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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
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RMIT University
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Specific Comments
1. Introduction to Section 3

Structure - The introduction of the Elements of Research (reflecting the life cycle of human research projects) to order the guidance contained in Chapter 3.1 is logical and welcomed.

However, the way in which the guidelines are ordered within each of these elements requires revision. We recommend structuring information so that general information is first, followed by more specific information to improve logic and cohesiveness, e.g. in Chapter 3.1, Element 1: the introduction - stating that in designing a human research project researchers must consider how their project will meet the requirement that research has merit and integrity - should be the first guideline and precede 3.1.1, which contains more specific advice to researchers on what they should include in an application. Also, in Chapter 3.1, Element 2 - Recruitment: the last sentence in the introduction (selected recruitment strategies adhering to ethics principles of justice and respect) should be the first guideline for this element.

Group guidelines, e.g. by audience - researchers, reviewers.

2. Chapter 3.1

Scope - The revision of Chapter 3.1. to provide ethics guidance which applies to all types of human research is welcome, as it will enable the National Statement to speak more broadly to the research and wider community.

However, we recommend that the scope is limited to guidance on ethics issues related to human research, rather than general research integrity issues, in order
to avoid overlap with the Australian Code for the Responsible Conduct of Research (the Code) and/or with other parts of the National Statement, e.g.
Chapter 3.1 the introduction to Element 6 contains information that is not relevant to ethics considerations; 3.1 .73 is an integrity issue that is covered by the Code; 3.1.8 replicates guidance already provided in Section1 , 1.1 (e) and (f).

Many guidelines focus on researchers, without adequate consideration of research participants and/or of how ethics reviewers would apply the guidelines.

1. Introduction to Section 3

Consistent terminology - Use 'ethics' rather than 'ethical'. An ethical review process is one in which the process is conducted ethically. An ethics review process is one in which the ethics of a proposal are reviewed, (see also ethical considerations, ethical issues, ethical principles, ethical requirements).

Interchangeable use of 'reviewers' and 'ethics research reviewers'.

Interchangeable use of the terms 'clinical trial', 'clinical research' , 'health intervention', 'health treatment', 'research into health care', making it unclear which type of projects require the special measures associated with clinical trials (see additional point below regarding clinical research).

2. Chapter 3.1

Scope - The introduction of ethics guidance which applies to all types of human research is welcome, as it will enable the National Statementto speak more broadly to the research and wider community.

2. Chapter 3.1

Length - The revisions of Chapter 3.1 have extended the length and diluted the focus. The focus should be on broad ethics guidelines which can be applied to all human research, by researchers and ethics reviewers.

There is also too much introductory content (for example, there is an introduction to Section 3, Chapter 3.1 and to each of the Elements) - see also point directly below.

Some individual guidelines are very wordy which negatively impacts the clarity and cohesiveness of this Chapter as a whole.

2. Chapter 3.1

Introductions - We like that there is an introduction to Chapter 3.1; however it should provide context and an overview of the Elements contained in this chapter. The introduction should not contain guidelines.

Introductions to Chapter 3.1 and to each of the Elements could be shortened by moving guidance information into the Elements of Research as guidelines e.g. comments about conflict between professional/researcher roles; the information in the introduction to Banking and Sharing of Data; the introduction to Element 1, Element 5 (in particular paragraph 2) and Element 6.

2. Chapter 3.1

Focus on researchers - Paragraph 5 (on impact) puts too much emphasis on the impact towards researcher interests (professionalism). We recommend inserting an additional paragraph about participant impact.

2. Chapter 3.1

Recruitment and consent - We recommend distinguishing between recruitment and consent, e.g. in the Element 'Recruitment', remove references to consent but include a comment about impact of recruitment on consent to segue to Element 3 'Consent'.

Guidelines 3.1.26; 3.1 .28; 3.1.77 are welcome additions.

2. Chapter 3.1

Some guidelines would benefit from greater clarity - For example: 3.1.1 (b) (ii) appears to limit the potential benefits of research. Is this the intent?

