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

ID: 
53
Personal Details
This submission reflects the views of
Organisation Name: 
Australian Academy of Health and Medical Sciences
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, we 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. The Code will not only serve as a guide for individuals and institutions, every word will also be examined in detail by lawyers who will exploit any ambiguities or imprecisions for the benefit of their clients, so it is important that it is clear, explicit, and unambiguous.
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 (we 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.: 
A definition of misconduct is required, and institutions should not be able to define misconduct themselves. Without a generally accepted definition of misconduct there will be two major problems: 1) confusion because people will use the word “misconduct” to refer to different things; 2) institutions will find it easy to white-wash all misbehaviour because there were no findings of “misconduct”. It appears that the reason the word “misconduct” is to be dispensed with is because it “ has been problematic in its application to an investigation outcome and findings, particularly in relation to enterprise agreements and current approaches to the management of behaviours that may require corrective action.” This suggests what needs to be corrected is the management of misconduct at a particular institution, rather than removing the term “misconduct” from a national policy on managing misconduct.
Question 4: Do you think the process described for investigating and managing potential breaches of the Code is clearly described and practical?: 
All investigations that are contested, and have the potential for return of funding, or retraction of publications, or dismissal, should be conducted by panels entirely composed of independent, external members. The processes are reasonably described (but see some points below). However, investigations are often not properly done in our experience when they are conducted and resourced by an NHMRC/ARC administering institution because of inevitable conflicts of interest. 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 our view that major investigations should not be conducted by the administering institution but by an external organisation.
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 would help establishment of a culture of good practice, but the emphasis should be on how and where to obtain advice, e.g. from research integrity advisors. Training research integrity advisors and a pool of potential members of investigatory panels should be a priority. Until a national office of research integrity or ombudsman is established, the NHMRC should keep a list of experienced and qualified people who could serve as external panel members. Each institution and the national academies could be asked to nominate people to serve when required. 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 we appreciate it may raise 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. Advice must be provided so that cases can be appealed based on evidence, not just process.
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 publication is necessarily commendable. The use of a standardised authorship statement, in which the contribution of each author is briefly listed, as is required by some journals and institutions should be encouraged if not mandated. Second, the topic of ‘conflict of interest’ is poorly understood and a topic on which public opinion is rightly becoming stronger. Hence, 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.
General comments
Comments: 


Introductory remarks

These are comments on the draft new Code and Guide to Investigating and Managing Potential Breaches of the Code written on behalf of the Australian Academy of Health and Medical Sciences.

We see the revised Code and Guide as major steps forward, and we welcome the opportunity to provide constructive comments for their further improvement.

We have included (below) a summary and recommendations; comments on each of the draft documents (not only the Code and the Guide, but also the revised “misconduct policy related to funding”, the three Fact Sheets, “Frequently asked Questions”); and answers to the specific consultation questions.

 

Summary and Recommendations

Critical outstanding requirements are:

  1. an agreed definition of  “misconduct”
  2. a mechanism for increased oversight
  3. a mechanism to prevent institutions from carrying out all processes internally
  4. mechanisms for appeal that can consider evidence, not just process
  5. a process for training of scientific integrity advisors and potential investigatory panel members

As currently written, the Code and Guide would allow institutions to come up with their own 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.” We anticipate this will cause confusion, as different institutions come up with different definitions, even if this is not a requirement of institutions. Furthermore, the word “misconduct” appears many times in many guidelines and Fact Sheets from the NHMRC.

We therefore suggest defining misconduct as “a deliberate breach, or repeated breaches, of the Code”.

(We do acknowledge that like breaches, misconduct will occur along a spectrum of seriousness. If there is something in Enterprise Bargaining Agreements that prevents or limits misconduct investigations, then the relevant terms should be quoted so that we know what we’re dealing with.)

The draft Guide makes inclusion of any independent, external investigatory panel members optional, and leaves this to the discretion of the Designated Officer. We see this a major flaw, as having any internal investigatory panel members will necessarily lead to conflicts of interest.

A recommendation to be considered is that where cases are contested, and potentially involve retraction of papers, or return of grant funds, or termination of employment, investigatory panels should be entirely composed of independent external panel members.

Note that the Academy does not have a consensus view on whether panels must always be fully comprised of external representatives, or under what circumstances it would not be necessary.  Arguments in favour and against of independent external panels include:

   Pro:

  • avoids internal cover-ups
  • avoids conflicts of interest
  • ensures procedural integrity if there is a sufficiently senior and qualified chair
  • in the interests of a person under investigation, if they are at conflict with their organisation
  • recommended from past experience of problems (e.g. Hall affair).

