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National Ethics Application Form

 Annual Report Form
 Email the Ethics Secretary
 Cancer Council NSW Ethics Committee (NHMRC # EC000345)
 Membership of the Committee
 2010 Meeting dates
 Submitting proposals to the Cancer Council NSW Ethics Committee for review
 What can I expect from the Ethics Committee?
 Contact Us
 Frequently Asked Questions
 External Ethics Links

Cancer Council NSW (CCNSW) is committed to best ethical practice in all aspects of research.

Any research involving humans, regardless of the data being used, conducted by CCNSW staff, must receive ethical approval from Cancer Council NSW Ethics Committee (NHMRC # EC000345).

If you are a future or current research participant seeking to contact the Ethics Secretary or Ethics Officer of CCNSW contact details are provided at the bottom of this page or by following the ‘Contact Us’ link on the right.

If you are a researcher seeking advice on submitting an ethics application, details of the Committee, guidelines for submission, and answers to frequently asked questions can be found below or by following the relevant links to the right.


Cancer Council NSW Ethics Committee (NHMRC # EC000345)

The Ethics Committee, a committee of the Board of Cancer Council NSW, considers research proposals and the ethical aspects of requests for:

  • Access to identifying or potentially identifying data owned or held by CCNSW for research or other purposes;
  • Linkage of data obtained from different sources within the CCNSW or linkage of data from a CCNSW data collection with data from an extra collection; or
  • Research involving human subjects undertaken by staff of the CCNSW

The Ethics Committee communicates with the Board of CCNSW through confirmed Minutes and Recommendations, which are included on the Board's meeting agenda.

All Ethics Committees are required to report annually to NHMRC in order to maintain ethical standards uniformly across the state.

At the present time, this Ethics Committee does not have Lead Human Research Ethics Committee (HREC) status. As a consequence ethical approvals given by our Committee do not apply to other jurisdictions.

 

The Committee adheres to the:

  • National Health and Medical Research Council (NHMRC) guidelines for Human Research Ethics Committees as stated in the National Statement on Ethical Conduct in Research Involving Humans 2007.
  • Cancer Council NSW Ethics Committee Terms of Reference

Membership of the Committee

Membership of the Ethics Committee is bound by the NHMRC National Statement on Ethical Conduct in Research Involving Humans 2007, which states that HRECs should be composed of both men and women with at least seven core members as follows:

  • A chairperson;
  • A layman not associated with the Cancer Council and not closely involved in scientific or legal work;
  • A laywoman not associated with the Cancer Council and not closely involved in medical, scientific or legal work
  • A minister of religion or one who serves a similar role in a community;
  • A lawyer;
  • A person with knowledge of, and current experience in, the areas of research considered by the Committee
  • A person with knowledge of, and current experience in, the professional care and counselling or treatment of people.

Members of the Committee are appointed by the Board of Cancer Council NSW.

Names of Committee members are available on request, from the Ethics Secretary on ph (02) 9334 1708 or at ethics@nswcc.org.au.

Expressions of interest in becoming a member of the Ethics Committee are also welcomed.


Committee Meetings

The Ethics Committee meets a minimum of 6 times a year. More meetings may be scheduled if sufficient submissions are made.

Meeting Dates for 2010 are:

Please contact the Ethics Secretary, Stephanie Deuchar, ph (02) 9334 1708, ethics@nswcc.org.au for any further information about the following meetings:

Meeting Date Submission Cut off Dates
4 February 19 January
1 April 16 March
3 June 18 may
5 August 20 July
7 October 21 September
2 December 16 November

 

Submitting proposals to the Cancer Council NSW Ethics Committee for review

The Cancer Council NSW Ethics Committee will accept applications using the National Ethics Application Form only. Researchers must access this form at www.ethicsform.org/au (ie. NOT at www.neaf.gov.au).

Once completed, applications MUST:

  • have a LOCKED National Ethics Application Form. This is done on the online site and is the Committee’s guarantee that the form cannot be changed. Locked forms will display a ‘lock code’ on the bottom right hand corner of every page of the form.
  • have version numbers or dates (of last modification) either visible on ALL attachments, or where this is not appropriate (ie. if it may cause confusion for participants) version numbers and dates MUST be provided in a cover letter. Documents will not be approved until this information is provided.
  • be printed out. This copy must be signed by all appropriate individuals and then photocopied (preferably double-sided and with NO staples) 15 times. The original and 15 copies, along with any cover letter, attachments etc copied 15 times, must then be forwarded to:

    Ethics Officer
    Cancer Council NSW
    PO Box 572
    Kings Cross NSW 1340
    Ph (02) 9334 1889

    Or couriered to:

    Ethics Officer
    Cancer Council NSW
    153 Dowling Street
    Woolloomooloo NSW 2011

Applications must be received by COB on the submission cut-off date to be included in the agenda for the subsequent meeting. If researchers are unable to obtain all the relevant signatures by the cut-off date for submissions, copies should still be submitted on the understanding that the original signature pages are received by the Cancer Council by the date of meeting.


What can I expect from the Ethics Committee?

Researchers should expect a fair and timely review of their proposal. The initial review notification should be received within two weeks after the meeting date. It is our goal to have each review completed within 6 weeks of the initial review meeting. Researchers may contact the Ethics Secretary via email or telephone if they do not receive a response within these time frames.


What is expected of me as an applicant/researcher?

