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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

ID: 
13
This submission reflects the views of
Organisation Name: 
Bellberry Limited
Personal Details
Specific Comments
Comments: 
2. Chapter 3.1

3.1.2

“(e) 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; and”

 

This is difficult to understand but if we understand it correctly, the standard required to meet this is difficult or impossible to attain.

 

In a trial of an investigational drug in advanced cancer where standard options have been exhausted, it is likely that “the benefits or risks cannot be accurately estimated in advance”. Since there is no standard beneficial therapy against which the new treatment could be compared, there is no way of determining whether “the known risk to participants must be lower than for research in which there are likely benefits”.

2. Chapter 3.1

3.1.24

Suggest removal of the word "drafts" as the HREC should approve the final version of any recruitment material.

2. Chapter 3.1

Element 4: Data Collection and Management

Second paragraph, second sentence.  Suggest re-wording to "Data may include 'research materials' such as information derived from human biospecimens, laboratory........." for correctness and consistency with last bullet point on page 15.

1. Introduction to Section 3

Third paragraph on page 4. 

Should the principles read "research merit and integrity" rather than "research merit and vaildity"?

1. Introduction to Section 3

Page 7 mentions the core principles.  We believe the core principles described in the current NS in 3.1.1 through 3.1.17 should still be included (possibly summarised) to provide a high level overview of the ethical aspects to be considered.  We suggest these could be included on page 4 following the sentence "It is up to each resercher and HREC to apply the guidance......" which could become a stand alone paragraph.

It is our experience that the principles laid out at 3.1.1 to 3.1.17 are a very useful guide for investigators and HREC members. 

Our HRECs consistencly refer to 3.1.1 to 3.1.17 in responses to Investigators, particularly to provide justificatioon for either study rejection or questions for clarification.  This approach leaves the responsibility for trial design with the researcher, while giving full and transparent justification for the decision.

Page reviewed: 10 July, 2018