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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: 
Charles Sturt University
Personal Details
Specific Comments
2. Chapter 3.1

Element 1: Research Scope, Aims, Themes, Questions and Methods.
This section is very relevant and useful for the Charles Sturt University HREC, as the HREC deals with a wide range of human research activities. The updated text is very thorough and clearly written. The intent of the content is not new, but the revision makes explicit that which formerly had to be extracted by careful reading and broad interpretation.

2. Chapter 3.1

Element 2: Recruitment:
Generally this section is very clear, but note the following three points:
The word ‘recruitment’ has puzzled some international collaborators in CSU research projects, where recruitment is confined to employment and implies contracts and payment. Perhaps this section could start with a sentence that explains that recruitment is the seeking, sourcing and inviting of potential research participants to ensure everyone understands this term?

3.1.15 - Consideration of over researching some populations is very difficult for both individual researchers and reviewers to implement. Are there any further guidelines for what might constitute over-researching?

3.1.20 - This point could be usefully strengthened by requiring researchers to articulate, as well as consider, the participant experience.

2. Chapter 3.1

Element 3: Consent:
The introduction states: ‘Obtaining consent may be a component of broader processes of consultation, engagement and negotiation, particularly in the context of research involving Aboriginal and Torres Strait Islander Peoples’. It would be useful to also note here that gaining consent may be an ongoing process (as noted later in 3.1.26) rather than always the single point as implied in the current text.

2. Chapter 3.1

Element 4: Data Collection and Management
The inclusion of 3.1.42 is excellent, as this point is often overlooked by researchers.

3.1.45 - It is not immediately clear what is intended by the text ‘For research using internet-derived data, researchers should make study designs readily available to persons to whom the data relates, including information about …’. This is relatively straightforward for social media sites, but less so for large public websites. Should study designs be prepared for distribution in case someone asks? (But would website owners/ authors necessarily know to ask?). Or is the implication that researchers should be more active in telling internet users that their research is underway? If this is the intent, what are the implications for the researcher if this cannot be achieved, e.g. if the owners of web sites are not listed?

Similarly the intent of 3.1.46 is difficult to grasp. ‘Unless a waiver of the requirement for consent is obtained, any research use of internet-derived data must be in accordance with the consent obtained from the person to whom the data relates’. If, for example, a researcher is looking at some element of make-up advertisements on public display on the internet; do they have to contact every website owner and seek consent? Or should they contact the manufacturer whose make-up is in the advertisement? Or will the researcher be expected to seek a waiver of consent (in which they have to guess whether the owners would have consented if they knew, which may be unlikely…but how will anyone know?) Is section 3.1.46 likely to generate many more applications for waiver of consent? If so, that section, although recently updated, may need another review, as it appears to be poorly understood by researchers.

2. Chapter 3.1

Element 5: Communication of research findings or results
3.1.71 - The intent of this section is unclear with regards to what reviewers are expected to do. Do specific guidelines or suggestions exist, for example, elsewhere in the National Statement or Code of Research Conduct?

2. Chapter 3.1

Element 7: After the project
Some clarity on what is meant by ‘project is completed’ would be useful here and elsewhere in the National Statement. Is this when data collection/ creation is finished? Or when an official term of funding ends? Or after publication? Or something else?

3. Chapter 3.5

Chapter 3.5 - The CSU HREC has rarely reviewed genomic research proposals, so the proposed text was reviewed for clarity of meaning. Although complex, Chapter 3.5 appears to be thorough and accessible.

General Comments

The majority of the changes suggested in the draft are welcomed as they expand the focus of the National Statement to fully include a range of human research activities. This is an improvement on the prior focus on medical activities. Overall the draft
 provides sufficient guidance to address the key ethical issues in relation to human research
 is presented and written in a manner that is appropriate for the target audience (researchers, HRECs).

For consistency a decision on data being plural or singular should be made. Currently it varies; mostly data are treated as plural, but sometimes singular, e.g. 3.1.4., 3.1.58, 3.1.65.

The above overall endorsement of the draft notwithstanding, some specific comments on Chapters 3.1 and 3.5 are provided.

Supporting attachments

Page reviewed: 10 July, 2018