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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: 
47
This submission reflects the views of
Organisation Name: 
University of South Australia
Personal Details
Specific Comments
Comments: 
1. Introduction to Section 3

See attached letter.

1. Introduction to Section 3

See attached letter.

2. Chapter 3.1

With respect to the language used in Element 4, UniSA is in favour of retaining the terms ‘individually identifiable data’, ‘re-identifiable data’ and ‘non-identifiable data’. We consider it necessary not only because it is important to ensure the National Statement remains internally consistent, but also because the terms themselves have greater clarity. Although this means that the terms are not the same as those used in Privacy legislation, the greater clarity will protect against misunderstanding and lead to more accurate descriptions of researchers’ data. This will contribute to greater protection of participants.

2. Chapter 3.1

Besides the more general comments above we also wish to provide some commentary on one specific aspect, viz., engagement with Aboriginal and Torres Strait Islander (ATSI) research, about which there appear to be some deficiencies.

Chapter 3.1 refers to Indigenous people/research in just two places; the first on page 5 which refers researchers planning any type of research involving ATSI people to Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Research (2003) and Keeping Research on Track (2005) and the AIATSIS Ethics Guidelines (Section 4.7, the current section of the National Statement that deals directly with ATSI research is not mentioned). There is another brief mention on page 13, relating to obtaining consent. There are also two brief references in unchanged sections of Chapter 5.

Chapter 3.1’s strategy of referral to other documents for guidance on ATSI ethics issues is insufficient within what is the primary document informing Australian researchers on ethics. Whilst these other documents are critically important, they cannot replace or justify the exclusion of ATSI ethical issues within what is a major chapter of the National Statement. The current lack of direct engagement with ATSI ethical guidelines is a gap that will continue to contribute to the current problems in this area of research.

There is a need to develop strategies to address poor engagement issues and to clarify guidelines for HRECs on how to assess Indigenous community research project applications, especially in relation to:
• Legitimacy of Indigenous methods and methodologies;
• Indigenous community research practices, which will vary from community to community;
• Community participation;
• Community consent; and
• Community data ownership.

Appropriate references to these issues could be included within the new Chapter 3.1 as follows:

Element 1: Research Scope, Aims, Themes, Questions and Methods
• This section should include a reference to Indigenous methods and methodologies, perhaps a new clause under 3.1.6. Such an inclusion will address the problem faced by ATSI researchers whereby HRECs interpret Indigenous methodologies as not fitting with the National Statement.

Element 2: Recruitment
• This section should contain a clause to the effect that recruitment of ATSI participants can, and sometimes should be, at the community level rather that at the individual level alone. This could attach to 3.1.16.
• Section 3.3.15 on the potential of some populations to be over-researched should explicitly refer to ATSI people as one of those groups.

Section 3: Consent.
• The first paragraph refers to ATSI consent potentially requiring broader processes of consultation, engagement and negotiation but does not provide any further information of what that might look like. A clarifying statement is appropriate. In lieu, a reference to Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Research (2003) could be inserted here. Reference could also be made to the minimum standards on consent as outlined in the UN Declaration on the Rights of Indigenous Peoples.

Section 4: Data Collection and Management
• 3.1.41 should recognise that for ATSI peoples the risk of potentially identifiable data belongs to the community, and not just to individuals.
• 3.1.52 should specifically refer to the added ethical risks of sharing data on already marginalised populations such as ATSI people.
• 3.1.60 refers to respect for cultural ownership but does not make explicit what this means. Again specific reference to ATSI cultural ownership will provide more guidance for researchers. If the cultural ownership reference goes beyond Indigenous peoples this could be made clear here also.
• 3.1.66 should include specific reference to ATSI data given the additional risks already marginalised ATSI people, communities face of their data being used for purposes to which participants have not specifically agreed.

Element 5: Communication of Research Findings and Results
• This element references values and preferences of traditional custodians, but this is not explained. A more detailed explanation is required in this section.

This element also refers to the risks to participant welfare. This section should include a specific reference to the risks to ATSI welfare and well-being at the individual and community level, particularly those that present negative results.

Element 6: Dissemination of Project Outputs and Outcomes
• Another reference to Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Research (2003) on sharing of results might be appropriate here.

Element 7: After the Project
• The importance of retaining and safely securing ATSI data is an issue of emerging importance. A reference to this should be included in this section.

Indigenous peoples are also referenced on page 25 in relation to Genomic Research. This reference is welcome, but given the high level of risk in genomic research for ATSI peoples, as per international experiences, more reference to this risk at the level of peoples rather than as individuals, is appropriate.

General Comments
Comments: 

See attached letter.

UniSA is broadly supportive of the proposed changes, particularly as the new structure provides guidance that is well directed to the way in which research naturally proceeds. As such it will serve as a more useful document both for researchers and for the Ethics Committees who consider their applications.

In general, the new approach provides sufficient guidance with regard to the key ethical issues that arise in each of the aspects of the research cycle described in the new ‘Elements’. Moreover, the style is more accessible to both researchers and ethics committees. In this sense it has the potential to help draw the two parties together and promote greater understanding on both sides. However, with the introduction of this style and use of language, pressure will be applied to modify the rest of the National Statement accordingly, and UniSA is supportive of such changes.

Supporting attachments

Page reviewed: 10 July, 2018