- annual reports

Every year, from the time your project receives approval, an annual report is required for monitoring purposes. To do this you need to use the standardised form. A link to this form is located in the ‘Quick links’ box at the top of this page.


- adequate understanding of research ethics

In order to complete an ethics application you must have an adequate understanding of ethical conduct in human research and the ethical review process. While completing the National Ethics Application Form you will have access to guidance and relevant sections of the National Statement on Ethical Conduct in Human Research 2007 via the form. It is our advice however that you take best ethical practice into consideration when designing the project itself. Doing so may hasten the ethical review process for you and help avoid the sometimes major changes to protocol required to ensure the project is ethically sound.


- notification of change to previously approved projects and the relevant study materials

Any changes to study protocol including research sites, research investigators or changes to study documentation such as addition or deletion of questions from participant questionnaires MUST be approved by the Committee.


- adherence to the conditions outlined by the Committee

Final ethical approval is given with conditions that will be outlined on your notification letter. These conditions include submissions of annual reports and adherence to carrying out the project as approved. Failure to do this may result in the withdrawal of ethical approval for your project.


FAQ’s

Is the Cancer Council NSW Ethics Committee a Lead HREC?

No. This Committee is not currently a Lead Committee. For a list of Lead Committee’s please see the NSW Health website (link below).


Do I need to complete an ethics application?

All research involving humans conducted within the NSW public health system must be ethically and scientifically reviewed and approved by a NSW Health Human Research Ethics Committee (HREC) in accordance with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2007). If this research is being conducted by CCNSW staff and involves humans, regardless of the data used, it must be ethically approved by the Cancer Council NSW HREC. For some types of research such as multi-centre research, it may be more appropriate to seek approval from a Lead HREC of an institution that is involved in your research. In such cases a Site-Specific Assessment form would be submitted to the Research Governance Officer (Angela Aston) at the Cancer Council NSW and approved before research commences at this site. Additionally, in order to publish research in peer-reviewed journals, investigators must be able to show that the research was ethically approved.


Who do I address the cover letter to?

You can address the cover letter to:
A/Prof Bettina Meiser
Chair, Ethics Committee
Cancer Council NSW
PO Box 572
Kings Cross NSW 1340


Do I need to complete a Site-Specific Assessment (SSA) for Cancer Council NSW?

This form is an additional requirement for each public health site where the research will take place. If you are submitting to the Cancer Council NSW Ethics Committee, you will also need to submit an SSA form to Angela Aston, Research Governance Officer (RGO) at Cancer Council NSW. Additionally, if another Ethics Committee (that is a Lead HREC) approves your research, for which Cancer Council NSW is a site, a SSA form will need to be completed and approved by the RGO at Cancer Council NSW before research at this site can be undertaken.


Does an SSA go to the full Ethics Committee?

No. An SSA form only goes to the Research Governance Officer.


When do I submit an SSA?

As the SSA only goes to the RGO there are no meeting submission deadline dates to adhere to, although you must have SSA approval as well as ethical approval for research to commence at this site. An SSA cannot be approved before ethical approval has been granted, although you may submit it at the same time as your National Ethics Application Form and submit evidence of approval once it is obtained.


How do I submit an amendment?

Any changes to study protocol including research sites, research investigators or changes to study documentation such as addition or deletion of questions from participant questionnaires MUST be approved by the Committee. Write a detailed cover letter of requested changes outlining why you propose to make these changes and include any effected study documentation highlighting the changes. As for the initial ethics application, you are required to copy the original signed version 15 times (preferably double sided with no staples).


Does an amendment go to the full committee or only the Chair?

It is standard practise that any amendments go to the full Committee. In some cases, e.g., when the amendment is small and there are time constraints, expedited review can be arranged.


When do I submit an annual report?

Annual report forms should be submitted for the meeting closest to one year from the date of ethical approval or the previous annual report. For example if your project was submitted on the 1st February but did not gain full approval until 1st June you should submit a report for the August meeting.


Is there a standard annual report form?

Yes. A link to this form is located in the quick links box at the top of the page.


What do I do if there is an adverse event?

In the case of an adverse event, contact the Ethics Officer immediately and seek advice. A report must be submitted to the full Committee detailing the event and what steps the investigators are taking to adapt the research or change their policies such that future events are minimised or avoided completely. Depending on the nature of the adverse event, the research may be allowed to continue with minor changes to protocol, or suspended or have ethical approval withdrawn.


What do I do at the completion of a study?

A report must be submitted to the Committee at the completion of a study. Use the same form as the annual report and indicate that the project is complete. A copy of any publications specifically arising from the research should also be submitted when printed.


Further tips for researchers

Common mistakes:
- Spelling errors in study materials
- Not submitting evidence of peer review
- Not locking the NEAF form
- Not putting dates and version numbers on forms


Contact Information

Please contact the Ethics Secretary, Stephanie Deuchar, or the Ethics Officer, Angela Aston, if you have further questions about The Cancer Council NSW Ethics Committee or Ethical Review Process, at ethics@nswcc.org.au or ph (02) 9334 1708 (Stephanie), ph (02) 9334 1889 (Angela).


External Ethics Links

- The National Statement on Ethical Conduct in Research Involving Humans
- NSW Health Ethics
- The Declaration of Helsinki
- NHMRC Health Ethics

- Privacy Act 1988


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