   Con:

  • takes more time
  • may cost more 
  • less ability to control leakage during the process that could be damaging to the person under investigation and their institution

 Although the Code mentions 12 responsibilities of institutions, the Guide mainly focuses on handling of allegations of breaches of the Code by individual researchers, and does not say how potential breaches of the Code by institutions can be reported or how they will be handled. We recommend that the Guide also explains what should be done if an institution does not fulfil its responsibilities, and what penalties would be imposed if it breaches the Code, and therefore does not comply with its funding agreement.

We believe that a mechanism should be established to that appeal can be made that are based on evidence, not only based on process (as is currently the case with ARIC).

To improve transparency, we recommend that procedural fairness be extended to the complainant (as well as the person accused), so that they are informed not only of the outcome of an investigation, but also the justification for it. Where necessary, they could also be asked to sign confidentiality agreements.

We suggest that the Guide explains where exceptions to procedural fairness can or should be made (for example where patient safety or animal welfare are at risk, or large amounts of public funding are involved).

Rather than saying that the principles of procedural fairness are applied “during the preliminary assessment”, and “the principles of procedural fairness must always be applied”, it would be better to indicate which aspects of procedural fairness should be applied at each stage. For example, a key aspect of procedural fairness is the ability to see the evidence, and to rebut arguments. However, if the accused person is to be shown the evidence throughout the preliminary assessment phase, even before it is considered by the investigatory panel, processes will inevitably be delayed.

We believe these issues of procedural fairness can and should be addressed by re-writing those sections of the Guide, and in training of research integrity officers and panel members, so that not only the rights of the accused and complainant are considered, but also other stakeholders, such as patients, colleagues, animals, the scientific community and research funders.

We advocate establishment of a national office or ombudsman for research integrity, recognising that this needs to be adequately resourced without diverting research funding. Until this is established, we recommend that the NHMRC composes and maintains a list of potential qualified, experienced, investigatory panel members. We recommend that the NHMRC gives them training. This would make it easier for institutions to carry out proper and thorough external investigations.

We recommend that the NHMRC also provides training for research integrity advisors, and when cases arise, a research integrity advisor is appointed to assist the person accused, as well as the complainant.

We have also commented on the Fact Sheets, but we understand they will have to be substantially re-written in the context of the revised Code and Policy.


Comments on each document

1. Draft guide to investigating and managing potential breaches (draftguideforpcfinal.pdf)

General

This document, and all of the others, must use the word “misconduct”, and must give a definition. If an institution fails to live up to its responsibilities, is that “misconduct”?

If investigations are to only find if “breaches” have occurred, and not whether misconduct has occurred, too much power rests with the institution, which will necessarily be conflicted, and have an incentive to find that there was no misconduct.

The stage at which “procedural fairness” needs to be invoked, exceptions, and fairness to complainants needs to be more explicit.

Specific

pg 2  Should note that institutions that do not comply with the Code are in breach of the Funding Agreement

pg 4  Making each institution choose whether or not to use the term “misconduct”, and if so to come up with their own definition, will lead to confusion, and weaken the Code. In addition, several of the other NHMRC draft documents use the terms “misconduct” and “research misconduct”. Consistency from the NHMRC is needed.

pg 4  The extent of the effects of the potential breach on third parties is not very important – if results are fabricated, whether they turn out to be correct is not important. The term “significant departure” needs to be defined.

pg 4  Box 1.  ‘The extent to which the principles ...’  This implies a partial ‘breach’. The behaviour is wrong or not wrong.  There may be extenuating circumstances which would impact on the REO’s actions.

pg 5  “Distortion of visual presentation of data” is vague and does not sound minor. We suggest “Cropping out cross reactive bands on a blot”. Rather than “Authorship not given to someone who appropriately contributed to research”, “Authorship not given despite substantial intellectual contribution to research.” Where there are major breaches, all members of an investigation panel should be external. Add an example related to false statements in grant applications, and suspension, removal, or return of grant funds.

pg 6  “Confidential Information should not be shared unless required.” This is unclear and seems to contradict the requirement for transparency. Not 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. For procedural fairness, the complainant and the person accused should be provided with detailed evidence and reasoning behind findings. If necessary and in exceptional circumstances they could be asked to sign confidentially agreements.

pg 7  Figure 2 The roles of the REO, RIA, RIO, DO, AO etc. should be outlined. ‘Next step based on response, evidence and complexity’.   Add ‘seriousness’.

pg 8  It would be difficult to staff all of these roles in small universities and medical research institutes.

pg 9   ‘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 proven in court.  This avenue is appropriate to consider when the public purse is funding the research.

pg 10  If all decisions and reasons are to be documented, there should be guidance as to who will have access to this documentation.

pg 10  5.2: ‘As complaints arise…’  This sentence is unclear.

pg 10  5.2: ‘The process of making a complaint…’  We suggest expanding this section to give more explanation, e.g.:

  • What information should be provided, and in what form, to enable a preliminary assessment.

