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Review of the Australian Code for the Responsible Conduct of Research Submission

ID: 
17
Personal Details
This submission reflects the views of
Organisation Name: 
General Ethical Issues S-C of Alfred Hospital EC
Specific comments
Specific comments: 
Preamble in Code
  • Excellent preamble.  We agree that moral leadership and an institutional culture of honesty and integrity are critical.

Principles in Code
  • Useful summary of the key features of responsible research conduct.

Responsibilities for Institutions in Code
  • R1: [research culture and environment that supports researchers in ethical and responsible conduct] In animal research there seems to be greater knowledge about, and commitment to, research ethics and responsible research conduct.   While this could, in part, be due to the greater vulnerability of animals it does also demonstrate that a robust culture of awareness and responsibility is achievable.

  • R3: [providing training] Researcher and administrator training is an ongoing challenge for many institutions, not only cost but also the availability of suitable programs particularly in the non-clinical trial area.

  • R7: [storage and management of research data, records, etc] This is an area in urgent need of systematic guidance, particularly in the area of electronic data.  Standard operating procedures would be a great help.  The focus has been largely on data security; however, it is equally important to be able to access and find data when needed (proper curation, indexing system, systematic filing, etc).  Researchers should plan ahead and provide more detail about this up-front (e.g. in their ethics applications).

  • R9: [receive concerns or complaints about breaches] It is somewhat unfortunate that the Code places breaches in a ‘concerns and complaints’ framework.  Many unintended and more minor breaches are self-reported (e.g. as protocol deviations, or simply appealing to the ethics/research governance office for advice and assistance in rectifying an error).  It is not clear where (or whether) this self-reporting fits into a concerns/complaints framework. Self-reporting is something that should be encouraged and is in keeping with the ‘open disclosure’ approach used in other contexts such as medical errors.  Treating breaches as complaints/concerns works against this and potentially against the principle of honesty in research conduct [R13].

  • R9: As mentioned below, the spectrum of breaches takes in those that are potentially very minor and could be dealt with quickly and directly without having to enter the process set out in the Guide. Without resorting to a ‘binary’ (major breach/minor breach) approach rather than taking a ‘spectrum’ approach to breaches (which we support), there needs to be a prior step to catch the really trivial concerns before entering the process proper.  More serious grievances need to be identified so that investigative processes are not flooded with minor issues.  An additional issue is whether to record/document breaches at the most minor end of the spectrum rather than simply dealing with them.  Do we really want a whole heap of records to clutter the system?

  • R9: ‘Concern’ and ‘complaint’ are not defined; the inclusion of definitions should be considered.

  • R10: [Research Integrity Advisors] These need to be available, senior and trusted.

  • R11: The meaning of the last sentence is unclear. [“Findings are to be made on the balance of probabilities.”]  The definition of the term “Balance of probabilities” provided on p.5 is not sufficiently helpful.

Responsibilities for Researchers in Code
  • R24: [guidance and mentorship by researchers] This is an important and valuable responsibility for senior staff.  We believe a Guide on supervision is needed and should be a ‘priority area’.  We suggest that the Guide include a recommendation that institutions make explicit mention, in position descriptions and employment contracts, of expectations and roles regarding research. 

  • R28: [reporting suspected breaches to institution/authority] The comments on R9 above are also relevant here.  If this ‘responsibility’ also encompasses self-reporting, this needs to be made clearer.

Definitions in Code
  • Breaches: some simple examples or a brief sentence describing the spectrum would be helpful.

  • As per comment on R9 above, definitions of ‘concern’ and ‘complaint’ should be considered.

Guide Section 3
  • On the whole, the Guide provides helpful and workable advice.

  • 3.2: [Extent: breaches occur on a spectrum] As per comments on R9 above, we have concerns about framing breaches in a ‘complaints’ context, and the efficient and proportionate management of departures from the Code that are at the minor end of the spectrum.

Guide Section 6
  • 6.5: [Summary] It would be helpful if the acronyms in the table were replaced with the full term.

Guide Section 7
  • 7.6: [Mechanisms for review of an investigation] As per the response to Q.6 below, more information is needed in this section between paragraph 1 and 2 about ARIC (Australian Research Integrity Committee): How ARIC relates to review of an investigation – what kind of review system does ARIC provide, when and how ARIC would become involved in an appeal – needs to be explained.

Guide Appendix 1

We have no specific comments on Appendices 1-3.

Specific consultation questions
Question 1: Do you like the new approach to the Code, namely the principles-based document being supported by several guides that provide advice on implementation?: 
• We support the principles-based approach and think the revised Code is an excellent document that is largely workable.
Question 2:The draft Code is intended to be used by all research disciplines. Do the principles adequately capture the expectations for responsible research across all research disciplines?: 
• The principles-based approach makes the document more easily applicable to a wide range of research disciplines and provides a good general foundation.
Question 3: The draft Guide refers to breaches of the Code rather than providing a definition of research misconduct, and states that institutions can decide whether or not to use the term research misconduct in their own processes.: 
• The term ‘research misconduct’ implies a degree of conscious and deliberate deviation from good research conduct, and is more pejorative. We therefore agree that the term ‘breach’ is more neutral and lends itself to being applied more broadly. • The continued use of the term ‘research misconduct’ at a local level, with idiosyncratic and varying definitions, may be unhelpful – particularly with the current trend towards streamlining ethics and governance processes. However, if the final guidance does continue to suggest that institutions make their own decisions about using the term, some examples of commonly accepted definitions might help to avoid too much confusion. A more detailed background to the decision not to use or define the term ‘research misconduct’ would also have been useful to include in the supporting documents. • In terms of the guidance being implementable, we have some concern about the very broad applicability of ‘breach’ which encompasses minor or trivial deviations from good research practice. Issues at the ‘trivial’ end of the spectrum could take time and attention away from less frequent but more serious breaches.
Question 4: Do you think the process described for investigating and managing potential breaches of the Code is clearly described and practical?: 
• We have some concern that in large organisations the process involves too much escalation too high up the ‘tree’ too quickly. While this is appropriate for breaches at the more serious end of the spectrum, it is ‘overkill’ for less serious breaches.
Question 5: The Code Review Committee and working group are considering what additional resources should be developed to support implementation of the Code and Guide.: 
• Yes, case studies or vignettes would be very useful.
Question 6: Are the mechanisms for review of an investigation clearly and correctly described in Section 7.6 of the Guide? If not, where are the inaccuracies?: 
• We found this section somewhat confusing and thought there needed to be more information between paragraphs 1 and 2. How ARIC relates to review of an investigation – what kind of review system does ARIC provide, when and how ARIC would become involved in an appeal – needs to be explained.
Question 7: Please comment on which three topics you would nominate as being the highest priority and why.: 
• We agree that data management (with specific guidance on the systematic storage of electronic records) is much needed and is a priority for one of the next two Guides. • Our suggestions for 3 priority areas for additional Guides are: 1. Supervision 2. Strategies to encourage compliance with the Code 3. Intellectual property and copyright.
General comments
Comments: 
  • No additional comments.

Page reviewed: 17 September, 2018