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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: 
46
This submission reflects the views of
Organisation Name: 
Office of Research Ethics and Integrity, QUT
Personal Details
Specific Comments
Comments: 
2. Chapter 3.1

Introduction

  • States that 'effective research ethics review' will have an 'understanding' or 'access' to 'expert advice about relevant methods or areas of practice'. This seems to imply that HRECs and reviewers will need to equip their membership to include relevant expertise or have access to expert scientific review or peer review processes.
  • Statement about 'Researchers have a role to inform participants whenever they are acting in a professional rather than a research role.' Suggest this be cross referenced with Chpater 4.3 and also mention the risk of actual. potential or perceived conflicts of interest and include that research should ensure they have an ethically defensible management plan to address these actual, perceived or potential conflict of interest.
  • Statement in last paragraph that 'There should be clear protocols for dealing with distress that might be experienced by participants during the process of data collection or conduct of research procedures'.  Use of the language 'protocol' suggests a standard operating procedure.  Is this intended? Suggest use of management plans that is consistent with language used in the remainder of the document.

Section 3.1.2

Section 3.1.3

  • Likewise there is no definition of 'clinical trial research' but it is assumed this is defined by the 'publically accessible register' e.g. ANZ Clinical Trial Register

Section 3.1.5

  • Statement about 'In their assessment of research quality ..' Research quality is a difficult term to define.  Suggest this is reworded to refer to 'research merit and integrity' for consistency.

Section 3.1.8

  • Subsections (a) and (b) about ensuring resources and facilities are in place to complete the research could also cross reference with Section 5:  Processes for Research Governance and Ethical review, as this is also an Institutional responsibility.

Section 3.1.16

  • Subsection (f).  There should be a general expectation that participants will be recruited by co-researchers familiar with the guidance of the National Statement.
  • Subsection (g).  This is very broad.  Recommend cross reference to Chapter 4.7. Furthermore, the language of 'research agreements' also may incude contractual arrangements that are part of Section 5:  Processes for Research Governance and Ethical Review

Sections 3.17-3.1.23

  • The guidance provisions seem to relate to Chpater 2.2 General Requirements for Consent, in particular Section 2.2.6

Section 3.1.19

  • Suggest also cross referencing or mentioning the designated chapters where applicable.

Section 3.1.18

  • Suggest this may be better placed in 2.2.6 Requirements for the Participant Information Sheet or otherwise cross -reference to 2.2.6

Data identifiability and privacy legislation

  • In principle, consistency between Privacy legislation (both State and Federal) and the National Statement is preferable
2. Chapter 3.1

General comments on the revised Section 3.1

Thank you for the opportunity to provide comment on the proposed changes to section 3.1 of the National Statement on Ethical Conduct in Human Research, 2007 (National Statement).

The ethical guidance under the revised chapter 3.1 is structured under the headings of 'elements of research' and the chapter now has a much broader scope that now encompasses all types of human research.  This is a timely revision but does present a significant change to the overall format and presentation of the existing National Statement.  The general layout of the revised section 3.1 is now inconsistent with the other remaining chapters of the document, which present a general introduction followed by guidelines, arranged under the core ethical principles of research merit and integrity, justice, beneficence and respect.

Specific comments relating to the 'headings of 'elements of research' and the broadened scope of section 3.1 are:

  • The guidelines presented under the headings of 'elements of research' are understandably broad and less specific.  This may prove difficult for reviewers and HRECs to communicate specific and consistent advice to researchers
  • The language in the original version of the National Statement is directed primarily at researchers.  Many of the ethical guidelines in the revised National Statement are written for reviewers and researchers and these are listed interchangeably throughout the revised chapter e.g. 3.1.6 and 3.1.22.  Could these be ordered under the headings of 'For reviewers' and 'For researchers' or be rephrased to refer to both researchers and reviewers alike.
  • There are a number of areas where the revised section could be enhanced by cross referencing or consolidation with other chapters, for example:
  • There are now two chapters that refer to consent - Chapter 2.2 (General Requirements for consent) and Chapter 3.1 Element 3: Consent.  We suggest combine into a core Chapter on 'Consent' to minimise multiple 'cross referencing and potential duplication of information.
  • There are a number of guidelines that would benefit from cross-referencing with other sections of the National Statement.  These are further outlined under 'Specific Comments' above.
  • The Elements on 'Research Data Management' and 'Dissemination of Research' may possibly duplicate the guidelines in the Australian Code for the Responsibile Conduct of Research.  According to information about the revised Code, there are plans to develop a Better Practice Guide on 'Research Data Management'.  Is the revised National Statement planning to cross reference these Guides also?

 

General Comments
Comments: 

General Comment

The restructuring of information in terms of "elements" is great.  The proposed elements follow the research project lifecycle, and we think this will be beneficial.

However, adopting the new "elements" strategy creates significant overlap between sections 2 and 3.  The old Section 2 could now be merged into the new Section 3.

Risk and Benefit (of Section 2) should be added as one of the elements (in Section 3).  In all cases, the information can be merged.

This merging would remove overlaps and improve readability.

Comment about the identifiability of genomic data

These two sections on pages 17 (3.1.44) and 25 (chapter 3.5: Genomic research - introduction) are prima facie inconsistent:

"p 17 - With advances in genomic knowledge and data linkage and the proliferation of biobanks, biospecimens and, in some cases, the data associated with them should always be regarded as, in principle, re-identifiable."

"p 25 - As a general principle, research including genomics will require review by an HREC; however, if non-identfiable information is used and no linkage of data is planned, the research may be determined to carry low risk."

We would like an example of non-identifable genomic research that would count as low risk.  Possibly, an example is offered on p.25:

"....a population survey of perferences regarding disclosure of genomic information where survey results are non-identifiable."

This is an example of research that asks questions about genomic research, and probably not an example of genomic research itself.  In any case, further clarity is needed about whether genomic research is always re-identifable, or whether there are exceptions.  If there are exceptions, criteria for such exceptions would be very helpful.

Page reviewed: 10 July, 2018