Renewal Application Form - Hunter New England Health by zhouwenjuan

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									                             HUNTER NEW ENGLAND
                         HUMAN RESEARCH ETHICS COMMITTEE

                      APPLICATION FOR RENEWAL OF ETHICS APPROVAL
                            FOR RESEARCH INVOLVING HUMANS
                                 Version: October 2010




NOTES:

    This form is to be used for requesting RENEWAL of ethics approval for research projects involving humans
     which have been approved the Hunter New England Human Research Ethics Committee (HNEHREC) of
     Hunter New England Health. This includes multi-centre trials within NSW Health for which

    Ethics approval is granted for three or five years contingent on the estimated duration of the project stated
     in the initial application. The project will be monitored annually to ensure adherence to the approved
     protocol. You will be advised if you are required to submit an application to renew approval.

    You are expected to have read the National Statement on Ethical Conduct in Human Research (2007)
     and incorporated the ethical principles therein as part of your research plan. The Statement applies to all
     human research. It is available at www.nhmrc.gov.au/publications/synopses/e35syn.htm

    Care should be taken in the preparation of the application, ensuring that all questions are fully answered
     and that the application is professionally presented.

    Answers to questions must be:

     Typed using a font size no smaller than Arial 10pt or Times New Roman 11pt.

     Expressed in plain English. Prior knowledge should not be assumed. Where it is necessary to use
     technical terms these must be explained.

     Enter the answer in the space provided – this can be expanded if insufficient although answers should be
     concise while at the same time providing the required detail. Do not answer questions with ‘see attached”
     or “refer to funding application”.

Submission:

Submit the original version of the completed application for Renewal and attachments as required as
well as an electronic version of the completed application for Renewal and attachments as required to
hnehrec@hnehealth.nsw.gov.au

     The Application should be posted to        Hunter New England Human Research Ethics Committee
                                                Hunter New England Health
                                                Locked Bag 1
                                                New Lambton NSW 2305

     Or Hand Delivered to                       Hunter New England Health Research Ethics Unit
                                                Administration Building
                                                Lookout Road
                                                New Lambton NSW 2305

     Please Contact                             Dr Nicole Gerrand
                                                Manager Research Ethics and Governance
                                                Tel: 49214950 or 49214943
                                                Email: hnehrec@hnehealth.nsw.gov.au

                       THERE IS NO CLOSING DATE FOR RENEWAL APPLICATIONS AS
                              SUBMISSIONS WILL BE REVIEWED ON RECEIPT


                            DO NOT COPY THIS PAGE WITH YOUR APPLICATION


APPLICATION – RENEWAL OF ETHICS APPROVAL FOR RESEARCH INVOLVING HUMANS – October 2010                   1
                                 HUNTER NEW ENGLAND
                             HUMAN RESEARCH ETHICS COMMITTEE

                          APPLICATION FOR RENEWAL OF ETHICS APPROVAL
                                FOR RESEARCH INVOLVING HUMANS
                                     Version: October 2010



1    TITLE OF PROJECT (as it appears on the approval notification)




2    APPROVAL DETAILS
     What is the Hunter New England Human Research Ethics Committee reference number for the project?




3    CHIEF INVESTIGATOR or PROJECT SUPERVISOR (first named on approval notification)

       Name:      Title / first name / family name
       Qualifications & position held:
       Organisational unit & mailing address:
       Telephone and Fax:
       Email address:


4    CO-INVESTIGATORS and/or STUDENT RESEARCHER

       Name:      Title / first name / family name
       Qualifications & position(s) held:
       Organisational unit & mailing address:
       Telephone and Fax:
       Email address:

      Name:      Title / first name / family name
      Qualifications & position(s) held:
      Organisational unit & mailing address:
      Telephone and Fax:
      Email address:
     Copy table and repeat for each additional co-investigator.