Clarify 3.1.2 (e) to improve ease of comprehension.

3.1.2 (f) could be clarified as follows: "Where current treatments are effective and or there is known risk of significant harm in the absence of treatment, placebo or non-treatment groups are not ethically acceptable. Placebo or non-treatment groups may only be used where there is genuine uncertainty about current clinical benefit".

3.1.4 should speak to merit and integrity , rather than 'rigour and disciplinary merit'.

3.1 .7 could be clarified and should specify ethics approval.

3.1 .20 meaning is unclear and duplicates information provided below.

3.1.25, sub-points (a) - (c) appear to overlap.

Clarify 3.1.26 by dividing into two sentences.

3.1 .30 (a) appears to contradict the introductory statement for this guideline.

3.1.54 should clarify that historical significance cannot justify breaches of privacy or compromise the overarching values.

2. Chapter 3.1

Research data management - Some guidelines on this issue relate to governance not ethics. The ethics guidelines provide greater assistance to researchers and ethics reviewers by clarifying which data must be permanently retained so that the guidelines can be consistently applied e.g. 3.1.31; 3.1.54; 3.1.60; 3.1 .77; 3.1. 78. Also, the significance of data may not be obvious at an early stage.

2. Chapter 3.1

Internet derived data - Guidelines 3.1.45-3.1.48 are welcome but require refinement.

2. Chapter 3.1

Clinical/health research - Move guidelines on clinical and health research in Chapter 3.1 to Chapter 3.5 for ease of use for researchers and reviewers, (i.e. 3.1 .2 - 3.1.3; 3.1.17 - 19; 3.1.33 - 34; 3.1.44, 3.1 .55 and 3.1.67.). Given the number and importance of the specific ethics considerations which accrue to this type of research, it points to the need for a separate Chapter on Clinical Research to be retained.

3. Chapter 3.5

The additional guidance on managing information that has hereditary implications in human research and the content of related ethically defensible plans is a welcome addition, as is the related decision tree which will prove a useful tool for both researchers and reviewers.

The more up to date introduction and guidance is also welcome, in particular the recognition of the unique and sensitive nature of genomic information, as well as the advances and rapid evolution of genomic research.

We recommend that Chapter 3.5 contains only supplementary guidelines to Chapter 3.1 to avoid duplication.

4. Section 5

Changes to this Section are minor and consequential, no comments.

5. Glossary

Changes to this Section are minor and consequential, no comments.

General Comments

RMIT recognises the need for these revisions to key areas of the National Statement, as identified by the
Australian research community. RMIT welcomes the revised scope of the guidelines in Chapter 3.1 to apply to all types of human research. This ensures that the guidelines now speak to a broader range of research
methods; for example, ethnographic, experimental and observational research. RMIT also welcomes the
reordering of these guidelines into the Elements of Research which follow a logical and intuitive 'life cycle' of human research projects. The additional guidance provided in Chapter 3.1 on internet-derived data and
databanks is especially welcome. These key areas are subject to continuous change and the additional
guidance provides greater clarification and certainty for researchers and ethics reviewers.

RMIT welcomes the direction taken regarding the revision of Section 3, and acknowledges the considerable
progress made. However, we recommend that additional consultation and revision is required prior to
finalisation . The order of Chapter 3.1 and the guidelines within each of the elements would benefit from further simplification to ensure that information is provided sequentially, avoids repetition and is relevant to ethics considerations. RMIT also recommends that clinical research guidelines are separately addressed in a standalone Chapter on Clinical Research. We note that the term 'ethical review process' is used throughout the document and the way in which this alters the intended meaning. That is, an ethical review process is one in which the process is conducted ethically whereas, an ethics review process is one in which the ethics of a proposal are reviewed. The same is true for ethical considerations, ethical issues, ethical principles, and so on.

Supporting attachments

Page reviewed: 10 July, 2018