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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: 
Hunter New England Local Health District
Personal Details
Specific Comments
1. Introduction to Section 3

The introduction was considered wordy and repetitive - the section could be reduced

2. Chapter 3.1

Section 3.1. 1 an additional requirement sould be added "Will the proposed methodology address the aims of the study or answer the research question

Section 3.1.20 add "and could be affected by" as there may be after effects if the potential particpants foung th rcruitment process traumatic

section 3.1.27 it is unclear what is meant by "supervisors of participants" an example may help

section 3.1.30(b) "tiered information" needs to be explained

section 3.1.30(c) - it may be worth adding that the time allowed for potential participants to comprehend the information statement should be proportional to the complexity of the research

section 3.1.33 need to add "after completion of the study or active treatment phse of the study";

sections 3.1.45 and 3.1.46 do not seem to be sufficiently detailed given the novelty of this research

section 3.1.60  Thiere is no mention of obtaining consent for future use of data at the time of collection (should be cross referenced with the relevant section in Chapter 2

section 3.1.69  Need to also include consideration/evaluation of the limitations of the finding(whether at all clinically sinificant) and who is the appropriat person to communicate results to potential participants

Element 6 should explicitly acknowledge that some research is primarily undertaken to obtain a degree


General Comments

Due to time comments have not been provided on section 3.5


The changes to Chapter 5 are agreed with


Page reviewed: 10 July, 2018