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

Personal Details
First Name: 
Last Name: 
Specific comments
Specific comments: 
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?: 
In general, I think that this approach is sensible provided that each of the individual guides is clear and provides practical advice on dealing with often complex issues. See also points below.
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?: 
Yes the principles appear to be clear across disciplines. It is likely that those needing to use any Code and its Guides should be familiar with NHMRC/ARC principles and with local institutional principles. Further care should be given to dealing with multi-institutional issues (I note section 8), the role of inter-institutional legal agreements, enterprise-bargain agreements, and agreements with overseas entities.
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.: 
I appreciate the difficulties with the definition of behaviour which is not ‘acceptable’. However, the lack of direction on what constitutes serious misbehaviour is a deficiency. It is easy to be soft on this problem and to avoid it (‘misconduct’), but ultimately decisions will be made by the ‘Responsible Executive Officer’ (and even the ‘Designated’ and ‘Assessment’ officers) depending on the seriousness of the misbehaviour. Ultimately it is a cop out to use a ‘slider’ scale of seriousness without saying that certain behaviours are simply dishonest and clear misconduct and those perpetrating these actions should be dealt with accordingly. Hence, I do not believe that the proposed Code is easy to implement. Where will each institution position the slider for their own staff? How will this advance the implementation of higher levels of research integrity across the country and indeed the world. Hence I am worried that the current Code and Guide allows institutions to generate their own local definitions of misconduct: “Institutions may determine whether to include a definition of research misconduct in their own processes to describe breaches of the Code, or they may prefer to refer only to breaches, consistent with this Guide.”
Question 4: Do you think the process described for investigating and managing potential breaches of the Code is clearly described and practical?: 
The process is reasonably described (but see some points below). However, investigations are often not properly done in my experience when they are conducted and resourced by an NHMRC/ARC administering institution. The institutional response is not infrequently one of deliberate obfuscation, improper process, and a lack of transparency. In many investigations the ‘administering institution’ has much to lose in both funding and perhaps also reputation. Hence, the institution can be conflicted, sometimes at a very high level. This motivates my view that major investigations and all appeals should not be conducted by the administering institution but by an external organisation. This could be a specific ombudsman or office of research integrity. Such offices are present in many countries, including Denmark, Sweden, the Netherlands, USA, and Germany.
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, explicit case studies can be useful (as occurred for iterations of Human Research Ethics Committee guidelines). Training of all health and medical researchers from an early career stage is vital to establishment of a culture of good practice. Note that the insistence on confidentiality at all times has the negative effect of hiding the actual process, the actual results and outcomes. It does not give any support to the genuine ‘whistle-blower’. The issue of the ‘whistle-blower’ should be considered explicitly in the Guide, although I appreciate it raises further legal issues.
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?: 
No, this is unclear and peremptory. Yes, it is appropriate to describe the role of the Australian Research Integrity Committee (ARIC) but because it is only able to comment on process. The avenue for a proper ‘retrial’ is not clear enough. As indicated above this should involve an external office.
Question 7: Please comment on which three topics you would nominate as being the highest priority and why.: 
First, the sooner the Guide on authorship is drafted the better. It is a seriously contentious issue, not easily resolved, and driven by the ‘bean-counting’ mentality that more publications is necessarily commendable. Second, the topic of ‘conflict of interest’ is poorly understood and a topic on which public opinion is rightly becoming more strong. In that vein, the idea that a university can investigate say multiple infractions by a senior scientist who may have patents, grants etc that directly benefit the university is problematic if not also unethical. Third, I propose that the role and training of research integrity advisors be tackled. The quicker we have sensible advisors on the ground in institutions doing research the better.
General comments

The definition of research should be broadened.  There is a major issue with the lack of reproducibility in health and medical research. Hence studies that seek to reproduce published findings should also be considered ‘research’.  Furthermore, I contend that funding or performing underpowered research is itself unethical.

The issue of procedural fairness.  The concept of fairness should be extended to include not only the rights of the accused and complainants, but potentially also others, such as patients, colleagues, animals, the scientific community and research funders.

  • P3: Misrepresentation of research data: this is too vague.
  • P3: Authorship: the use of a standarised authorship statement would be beneficial.  This is required by some journals and institutions.
  • P4: Box 1.  ‘The extent to which the principles .. (my emphasis)’  Surely you cannot allow a partial ‘breach’. The behaviour is wrong or not wrong. There may be extenuating circumstances which would impact on the REO’s actions.
  • P6: ‘vi’ I am not convinced that all aspects of an investigation should remain confidential. For example, once an investigation is concluded, there is an argument that the skeleton information be revealed.
  • P7: Figure 2.  ‘Next step based on response, evidence and complexity’.  I would add ‘seriousness’
  • P9: ‘Corrupt conduct…’  It may help to have a simple definition of corrupt conduct. There have been key cases, including in Australia, in which corrupt conduct has been found formally in court. This avenue is appropriate to consider when the public purse is funding the research.
  • P10: 5.2: ‘As complaints arise…’  This sentence is unclear.
  • P10: 5.2: ‘The process of making a complaint…’  This section is not clear enough. I believe it is reasonable to ask a complainant (perhaps with an advisor) to state which parts of the Code and relevant policies have not been adhered to.
  • P12:  delete ‘disciplinary’ between ‘specific’ and ‘practice’ (mid page)
  • P13: a practical difficulty in these cases is locking down the electronic, lab book and other data. While it is burdensome, the earlier this happens the better (and this can be hard to foresee).
  • P13: When a person complained about resigns, it is right to complete the investigation. But, this is an example of when the existence of an investigation and its outcomes should not remain confidential.  It must be passed at least to new employers of the person. If this does not happen, the whole procedure is ‘toothless’ in dealing with someone who has seriously misbehaved.
  • P15: 3 lines from the bottom. ‘follow the procedures of the investigation’. This should be made more specific or else it is unhelpful.
  • P16: 7.3: the guide is not consistent about whether a ‘support’ person be allowed. They should always be allowed at an investigation. Further, I have no problem with the person being legally trained provided they do not say one word.
  • P17: First paragraph.  This is a good point and should be emphasised, perhaps in the initial terms of reference or letter to panel members.
  • P18: 7.6 The role of ARIC has been mentioned above. An external umpire with more power should be used. 

Simon Gandevia FAA FAHMS FRACP

January 2017

Page reviewed: 17 September, 2018