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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: 
24
This submission reflects the views of
Organisation Name: 
University of Technology Sydney
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Specific Comments
Comments: 
2. Chapter 3.1

Introduction to section 3

 The inclusion of the INTRODUCTION to Section 3 is very useful.

Chapter 3.1

Element 1: Research Scope, Aims, Themes, Questions and Methods

3.1.1 – the METHOD should also be briefly described in plain language

3.1.2 - We wonder whether the rules about research involving placebos leaves room for research into the placebo effect itself?

3.1.4 – An additional item should be considered for assessment: whether the total burden of participation is acceptable relative to the potential significance of the aims/objectives

3.1.7 – We strongly support the need for ethics review for one part of a research project to be considered in the context of the project as a whole. It should be specifically emphasised here that the HREC may not be able to fully approve the successive stages of the research until the required information is subsequently provided (where information is not available in advance).

3.1.8 - The requirement for a plan for funding is sensible providing that it includes, for example, a plan to submit for funding at later stages.

Element 2: Recruitment

Introduction: the issue of relationships with anyone who will be acting as a recruitment agent needs to also be considered– their relationship with the researchers, and with those they will recruit.

3.1.13 – There should be a requirement for researchers to justify why certain group(s) of participants are excluded from a study (i.e., explain under what circumstances it would be inappropriate/ unfeasible)

3.1.16. Should this include ability to consent?

3.1.22 On payment: could be a pressure, but could also be an inducement that is disproportionate, or that may skew recruitment in some way.

Element 3: Consent

Should there be some specific reference to consenting of children, vulnerable populations, and other populations where there is a guardian or primary carer?

Element 4: Data Collection and Management

This section could also include a category ‘health and medical records’.

Element 6: Dissemination of Research Outputs and Outcomes

Perhaps could mention here that many publications require researchers to specifically declare that the study has been undertaken in accordance with ethical principles and to state which HREC gave approval.

Element 7: After the Project

Perhaps need to emphasise that many journals are requiring that data sets are shared (at least in part) when submitting manuscripts for review/ publication.

 

3. Chapter 3.5

These guidelines appear to be very clear and well informed and take into account key issues including:  participants' right not to know the results of genetic and genomic testing and screening, the implications results may have for relatives of the participant, the issue of DNA samples being identifiable and potentially re-identifiable, the potential impact on access to insurance & financial services, and the need for certain genetic results communication to be done via genetic counsellors. HRECs will need to read future applications carefully to ensure researchers have suitable plans for safe storage of both biological material (because DNA can be re-tested in ways which may reveal identity) and results data (which may have health, financial and insurance implications for participants and may also pose a risk of re-identification through data linkage.

Suggestions

Page 25 - paragraph 5, the statement refers to banking but should perhaps specifically refer to implications for access to "mortgages and other loans" - as mortgage application can be a major life event for people.

Page 25 -last paragraph - the reference to judging something as low risk should be re-worded because DNA samples are in themselves potentially identifying information and databases are at risk of allowing re-identification of individuals – Suggested rewording: "... May be determined to carry low risk as long as plans for storage of samples and results are well designed and applied."

Page 27 – Element 2: Recruitment

3.5.4 - the reference to relatives suggest that it is necessary for them to provide information and samples to become involved in research; however, a relative's genetic status can be revealed even if they don't provide any samples or information, for example a parent who has not been tested for Huntington's disease may have their status revealed if their child has a test which shows the child has the HD gene.

Suggested rewording: "In addition to participants who provide information or bio specimens for genetic research (known as index cases or probands), relatives of these people become participants in the research in their own right"

3.5.8 - Re word "may implicate cultural values" to "may have implications for cultural values" or "may be influenced by cultural values"

Page 28 - Element 3: Consent

3.5.10 - suggest adding additional point "security of storage of bio specimens and genetic/genomic results"

Page 29 - Element 4: Data Collection and Management

3.5.20 - suggest add "and storage of original bio specimens and results are secure, especially if the project involves online or cloud storage"

4. Section 5

5.1.26 – should these established ‘standards’ be publicly accessible

5.2.11 (b) – should refer to dissemination more broadly (not just publication)

5.5.12 (b) – should this be ‘adverse effects’ or ‘side effects’ more broadly?

Page reviewed: 10 July, 2018