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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: 
23
This submission reflects the views of
Organisation Name: 
University of Tasmania
Personal Details
Specific Comments
Comments: 
General Comments
Comments: 

The University of Tasmania thanks the National Health and Medical Research Council (NHMRC) for the opportunity to comment on the revised National Statement on Ethical Conduct in Human Research (National Statement). The University commends the NHMRC, Australian Health Ethics Committee, the Australian Research Council and Universities Australia on the concise and considered revisions.

In response to the specific questions raised by the NHMRC, the University believes the revised sections, when read in conjunction with the existing sections:

-       Provide researchers and Human Research Ethics Committees (HREC) with sufficient guidance to address the key ethical issues in relation to human research;

-       That the revised Chapter is presented in an appropriate format for the target audience.

Detailed comments regarding specific sections (Chapters 3.1, 5 and Glossary) have been included as an appendix (Appendix 1). Chapter 3.5 has been considered in detail by the University’s Centre for Law and Genetics, who will make an independent submission on this Chapter. 

In particular the explicit mention of open-access data repositories, data linkage, and data sharing are welcome inclusions.  Australian research is data rich, and making this data more readily accessible to researchers is an important step in increasing Australia’s research output.  The new section on internet derived data is also very welcome.  Keeping the guidance deliberately high level provides Institutions with principles and values to embed in their own Policies and Procedures which the University feels is appropriate.  However, balancing high level principles with specific statements to guide research practice can be difficult, and specific comments are included in Appendix 1 where the University feels further consideration may be required.  

A common concern raised by the University of Tasmanian HRECs is related to “rightful access” to participant information, and when accessing this information crosses the boundary from clinical care into research. An example is a cardiology clinician; as part of their role as a clinician has access to all the cardiology clinic lists. There is a new clinical trial soon to be approved by the local HREC, and the protocol clearly stipulates the inclusion and exclusion criteria. Can the clinician access the clinic lists to identify potential patients for the trial, prior to the trial being approved? The participants would not be contacted, nor would any information be stored outside of the hospital clinic list. Specific consideration to this grey area would be greatly appreciated under element 2.   

Research in the field of creative arts has often been more difficult to align with particular sections of the National Statement, particularly in the identification of ‘research data’ and ‘personal information’. The inclusion of specific examples of ‘data’ in the introduction of element 4 is useful, but the University suggests that further input be sought from those working creative arts research to ensure the definitions are inclusive enough for that discipline.

The University strongly supports the definitions used to describe the identifiably of data as it reduces ambiguity.  National and State-based legislation can use different definitions, and therefore it will be important for Institutions to promote and educate researchers on how the differing definitions are to be used.

IN ADDITION - general comments regarding Aboriginal Research

Lack of adequate Engagement with Aboriginal and Torres Strait Islander Research
My overarching comment is the lack of adequate engagement with Aboriginal and Torres Strait Islander research ethics. Chapter 3.1 refers to Indigenous people/research in just two place; the first in the page 5 paragraph which refers researchers planning any type of research involving Aboriginal and Torres Strait Islander 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 Aboriginal and Torres Strait Islander research is not mentioned, although I understand it too will be reviewed); and another brief mention on page 13, relating to obtaining consent. There are also two mentions in the non-red sections of Chapter 5.

Chapter 3.1’s strategy of referral to other documents for guidance on Aboriginal and Torres Strait Islander ethics issues is insufficient within what is the primary document informing Australian researchers on ethics.  The critical importance of the other various guidelines for conducting ethical research with Aboriginal and Torres Strait Islander peoples is not contested. But these documents, of themselves, cannot replace or justify the absence/exclusion of consideration of Aboriginal and Torres Strait Islander ethical issues within what is a major chapter of the National Statement.

An example of how national ethical guidelines can address Aboriginal and Torres Strait Islander ethical issues within broader national guidelines comes from Aotearoa New Zealand.  The document, Ethical Guidelines for Observational Studies: Observational research, audits and related activities is inclusive, listing ‘promoting well-being of Māori and ensure mechanisms for Māori participation in both research and ethical review’ (2012: iii) as one of its five key objectives. Māori ethical considerations are not segregated but included within the main document body as a separate section. Neither are Māori grouped, as is the case in Australia, with the other identified vulnerable populations. Most other sections within this document, outside of the Māori specific section, also specify how the guidelines relate to Māori and Māori are directly referenced in the sections on research being scientifically sound, on collection consent and on gathering health information.

Specific Commentary on a More Inclusive Approach
This lack of direct engagement with Aboriginal and Torres Strait Islander ethical guidelines will likely continue current problems emerging from mainstream ethical guidelines. One such issue was highlighted in the November 2016 paper to the [NHMRC has removed third party information] meeting. This paper stated in part:

The problem we address here is how elements of the National Statement, as currently interpreted by Human Research Ethics Committees (HRECs), can be out of alignment with Indigenous community of expectations ethical practices. Rigid interpretations of the National Statement can impede and/or limit community based practice. At best these can put Indigenous HDR students in the invidious position of having to prioritise HREC expectations on ethical research practices over their own, and their communities, research values. At worst they can derail the research project, harming the communities and the student via research non-completion.  (Walter & Jackson Pulver, Indigenous Research Higher Degrees: 4 Active Steps for Change).

This paper, which was endorsed at the meeting, set out a strategy to help address this issue of clarifying guidelines for HRECs on how to assess Indigenous community research project applications, especially related to:  

•           Legitimacy of Indigenous methods and methodologies

•           Indigenous community research practices, which will vary from community to community

•           Community participation

•           Community consent

•           Community data ownership

Inclusion of appropriate references to these issues within the new Chapter 3.1, in line with how the New Zealand document is inclusive of Māori would obviate for clarifying guidelines. 

Page reviewed: 10 July, 2018