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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: 
Haemophilia Foundation Australia
Personal Details
Specific Comments
2. Chapter 3.1

We can appreciate the work that has gone into consolidating the content in Chapter 3 to cover the diverse range of research methods. This is very comprehensive and we have only a few small comments:

In relation to:

3.1.2 …whether the research is without likely benefit to participants, or whether the benefits or risks cannot be accurately estimated in advance. For such research to be ethically acceptable, the known risk to participants must be lower than for research in which there are likely benefits

It would be valuable to define “lower risk” a little more closely in this context, as it may be difficult to assess what degree of “lower risk” is acceptable.

In relation to:

3.1.17 In clinical trials, researchers must ensure that participants understand whether there is intended to be any therapeutic benefit to them from the trial and whether access to the interventional therapy is available only through participation in the trial.

It would be valuable to also consider and explain the ethical frameworks other types of research, for example researching an education intervention rather than a clinical trial, where a particular product or activity may be considered to have some benefit but only be available through participation in the study. This would help those engaged in this type of research understand their ethical responsibilities in relation to this research.

In relation to:

3.1.30 The complexity of an information and consent document or other consent mechanism should be
proportional to the project’s risks and ethical sensitivity. Specifically,
(a) written information should not be unduly long or complex, even for complex interventional

We suggest that written information should also be in plain English.


4. Section 5

In relation to:

5.2.11 For relevant research, this disclosure should specify: (a) any business, financial or other similar association between a researcher and the supplier of a drug or surgical or other device to be used in the research; and...

It would be helpful to add a non-clinical aspect to this as well, as we assume this relates to a potential commercial conflict of interest - and in human research this may be in a health environment that is not clinical, eg "the supplier of a drug or surgical or other device or other product to be used in the research..."

General Comments

Thank you for the opportunity to provide comment on this important document.

We rely on this Statement to guide us with our own organisation's research, as well as to understand the ethical frameworks for other human research that our community members participate in.

In general, we are satisfied with the changes and think they are comprehensive, thoughtful, careful and clear. We have only a few small comments to make, mostly about some inclusions for non-clinical research, which we have made in Specific Comments.

Page reviewed: 10 July, 2018