  • If the study involves a therapeutic substance, and is supported by a sponsor, the payment of a fee is required to offset the costs of meeting the demands of appropriate ethical review. For further information on the fee structure see Application Fees for Review of Clinical Trials.

Sufficient number of compiled copies of the application, protocol and supporting information mustbe provided by the correct date for timely review. Please see General Informationfor the number of required copies and Meeting datesfor the day by which your application must be received in the Research Secretariat.

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rec: applform.22/5/08