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Section 3 (Chapters 3.1 & 3.5), Glossary and Revisions to Section 5 National Statement on Ethical Conduct in Human Research, 2007 submission

This submission reflects the views of
Organisation Name: 
Cancer Council Victoria
Personal Details
Specific Comments
1. Introduction to Section 3

The introduction to Section 3 introduces the new content and effectively explains the new themes and structure for the section.

2. Chapter 3.1

Chapter 3.1 provides an informative and easy to use guide to the elements of research, and is appropriately written.  This new section is arranged thematically, but it would be useful to have more information on clinical trials included in this section.  We note that under Section 5, Chapter 5.2, researchers are directed to show that research meets the relevant requirements of the CPMP/ICH Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95), ISO 14155 Clinical Investigation of Medical Devices, and the TGA are referred to under researcher responsibilities, and it would be helpful to refer to these earlier in Section 3. Similarly, some of the advice in Chapter 5.5 on monitoring approved research in relation to clinical trials would be useful in this section to assist researchers in considering at the planning stage of their clinical trials how research will be monitored.

3. Chapter 3.5

The guidelines in Chapter 3.5 are clearly written.

4. Section 5

Section 5 and glossary comments:

The updates to the Glossary and Section 5 are appropriate.

General Comments

Cancer Council Victoria has reviewed the proposed changes to the National Statement, specifically to Section 3 and Section 5.

It is our view that that the new sections are, overall, clear and comprehensive and add considerably to the document.

Over the last 2.5 years, Cancer Council Victoria has fought a freedom of information request in which British American Tobacco sought to access to data files containing information provided by thousands of Australian school children through the Australian Secondary Schools Alcohol and Drugs Survey (ASSAD).  VCAT ultimately found in Cancer Council Victoria’s favour and denied access to the information. While this was a relief, the defence of this request substantially diverted researchers’ time.  Importantly, this experience raised the question of guidance around confidentiality of research data.  In conducting this survey, schools and participants are assured of the confidentiality of the information they provide.  In reflecting on the guidance provided by the National Statement on confidentiality, we want to highlight that while confidentiality is mentioned at various points throughout the current  National Statement, the only standalone statement on confidentiality is in Chapter 3.5: Human Genetics and is thus in the context of genetic research.  In our view, a clear, standalone statement on the dimensions of confidentiality and the importance of managing confidentiality of research data would be beneficial.  This could be included in the new Section 3.1, Element 4: Data Collection and Management, or inserted as a separate clause in Section 1 of the National Statement.


Page reviewed: 10 July, 2018