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Draft Policies for NHMRC Committees and Working Groups Developing Guidelines Submission

ID: 
20
Personal Details
First Name: 
Melissa
Last Name: 
Raven
E. Submission
Submission options: 
Section 1 – Policies Document
Section 2 – Key Elements and Flow Chart
Section 1 – Policies Document
1. Are there any gaps in the issues addressed in this document?: 

Yes.

One very important omission is the issue of institutional links and potential COI. Personal/career commitment is also omitted, as is unpublished negative findings (apart from a brief mention in the background). See section 4.

2. Does the document strike the right balance between ensuring adequate expertise is available to be deployed on the committee and creating a framework to ensure conflicts are managed appropriately? : 

No.

It needs to be recognised and acknowledged that many medical experts have gained that status largely on the basis of industry-funded research.

It is good that clause 1.2.4 clearly states that:

Typically, expertise will coexist with interests and involvement in the topic and personal circumstances that need to be declared.

However, it needs to be acknowledged that the dominance of industry funding tends to bias research and clinical practice, and career orientations of ambitious academics and clinicians, towards pharmaceutical (and medical device) interventions.

There may be much less prominent researchers and clinicians with expert knowledge but not expert status (partly because of not receiving industry funding), and where possible such people should be recruited as group members.

Also 'adequate expertise' should be broadened to explicitly include at least one methodological expert (e.g. an epidemiologist, or someone who has a strong background in evidence-based medicine at a meta-level) who does not have in-depth knowledge of the focus of the guidelines and therefore can bring fresh eyes to the evidence and issues. [Here I should declare that I am an epidemiologist, and therefore potentially biased in my opinion of the importance of epidemiology.] See also my comments on personal/career commitment in section 1, number 4.

In situations in which the pool of experts is relatively small, it is particularly crucial for guideline groups to include at least one such participant

3. Do you have any suggestions for further guidance on matters to be declared?: 

Yes.

I believe that appropriate disclosure of potential COIs requires two related categories of disclosure:

1. All relevant links, to be declared matter-of-factly (having links is not in and of itself problematic; not declaring them is very problematic).

2. Links that the member believes may constitute, or be perceived to constitute, COI, and the member's assessment of the actual or perceived COI.

Although it is not possible to provide an exhaustive list of potential conflicts of interest, it is crucial that the list be more comprehensive.

Furthermore, the draft guidelines currently contain two potentially conflicting lists: 1.4.2 and 1.5.2. This increases the likelihood of subjective interpretation. There should only be one list.

4. Is there anything that should be declared which has not been included in this section?: 

Yes.

Several important (potential) types of COI are omitted:

1. Funded chairs or other academic posts

Funded chairs or other academic posts should be explicitly included in the list of links to be declared.

2. Institutional links and potential conflict of interest

There are many instances in which individual researchers have no personal COI, but their departments/institutions have strong links with relevant pharmaceutical companies and medical device manufacturers etc. This is often the case for relatively junior researchers, who would be less likely to be appointed to expert working groups, but it can also apply to senior researchers.

It is naïve to think that financial links of colleagues, and particularly superiors, could not constitute COI.

3. Personal/career commitment

Experts have long-term and deep personal/professional interests. Although the importance of financial COI is widely recognised, there has been a serious lack of recognition of the importance of non-financial COI such as decades-long investment in research and clinical practice (with or without ideological commitment).

McLaughlin et al. 2011 (emailed) recently expressed this forcefully in relation to monograph working groups of the International Agency for Research on Cancer:

'We have argued that in restricting conflict of interest concerns to only financial issues, IARC cannot see the elephant in the room. IARC working groups are composed of investigators from various fields. In our field of epidemiology, the area of research given the most weight in IARC decision making, the working group is often composed of researchers who have a strong, if not lifelong interest in the potential carcinogenicity of the exposure under consideration. As Erren correctly points out, the IARC Working Group Preamble makes clear that members will be chosen because of this qualification. To argue that researchers who have spent years publishing on the possible carcinogenicity of an exposure are the best judges of the validity and methodological soundness of their own and allied work strikes us as naive, if not anti-scientific. They are clearly not disinterested evaluators of the research evidence being considered, as much of it represents their own work.'

McLaughlin JK, Boffetta P, La Vecchia C, Lipworth L, Blot WJ, Tarone RE. Problems with IARC's 'expert' working groups Int. J. Epidemiol. (2011) doi: 10.1093/ije/dyr158 First published online: November 16, 2011

NB: The word 'prejudice' in 1.4.1 b. is problematic. No-one will declare a prejudice. It should be expressed in term of potentially being perceived as prejudice.

4. Unpublished negative findings

These are brief mentioned in the background, but are not included in the list of COIs that should be disclosed. Any relevant unpublished negative findings should be disclosed.

5. Is the amount to trigger a declaration of interests reasonable?: 

No.

There should be no level below which interests do not need to be declared, nor any time limit. This will reduce potential criticism about undeclared interests. However, minor disbursements should not be required to be declared in detail.

Section 2 – Key Elements and Flow Chart
1 - Are there any gaps in this section in relation to the guidance for the responsible Senior Officials at the Office of NHMRC to apply their judgement in how to manage any conflicts?: 

Yes.

Some things are unclear.

Will the meeting of potential group members to discuss disclosures also include NHMRC staff? I think this is important, e.g. for clarification of policies, terminology etc. Also, if no NMHRC staff participate, it is possible that this meeting might generate unhelpful 'group-think'.

On what basis will prospective chairs of groups (mentioned in 2.1.2) be selected?

1.5.1 a. should say 'consider whether or no there are factors that may adversely affect….'

2. Is the flow chart an adequate representation of the proposed process?: 

If NHMRC staff will participate in the meeting of potential group members, the flowchart box should be amended to reflect this.

NB: There is a typo in point 3: 'the real' should be 'be real'.

Page reviewed: 5 November, 2012