The process of making a complaint should not be onerous, and it is not the responsibility of the complainant to provide all of the necessary material to reach a conclusion, nor is the complainant responsible for identifying parts of the Code or relevant policy that may have been breached. Nevertheless, the complainant must be willing to cooperate with institutional officials to construct a complaint that can be handled optimally. For example, the scientific integrity advisor could assist the complainant formulate their complaint, and advise how it should be lodged. They could advise if complaints or parts of complaints might be better directed to the police (e.g. fraud) or to HR (e.g. bullying) rather than through the research integrity process. The scientific integrity advisor might also be able to tell the Designated Officer or Assessment Officer what evidence needs to be secured, e.g. computer hard drives, email communications, films.

pg 11  Guidance on communication with complainant would be helpful, e.g. recommend providing updates on a monthly basis.

pg 12  In applying procedural fairness, it is important that the person accused ultimately has the ability to hear and comment upon all evidence used against them, but at several places in this document, it says procedural fairness should be applied at all times. This could be interpreted as implying that the accused person needs to be present as the evidence is obtained, which would interfere with the investigation.

It is excellent that the Latin term “prima facie” has been removed!

The AO should consider contacting and interviewing all co-authors on contested publications or other research outputs (e.g. conference papers, patents etc).

The use of “investigation”, “assessment”, “preliminary assessment”, “investigation”, “further investigation” needs to be tidied up. What is the difference between gathering, securing and interpreting evidence, and an investigation?

pg 12  Delete ‘disciplinary’ between ‘specific’ and ‘practice’ (mid page)

pg 13  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).

pg 13  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 on 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.

pg 14  To apply all the principles of procedural fairness (e.g. the right to be heard) at the preliminary assessment stage would be unworkable.

pg 15  The principles of procedural fairness can be bypassed where human safety, animal welfare, or large amounts of funding might be compromised.

pg 15  We suggest adding a recommendation to anticipate extending or changing the terms of reference if the investigation uncovers further potential questionable practices. There must be provision for changes to the terms of reference.

pg 15  Justification should be given for not having an entirely external independent panel

pg 15  3 lines from the bottom:  ‘follow the procedures of the investigation’.  This should be made more specific or else it is unhelpful.

pg 16  The investigatory panel must give the complainant the opportunity to be heard, if they wish to be.

pg 16  “Legal counsel should not be engaged…” This is too vague.

Guidance should be provided as to if and or when all of the authors on a questioned publication should be interviewed.

The guide is not consistent about whether or when a ‘support’ person is allowed.  They should always be allowed at an investigation.  Further, we have no problem with the person being legally trained provided they do not say one word.

pg 17  First paragraph:  This is a good point and should be emphasised, perhaps in the initial terms of reference or letter to panel members.

pg 17  The draft report should also be given to the complainant for comments.

pg 17  “The institution is responsible for ensuring the public record is corrected.” What can/should be done if the institution fails to correct the public record?

pg 18  ARIC can only look at processes, and cannot consider the merits of a case. There must be an avenue for appeal based on evidence. Australia needs a national body such as an office or an ombudsman that can provide oversight, advice, and a mechanism for appeal that can consider evidence and not just process.

 

2. The Australian code for the responsible conduct of research (draftcodeforpcfinal.pdf)

General

This is a great improvement.

Specific

pg 3  Good to see responsibilities of institutions listed explicitly, and mention of accountability to funding organisations.

R11 patient safety, animal welfare, and large amounts of public finding should take priority over procedural fairness.

Suggested R13 Manage conflicts of interest

pg 4  R23 What is “significant”? Suggest using the word “substantial”.

pg 5  A definition of misconduct is necessary, because that is the term everyone uses (including the NHMRC – see fact sheets). How about “a deliberate breach, or persistent breaches, of the Code”?

 

 [NHMRC has removed information that is not within the scope of the public submission request]

 

Page reviewed: 17 September, 2018