5     IS THIS RESEARCH BEING CONDUCTED AS

      SINGLE CENTRE RESEARCH (ie only within Hunter New England Health)

      MULTI CENTRE RESEARCH

      If so, please name those sites for which approval from the Hunter New England Human Research
      Ethics Committee extends:




APPLICATION – RENEWAL OF ETHICS APPROVAL FOR RESEARCH INVOLVING HUMANS – October 2010             2
6    STUDENT RESEARCH

      Is the research being completed as part or whole of a degree or qualification?     Yes             No

       If YES:   Name of student:
                 Course of study:
                 Principal supervisor:
                 Name of Institution


7    ESTIMATED COMPLETION OF PROJECT (dd/mm/yy)
     This is the point at which you anticipate the analysis of your data will be completed:

      Date:


8    SUMMARY OF AIMS AND VALUE OF PROJECT

     Using plain English, provide a concise and simple description of your project, which sets out the
     background, precise aims/hypotheses/research questions, why you consider the research is worth
     doing, and what its potential merit and significance might be.




9    PROGRESS TO DATE

     Provide a concise summary of progress to date, giving details of what data collection has been
     completed/yet to be completed, number of participants recruited and current involvement, tissues samples
     collected, personal records accessed, and results/interpretations of any interim analyses conducted.




10   VARIATIONS/AMENDMENTS

       Have there been any additions or variations/amendments to the
       Research protocol?                                                        Yes           No

     If YES, please attach a list detailing the additions or variations/amendments, and date of approval from
     HNEHREC. (this can be incorporated in the list of approved documentation – see question 11)

       Are there any additions or variations/amendments to the research
       protocol or which you wish to obtain approval?                           Yes             No
                                                                                                     N
                                                                                                     o

      If YES, please complete and attach the Application for Variation to Approved Research Involving Humans.




APPLICATION – RENEWAL OF ETHICS APPROVAL FOR RESEARCH INVOLVING HUMANS – October 2010                     3
11   SUMMARY OF ANY NEW ETHICAL CONSIDERATIONS (ie, not covered by current approval)
     Referring to the National Statement on Ethical Conduct in Human Research (2007), (particularly
     Section 1 and other sections relevant to your research) what are the additional ethical issues posed by your
     project and how will they be addressed?




12   APPROVED DOCUMENTATION
     When you received ethics committee approval for the initial research protocol, and for subsequent
     variations/amendments, the approval included specific documentation relating to the project.

     Please attach a list of all approved documentation and the date of approval (where there have been one or
     more versions of a document, list the most recent approved version) It is not necessary to send copies of
     documentation that has already been approved. Examples of this documentation are

    Participant information and consent documents.

    Letters, advertisements, posters or other recruitment material, which are (or will be) in      use.

    For clinical trials registered under the Clinical Trial Notification (CTN) scheme, list the version of the clinical
     protocol initially approved by the ethics committee, plus all amendments




APPLICATION – RENEWAL OF ETHICS APPROVAL FOR RESEARCH INVOLVING HUMANS – October 2010                          4
13      DECLARATION (Please ensure declaration and signature are on the one page)

In signing this application, I declare that:

1.      All questions have been answered.

2.      The research protocol conforms to the National Statement on Ethical Conduct in Human Research (2007),
        which I have read.

3.      Where relevant, I have attached documents as called for in Q9 and Q11.

4.      I make this application on the basis that the information it contains is confidential and will be used by Hunter
        Health New England for the purposes of ethical review and monitoring of the research project described
        herein, and to satisfy reporting requirements to regulatory bodies. The information will not be used for any
        other purpose without my prior consent.

5       As required by the Executive of Hunter New England Health, following approval of this application for
        Renewal of Ethics Approval, the title of this research will be listed as part of a monthly activity report posted
        by the Hunter New England Human Research Ethics Committee on the Hunter New England Health
        Intranet site.

I agree to the title of my research being listed on the Hunter New England Health Intranet site as part of the
Hunter New England Human Research Ethics Committee monthly activity report as required by Hunter New
England Health.

                  YES              NO
If you object to the title of your research being included could you please provide a valid reason for its omission
from the reporting process.




     Signature of chief investigator/project supervisor:


     Date:




PLEASE ENSURE AN ELECTRONIC COPY OF THIS FORM AND ATTACHED
                DOCUMENTS IS SUBMITTED TO

                              HNEHREC@HNEHEALTH.NSW.GOV.AU




APPLICATION – RENEWAL OF ETHICS APPROVAL FOR RESEARCH INVOLVING HUMANS – October 2010                           5

								
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